Aciclovir Katwijk may be available in the countries listed below.
Ingredient matches for Aciclovir Katwijk
Acyclovir
Aciclovir is reported as an ingredient of Aciclovir Katwijk in the following countries:
- Netherlands
International Drug Name Search
Monday, 28 December 2009
Sunday, 27 December 2009
Folaren
Folaren may be available in the countries listed below.
Ingredient matches for Folaren
Calcium Folinate
Calcium Folinate is reported as an ingredient of Folaren in the following countries:
- Italy
International Drug Name Search
Friday, 25 December 2009
Hypnoforin
Hypnoforin may be available in the countries listed below.
Ingredient matches for Hypnoforin
Zolpidem
Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Hypnoforin in the following countries:
- Greece
International Drug Name Search
Thursday, 24 December 2009
Boinlil
Boinlil may be available in the countries listed below.
Ingredient matches for Boinlil
Tiapride
Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Boinlil in the following countries:
- Japan
International Drug Name Search
Wednesday, 23 December 2009
CellCept
CellCept is a brand name of mycophenolate mofetil, approved by the FDA in the following formulation(s):
CELLCEPT (mycophenolate mofetil - capsule; oral)
Manufacturer: ROCHE PALO
Approval date: May 3, 1995
Strength(s): 250MG [RLD][AB]
CELLCEPT (mycophenolate mofetil - suspension; oral)
Manufacturer: ROCHE PALO
Approval date: October 1, 1998
Strength(s): 200MG/ML [RLD]
CELLCEPT (mycophenolate mofetil - tablet; oral)
Manufacturer: ROCHE PALO
Approval date: June 19, 1997
Strength(s): 500MG [RLD][AB]
CELLCEPT (mycophenolate mofetil hydrochloride - injectable; injection)
Manufacturer: ROCHE PALO
Approval date: August 12, 1998
Strength(s): 500MG/VIAL [RLD]
Has a generic version of CellCept been approved?
A generic version of CellCept has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to CellCept and have been approved by the FDA:
mycophenolate mofetil capsule; oral
Manufacturer: ACCORD HLTHCARE INC
Approval date: May 4, 2009
Strength(s): 250MG [AB]
Manufacturer: APOTEX CORP
Approval date: April 22, 2009
Strength(s): 250MG [AB]
Manufacturer: DR REDDYS LABS LTD
Approval date: October 27, 2011
Strength(s): 250MG [AB]
Manufacturer: ENDO PHARMS
Approval date: December 22, 2009
Strength(s): 250MG [AB]
Manufacturer: MYLAN
Approval date: May 4, 2009
Strength(s): 250MG [AB]
Manufacturer: ROXANE
Approval date: July 29, 2008
Strength(s): 250MG [AB]
Manufacturer: SANDOZ
Approval date: October 15, 2008
Strength(s): 250MG [AB]
Manufacturer: STRIDES ARCOLAB LTD
Approval date: June 10, 2010
Strength(s): 250MG [AB]
Manufacturer: TEVA PHARMS
Approval date: May 6, 2009
Strength(s): 250MG [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: May 4, 2009
Strength(s): 250MG [AB]
mycophenolate mofetil tablet; oral
Manufacturer: ACCORD HLTHCARE
Approval date: May 4, 2009
Strength(s): 500MG [AB]
Manufacturer: ALKEM LABS LTD
Approval date: November 4, 2011
Strength(s): 500MG [AB]
Manufacturer: APOTEX
Approval date: April 22, 2009
Strength(s): 500MG [AB]
Manufacturer: ENDO PHARMS
Approval date: July 16, 2010
Strength(s): 500MG [AB]
Manufacturer: MYLAN
Approval date: May 4, 2009
Strength(s): 500MG [AB]
Manufacturer: ROXANE
Approval date: July 29, 2008
Strength(s): 500MG [AB]
Manufacturer: SANDOZ
Approval date: October 15, 2008
Strength(s): 500MG [AB]
Manufacturer: STRIDES ARCOLAB LTD
Approval date: June 10, 2010
Strength(s): 500MG [AB]
Manufacturer: TEVA PHARMS
Approval date: May 4, 2009
Strength(s): 500MG [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: May 4, 2009
Strength(s): 500MG [AB]
Note: No generic formulation of the following products are available.
- mycophenolate mofetil - suspension; oral
- mycophenolate mofetil hydrochloride - injectable; injection
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of CellCept. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Crystalline anhydrous mycophenolate mofetil and intravenous formulation thereof
Patent 5,543,408
Issued: August 6, 1996
Inventor(s): Fu; Roger C. & Leung; De-Mei & Fleitman; Jeffrey S. & Rizzolio; Michele C. & Miksztal; Andrew R.
Assignee(s): Syntex (U.S.A.) Inc.
The crystalline anhydrous salt formed by complexing mycophenolate mofetil with an anion selected from the group chloride, sulfate, phosphate and acetate (in particular the hydrochloride salt), and pharmaceutical compositions, intravenous formulations and a kit thereof, and associated methods of treatment.Patent expiration dates:
- September 15, 2013✓
- September 15, 2013
Mycophenolate mofetil high dose oral suspensions
Patent 5,688,529
Issued: November 18, 1997
Inventor(s): Lidgate; Deborah Marilyn & Wang-Kessler; Li-hua & Joshi; Bindu & Hegde; Sayee Gojanan & Gu; Leo
Assignee(s): Syntex (U.S.A) Inc.
High dose, dry granulations or powder blends and aqueous oral suspensions of mycophenolate mofetil or mycophenolic acid, contain: active compound (7.5-30%), suspending/viscosity agent, sweetener, flavor, buffer (to a pH of 5-7.5), and optionally contain flavor enhancer, wetting agent, antimicrobial agent and color.Patent expiration dates:
- November 18, 2014✓
- November 18, 2014
See also...
