Candid may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Candid in the following countries:
Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Candid in the following countries:
International Drug Name Search
Spiramycine may be available in the countries listed below.
Spiramycine (DCF) is known as Spiramycin in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Short-term treatment of painful muscle conditions. It is used along with rest and physical therapy. It may also be used for other conditions as determined by your doctor.
Orphenadrine Extended-Release Tablets are a skeletal muscle relaxant. It works by helping to decrease pain, which helps muscles to relax.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Orphenadrine Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Orphenadrine Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Orphenadrine Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Orphenadrine Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Orphenadrine Extended-Release Tablets.
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; constipation; dizziness or lightheadedness; drowsiness; dry mouth; headache; nausea; stomach irritation or upset; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chills, fever, or sore throat; confusion; fainting; fast or irregular heartbeat; hallucinations; severe or persistent tiredness or weakness; tremor; trouble urinating or inability to urinate; unusual bruising or bleeding; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Orphenadrine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular heart rate; loss of consciousness; seizures.
Store Orphenadrine Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Orphenadrine Extended-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Orphenadrine Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Kulilolel may be available in the countries listed below.
Sulindac is reported as an ingredient of Kulilolel in the following countries:
International Drug Name Search
Generic Name: capsaicin (Topical route)
kap-SAY-sin
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Capsaicin is used to help relieve a certain type of pain known as neuralgia (shingles). Capsaicin is also used to help relieve minor pain associated with rheumatoid arthritis or muscle sprains and strains. This medicine will not cure any of these conditions.
Neuralgia is a pain that comes from the nerves near the surface of your skin. This pain may occur after an infection with herpes zoster (shingles or postherpetic neuralgia). Capsaicin will help relieve the pain of postherpetic neuralgia, but it will not cure the condition.
This medicine is available both over-the-counter (OTC) and with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies have not been performed on the relationship of age to the effects of capsaicin in children. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capsaicin in the elderly.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain capsaicin. It may not be specific to Double Cap. Please read with care.
A nurse or other trained healthcare professional will apply the topical Qutenza™ patch to the affected area.
If you are using the topical cream, gel, lotion, or ointment for neuralgia, muscle pain, or arthritis, follow the instructions on the medicine label.
Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.
If capsaicin gets on your face, scalp, or in your mouth, it may cause a burning sensation. Wash these areas with warm (not hot) soapy water.
If you are using the cream, gel, lotion, or ointment:
The dose of this medicine 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 this medicine. 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.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If you use the Qutenza™ patch:
If you use the cream, gel, lotion, or ointment:
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 immediately if any of the following side effects occur:
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:
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.
See also: Double Cap Topical side effects (in more detail)
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Lamivudina Microsules may be available in the countries listed below.
Lamivudine is reported as an ingredient of Lamivudina Microsules in the following countries:
International Drug Name Search
Etizem may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Etizem in the following countries:
International Drug Name Search
Each Donnatal(r) 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
Phenobarbital, USP....................................... 6.2 mg
This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.
Donnatal® Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom Phenobarbital produces restlessness and/or excitement.
In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
Donnatal® Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.
Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.
Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.
Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
GENERAL
Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.
Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Donnatal® Elixir. It is not known whether Donnatal®
Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® Elixir should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® Elixir is administered to a nursing woman.
Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be used.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
HOW SUPPLIED:
Donnatal® Elixir is a purple colored, grape flavored liquid.
4 fl oz (118 mL) bottles NDC 66213-423-04.
1 Pint (473 mL) bottles NDC 66213-423-16.
AVOID FREEZING
Store Donnatal® Elixir at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser.
Example bottle label
| DONNATAL phenobarbital elixir elixir | ||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 11/01/2009 | ||
| Labeler - PBM Pharmaceuticals Inc. (785470050) |
| Registrant - IriSys Inc (959205568) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| IriSys Inc | 959205568 | manufacture | |
Stresam may be available in the countries listed below.
Etifoxine is reported as an ingredient of Stresam in the following countries:
Etifoxine hydrochloride (a derivative of Etifoxine) is reported as an ingredient of Stresam in the following countries:
International Drug Name Search
Accoleit may be available in the countries listed below.
Zafirlukast is reported as an ingredient of Accoleit in the following countries:
International Drug Name Search
