Leader Childrens Ibuprofen

Generic Name: ibuprofen

Dosage Form: suspension
Cardinal Health Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache


• reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives


• facial swelling


• asthma (wheezing)


• shock


• skin reddening


• rash


• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if the child:

• has had stomach ulcers or bleeding problems


• takes a blood thinning (anticoagulant) or steroid drug


• takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)


• takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer


• right before or after heart surgery

Ask a doctor before use if the child has

• problems or serious side effects from taking pain relievers or fever reducers


• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain


• ulcers


• bleeding problems


• not been drinking fluids


• lost a lot of fluid due to vomiting or diarrhea


• high blood pressure


• heart or kidney disease


• taken a diuretic

Ask a doctor or pharmacist before use if the child is

• taking any other drug containing an NSAID (prescription or nonprescription)


• taking a blood thinning (anticoagulant) or steroid drug


• under a doctor’s care for any serious condition


• taking any other drug

When using this product

• give with food or milk if stomach upset occurs


• long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

• the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.


• stomach pain or upset gets worse or lasts


• the child does not get any relief within first day (24 hours) of treatment


• fever or pain gets worse or lasts more than 3 days


• redness or swelling is present in the painful area


• any new symptoms appear

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• this product does not contain directions or complete warnings for adult use


• do not give more than directed


• do not give longer than 10 days, unless directed by a doctor (see Warnings)


• shake well before using


• find right dose on chart below. If possible, use weight to dose; otherwise use age.


• use only with enclosed measuring cup


• if needed, repeat dose every 6-8 hours


• do not use more than 4 times a day


• replace original bottle cap to maintain child resistance


• wash dosage cup after each use

Dosing Chart
Weight (lb)	Age(yrs)	Dose (teaspoonful or mL)
under 2 years		ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

Other information

• do not use if printed neckband is broken or missing


• store at 20-25°C (68-77°F)


• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

1-800-719-9260

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Compare to Children’s Motrin® active ingredient

For Ages 2 - 11

Children’s

Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Lasts Up to 8 Hours

Berry Flavor

Alcohol Free

Children's Ibuprofen Oral Suspension Carton

Leader Childrens Ibuprofen  ibuprofen  suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 37205-643 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score      Shape Size Flavor BERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 37205-643-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (37205-643-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	01/28/1999

Labeler - Cardinal Health (097537435)

Revised: 11/2009Cardinal Health

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Ampicillin and Sulbactam Injection

Dosage Form: injection, powder, for solution
Ampicillin and Sulbactam for Injection, USP

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Ampicillin and Sulbactam Injection Description

Ampicillin and sulbactam for injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration.

 

Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R) - 6 - [(R) - 2 - amino - 2 - phenylacetamido] - 3,3 - dimethyl - 7 - oxo - 4 - thia - 1 - azabicyclo[3.2.0]heptane - 2 - carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:

Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:

Ampicillin and sulbactam for injection parenteral combination, is available as a white to off-white, crystalline powder for reconstitution. Ampicillin and sulbactam for injection crystalline powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10.

 

Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same.

 

Each 1.5 g vial contains: 1.5 g of ampicillin and sulbactam for injection (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). The sodium content per vial is 115 mg (5 mEq).

 

Each 3 g vial contains: 3 g of ampicillin and sulbactam for injection (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). The sodium content per vial is 230 mg (10 mEq).

Ampicillin and Sulbactam Injection - Clinical Pharmacology

General

Immediately after completion of a 15 minute intravenous infusion of ampicillin and sulbactam for injection, peak serum concentrations of ampicillin and sulbactam are attained. Ampicillin serum levels are similar to those produced by the administration of equivalent amounts of ampicillin alone. Peak ampicillin serum levels ranging from 109 to 150 mcg/mL are attained after administration of 2000 mg of ampicillin plus 1000 mg sulbactam and 40 to 71 mcg/mL after administration of 1000 mg ampicillin plus 500 mg sulbactam. The corresponding mean peak serum levels for sulbactam range from 48 to 88 mcg/mL and 21 to 40 mcg/mL, respectively. After an intramuscular injection of 1000 mg ampicillin plus 500 mg sulbactam, peak ampicillin serum levels ranging from 8 to 37 mcg/mL and peak sulbactam serum levels ranging from 6 to 24 mcg/mL are attained.

 

The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers.

 

Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration of ampicillin and sulbactam for injection to individuals with normal renal function. Somewhat higher and more prolonged serum levels of ampicillin and sulbactam can be achieved with the concurrent administration of probenecid.

 

In patients with impaired renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin (see DOSAGE AND ADMINISTRATION).

 

Ampicillin has been found to be approximately 28% reversibly bound to human serum protein and sulbactam approximately 38% reversibly bound.

 

The following average levels of ampicillin and sulbactam were measured in the tissues and fluids listed:

TABLE A Concentration of Ampicillin and Sulbactam for Injection in Various Body Tissues and Fluids

Fluid or Tissue	Dose (grams) Ampicillin/Sulbactam	Concentration (mcg/mL or mcg/g) Ampicillin/Sulbactam
Peritoneal Fluid	0.5/0.5 IV	7/14
Blister Fluid (Cantharides)	0.5/0.5 IV	8/20
Tissue Fluid	1/0.5 IV	8/4
Intestinal Mucosa	0.5/0.5 IV	11/18
Appendix	2/1 IV	3/40

Penetration of both ampicillin and sulbactam into cerebrospinal fluid in the presence of inflamed meninges has been demonstrated after IV administration of ampicillin and sulbactam.

 

The pharmacokinetics of ampicillin and sulbactam in pediatric patients receiving ampicillin and sulbactam are similar to those observed in adults. Immediately after a 15 minute infusion of 50 to 75 mg ampicillin and sulbactam/kg body weight, peak serum and plasma concentrations of 82 to 446 mcg ampicillin/mL and 44 to 203 mcg sulbactam/mL were obtained. Mean half-life values were approximately 1 hour.

MICROBIOLOGY

Ampicillin is similar to benzyl penicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of cell wall mucopeptide biosynthesis. Ampicillin has a broad spectrum of bactericidal activity against many gram-positive and gram-negative aerobic and anaerobic bacteria. (Ampicillin is, however, degraded by beta-lactamases and therefore the spectrum of activity does not normally include organisms which produce these enzymes.)