- Cellcept Consumer Information (Drugs.com)
- CellCept Consumer Information (Wolters Kluwer)
- CellCept Capsules Consumer Information (Wolters Kluwer)
- CellCept Solution Consumer Information (Wolters Kluwer)
- CellCept Suspension Consumer Information (Wolters Kluwer)
- CellCept Consumer Information (Cerner Multum)
- Cellcept Advanced Consumer Information (Micromedex)
- Cellcept Oral Advanced Consumer Information (Micromedex)
- Mycophenolate Mofetil Consumer Information (Wolters Kluwer)
- Mycophenolate Mofetil Capsules Consumer Information (Wolters Kluwer)
- Mycophenolate Mofetil Solution Consumer Information (Wolters Kluwer)
- Mycophenolate Mofetil Suspension Consumer Information (Wolters Kluwer)
- Mycophenolate mofetil Consumer Information (Cerner Multum)
- Mycophenolate Intravenous Advanced Consumer Information (Micromedex)
- Mycophenolate mofetil Advanced Consumer Information (Micromedex)
- Mycophenolate mofetil Oral, Intravenous Advanced Consumer Information (Micromedex)
- Mycophenolate AHFS DI Monographs (ASHP)
Friday, 18 December 2009
Betolvex
Betolvex may be available in the countries listed below.
Ingredient matches for Betolvex
Cyanocobalamin
Cyanocobalamin is reported as an ingredient of Betolvex in the following countries:
- Egypt
- Ethiopia
- Iceland
- Iraq
- Jordan
- Kuwait
- Lebanon
- Libya
- Norway
- Qatar
- Saudi Arabia
- Sudan
- Sweden
- United Arab Emirates
- Yemen
Cyanocobalamin complex with zinc tannate (a derivative of Cyanocobalamin) is reported as an ingredient of Betolvex in the following countries:
- Denmark
Cyanocobalamin tannate (a derivative of Cyanocobalamin) is reported as an ingredient of Betolvex in the following countries:
- Bahrain
- Egypt
- Iraq
- Jordan
- Kuwait
- Lebanon
- Libya
- Qatar
- Saudi Arabia
- Sudan
- Sweden
- Switzerland
- United Arab Emirates
- Yemen
International Drug Name Search
Wednesday, 16 December 2009
Kaptopril Alkaloid
Kaptopril Alkaloid may be available in the countries listed below.
Ingredient matches for Kaptopril Alkaloid
Captopril
Captopril is reported as an ingredient of Kaptopril Alkaloid in the following countries:
- Serbia
- Slovenia
International Drug Name Search
Saturday, 12 December 2009
Doxymina
Doxymina may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Doxymina
Doxycycline
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Doxymina in the following countries:
- Poland
International Drug Name Search
Risperidon Aristo
Risperidon Aristo may be available in the countries listed below.
Ingredient matches for Risperidon Aristo
Risperidone
Risperidone is reported as an ingredient of Risperidon Aristo in the following countries:
- Germany
International Drug Name Search
Friday, 11 December 2009
Regulacid
Regulacid may be available in the countries listed below.
Ingredient matches for Regulacid
Omeprazole
Omeprazole is reported as an ingredient of Regulacid in the following countries:
- Argentina
International Drug Name Search
Thursday, 10 December 2009
disopyramide
Generic Name: disopyramide (DYE soe PIR a mide)
Brand Names: Norpace, Norpace CR
What is disopyramide?
Disopyramide affects the way that your heart beats.
Disopyramide is used to treat seriously irregular heartbeat patterns.
Disopyramide may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about disopyramide?
Do not skip doses or change your dosing schedule without talking to your doctor. Changing your schedule could make your condition much worse. Use caution when driving, operating machinery, or performing other hazardous activities. Disopyramide may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Do not crush, chew, or break any controlled-release (CR) forms of disopyramide. Swallow them whole. They are specially formulated to release slowly in your body.
What should I discuss with my healthcare provider before taking disopyramide?
Before taking disopyramide, tell your doctor if you have
any other type of heart disease or heart problem,
- liver disease,
- kidney disease,
difficulty urinating or an enlarged prostate,
glaucoma, or
myasthenia gravis.
You may not be able to take disopyramide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
Disopyramide is in the FDA pregnancy category C. This means that it is not known whether disopyramide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Disopyramide passes into breast milk. It is not known whether disopyramide will affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
How should I take disopyramide?
Take disopyramide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Do not crush, chew, or break any controlled-release (CR) forms of disopyramide. Swallow them whole. They are specially formulated to release slowly in your body. Do not skip doses or change your dosing schedule without talking to your doctor. Changing your schedule could make your condition much worse. Store disopyramide at room temperature away from moisture and heat.
See also: Disopyramide dosage (in more detail)
What happens if I miss a dose?
Try not to miss any doses of this medication. Missing doses could be very dangerous.
If you do miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be dangerous.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of a disopyramide overdose include dry mouth and eyes, blurred vision, constipation, difficulty urinating, dizziness, worsening irregular heartbeats, loss of consciousness, and death.
What should I avoid while taking disopyramide?
Use caution when driving, operating machinery, or performing other hazardous activities. Disopyramide may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase side effects while you are taking disopyramide.
Follow any other special instructions given by your doctor regarding food, beverages, and activities.
Disopyramide side effects
If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
a new or a worsening irregular heartbeat pattern;
chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or
severe dizziness.
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience
mild dizziness or tiredness,
headache,
blurred vision,
dry mouth,
rash, itching,
muscle aches or pains, or
difficulty urinating.
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.
Disopyramide Dosing Information
Usual Adult Dose for Arrhythmias:
400-800 mg/day. The recommended dose for most adults is 600 mg/day. Patients Immediate-release form: The dose is divided and administered every 6 hours.
Extended-release form: The dose is divided and administered every 12 hours.
What other drugs will affect disopyramide?
Before taking disopyramide, tell your doctor if you are taking any of the following medications:
other medicines used to treat irregular heartbeats such as quinidine (Cardioquin, Quinora, others), amiodarone (Cordarone), bepridil (Vascor), procainamide (Pronestyl, Procan, Procanbid), and others;
a beta-blocker such as acebutolol (Sectral), propranolol (Inderal), metoprolol (Lopressor), carteolol (Cartrol), labetalol (Normodyne, Trandate), pindolol (Visken), nadolol (Corgard), and others;
erythromycin (E-Mycin, E.E.S., Ery-Tab, and others) or clarithromycin (Biaxin);
phenytoin (Dilantin);
phenobarbital (Solfoton, Luminal);
cisapride (Propulsid);
rifampin (Rimactane, Rifadin); or
warfarin (Coumadin).
