Fosfocine

Fosfocine may be available in the countries listed below.

Ingredient matches for Fosfocine

Fosfomycin

Fosfomycin is reported as an ingredient of Fosfocine in the following countries:

• Tunisia

Fosfomycin disodium salt (a derivative of Fosfomycin) is reported as an ingredient of Fosfocine in the following countries:

• France

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Ginedazol

Ginedazol may be available in the countries listed below.

Ingredient matches for Ginedazol

Miconazole

Miconazole is reported as an ingredient of Ginedazol in the following countries:

• Peru

Tinidazole

Tinidazole is reported as an ingredient of Ginedazol in the following countries:

• Peru

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Desomedin

Desomedin may be available in the countries listed below.

Ingredient matches for Desomedin

Hexamidine

Hexamidine diisetionate (a derivative of Hexamidine) is reported as an ingredient of Desomedin in the following countries:

• Switzerland

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Citalorin

Citalorin may be available in the countries listed below.

Ingredient matches for Citalorin

Citalopram

Citalopram is reported as an ingredient of Citalorin in the following countries:

• Russian Federation

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Klindamicin

Klindamicin may be available in the countries listed below.

Ingredient matches for Klindamicin

Clindamycin

Clindamycin is reported as an ingredient of Klindamicin in the following countries:

• Serbia

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Deferasirox

Pronunciation: dee-FER-a-sir-ox
Generic Name: Deferasirox
Brand Name: Exjade

Deferasirox may cause severe and sometimes fatal kidney problems, liver problems, or stomach or bowel bleeding. The risk may be greater in patients who have low blood platelet counts or who already have kidney or liver problems. It may also be greater in the elderly and in patients who have certain blood or bone marrow problems (high-risk myelodysplastic syndromes [MDS]). Lab tests, including kidney and liver function, may be performed while you use Deferasirox to check for side effects. Be sure to keep all doctor and lab appointments.

Tell your doctor if you develop symptoms of kidney problems (eg, decreased urination) or liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite). Tell your doctor if you develop symptoms of stomach or bowel bleeding (eg, stomach pain; black, tarry stools; vomit that looks like coffee grounds).

Deferasirox is used for:

Treating high levels of iron in the blood caused by blood transfusions.

Deferasirox is an iron-chelating agent. It works by binding to the extra iron in the blood and removing it from the body.

Do NOT use Deferasirox if:

• you are allergic to any ingredient in Deferasirox


• you have severe kidney or liver problems, or very low blood platelet levels


• you have certain blood or bone marrow problems (high-risk MDS) or advanced cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using Deferasirox:

Some medical conditions may interact with Deferasirox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney problems (eg, kidney failure), liver problems (eg, cirrhosis), or stomach or bowel problems (eg, bleeding, ulcers)


• if you have cancer, blood or bone marrow problems, low blood platelets, vision or eye problems, hearing problems, or an infection


• if you are dehydrated


• if you are 65 years or older and have MDS

Some MEDICINES MAY INTERACT with Deferasirox. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), oral bisphosphonates (eg, alendronate), corticosteroids (eg, prednisone), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of stomach ulcers or bleeding may be increased


• Other iron-chelating medicines (eg, deferoxamine) because they may increase the risk of Deferasirox's side effects


• Cholestyramine, fosphenytoin, phenobarbital, phenytoin, rifampin, or ritonavir because they may decrease Deferasirox's effectiveness


• Cyclobenzaprine, fluvoxamine, haloperidol, imipramine, mexiletine, olanzapine, paclitaxel, repaglinide, theophyllines (eg, aminophylline), tizanidine, zileuton, or zolmitriptan because the risk of their side effects may be increased by Deferasirox


• Cyclosporine, hormonal contraceptives (eg, birth control), or simvastatin because their effectiveness may be decreased by Deferasirox


• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, NSAIDs [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if Deferasirox 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.

How to use Deferasirox:

Use Deferasirox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Deferasirox by mouth on an empty stomach at least 30 minutes before eating. Take it at the same time each day.


• Do not chew or swallow the tablet whole. You must mix Deferasirox with water, orange juice, or apple juice before you take it. Ask your doctor or pharmacist how much fluid you should use to mix your dose of Deferasirox.


• To mix Deferasirox, place the tablet in the correct amount of water, orange juice, or apple juice. Stir well until the tablet has completely dissolved, then immediately drink all of the liquid. Rinse the container with an additional small amount of water, orange juice, or apple juice and drink the contents to ensure the entire dose is taken.


• Take Deferasirox on a regular schedule to get the most benefit from it.


• Do not take an antacid that has aluminum in it at the same time you take Deferasirox. If you take antacids that contain aluminum, ask your doctor or pharmacist how to take them with Deferasirox.


• If you miss a dose of Deferasirox, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Deferasirox.