 

A wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins have been shown in biochemical studies with cell free bacterial systems to be irreversibly inhibited by sulbactam. Although sulbactam alone possesses little useful antibacterial activity except against the Neisseriaceae, whole organism studies have shown that sulbactam restores ampicillin activity against beta-lactamase producing strains. In particular, sulbactam has good inhibitory activity against the clinically important plasmid mediated beta-lactamases most frequently responsible for transferred drug resistance. Sulbactam has no effect on the activity of ampicillin against ampicillin susceptible strains.

 

The presence of sulbactam in the ampicillin and sulbactam for injection formulation effectively extends the antibiotic spectrum of ampicillin to include many bacteria normally resistant to it and to other beta-lactam antibiotics. Thus, ampicillin and sulbactam for injection possesses the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

 

While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the indications section has not been documented.


Gram-Positive Bacteria

 

Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing), Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing), Staphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing), Streptococcus faecalis1 (Enterococcus), Streptococcus pneumoniae1 (formerly D. pneumoniae), Streptococcus pyogenes1, Streptococcus viridans1.


Gram-Negative Bacteria

 

Hemophilus influenzae (beta-lactamase and non-beta-lactamase producing), Moraxella (Branhamella) catarrhalis (beta-lactamase and non-beta-lactamase producing), Escherichia coli (beta-lactamase and non-beta-lactamase producing), Klebsiella species (all known strains are beta-lactamase producing), Proteus mirabilis (beta-lactamase and non-beta-lactamase producing), Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Morganella morganii, and Neisseria gonorrhoeae (beta-lactamase and non-beta-lactamase producing).


Anaerobes


Clostridium species1, Peptococcus species1, Peptostreptococcus species, Bacteroides species, including B. fragilis.

 

1 These are not beta-lactamase producing strains and, therefore, are susceptible to ampicillin alone.


Susceptibility Testing

 

Diffusion Technique

 

For the Kirby-Bauer method of susceptibility testing, a 20 mcg (10 mcg ampicillin + 10 mcg sulbactam) diffusion disk should be used. The method is one outlined in the NCCLS publication M2-A4.1 With this procedure, a report from the laboratory of "Susceptible" indicates that the infecting organism is likely to respond to ampicillin and sulbactam for injection therapy and a report of "Resistant" indicates that the infecting organism is not likely to respond to therapy. An "Intermediate" susceptibility report suggests that the infecting organism would be susceptible to ampicillin and sulbactam for injection if a higher dosage is used or if the infection is confined to tissues or fluids (e.g., urine) in which high antibiotic levels are attained.

 

Dilution Techniques

 

Broth or agar dilution methods may be used to determine the minimal inhibitory concentration (MIC) value for susceptibility of bacterial isolates to ampicillin/sulbactam. The method used is one outlined in the NCCLS publication M7-A2.2 Tubes should be inoculated to contain 105 to 106 organisms/mL or plates "spotted" with 104 organisms.

 

The recommended dilution method employs a constant ampicillin/sulbactam ratio of 2:1 in all tubes with increasing concentrations of ampicillin. MIC's are reported in terms of ampicillin concentration in the presence of sulbactam at a constant 2 parts ampicillin to 1 part sulbactam.

Recommended Ampicillin/Sulbactam, Susceptibility Ranges*,†,‡

	Resistant	Intermediate	Susceptible
* The non-beta-lactamase producing organisms which are normally susceptible to ampicillin, such as Streptococci, will have similar zone sizes as for ampicillin disks. † Staphylococci resistant to methicillin, oxacillin, or nafcillin must be considered resistant to ampicillin and sulbactam. ‡ The quality control cultures should have the following assigned daily ranges for ampicillin/sulbactam:
Gram(-) and Staphylococcus
Bauer/Kirby	≤11 mm	12–13 mm	≥14 mm
Zone Sizes
MIC (mcg of ampicillin/mL)	≥32	16	≤8
Hemophilus influenzae
Bauer/Kirby	≤19	—	≥20
Zone Sizes
MIC (mcg of ampicillin/mL)	≥4	—	≤2

		Disks	Mode MIC (mcg/mL ampicillin/ mcg/mL sulbactam)
E. coli	(ATCC 25922)	20–24 mm	2/1
S. aureus	(ATCC 25923)	29–37 mm	0.12/0.06
E. coli	(ATCC 35218)	13–19 mm	8/4

Indications and Usage for Ampicillin and Sulbactam Injection

Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.


Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2

 

NOTE: For information on use in pediatric patients see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections.

 

Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2


Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis 2).


2  Efficacy for this organism in this organ system was studied in fewer than 10 infections.

 

While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibiotic.

 

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection.

 

Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.

 

To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of hypersensitivity reactions to any of the penicillins.

Warnings

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE APT TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR HYPERSENSITIVITY REACTIONS TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE THERAPY WITH A PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMPICILLIN AND SULBACTAM FOR INJECTION SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED.

 

SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.


Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ampicillin and sulbactam for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.


C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

 

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

General

A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash. Thus, ampicillin class antibiotics should not be administered to patients with mononucleosis. In patients treated with ampicillin and sulbactam the possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

 

Prescribing ampicillin and sulbactam for injection in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be counseled that antibacterial drugs including ampicillin and sulbactam for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ampicillin and sulbactam for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ampicillin and sulbactam for injection or other antibacterial drugs in the future.

 

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam and allopurinol administered concurrently. Ampicillin and sulbactam and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of ampicillin and sulbactam.

Drug/Laboratory Test Interactions

Administration of ampicillin and sulbactam will result in high urine concentration of ampicillin. High urine concentrations of ampicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest™, Benedict's Solution or Fehling's Solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix™ or Testape™) be used. Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with ampicillin and sulbactam.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential.

Pregnancy

Pregnancy Category B

 

Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. (See–Drug/Laboratory Test Interactions.)

Labor and Delivery

Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. However, it is not known whether the use of ampicillin and sulbactam in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when ampicillin and sulbactam is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of ampicillin and sulbactam for injection have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults. Use of ampicillin and sulbactam for injection in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance. (See CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, and CLINICAL STUDIES sections.)

 

The safety and effectiveness of ampicillin and sulbactam for injection have not been established for pediatric patients for intra-abdominal infections.

Adverse Reactions

Adult Patients


Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported.


Local Adverse Reactions

 

Pain at IM injection site – 16%

Pain at IV injection site – 3%

Thrombophlebitis – 3%


Systemic Adverse Reactions

 

The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients.