You may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with disopyramide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More disopyramide resources
- Disopyramide Side Effects (in more detail)
- Disopyramide Dosage
- Disopyramide Use in Pregnancy & Breastfeeding
- Drug Images
- Disopyramide Drug Interactions
- Disopyramide Support Group
- 4 Reviews for Disopyramide - Add your own review/rating
- disopyramide Advanced Consumer (Micromedex) - Includes Dosage Information
- Disopyramide MedFacts Consumer Leaflet (Wolters Kluwer)
- Disopyramide Prescribing Information (FDA)
- Disopyramide Phosphate Monograph (AHFS DI)
- Norpace Prescribing Information (FDA)
- Norpace CR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
Compare disopyramide with other medications
- Arrhythmia
Where can I get more information?
- Your pharmacist can provide more information about disopyramide.
See also: disopyramide side effects (in more detail)
Wednesday, 9 December 2009
Uropol Forte N
Uropol Forte N may be available in the countries listed below.
Ingredient matches for Uropol Forte N
Phenazopyridine
Phenazopyridine hydrochloride (a derivative of Phenazopyridine) is reported as an ingredient of Uropol Forte N in the following countries:
- Peru
International Drug Name Search
Monday, 7 December 2009
Ketoconazol MK
Ketoconazol MK may be available in the countries listed below.
Ingredient matches for Ketoconazol MK
Ketoconazole
Ketoconazole is reported as an ingredient of Ketoconazol MK in the following countries:
- Colombia
- Costa Rica
- Ecuador
- Romania
International Drug Name Search
Sunday, 6 December 2009
Amoxicat
Amoxicat may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Amoxicat
Amoxicillin
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicat in the following countries:
- Switzerland
International Drug Name Search
Oneflex
Oneflex may be available in the countries listed below.
Ingredient matches for Oneflex
Cefalexin
Cefalexin is reported as an ingredient of Oneflex in the following countries:
- Philippines
International Drug Name Search
Wednesday, 2 December 2009
Serpalan
Ingredient matches for Serpalan
Reserpine
Reserpine is reported as an ingredient of Serpalan in the following countries:
- United States
International Drug Name Search
Saturday, 28 November 2009
Enidap
Enidap may be available in the countries listed below.
Ingredient matches for Enidap
Sertraline
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Enidap in the following countries:
- Greece
International Drug Name Search
Esomeprazole Magnesium
Esomeprazole Magnesium may be available in the countries listed below.
Ingredient matches for Esomeprazole Magnesium
Esomeprazole
Esomeprazole Magnesium (BAN, USAN) is known as Esomeprazole in the US.
International Drug Name Search
Glossary
| BAN | British Approved Name |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Supremon
Supremon may be available in the countries listed below.
Ingredient matches for Supremon
Buserelin
Buserelin acetate (a derivative of Buserelin) is reported as an ingredient of Supremon in the following countries:
- Taiwan
International Drug Name Search
Wednesday, 25 November 2009
Levam
Levam may be available in the countries listed below.
Ingredient matches for Levam
Levamisole
Levamisole hydrochloride (a derivative of Levamisole) is reported as an ingredient of Levam in the following countries:
- Argentina
International Drug Name Search
Tuesday, 24 November 2009
Hepanavit
Hepanavit may be available in the countries listed below.
Ingredient matches for Hepanavit
Silibinin
Silibinin is reported as an ingredient of Hepanavit in the following countries:
- Peru
International Drug Name Search
Mg Inresa
Mg Inresa may be available in the countries listed below.
Ingredient matches for Mg Inresa
Magnesium Sulfate
Magnesium Sulfate heptahydrate (a derivative of Magnesium Sulfate) is reported as an ingredient of Mg Inresa in the following countries:
- Germany
International Drug Name Search
Alve
Alve may be available in the countries listed below.
Ingredient matches for Alve
Tiemonium Methylsulfate
Tiemonium Methylsulfate is reported as an ingredient of Alve in the following countries:
- Bangladesh
International Drug Name Search
Sunday, 22 November 2009
Lisiken
Lisiken may be available in the countries listed below.
Ingredient matches for Lisiken
Clindamycin
Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Lisiken in the following countries:
- Mexico
International Drug Name Search
Friday, 20 November 2009
Norinyl T28
Norinyl T28 may be available in the countries listed below.
Ingredient matches for Norinyl T28
Ethinylestradiol
Ethinylestradiol is reported as an ingredient of Norinyl T28 in the following countries:
- Japan
Norethisterone
Norethisterone is reported as an ingredient of Norinyl T28 in the following countries:
- Japan
International Drug Name Search
Tuesday, 17 November 2009
Calcidia
Calcidia may be available in the countries listed below.
Ingredient matches for Calcidia
Calcium Carbonate
Calcium Carbonate is reported as an ingredient of Calcidia in the following countries:
- France
International Drug Name Search
Monday, 9 November 2009
Rhinox
Rhinox may be available in the countries listed below.
Ingredient matches for Rhinox
Oxymetazoline
Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Rhinox in the following countries:
- Norway
International Drug Name Search
Piroxicam Biogaran
Piroxicam Biogaran may be available in the countries listed below.
Ingredient matches for Piroxicam Biogaran
Piroxicam
Piroxicam is reported as an ingredient of Piroxicam Biogaran in the following countries:
- France
International Drug Name Search
Saturday, 7 November 2009
Pyopen
Pyopen may be available in the countries listed below.