Important safety information:

• Deferasirox may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Deferasirox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Serious and sometimes fatal stomach ulcers or bleeding have been reported with the use of Deferasirox. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Deferasirox. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests, including liver and kidney function, blood ferritin and iron levels, vision, hearing, and complete blood cell counts, may be performed while you take Deferasirox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Deferasirox with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems, liver problems, and stomach or bowel bleeding.


• Deferasirox should be used with extreme caution in CHILDREN younger than 2 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Deferasirox while you are pregnant. It is not known if Deferasirox is found in breast milk. Do not breast-feed while taking Deferasirox.

Possible side effects of Deferasirox:

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:

Diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody, black, or tarry stools; change in the amount of urine produced; decreased hearing, hearing loss, or other hearing problems; symptoms of infection (eg, fever, chills, persistent sore throat or cough); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); unusual bruising or bleeding; unusual tiredness or fatigue; vision changes (eg, blurred or cloudy vision, decreased vision); vomit that looks like coffee grounds.

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: Deferasirox side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea and diarrhea.

Proper storage of Deferasirox:

Store Deferasirox at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Deferasirox out of the reach of children and away from pets.

General information:

• If you have any questions about Deferasirox, please talk with your doctor, pharmacist, or other health care provider.


• Deferasirox is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Deferasirox. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Deferasirox resources

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

• Deferasirox Professional Patient Advice (Wolters Kluwer)


• Deferasirox Monograph (AHFS DI)


• deferasirox Advanced Consumer (Micromedex) - Includes Dosage Information


• Exjade Prescribing Information (FDA)


• Exjade Consumer Overview

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Tiaprid-biomo

Tiaprid-biomo may be available in the countries listed below.

Ingredient matches for Tiaprid-biomo

Tiapride

Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Tiaprid-biomo in the following countries:

• Germany

International Drug Name Search

Desonide Lotion

Desonide Lotion 0.05%

Rx Only

For Dermatologic Use Only

Not for Ophthalmic Use

Desonide Lotion Description

Desonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 -[(1-melhylethylidene)bis(oxy)]-,(11β, 16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.

Chemically, desonide is C24H3206. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.

Desonide Lotion - Clinical Pharmacology

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Desonide Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.

INDICATION AND USAGE

Desonide Lotion is low to medium potency corticosteroids indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Contraindications

Desonide Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Precautions

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See   PRECAUTIONS: Pediatric Use).

If irritation develops, Desonide Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide Lotion should be discontinued until the infection has been adequately controlled.

Information for patients

Patients using topical corticosteroids should receive the following information and Instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

4. Patients should report to their physician any signs of local adverse reactions.

Laboratory tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment or fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of Desonide Lotion.

Pregnancy

Teratogenic effects: Pregnancy category C:

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relativity low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with Desonide Lotion. It is also not known whether Desonide Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Desonide Lotion should be given to a pregnant woman only if clearly needed.

Nursing mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonide Lotion is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%. Irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.

The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied Desonide Lotion can be absorbed in sufficient amounts to produce systemic effects (see  PRECAUTIONS)

Desonide Lotion Dosage and Administration

Desonide Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Desonide Lotion should not be used with occlusive dressings.

How is Desonide Lotion Supplied

Desonide Lotion 0.05% is supplied as follows:

2 fl oz bottle - NDC 0472-0803-02

4 fl oz bottle - NDC 0472-0803-04

Storage Conditions

Store between 2° and 30°C (36° and 86°F).

Distributed by:

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

Manufactured by

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

325097-0209     Revised: February 2009

Desonide Lotion 0.05% 4 fl oz - Front Label

Desonide Lotion 0.05% 4 fl oz - Back Label

Desonide Lotion 0.05% 2 fl oz - Front Label

Desonide Lotion 0.05% 2 fl oz - Back Label

DESONIDE  LOTION 0.05% Desonide Lotion 0.05%  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0472-0803 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESONIDE (DESONIDE) DESONIDE 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0472-0803-02 57.1 g In 1 BOTTLE, PLASTIC None 2 0472-0803-04 114.1 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072354	05/28/2009

Labeler - Actavis Mid Atlantic LLC, Lincolnton, NC 28092 (605461925)

Revised: 06/2009Actavis Mid Atlantic LLC, Lincolnton, NC 28092

More Desonide Lotion resources

• Desonide Lotion Side Effects (in more detail)
• Desonide Lotion Use in Pregnancy & Breastfeeding
• Desonide Lotion Drug Interactions
• Desonide Lotion Support Group
• 17 Reviews for Desonide - Add your own review/rating

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Hyaluronic Acid is reported as an ingredient of Suprahyal in the following countries:

• Peru

Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Suprahyal in the following countries:

• Brazil


• Chile


• Ecuador


• Mexico


• Venezuela

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Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Ostan in the following countries:

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Euceta may be available in the countries listed below.

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Aluminium Acetotartrate

Aluminium Acetotartrate is reported as an ingredient of Euceta in the following countries:

• Switzerland

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Pendine

Pendine may be available in the countries listed below.

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