 

Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.


Pediatric Patients

 

Available safety data for pediatric patients treated with ampicillin and sulbactam demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin and sulbactam for injection.


Adverse Laboratory Changes

 

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:


Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.


Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.


Blood Chemistry: Decreased serum albumin and total proteins.


Renal: Increased BUN and creatinine.


Urinalysis: Presence of RBC's and hyaline casts in urine.

 

The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with ampicillin and sulbactam.


Gastrointestinal

 

Gastritis, stomatitis, black "hairy" tongue and enterocolitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)


Hypersensitivity Reactions

 

Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with a penicillin. (See WARNINGS.)


Hematologic

 

In addition to the adverse laboratory changes listed above for ampicillin and sulbactam, agranulocytosis has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with ampicillin and sulbactam, as with other beta-lactam antibiotics.

Overdosage

Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.

Clinical Studies

Skin and Skin Structure Infections in Pediatric Patients

 

Data from a controlled clinical trial conducted in pediatric patients provided evidence supporting the safety and efficacy of ampicillin and sulbactam for injection for the treatment of skin and skin structure infections. Of 99 pediatric patients evaluable for clinical efficacy, 60 patients received a regimen containing intravenous ampicillin and sulbactam, and 39 patients received a regimen containing intravenous cefuroxime. This trial demonstrated similar outcomes (assessed at an appropriate interval after discontinuation of all antimicrobial therapy) for ampicillin and sulbactam- and cefuroxime-treated patients:

Therapeutic Regimen	Clinical Success	Clinical Failure
Ampicillin and Sulbactam	51/60 (85%)	9/60 (15%)
Cefuroxime	34/39 (87%)	5/39 (13%)

Most patients received a course of oral antimicrobials following initial treatment with intravenous administration of parenteral antimicrobials. The study protocol required that the following three criteria be met prior to transition from intravenous to oral antimicrobial therapy: 1) receipt of a minimum of 72 hours of intravenous therapy; 2) no documented fever for prior 24 hours; and 3) improvement or resolution of the signs and symptoms of infection.

 

The choice of oral antimicrobial agent used in this trial was determined by susceptibility testing of the original pathogen, if isolated, to oral agents available. The course of oral antimicrobial therapy should not routinely exceed 14 days.

Ampicillin and Sulbactam Injection Dosage and Administration

Ampicillin and sulbactam for injection may be administered by either the IV or the IM routes.

 

For IV administration, the dose can be given by slow intravenous injection over at least 10 to 15 minutes or can also be delivered, in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes.


Ampicillin and sulbactam for injection may be administered by deep intramuscular injection. (See Preparation for Intramuscular Injection.)

 

The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.


Pediatric Patients 1 Year of Age or Older

 

The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection. (See CLINICAL STUDIES section.)


Impaired Renal Function

 

In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations: 

Ampicillin and Sulbactam for Injection Dosage Guide For Patients With Renal Impairment

Creatinine Clearance (mL/min/1.73 m2)	Ampicillin/Sulbactam Half-Life (Hours)	Recommended Ampicillin and Sulbactam for Injection Dosage
≥30	1	1.5–3 g q 6 h – q 8 h
15–29	5	1.5–3 g q 12 h
5–14	9	1.5–3 g q 24 h

When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.


Males                     weight (kg)×(140 – age)    

                                 72 × serum creatinine


Females              0.85 × above value

COMPATIBILITY, RECONSTITUTION AND STABILITY

Ampicillin and sulbactam for injection sterile powder is to be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] prior to reconstitution.

 

When concomitant therapy with aminoglycosides is indicated, ampicillin and sulbactam and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.

DIRECTIONS FOR USE

General Dissolution Procedures

 

Ampicillin and sulbactam for injection sterile powder for intravenous and intramuscular use may be reconstituted with any of the compatible diluents described in this insert. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.


Preparation for Intravenous Use


Reconstitution of ampicillin and sulbactam for injection, at the specified concentrations, with these diluents provide stable solutions for the time periods indicated in the following table: (After the indicated time periods, any unused portions of solutions should be discarded.)

Maximum Concentration (mg/mL)
Diluent	Ampicillin and Sulbactam for Injection	Use Periods
Sterile Water for Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	48 hrs @ 4°C
	30 (20/10)	72 hrs @ 4°C
0.9% Sodium Chloride Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	48 hrs @ 4°C
	30 (20/10)	72 hrs @ 4°C
5% Dextrose Injection	30 (20/10)	2 hrs @ 25°C
	30 (20/10)	4 hrs @ 4°C
	3 (2/1)	4 hrs @ 25°C
Lactated Ringer's Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	24 hrs @ 4°C
M/6 Sodium Lactate Injection	45 (30/15)	8 hrs @ 25°C
	45 (30/15)	8 hrs @ 4°C
5% Dextrose in 0.45% Saline	3 (2/1)	4 hrs @ 25°C
	15 (10/5)	4 hrs @ 4°C
10% Invert Sugar	3 (2/1)	4 hrs @ 25°C
	30 (20/10)	3 hrs @ 4°C

Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg ampicillin and sulbactam per mL (250 mg ampicillin/125 mg sulbactam per mL). An appropriate volume should then be immediately diluted with a suitable parenteral diluent to yield solutions containing 3 to 45 mg ampicillin and sulbactam per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL).


Preparation for Intramuscular Injection


1.5 g and 3 g Standard Vials: Vials for intramuscular use may be reconstituted with Sterile Water for Injection USP, 0.5% Lidocaine Hydrochloride Injection USP or 2% Lidocaine Hydrochloride Injection USP. Consult the following table for recommended volumes to be added to obtain solutions containing 375 mg ampicillin and sulbactam per mL (250 mg ampicillin/125 mg sulbactam per mL). Note: Use only freshly prepared solutions and administer within one hour after preparation.  

Ampicillin and Sulbactam for Injection Vial Size	Volume of Diluent to be Added	Withdrawal Volume*
*   There is sufficient excess present to allow withdrawal and administration of the stated volumes.
1.5 g	3.2 mL	4 mL
3 g	6.4 mL	8 mL

Animal Pharmacology

While reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.

How is Ampicillin and Sulbactam Injection Supplied

Ampicillin and Sulbactam for Injection USP, 1.5 g is a white to off-white powder filled in 15 mL capacity clear glass tubular vials, stoppered with grey color bromo butyl rubber stoppers and sealed with light green color flip off aluminum seals.