Ingredient matches for Pyopen
Carbenicillin
Carbenicillin disodium salt (a derivative of Carbenicillin) is reported as an ingredient of Pyopen in the following countries:
- Bahrain
- Ethiopia
- Iran
- Kuwait
- Qatar
- United Arab Emirates
International Drug Name Search
Wednesday, 4 November 2009
Sulfametrole
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0032909-92-5
Chemical Formula
C9-H10-N4-O3-S2
Molecular Weight
286
Therapeutic Category
Antibacterial: Sulfonamid
Chemical Name
Benzenesulfonamide, 4-amino-N-(4-methoxy-1,2,5-thiadiazol-3-yl)-
Foreign Names
- Sulfametrolum (Latin)
- Sulfametrol (German)
- Sulfamétrole (French)
- Sulfametrol (Spanish)
Generic Names
- Sulfametrole (OS: BAN)
- Sulfamétrole (OS: DCF)
- ST 8005 (IS)
Brand Names
- Lidaprim Nycomed (Sulfametrole and Trimethoprim)
Nycomed, Austria - Lidaprim (Sulfametrole and Trimethoprim)
Alkaloid, Bosnia & Herzegowina; Novartis, Ghana; Novartis, Guyana; Novartis, Kenya; Novartis, Libya; Novartis, Nigeria; Novartis, Sudan; Novartis, Tanzania; Novartis, Zimbabwe; Nycomed, Austria; Nycomed, Estonia; Nycomed, Greece; Nycomed, Hong Kong; Nycomed, Latvia
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Benzoyl Peroxide Cleanser
Dosage Form: solution
Benzoyl Peroxide Cleanser 3%, 6% and 9%
Rx Only
Benzoyl Peroxide Cleanser Description
Benzoyl Peroxide Cleanser 3%, 6%, and 9% are topical, gel-based, benzoyl peroxide containing preparations for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.
Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:
Benzoyl Peroxide Cleanser 3%, 6% and 9% contain hydrous benzoyl peroxide 3%, 6% and 9% as the active ingredient in a vehicle consisting of: alpha olefin sulfonate, cetostearyl alcohol, glycerin, glyceryl monostearate SE, methylparaben, phosphoric acid, propylene glycol, sodium PCA, white petrolatum and purified water.
Benzoyl Peroxide Cleanser - Clinical Pharmacology
The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
Indications and Usage for Benzoyl Peroxide Cleanser
Benzoyl Peroxide Cleanser 3%, 6%, and 9% is indicated for the topical treatment of acne vulgaris.
Contraindications
These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
Warnings
When using this product, avoid unnecessary sun exposure and use a sunscreen.
Precautions
General
For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for patients
Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, mutagenesis, impairment of fertility
Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
Pregnancy
Teratogenic effects
Pregnancy Category C: Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.
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 benzoyl peroxide is administered to a nursing woman.
Pediatric use
Safety and effectiveness in children have not been established.
Adverse Reactions
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Overdosage
If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
Benzoyl Peroxide Cleanser Dosage and Administration
Benzoyl Peroxide Cleansers: Wash affected areas once or twice daily, or as directed by your dermatologist. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often.
How is Benzoyl Peroxide Cleanser Supplied
Benzoyl Peroxide Cleanser 3%
6 oz. (170 g) tube - NDC 68462-411-38
12 oz. (340 g) bottle - NDC 68462-411-34
Benzoyl Peroxide Cleanser 6%
6 oz. (170 g) tube - NDC 68462-412-38
12 oz. (340 g) bottle - NDC 68462-412-34
Benzoyl Peroxide Cleanser 9%
6 oz. (170 g) tube - NDC 68462-413-38
12 oz. (340 g) bottle - NDC 68462-413-34
Store at 15° to 25°C (59° to 77°F). [see USP Controlled Room Temperature].
Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Generics Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkgenerics.com
February 2009
3% Principal Display Panel
6% Principal Display Panel
9% Principal Display Panel
| BENZOYL PEROXIDE benzoyl peroxide solution | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/20/2009 | ||
| BENZOYL PEROXIDE benzoyl peroxide solution | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/20/2009 | ||
| BENZOYL PEROXIDE benzoyl peroxide solution | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/20/2009 | ||
| Labeler - Glenmark Generics Inc., USA (835917282) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Glenmark Generics Limited | 677318665 | ANALYSIS, MANUFACTURE | |
More Benzoyl Peroxide Cleanser resources
- Benzoyl Peroxide Cleanser Side Effects (in more detail)
- Benzoyl Peroxide Cleanser Use in Pregnancy & Breastfeeding
- Benzoyl Peroxide Cleanser Drug Interactions
- Benzoyl Peroxide Cleanser Support Group
- 15 Reviews for Benzoyl Peroxide - Add your own review/rating
- Acne Treatment Concise Consumer Information (Cerner Multum)
- Acne Treatment Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- BenzEFoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Benzac Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Benzac AC Wash MedFacts Consumer Leaflet (Wolters Kluwer)
- Brevoxyl Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Brevoxyl Creamy Wash Concise Consumer Information (Cerner Multum)
- Inova Pads MedFacts Consumer Leaflet (Wolters Kluwer)
- NeoBenz Micro Wash Plus Pack Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Oxy Balance Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- PanOxyl Bar MedFacts Consumer Leaflet (Wolters Kluwer)
- Triaz Cloths MedFacts Consumer Leaflet (Wolters Kluwer)
- Triazolam Monograph (AHFS DI)
Compare Benzoyl Peroxide Cleanser with other medications
- Acne
- Perioral Dermatitis
Thursday, 22 October 2009
Prolertus
Prolertus may be available in the countries listed below.
Ingredient matches for Prolertus
Diclofenac
Diclofenac resinate (a derivative of Diclofenac) is reported as an ingredient of Prolertus in the following countries:
- Ecuador
International Drug Name Search
Tuesday, 20 October 2009
Mucovital
Mucovital may be available in the countries listed below.
Ingredient matches for Mucovital
Carbocisteine
Carbocisteine lysine salt (a derivative of Carbocisteine) is reported as an ingredient of Mucovital in the following countries:
- Spain
International Drug Name Search
Rentylin
Rentylin may be available in the countries listed below.
Ingredient matches for Rentylin
Pentoxifylline
Pentoxifylline is reported as an ingredient of Rentylin in the following countries:
- Germany
- Luxembourg
International Drug Name Search
Saturday, 17 October 2009
Adglim
Adglim may be available in the countries listed below.
Ingredient matches for Adglim
Glimepiride
Glimepiride is reported as an ingredient of Adglim in the following countries:
- Bangladesh
International Drug Name Search
Friday, 16 October 2009
Enzoo Group
Enzoo Group may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Enzoo Group
Salicylic Acid
Salicylic Acid sodium (a derivative of Salicylic Acid) is reported as an ingredient of Enzoo Group in the following countries:
- France
Sulfaguanidine
Sulfaguanidine is reported as an ingredient of Enzoo Group in the following countries:
- France
International Drug Name Search
Thursday, 15 October 2009
Biravid
Biravid may be available in the countries listed below.