 

                     Box of 10                                 NDC 65862-351-10


Ampicillin and Sulbactam for Injection USP, 3 g is a white to off-white powder filled in 15 mL capacity clear glass tubular vials, stoppered with grey color bromo butyl rubber stoppers and sealed with white color flip off aluminum seals.

 

                     Box of 10                                 NDC 65862-352-10


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

REFERENCES

 

1. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests–Fourth Edition. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.


2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.

Clinitest™ is a registered trademark of Miles, Inc.

Clinistix™ is a registered trademark of Bayer Corporation.

Testape™ is a registered trademark of Eli Lilly Company.

 

Manufactured for:

Aurobindo Pharma USA, Inc.

2400 Route 130 North

Dayton, NJ 08810


Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 072, India

 

Issued: August 2008

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 g Standard Vial Label

Rx only      NDC 65862-351-15

Sterile

Ampicillin and Sulbactam

for Injection, USP

1.5 grams*/vial

For IM or  IV Use

AUROBINDO


 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 g Standard Vial Label

Rx only      NDC 65862-352-15

Sterile

Ampicillin and Sulbactam

for Injection, USP

3 grams*/vial

For IM or  IV Use

AUROBINDO

AMPICILLIN AND SULBACTAM  ampicillin sodium and sulbactam sodium  injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65862-351 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 1 g SULBACTAM SODIUM (SULBACTAM) SULBACTAM 0.5 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (White to Off-white) Score      Shape Size Flavor Imprint Code Contains

ketoconazole topical

Generic Name: ketoconazole topical (kee toe KOE na zole)

Brand Names: Extina, Kuric, Nizoral A-D, Nizoral Topical, Xolegel

What is ketoconazole topical?

Ketoconazole topical is an antifungal medication. Ketoconazole topical prevents fungus from growing on your skin.

Ketoconazole topical is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketoconazole topical is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

Ketoconazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ketoconazole topical?

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to. Avoid getting this medication in your eyes, nose, or mouth.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Stop using ketoconazole topical and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame. Do not use this medication on a child younger than 12 years old.

What should I discuss with my healthcare provider berfore using ketoconazole topical?

Do not use this medication if you are allergic to ketoconazole. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketoconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child younger than 12 years old.

How should I apply ketoconazole topical?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Do not use this medication for any skin condition that has not been diagnosed by a doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Store ketoconazole topical at room temperature away from moisture and heat. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

An overdose of ketoconazole topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using ketoconazole topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Ketoconazole topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ketoconazole topical and call your doctor if you have any of these serious side effects:

• 
  

  severe itching, burning, or irritation where the medicine is applied;

  
  


• 
  

  oily or dry scalp, mild hair loss;

  
  


• 
  

  redness, pain, or oozing of treated skin areas; or

  
  


• 
  

  eye redness, swelling, or irritation.

  
  

Less serious side effects include:

• 
  

  mild skin itching or irritation;

  
  


• 
  

  dry skin; or

  
  


• 
  

  headache.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Ketoconazole topical Dosing Information

Usual Adult Dose for Cutaneous Candidiasis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Corporis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Cruris:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Pedis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 6 weeks.

Usual Adult Dose for Tinea Versicolor:

2% Cream: Apply to the affected and surrounding area once a day for 2 weeks.

2% Shampoo: Apply to damp skin of the affected area and a wide margin surrounding this area. One application should be sufficient; however, an application once a day for 3 days has also been used.

Ketoconazole shampoo should be lathered, left in place for 5 minutes, and then rinsed off with water.

Usual Adult Dose for Seborrheic Dermatitis:

2% Cream: Apply to affected areas twice a day for 4 weeks or until clinical clearing.
2% Foam: Apply to affected areas twice a day for 4 weeks.
2% Gel: Apply to affected areas once a day for 2 weeks.

Usual Adult Dose for Dandruff:

1% Shampoo: Apply every 3 or 4 days for up to 8 weeks. Then apply as needed to control dandruff.

Ketoconazole shampoo should be used in sufficient quantity to produce lather, left on the scalp for 1 minute, and then rinsed. The application should be repeated, left on scalp for an additional 3 minutes, and then rinsed.

Usual Pediatric Dose for Seborrheic Dermatitis:

12 years or older:
2% Foam: Apply to affected areas twice a day for 4 weeks.
2% Gel: Apply to affected areas once a day for 2 weeks.

Usual Pediatric Dose for Dandruff:

12 years or older:
1% Shampoo: Apply every 3 or 4 days for up to 8 weeks. Then apply as needed to control dandruff.

Ketoconazole shampoo should be used in sufficient quantity to produce lather, left on the scalp for 1 minute, and then rinsed. The application should be repeated, left on scalp for an additional 3 minutes, and then rinsed.

Usual Pediatric Dose for Tinea Corporis:

2% Cream: Apply to the affected area once to twice a day.

What other drugs will affect ketoconazole topical?

There may be other drugs that can affect ketoconazole topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ketoconazole topical resources

• Ketoconazole topical Use in Pregnancy & Breastfeeding
• Ketoconazole topical Support Group
• 10 Reviews for Ketoconazole - Add your own review/rating

• Extina Consumer Overview


• Extina Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Extina Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Extina Prescribing Information (FDA)


• Kuric Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Nizoral A-D Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Xolegel Prescribing Information (FDA)


• Xolegel Consumer Overview


• Xolegel Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare ketoconazole topical with other medications

• Cutaneous Candidiasis
• Dandruff
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist can provide more information about ketoconazole.

Cystadane

Generic Name: betaine (BET aine)

Brand Names: Cystadane

What is Cystadane (betaine)?

Betaine is a nutrient that is important for functioning of the heart and blood vessels. Betaine works in the body by preventing the build-up of an amino acid called homocysteine. This amino acid can harm blood vessels and contribute to heart disease, stroke, or circulation problems.

Betaine is a byproduct of sugar beet processing.

Betaine is used to reduce homocysteine levels in people with a genetic condition called homocystinuria, in which the amino acid builds up in the body. Betaine is not a cure for homocysteinuria.

Betaine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Cystadane (betaine)?

You should not use betaine if you are allergic to it.

To make sure you can safely take betaine, tell your doctor about all of your medical conditions.

Follow the directions on your prescription label. Do not use in larger or smaller amounts or for longer than recommended. Your doctor may occasionally change your dose to make sure you get the best results.