Ingredient matches for Biravid
Ofloxacin
Ofloxacin is reported as an ingredient of Biravid in the following countries:
- Ireland
International Drug Name Search
Zalkorub
Zalkorub may be available in the countries listed below.
Ingredient matches for Zalkorub
Benzalkonium Chloride
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Zalkorub in the following countries:
- Japan
International Drug Name Search
Tuesday, 13 October 2009
Ritaalumin
Ritaalumin may be available in the countries listed below.
Ingredient matches for Ritaalumin
Sucralfate
Sucralfate is reported as an ingredient of Ritaalumin in the following countries:
- Japan
International Drug Name Search
Saturday, 10 October 2009
Mebendazol
Mebendazol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Mebendazol
Mebendazole
Mebendazole is reported as an ingredient of Mebendazol in the following countries:
- Chile
- Colombia
- Netherlands
- Serbia
- Venezuela
International Drug Name Search
Tuesday, 6 October 2009
Bezafibrat Hexal
Bezafibrat Hexal may be available in the countries listed below.
Ingredient matches for Bezafibrat Hexal
Bezafibrate
Bezafibrate is reported as an ingredient of Bezafibrat Hexal in the following countries:
- Germany
- Luxembourg
International Drug Name Search
Monday, 5 October 2009
Winstrol V
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Winstrol V
Stanozolol
Stanozolol is reported as an ingredient of Winstrol V in the following countries:
- United States
International Drug Name Search
Friday, 2 October 2009
Acide édétique
Acide édétique may be available in the countries listed below.
Ingredient matches for Acide édétique
Edetic Acid
Acide édétique (DCF) is also known as Edetic Acid (Rec.INN)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Sunday, 27 September 2009
Leukerin
Leukerin may be available in the countries listed below.
Ingredient matches for Leukerin
Mercaptopurine
Mercaptopurine monohydrate (a derivative of Mercaptopurine) is reported as an ingredient of Leukerin in the following countries:
- Japan
International Drug Name Search
Saturday, 26 September 2009
Chlormezanone
In the US, Chlormezanone is a member of the drug class miscellaneous anxiolytics, sedatives and hypnotics.
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
M03BB02
CAS registry number (Chemical Abstracts Service)
0000080-77-3
Chemical Formula
C11-H12-Cl-N-O3-S
Molecular Weight
273
Therapeutic Categories
Anxiolytic agent
Hypnotic and sedative agent
Muscle relaxant
Chemical Names
(+-) - Chlormezanone
(+-) - Fenarol
2-(p-Chlorophenyl)tetrahydro-3-methyl-4H-1,3-thiazin-4-one 1,1-dioxide
4H-1,3-Thiazin-4-one, 2-(4-chlorophenyl)tetrahydro-3-methyl-, 1,1-dioxide
dl - Chlormezanone
Foreign Names
- Chlormezanonum (Latin)
- Chlormezanon (German)
- Chlormézanone (French)
- Clormezanona (Spanish)
Generic Names
- Chlormezanone (OS: JAN, DCIT, BAN)
- Chlormézanone (OS: DCF)
- Chlormethazanone (IS)
- NSC 169108 (IS)
- Win 4692 (IS)
Brand Names
- Chlormezanone NCPC
NCPC GeneTech, China - Clormezanona L.CH.
Chile, Chile - Clormezanona
Mintlab, Chile; Pasteur, Chile; Sanitas, Chile - Tranthison
Yu Sheng, Taiwan
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Alprazolam Arrow
Alprazolam Arrow may be available in the countries listed below.
Ingredient matches for Alprazolam Arrow
Alprazolam
Alprazolam is reported as an ingredient of Alprazolam Arrow in the following countries:
- France
International Drug Name Search
Friday, 25 September 2009
Penfluridol
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
N05AG03
CAS registry number (Chemical Abstracts Service)
0026864-56-2
Chemical Formula
C28-H27-Cl-F5-N-O
Molecular Weight
523
Therapeutic Category
Neuroleptic
Chemical Name
4-Piperidinol, 1-[4,4-bis(4-fluorophenyl)butyl]-4-[4-chloro-3-(trifluoromethyl)phenyl]-
Foreign Names
- Penfluridolum (Latin)
- Penfluridol (German)
- Penfluridol (French)
- Penfluridol (Spanish)
Generic Names
- Penfluridol (OS: BAN, USAN, DCF)
- McN-JR 16341 (IS)
- R 16341 (IS: Janssen)
- TLP 607 (IS: Tanabe)
Brand Names
- Flupidol
Janssen, Greece - Penfluridol Nhwa
Nhwa, China - Semap
Janssen, Belgium; Janssen, Brazil; Janssen, Cyprus; Janssen, Israel; Janssen, Lebanon; Janssen, Luxembourg; Janssen, Mexico; Janssen, Netherlands; Janssen, Saudi Arabia; Janssen, Sudan; Janssen, Yemen; Janssen-Cilag, United Arab Emirates; Janssen-Cilag, Denmark; Janssen-Cilag, Egypt; Janssen-Cilag, Jordan - Sémap
Janssen-Cilag, France
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Wednesday, 23 September 2009
Cendalon
Cendalon may be available in the countries listed below.
Ingredient matches for Cendalon
Letrozole
Letrozole is reported as an ingredient of Cendalon in the following countries:
- Argentina
International Drug Name Search
Sunday, 20 September 2009
Rogluten
Rogluten may be available in the countries listed below.
Ingredient matches for Rogluten
Aminoglutethimide
Aminoglutethimide is reported as an ingredient of Rogluten in the following countries:
- Romania
International Drug Name Search
Ceftrifin
Ceftrifin may be available in the countries listed below.
Ingredient matches for Ceftrifin
Ceftriaxone
Ceftriaxone is reported as an ingredient of Ceftrifin in the following countries:
- Russian Federation
International Drug Name Search
Saturday, 12 September 2009
Romiver
Romiver may be available in the countries listed below.
Ingredient matches for Romiver
Terbinafine
Terbinafine is reported as an ingredient of Romiver in the following countries:
- Greece
International Drug Name Search
Friday, 11 September 2009
Desloratadine Orally Disintegrating Tablets
Desloratadine Orally Disintegrating Tablets contain either 2.5 mg or 5 mg of desloratadine, an antihistamine, to be administered orally. Each tablet also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor.
Desloratadine is a white to off-white powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure :
Desloratadine Orally Disintegrating Tablets - Clinical Pharmacology
Mechanism of Action
Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro.
Results of a radiolabeled tissue distribution study in rats and a radioligand H1-receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier.
Pharmacokinetics
Absorption: Following oral administration of desloratadine 5 mg once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (Tmax) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC) of 4 ng/mL and 56.9 ng·hr/mL were observed, respectively. Neither food nor grapefruit juice had an effect on the bioavailability (Cmax and AUC) of desloratadine.
Water had no effect on the bioavailability (AUC and Cmax) of Desloratadine Orally Disintegrating Tablets.
Distribution:Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87% and 85% to 89%, bound to plasma proteins, respectively. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function.
Metabolism:Desloratadine (a major metabolite of loratadine) is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated. The enzyme(s) responsible for the formation of 3- hydroxydesloratadine have not been identified. Data from clinical trials indicate that a subset of the general population has a decreased ability to form 3-hydroxydesloratadine, and are poor metabolizers of desloratadine. In pharmacokinetic studies (n= 3,748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours). These pharmacokinetic studies included subjects between the ages of 2 and 70 years, including 977 subjects aged 2 to 5 years, 1,575 subjects aged 6 to 11 years, and 1,196 subjects aged 12 to 70 years. There was no difference in the prevalence of poor metabolizers across age groups. The frequency of poor metabolizers was higher in Blacks (17%, n=988) as compared to Caucasians (2%, n=1,462) and Hispanics (2%, n=1,063). The median exposure (AUC) to desloratadine in the poor metabolizers was approximately 6-fold greater than in the subjects who are not poor metabolizers. Subjects who are poor metabolizers of desloratadine cannot be prospectively identified and will be exposed to higher levels of desloratadine following dosing with the recommended dose of desloratadine. Although not seen in these studies, an increased risk of exposure-related adverse events in patients who are poor metabolizers cannot be ruled out.
Elimination:The mean elimination half-life of desloratadine was 27 hours. Cmax and AUC values increased in a dose proportional manner following single oral doses between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14C-desloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxydesloratadine showed similar Tmax and half-life values compared to desloratadine.
Special Populations
Geriatric: In older subjects (≥ 65 years old; n=17) following multiple-dose administration of desloratadine tablets, the mean Cmax and AUC values for desloratadine were 20% greater than in younger subjects (<65 years old). The oral total body clearance (CL/F) when normalized for body weight was similar between the two age groups.The mean plasma elimination half-life of desloratadine was 33.7 hr in subjects ≥ 65 years old. The pharmacokinetics for 3-hydroxydesloratadine appeared unchanged in older versus younger subjects. These age-related differences are unlikely to be clinically relevant and no dosage adjustment is recommended in elderly subjects.
Pediatric Subjects: In subjects 6 to 11 years old, a single dose of 5 mL of desloratadine syrup containing 2.5 mg of desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg desloratadine tablet. In subjects 2 to 5 years old, a single dose of 2.5 mL of desloratadine syrup containing 1.25 mg of desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg desloratadine tablet. However, the Cmax and AUCt of the metabolite (3-OH desloratadine) were 1.27 and 1.61 times higher for the 5 mg dose of syrup administered in adults compared to the Cmax and AUCt obtained in children 2 to 11 years of age receiving 1.25 to 2.5 mg of desloratidine syrup.
A single dose of either 2.5 mL or 1.25 mL of desloratadine syrup containing 1.25 mg or 0.625 mg, respectively, of desloratadine was administered to subjects 6 to 11 months of age and 12 to 23 months of age. The results of a population pharmacokinetic analysis indicated that a dose of 1 mg for subjects aged 6 to 11 months and 1.25 mg for subjects 12 to 23 months of age is required to obtain desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg dose of desloratadine syrup.
The 2.5 mg desloratadine orally disintegrating tablet has not been evaluated in pediatric patients. In conjunction with the dose finding studies in pediatrics described, the pharmacokinetic data for Desloratadine Orally Disintegrating Tablets supports the use of the 2.5 mg dose strength in pediatric patients 6 to 11 years of age.
Renally Impaired: DESLORATADINE pharmacokinetics following a single dose of 7.5 mg were characterized in patients with mild (n=7; creatinine clearance 51 to 69 mL/min/1.73 m2), moderate (n=6; creatinine clearance 34 to 43 mL/min/1.73 m2), and severe (n=6; creatinine clearance 5 to 29 mL/min/1.73 m2) renal impairment or hemodialysis dependent (n=6) patients. In patients with mild and moderate renal impairment, median Cmax and AUC values increased by approximately 1.2- and 1.9-fold, respectively, relative to subjects with normal renal function. In patients with severe renal impairment or who were hemodialysis dependent, Cmax and AUC values increased by approximately 1.7- and 2.5-fold, respectively. Minimal changes in 3-hydroxydesloratadine concentrations were observed. Desloratadine and 3-hydroxydesloratadine were poorly removed by hemodialysis. Plasma protein binding of desloratadine and 3-hydroxydesloratadine was unaltered by renal impairment. Dosage adjustment for patients with renal impairment is recommended (see DOSAGE AND ADMINISTRATION).
Hepatically Impaired:Desloratadine pharmacokinetics were characterized following a single oral dose in patients with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment as defined by the Child-Pugh classification of hepatic function and eight subjects with normal hepatic function. Patients with hepatic impairment, regardless of severity, had approximately a 2.4-fold increase in AUC as compared with normal subjects. The apparent oral clearance of desloratadine in patients with mild, moderate, and severe hepatic impairment was 37%, 36%, and 28% of that in normal subjects, respectively. An increase in the mean elimination half-life of desloratadine in patients with hepatic impairment was observed. For 3-hydroxydesloratadine, the mean Cmax and AUC values for patients with hepatic impairment were not statistically significantly different from subjects with normal hepatic function. Dosage adjustment for patients with hepatic impairment is recommended (see DOSAGE AND ADMINISTRATION).