Betaine powder must be mixed with water, juice, milk, food or infant formula just before taking it. Stop using betaine and call your doctor at once if you have an unusual headache, dizziness, neck pain or stiffness, problems with memory or speech, changes in your mental state, vision changes, decreased consciousness, or seizure (black-out or convulsions).

Betaine is only part of a complete program of treatment that may also include other vitamin and mineral supplements and a special diet. Follow your diet and medication routines very closely.

What should I discuss with my health care provider before taking Cystadane (betaine)?

You should not use betaine if you are allergic to it.

To make sure you can safely take betaine, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether betaine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether betaine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cystadane (betaine)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Betaine powder must be mixed with water, juice, milk, or food just before you take it. When giving the medication to a child, you may mix the powder with infant formula. Stir the mixture thoroughly and drink it right away. Do not save the mixture for later use.

Measure the powder using the dose-measuring scoop provided with your medication, not with a regular table spoon.

Do not drink the liquid if it is colored and not clear after mixing. Call your doctor for a new prescription.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Betaine is only part of a complete program of treatment that may also include other vitamin and mineral supplements and a special diet. Follow your diet and medication routines very closely.

Store betaine powder at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Cystadane (betaine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Cystadane (betaine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using betaine and call your doctor at once if you have a serious side effect such as:

• 
  

  unusual headache, dizziness, neck pain or stiffness

  
  


• 
  

  memory problems;

  
  


• 
  

  changes in your mental state;

  
  


• 
  

  vision changes;

  
  


• 
  

  problems with speech, balance, or walking;

  
  


• 
  

  decreased consciousness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  nausea, upset stomach;

  
  


• 
  

  diarrhea;

  
  


• 
  

  unusual body odor; or

  
  


• 
  

  unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cystadane (betaine)?

There may be other drugs that can interact with betaine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cystadane resources

• Cystadane Side Effects (in more detail)
• Cystadane Use in Pregnancy & Breastfeeding
• Cystadane Support Group
• 0 Reviews for Cystadane - Add your own review/rating

• Cystadane Prescribing Information (FDA)


• Cystadane Advanced Consumer (Micromedex) - Includes Dosage Information


• Cystadane Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cystadane with other medications

• Nonalcoholic Fatty Liver Disease

Where can I get more information?

• Your pharmacist can provide more information about betaine.

See also: Cystadane side effects (in more detail)

protirelin Intravenous

proe-ti-REL-in

Commonly used brand name(s)

In the U.S.

• Thyrel TRH

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Thyroid Function

Uses For protirelin

Protirelin is used to test the response of the anterior pituitary gland in people who may have certain medical conditions involving the thyroid gland. Testing with protirelin may help to identify the problem or may ensure that the dose of medicine being used is correct.

Protirelin stimulates release of a hormone called thyroid-stimulating hormone or TSH from the anterior pituitary gland. TSH then stimulates the thyroid gland. By measuring the amount of TSH in the blood after protirelin is given, the doctor can determine how well the anterior pituitary is working.

How test is done: First, a sample of your blood is taken. Then protirelin is given by injection by your doctor. The dose of protirelin may be different for different patients. Adults are usually given 500 micrograms (mcg) injected into a vein. The dose for children is based on body weight and must be determined by your doctor. A little while after the dose is given, one or more blood samples are taken. Then the results of the test are studied. You will be asked to lie down before, during, and for 15 minutes after the test. This is to prevent dizziness and possible fainting.

Protirelin is to be used only under the supervision of a doctor.

Before Using protirelin

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to protirelin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

protirelin has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

protirelin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this diagnostic test with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyproheptadine


• Thioridazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or


• High blood pressure or


• Stroke (history of)—Sudden changes in blood pressure caused by protirelin may put patients with these conditions at greater risk

• Kidney disease—Test results may be affected if patient has kidney disease

Proper Use of protirelin

Dosing

The dose of protirelin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of protirelin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

protirelin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Fainting

For patients with pituitary tumors - Rare

• Loss of vision (temporary)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Flushing or redness of skin


• frequent urge to urinate


• headache (sometimes severe)


• lightheadedness


• nausea


• stomach pain


• unpleasant taste in mouth or dryness of mouth

Less common

• Anxiety


• drowsiness


• pressure in the chest or tightness in throat


• sweating


• tingling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Lindane Shampoo

Lindane Shampoo USP, 1%

Rx only

WARNINGS

Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice. (See INDICATIONS AND USAGE.)

Neurologic Toxicity

Seizures and deaths have been reported following Lindane Shampoo use with repeat or prolonged application, but also in rare cases following a single application according to directions. Lindane Shampoo should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh < 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.

Contraindications

Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

Proper Use

Instruct patients on proper use of Lindane Shampoo, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for retreatment with Lindane Shampoo. (See DOSAGE AND ADMINISTRATION.)

Lindane Shampoo Description

Lindane Shampoo USP, 1%, is an ectoparasiticide and ovicide effective against Pediculosis humanis capitis (head lice), Pthirus pubis (crab lice), and their ova. In addition to the active ingredient, lindane, it contains acetone, citric acid, polysorbate 60, purified water and triethanolamine lauryl sulfate to form a shampoo base. The pH may be adjusted with citric acid and/or triethanolamine. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:

C6H6Cl6                      M.W. 290.83

Lindane Shampoo - Clinical Pharmacology

Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibach1 reported approximately 10% absorption of a lindane acetone solution applied to the forearm of human subjects and left in place for 24 hours. This vehicle was different from the approved product and the percutaneous penetration of lindane is dependent on the vehicle. Therefore, the clinical significance of these observations is unknown. Dale, et al2 reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane-containing product. Ginsburg3 found a mean peak blood level of 28 ng/mL 6 hours after total body application of Lindane Lotion to scabietic infants and children. The half-life in blood was determined to be 18 hours.

Data available in the literature suggest that lindane has a rapid distribution phase followed by a longer β-elimination phase.1,2,3

There are no clinical dose ranging studies for Lindane Shampoo.

Indications and Usage for Lindane Shampoo

Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who

1. cannot tolerate other approved therapies, or


2. have failed treatment with other approved therapies.

Lindane Shampoo should be used in the context of an overall lice management program that includes:

• Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or "nits" can remain on hair shaft long after true infestation).


• Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp.


• Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.


• All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.

Caregivers applying this product to patients should wear gloves less permeable to Lindane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane.