Gender
Female subjects treated for 14 days with desloratadine tablets had 10% and 3% higher desloratadine Cmax and AUC values, respectively, compared with male subjects. The 3-hydroxydesloratadine Cmax and AUC values were also increased by 45% and 48%, respectively, in females compared with males. However, these apparent differences are not likely to be clinically relevant and therefore no dosage adjustment is recommended.
Race
Following 14 days of treatment with desloratadine tablets, the Cmax and AUC values for desloratadine were 18% and 32% higher, respectively, in Blacks compared with Caucasians. For 3-hydroxydesloratadine there was a corresponding 10% reduction in Cmax and AUC values in Blacks compared to Caucasians. These differences are not likely to be clinically relevant and therefore no dose adjustment is recommended.
Drug Interactions
In two controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) and female (n=12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days. In three separate controlled, parallel group clinical pharmacology studies, desloratadine at the clinical dose of 5 mg has been coadministered with azithromycin 500 mg followed by 250 mg once daily for 4 days (n=18) or with fluoxetine 20 mg once daily for 7 days after a 23 day pretreatment period with fluoxetine (n=18) or with cimetidine 600 mg every 12 hours for 14 days (n=18) under steady-state conditions to normal healthy male and female volunteers. Although increased plasma concentrations (Cmax and AUC0-24 hrs) of desloratadine and 3-hydroxydesloratadine were observed (see Table 1), there were no clinically relevant changes in the safety profile of desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval), clinical laboratory tests, vital signs, and adverse events.
Table 1
| Desloratadine | 3-Hydroxydesloratadine | |||
| Cmax AUC 0-24 hrs | Cmax AUC 0-24 hrs | |||
| Erythromycin | + 24% | +14% | + 43% | + 40% |
| (500 mg Q8h) | ||||
| Ketoconazole | + 45% | + 39% | + 43% | + 72% |
| (200 mg Q12h) | ||||
| Azithromycin | + 15% | + 5% | + 15% | + 4% |
| (500 mg day | ||||
| 1, 250 mg QD x 4 days) | ||||
| Fluoxetine | + 15% | + 0% | + 17% | + 13% |
| (20 mg QD) | ||||
| Cimetidine | + 12% | + 19% | - 11% | - 3% |
| (600 mg Q12h) | ||||
Pharmacodynamics
Wheal and Flare:Human histamine skin wheal studies following single and repeated 5 mg doses of desloratadine have shown that the drug exhibits an antihistaminic effect by one hour; this activity may persist for as long as 24 hours. There was no evidence of histamine-induced skin wheal tachyphylaxis within the desloratadine 5 mg group over the 28 day treatment period. The clinical relevance of histamine wheal skin testing is unknown.
Effects on QTc:Single dose administration of desloratadine did not alter the corrected QT interval (QTc) in rats (up to 12 mg/kg, oral), or guinea pigs (25 mg/kg, intravenous). Repeated oral administration at doses up to 24 mg/kg for durations up to 3 months in monkeys did not alter the QTc at an estimated desloratadine exposure (AUC) that was approximately 955 times the mean AUC in humans at the recommended daily oral dose. See OVERDOSAGE section for information on human QTc experience.
Clinical Trials
Seasonal Allergic Rhinitis:The clinical efficacy and safety of desloratadine tablets were evaluated in over 2,300 patients 12 to 75 years of age with seasonal allergic rhinitis. A total of 1,838 patients received 2.5 to 20 mg/day of desloratadine in four double-blind, randomized, placebo-controlled clinical trials of 2 to 4 weeks duration conducted in the United States. The results of these studies demonstrated the efficacy and safety of desloratadine 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. In a dose ranging trial, desloratadine 2.5 to 20 mg/day was studied. Doses of 5, 7.5, 10, and 20 mg/day were superior to placebo; and no additional benefit was seen at doses above 5 mg. In the same study, an increase in the incidence of somnolence was observed at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3 %).
In two 4 week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and concomitant asthma, desloratadine tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering desloratadine tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma.
Desloratadine tablets 5 mg once daily significantly reduced the Total Symptom Scores (the sum of individual scores of nasal and non-nasal symptoms) in patients with seasonal allergic rhinitis. See Table 2.
Table 2
TOTAL SYMPTOM SCORE (TSS)
Changes in a 2 Week Clinical
Trial in Patients with Seasonal Allergic Rhinitis
| Treatment Group (n) | Mean Baseline* (sem) | Change from Baseline** (sem) | Placebo Comparison (P- value) | |
| Desloratadine | 14.2 | (0.3) | -4.3 (0.3) | P<0.01 |
| 5 mg (171) | ||||
| Placebo (173) | 13.7 | (0.3) | -2.5 (0.3) | |
| *At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) was required for trial eligibility. TSS ranges from 0=no symptoms to 24=maximal symptoms. **Mean reduction in TSS averaged over the 2 week treatment period. | ||||
There were no significant differences in the effectiveness of desloratadine tablets 5 mg across subgroups of patients defined by gender, age, or race.
Perennial Allergic Rhinitis:The clinical efficacy and safety of desloratadine tablets 5 mg were evaluated in over 1,300 patients 12 to 80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/day of desloratadine in two double blind, randomized, placebo controlled clinical trials of 4 weeks duration conducted in the United States and internationally. In one of these studies desloratadine tablets 5 mg once daily was shown to significantly reduce symptoms of perennial allergic rhinitis (Table 3).
Table 3
TOTAL SYMPTOM SCORE (TSS)
Changes in a 4 Week Clinical
Trial in Patients with Perennial Allergic Rhinitis
| Treatment Group(n) | Mean Baseline* (sem) | Change from Baseline**(sem) | Placebo Comparison (P- value) | ||
| Desloratadine | 12.37 | (0.18) | -4.06 (0.21) | P=0.01 | |
| 5 mg (337) | |||||
| Placebo (337) | 12.30 | (0.18) | -3.27 (0.21) | ||
| *At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms, each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) of at least 10 was required for trial eligibility. TSS ranges from 0=no symptoms to 24=maximal symptoms. **Mean reduction in TSS averaged over the 4-week treatment period. | |||||
Indications and Usage for Desloratadine Orally Disintegrating Tablets
Seasonal Allergic Rhinitis: Desloratadine Orally Disintegrating Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 6 years of age and older.