Lindane Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.

Contraindications

Lindane Shampoo is contraindicated for premature infants because their skin may be more permeable than that of full term infants and their liver enzymes may not be sufficiently developed to metabolize Lindane.

Lindane Shampoo is also contraindicated for patients with crusted (Norwegian) scabies and other skin conditions (e.g., atopic dermatitis, psoriasis) that may increase systemic absorption of the drug.

Lindane Shampoo is contraindicated for patients with known uncontrolled seizure disorders and for individuals with a known sensitivity to the product or any of its components.

Warnings

(See boxed WARNINGS.)

Seizures and deaths have been reported following Lindane Shampoo use with repeat or prolonged application, but also in rare cases following a single application according to directions.

There have been cases of adverse events reported for Lindane Shampoo and Lindane Lotion in which a serious outcome (hospitalization, disability or death) has occurred.4 In approximately 20% of these cases, the shampoo and lotion were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many of which were remote from the time of actual Lindane use. Lindane toxicity, verified by autopsy was the cause of one infant's death, and was the cause of death reported for an adult in a successful suicide. The direct causes of death for the other cases were attributed to reasons other than lindane. Most of these adverse events occurred with Lindane Lotion.

Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 110 lbs (50 kg) may be at a greater risk of serious neurotoxicity. (See Pediatric Use and Geriatric Use.) Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.

Careful consideration should be given before prescribing Lindane Shampoo to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold. (See PRECAUTIONS: Drug Interactions.)

Patients should be instructed on the proper use of Lindane Shampoo, especially the amount to apply, how long to leave shampoo on, and the need to avoid retreatment. Patients should be informed that itching may occur after the successful killing of lice and repeat treatment may not be necessary.

A Lindane Shampoo Medication Guide must be given to the patient each time Lindane Shampoo is dispensed, as required by law.

Precautions

General

Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.

Information for Patients (and Caregivers)

• This product can be poisonous if misused.


• Other important information is found in the Medication Guide, which by law, must be dispensed with Lindane Shampoo.


• If putting Lindane Shampoo on another person, the person applying shampoo should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex should be avoided because it is more permeable to lindane.


• If the person applying Lindane Shampoo could be pregnant, contact with Lindane Shampoo should be avoided as much as possible.


• If the patient could be pregnant, other treatments may be preferable.


• Use Lindane Shampoo for lice only.


• The use of oil treatments, oil based hair dressings or conditioners immediately before and after applying Lindane Shampoo should be avoided. Oils can make the Lindane Shampoo go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).


• Information for Use
  
  • Shake Lindane Shampoo well.
  
  
  • Hair should be completely dry prior to application of Lindane Shampoo.
  
  
  • Use only enough Lindane Shampoo to lightly coat the hair and scalp.
  
  
  • Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck and behind the ears.
  
  
  • After 4 minutes, add small quantities of water to hair until a good lather forms.
  
  
  • Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces.
  
  
  • Towel briskly and then remove nits with nit comb or tweezers.
  
  
  • There may be some Lindane Shampoo left in the bottle. Close the bottle with the leftover Lindane Shampoo and immediately throw away the bottle in a trash can out of the reach of children.
  
  
  • Do not cover the hair with anything that does not breathe, like a shower cap or towel.
  
  
  • Do not ingest. Keep away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if open wounds, cuts or sores are present, unless specifically directed by your physician.
  
  
  • Wash all recently worn clothing, underwear and pajamas, hats, and used sheets, pillowcases, and towels in very hot water or dry-clean.
  
  
  • Patients may still itch after using Lindane Shampoo. This does not mean the medicine did not work. Lindane Shampoo sometimes makes this itch even worse. Other medications can be used to soothe the itch. Do not use more Lindane Shampoo.
  
  
  • If there are any questions or concerns about the condition or use of the Lindane Shampoo, contact your physician.
  
  

Drug Interactions

Oils may enhance absorption of lindane, therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying Lindane Shampoo.

In addition, there are many drugs that may lower the seizure threshold, and Lindane Shampoo should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:

• Antipsychotics


• Antidepressants


• Theophylline


• Cyclosporine, mycophenolate mofetil, tacrolimus capsules


• Penicillins, imipenem, quinolone antibiotics


• Chloroquine sulfate, pyrimethamine


• Isoniazid


• Meperidine


• Radiographic contrast agents


• Centrally active anticholinesterases


• Methocarbamol

Carcinogenesis, Mutagenesis, and Fertility

Although no studies have been conducted with Lindane Shampoo, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane as well as the alpha, beta, gamma (lindane) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of lindane. The results of mutagenicity tests in bacteria do not indicate that lindane is mutagenic. Lindane did not cause sister chromatid exchange in an in vivo assay. The number of spermatids in the testes of rats 2 weeks after oral administration of a single dose of 30 mg/kg body weight (12 times the estimated human exposure for scabies on a body surface area comparison and assuming 50% rat oral bioavailability and 10% human bioavailability) was significantly reduced compared to the control rats.

Pregnancy

Pregnancy Category C

All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Predictions of fetal risk from drug exposure rely heavily on animal data. However, animal studies may fail to predict effects in humans or may overstate such risks. Even if human data are available, the data may not be sufficient to determine whether there is an increased risk to the fetus, and individual reports of adverse outcomes in pregnancy in association with a drug may not reflect a causal relationship.

Lindane Shampoo should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Lindane Shampoo in pregnant women. There are no known maternal or fetal health risks described if lice are not treated, but risk of transmission of the lice to other household members is an additional consideration when deciding whether to use lice treatments. Lindane is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures during pregnancy to Lindane Lotion. The relationship of the maternal exposures to the fetal outcome is unknown.

Animal data suggest that lindane may increase the likelihood of neurologic developmental abnormalities (see below), based on findings at systemic exposures close to that expected in humans when Lindane Lotion is used to treat scabies. The immature central nervous system (as in the fetus) may have increased susceptibility to the effects of the drug. Systemic exposure resulting from Lindane Shampoo applied to hair covered areas is expected to be lower than that from Lindane Lotion that covers the entire body surface area.