Perennial Allergic Rhinitis: Desloratadine Orally Disintegrating Tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 years of age and older.
Contraindications
Desloratadine Orally Disintegrating Tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine.
Precautions
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2 year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated desloratadine and desloratadine metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of desloratadine is not known.
In a 2 year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated desloratadine and metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.
In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in two assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).
There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine exposures were approximately 45 times the AUC in humans at the recommended daily oral dose).Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
Pregnancy: Category C
Desloratadine was not teratogenic in rats at doses up to 48 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). Reduced body weight and slow righting reflex were reported in pups at doses of 9 mg/kg/day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on pup development at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.
Nursing Mothers
Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.
Pediatric Use
The 2.5 mg desloratadine orally disintegrating tablet has not been evaluated in pediatric patients. In conjunction with the dose finding studies in pediatrics described, the pharmacokinetic data for Desloratadine Orally Disintegrating Tablets supports the use of the 2.5 mg dose strength in pediatric patients 6 to 11 years of age.
Geriatric Use
Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (see CLINICAL PHARMACOLOGY- Special Populations).
Information for Patients
Patients should be instructed to use desloratadine tablets as directed. As there are no food effects on bioavailability, patients can be instructed that Desloratadine Orally Disintegrating Tablets may be taken without regard to meals. Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
Phenylketonurics: Desloratadine Orally Disintegrating Tablets contain phenylalanine 2.55 mg per 5 mg desloratadine orally disintegrating tablet or 1.28 mg per 2.5 mg desloratadine orally disintegrating tablet.
Adverse Reactions
Adults and Adolescents
Allergic Rhinitis:In multiple-dose placebo-controlled trials, 2,834 patients ages 12 years or older received desloratadine tablets at doses of 2.5 mg to 20 mg daily, of whom 1,655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the desloratadine group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of desloratadine tablets (5 mg once-daily), and that were more common with desloratadine tablets than placebo, are listed in Table 4.
Table 4
Incidence of Adverse Events Reported by ï€ 2% or More of Adult and Adolescent Allergic Rhinitis Patients in Placebo-Controlled, Multiple-Dose Clinical Trials with the Tablet Formulation of Desloratadine
| Adverse Experience | Desloratadine Tablets 5 mg(n=1,655) | Placebo (n=1,652) |
| Pharyngitis | 4.1% | 2.0% |
| Dry Mouth | 3.0% | 1.9% |
| Myalgia | 2.1% | 1.8% |
| Fatigue | 2.1% | 1.2% |
| Somnolence | 2.1% | 1.8% |
| Dysmenorrhea | 2.1% | 1.6% |
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
Pediatrics
Two hundred and forty-six pediatric subjects 6 months to 11 years of age received desloratadine for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1 mg once a day. In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects. In subjects 2 to 5 years of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving desloratadine and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%). In subjects 12 months to 23 months of age, adverse events reported for the desloratadine product and placebo in at least 2 percent of subjects receiving desloratadine and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4% 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased ( 3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection, (3.1%, 0%) pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%). In subjects 6 months to 11 months of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving desloratadine and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7.% 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%) coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3%, 1.6%), and nausea (3%, 0%). There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving desloratadine in the clinical trials discontinued treatment because of an adverse event.
Observed During Clinical Practice
The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.
DRUG ABUSE AND DEPENDENCE
There is no information to indicate that abuse or dependency occurs with desloratadine tablets.
Overdosage
Information regarding acute overdosage is limited to experience from clinical trials conducted during the development of the desloratadine product. In a dose ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported.
Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. In desloratadine-treated subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo. The QT interval was corrected for heart rate (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there was a mean increase of 8.1 msec in desloratadine-treated subjects relative to placebo. Using QTc (Fridericia) there was a mean increase of 0.4 msec in desloratadine-treated subjects relative to placebo. No clinically relevant adverse events were reported.
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated desloratadine exposures were approximately 290 times the human daily oral dose on a mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).
Desloratadine Orally Disintegrating Tablets Dosage and Administration
Adults and Children 12 years of Age and Over: The recommended dose of Desloratadine Orally Disintegrating Tablets is one 5 mg tablet once daily.
Children 6 to 11 Years of Age: The recommended dose of Desloratadine Orally Disintegrating Tablets is one 2.5 mg tablet once daily.
NOTE: Desloratadine Orally Disintegrating Tablets are not recommended for use in pediatric patients under 6 years of age as desloratadine syrup is better suited for these patients.
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.
Administration of Desloratadine Orally Disintegrating Tablets: Place desloratadine orally disintegrating tablet on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.
How is Desloratadine Orally Disintegrating Tablets Supplied
Desloratadine Orally Disintegrating Tablets 2.5 mg: Desloratadine tablets 2.5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side and are supplied in unit dose packages of 30 (5 x 6).
Unit dose packages of 30 (5 x 6) NDC 55111-551-31
Desloratadine Orally Disintegrating Tablets 5 mg: Desloratadine tablets 5 mg are light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side and are supplied unit dose packages of 30 (5 x 6).
Unit dose packages of 30 (5 x 6) NDC 55111-360-31
Store orally disintegrating tablets at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Rx Only
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli – 502 325 INDIA
Issued: 1207
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
2.5 mg : Unit dose package 30 (5x6)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
5 mg : Unit dose package 30 (5x6)
| DESLORATADINE desloratadine tablet, orally disintegrating | ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA078367 | 01/01/2012 | |
| DESLORATADINE desloratadine tablet, orally disintegrating | ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA078367 | 01/01/2012 | |
| Labeler - Dr. Reddy's Laboratories Limited (862179079) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Dr. Reddy's Laboratories Limited - FTO III | 918608162 | analysis, manufacture | |
Subscribe to:
Comments (Atom)