Data

When rats received lindane in the diet from day 6 of gestation through day 10 of lactation, reduced pup survival, decreased pup weight and decreased weight gains during lactation, increased motor activity and decreased motor activity habituation were seen in pups at 5.6 mg/kg (2 times the estimated human exposure) but not at 1.2 mg/kg. An increased number of stillborn pups was seen at 8 mg/kg, and increased pup mortality was seen at 5.6 mg/kg. No gross abnormalities were seen in this study or in a study in which rabbits received up to 20 mg/kg lindane by gavage on gestation day 6–18 (up to 10 times the human exposure on a body surface area comparison and assuming 50% rabbit oral bioavailability and 10% human bioavailability when lindane is applied to the entire body for the treatment of scabies).

Nursing Mothers

Lindane is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if lindane is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding if Lindane Shampoo is applied topically to the chest area. Nursing mothers who require treatment with Lindane Shampoo should be advised of the potential risks and be instructed not to use the product on the skin as would be done for treatment of scabies. They should also be counseled to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use.

Pediatric Use

Animal data demonstrated increased risk of adverse events in the young across species. Pediatric patients have a higher surface to volume ratio and may be at risk of greater systemic exposure when Lindane Shampoo is applied. Infants and children may be at an even higher risk due to immaturity of organ systems such as skin and liver. Lindane Shampoo should be used with caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Lindane Shampoo is indicated only for the treatment of lice; patients with scabies should use Lindane Lotion according to the labeled instructions.

Geriatric Use

There have been no studies of Lindane Shampoo in the elderly. There are four postmarketing reports of deaths in elderly patients treated with Lindane Lotion for the indication of scabies. Two patients died within 24 hours of Lindane Lotion application, and the third patient died 41 days after application of Lindane Lotion, having suffered a seizure on the day of death. A fourth patient died of an unreported cause of death on the same day that Lindane Lotion treatment for scabies was administered.

Adverse Reactions

Central nervous system stimulation ranging from dizziness to seizures, has been reported particularly with use of Lindane Lotion. Although seizures were almost always associated with ingestion or misuse of the product (to include repeat treatment), seizures and deaths have been reported when Lindane Shampoo was used according to directions. Irritant dermatitis from contact with this product has also been reported. (See WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)

Postmarketing Experience

The following adverse reactions reflect the additional postmarketing experience of Lindane Shampoo. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to lindane therapy is unknown.

Overdosage

Contact the closest Poison Control Center in the event of suspected overdosage with Lindane Shampoo.

If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils enhance absorption, saline cathartics for intestinal evacuation should be given rather than oil laxatives. If central nervous system manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.

Lindane Shampoo Dosage and Administration

Most patients will require only 1 ounce of Lindane Shampoo. Based on the length and density of hair, some patients may require 2 ounces of Lindane Shampoo.

Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces. Do not prescribe more than 2 ounces for larger adults. Do not retreat. (See boxed WARNINGS.)

Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.)

A Lindane Shampoo Medication Guide must be given to the patient each time Lindane Shampoo is dispensed as required by law. The Lindane Shampoo Medication Guide is an important part of the risk management program for the patient.

How is Lindane Shampoo Supplied

Lindane Shampoo USP, 1% is supplied in 2 fl oz (60 mL) NDC 61748-400-02 bottles.

SHAKE WELL BEFORE USING

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

REFERENCES

1. Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol., 28:126, 1974.


2. Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966.


3. Ginsburg, C.M., et al., J. Pediatr. 91:6, 998–1000, 1977.


4. FDA AERS database search, January 2003

Manufactured by:

AL&S, LLC

De Kalb, MS 39328

                                                                                                                                                             

Marketed by: 

VersaPharm Incorporated

Marietta, GA 30062

 

IVP40002-00

Issued: 05-24-2011

 

PHARMACIST—PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

Lindane (LIHN-dane) Shampoo USP, 1%

You must read and follow all instructions before using Lindane Shampoo. Read the information you get every time you or a family member get Lindane Shampoo. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Lindane Shampoo, ask your doctor or pharmacist.

What is the most important information I should know about Lindane Shampoo?

Lindane Shampoo is a poison if you do not use it the right way. Lindane Shampoo goes through your skin and can affect your brain and nerves. Lindane Shampoo can cause seizures, also called convulsions, "fits" or epilepsy.

• Seizures and death can happen in people who use Lindane Shampoo too much or too often.


• Seizures can happen in some people even if they use Lindane Shampoo exactly as directed.

If you or a family member has a seizure while using Lindane Shampoo, get emergency help right away.

• Do not use Lindane Shampoo unless
  
  • You have lice and another medicine did not work for you, or
  
  
  • You cannot use other, safer medicines to treat your lice
  
  


• Do not use Lindane Shampoo more than 1 time to treat an attack of lice. Do not use Lindane Shampoo to treat a second attack that comes soon after the first episode. No one knows a safe time to reuse Lindane Shampoo. Even if you still itch even after using Lindane Shampoo, do not use more or use it again. Lice (bugs) can make you itch for some time even after all of the bugs are dead.


• Do not use more Lindane Shampoo than your doctor tells you.


• Do not keep Lindane Shampoo on your hair for more than 4 minutes.


• Do not put Lindane Shampoo in your mouth because it is a poison if taken by mouth. If you get Lindane Shampoo in your mouth or swallow Lindane Shampoo, call your area Poison Control Center right away and get emergency help.

What is Lindane Shampoo?

Lindane Shampoo is a medicine that is used to treat lice. It kills lice and their eggs. Lice are very small bugs that attach to the skin on your head or pubic (crotch) area and lay eggs called nits in your hair. Some people call crotch lice "crabs". Lice can cause severe itching. Lindane Shampoo gets into the lice and the nits and kills them. It also goes through your skin. Lindane Shampoo is used only after safer medicines have not made your lice go away. The only time Lindane Shampoo is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.

Lindane Shampoo is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds use Lindane Shampoo only if your doctor thinks it is really needed. People who weigh less than 110 pounds and the elderly have higher chances for side effects because more Lindane may go through their skin.

Who should not use Lindane Shampoo?

Do not use Lindane Shampoo:

• if you do not have lice. Lindane Shampoo does not stop you from getting lice. Lindane Shampoo only kills the lice you already have.


• if you have or have ever had seizures, also called convulsions, "fits" or epilepsy, especially if they have been hard to control.


• if you have used Lindane Shampoo in the past few months. You should see your doctor if you think that you need another treatment.


• unless it is the only medicine you can use for lice.


• if you had a bad reaction to Lindane Shampoo before. Do not use Lindane Shampoo again.


• if you have open sores or crusted (scabby) sores on the skin around your head and neck, or lots of broken skin.


• if you need to treat a premature or young baby. More of the applied Lindane can go through the skin of babies and go to their brains where it can harm them.


• if you have scabies. These need a different medicine that you use in a different way.


• if you are allergic to Lindane Shampoo or any of its ingredients. The active ingredient is lindane. See the end of this Medication Guide for a list of all the ingredients in Lindane Shampoo.


• while you are breast-feeding. Lindane Shampoo can get in your milk and may be fed to your baby. Your baby may get sick. Ask your doctor for a safer medicine. If you use Lindane Shampoo, pump your breast milk and throw the milk away for at least 24 hours after using the medicine. During this time, feed your baby formula or breast milk that you stored from before you used Lindane Shampoo.

Tell your doctor if you:

• used Lindane Shampoo in the past few months.


• ever had a seizure or problem that could increase your chances of getting a seizure (like a head injury, tumor in your brain or spinal cord, cirrhosis of the liver, or heavy alcohol drinking.)


• have HIV or AIDS. Lindane Shampoo may cause seizures even if you never had them before.


• are pregnant. Lindane Shampoo can reach your baby and may harm it. Ask your doctor for a safer medicine. Use Lindane Shampoo only if needed.


• have a sexual partner and your lice (crabs) are in your pubic (crotch) area. Your partner should get checked and treated for lice so they don't give them back to you. Don't share your Lindane Shampoo with your partner.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Lindane Shampoo. Especially tell your doctor if you take medicines called sedatives (drugs to help you sleep).

How do I use Lindane Shampoo?

Before you put it on:

• Make sure you know how to use it exactly as your doctor prescribes.


• If you are putting Lindane Shampoo on another person, wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves because more Lindane can go through that kind of glove. Keep the gloves on until the Lindane Shampoo is washed out of your hair. Wash your hands well when you are done.


• Make sure your hair and skin on your head and neck do not have any other shampoo, cream, or oil on it. Oils can make the Lindane Shampoo go through your skin faster and may increase the risk of seizures.

When you put it on:

• Shake the bottle of Lindane Shampoo well.


• Make sure your hair is clean and dry before using Lindane Shampoo, but do not wash your hair within 1 hour before using Lindane Shampoo. Use regular shampoo without conditioner and dry your hair.


• Use just enough Lindane Shampoo on your dry hair to wet your hair and scalp. Do not add water to your hair at this time. Also, put Lindane Shampoo on the short hairs at the back of your neck.


• Keep Lindane Shampoo on your hair for 4 minutes. Use a watch or clock to time yourself.


• Do not wear a shower cap or any covering on your head while you wait for the 4 minutes to pass.


• Close the bottle with the leftover Lindane Shampoo and throw it away in a trash can out of the reach of children.

When you are supposed to wash it off:

• After 4 minutes has passed, soap up or lather the Lindane Shampoo. Use a small amount of warm water to do this. Hot water is not safe. Then wash the Lindane Shampoo off your head. Again, use warm, but not hot water. Do not leave any Lindane Shampoo on your head or hair. It will not kill more of the lice and may continue to go through your skin and cause serious problems, such as seizures.

After you wash off Lindane Shampoo:

• Dry your hair with a towel. Use a special comb called a nit comb or tweezers to remove the dead nits (lice eggs) from your hair. Someone else will probably have to do this for you.


• All recently worn clothing, underwear, pajamas, hats, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.


• Do not use Lindane Shampoo again. If you think you need to use it again, you must check with your doctor to find out if and when it is most safe.

You may still itch after you have used Lindane Shampoo. This does not mean you need more Lindane Shampoo. Even after all the lice (bugs) are dead, they can still make your skin itch for a long time. Lindane Shampoo sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.

What should I avoid while using Lindane Shampoo?

• Do not get Lindane Shampoo in your eyes. If you do, rinse your eyes with water right away. Get medical help if your eyes keep hurting.


• Do not get Lindane Shampoo on your hands. Wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves. Wash your hands well when you are done.


• If you are pregnant, do not use Lindane Shampoo unless you have talked to your doctor about using it. Avoid putting Lindane Shampoo on others if you are pregnant. See the special glove advice above if you have to put Lindane Shampoo on others.


• Do not use oils on your skin or hair, just before or after using Lindane Shampoo. Oils include oil-based hair products and conditioners.

What are the possible side effects of Lindane Shampoo?

Lindane Shampoo may cause serious side effects such as seizures (convulsions, fits) or death (See the section, "What is the most important information I should know about Lindane Shampoo?"). Lindane Shampoo can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Lindane Shampoo are:

• Itching skin


• Burning skin


• Dry skin


• A skin rash

These are not all of the possible side effects of Lindane Shampoo. For more information, ask your doctor or pharmacist.

General Information about Lindane Shampoo:

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Lindane Shampoo for any condition for which it was not prescribed. Do not give Lindane Shampoo to other people, even if they have the same symptoms that you have. It may harm them. Keep Lindane Shampoo and all medicines out of the reach of children.

This Medication Guide summarizes the most important information about Lindane Shampoo. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Lindane Shampoo that is written for health professionals.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

What are the ingredients in Lindane Shampoo?

Active Ingredient: Lindane.

Inactive Ingredients: acetone, citric acid, polysorbate 60, purified water and triethanolamine lauryl sulfate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Lindane is only available by a prescription from your doctor.

Manufactured by:

AL&S, LLC

De Kalb, MS 39328

 

Marketed by: 

VersaPharm Incorporated

Marietta, GA 30062

 

GVP40002-00

Issued: 05-24-2011

PRINCIPAL DISPLAY PANEL- CONTAINER LABEL

NDC 61748-400-02

LINDANE

SHAMPOO

USP, 1%

POISON: FOR EXTERNAL USE ONLY

HARMFUL OR FATAL IF SWALLOWED

WARNING : KEEP OUT OF REACH OF CHILDREN

Do not use if the seal

is broken or missing.

Rx Only

NET: 2 fl oz (60 mL)

LINDANE  lindane  shampoo

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61748-400 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINDANE (LINDANE) LINDANE 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ACETONE   ANHYDROUS CITRIC ACID   POLYSORBATE 60   WATER   TROLAMINE LAURYL SULFATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61748-400-02 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 60 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (61748-400-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA087266	11/21/2011

Labeler - VersaPharm Incorporated (956741896)

Revised: 12/2011VersaPharm Incorporated