Rosadan
Medimetriks Pharmaceuticals inc.

Rosadan® GEL Metronidazole Gel USP, 0.75%

ROSADAN- metronidazole gel 
ROSADAN- metronidazole   
Medimetriks Pharmaceuticals, Inc.

Rosadan® GEL
Metronidazole Gel USP, 0.75%

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Rx Only

2DESCRIPTION

Rosadan® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent.

Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

Chemical Structure

3CLINICAL PHARMACOLOGY

Bioavailability studies on the topical administration of 1 gram of Rosadan® (metronidazole) Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which Rosadan® (metronidazole) Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

4INDICATIONS AND USAGE

Rosadan® (metronidazole) Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

5CONTRAINDICATIONS

Rosadan® (metronidazole) Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

6PRECAUTIONS

6.1General

Metronidazole Gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

6.2Information for patients

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

6.3Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

6.4Carcinogenesis, mutagenesis, impairment of fertility

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

6.5Pregnancy

6.5.1Teratogenic effects

6.5.1.1Pregnancy category B

There has been no experience to date with the use of Metronidazole Gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

6.6Nursing mothers

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though Metronidazole Gel blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

6.7Pediatric use

Safety and effectiveness in pediatric patients have not been established.

7ADVERSE REACTIONS

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

8DOSAGE AND ADMINISTRATION

Apply and rub in a thin film of Rosadan® (metronidazole) Gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of Rosadan® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan® (metronidazole) Gel.

9HOW SUPPLIED

Rosadan® (metronidazole) Gel is supplied in a 45 g tube – NDC 43538-182-45.

9.1Storage conditions

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

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402
www.medimetriks.com

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

8-0637BFMDM1
Issued 02/12

IPO24-R1

11PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

MEDIMETRIKS
PHARMACEUTICALS, INC.

NDC 43538-182-45

Rx Only
Rosadan® GEL
Metronidazole Gel USP, 0.75%

NET WT 45 g

Principal Display Panel - 45 g Tube Carton

12PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-183-45

Rx Only
Rosadan®
Metronidazole Gel USP, 0.75%
GEL KIT

CONTENTS:
1-
Rosadan®
Metronidazole Gel USP,
0.75% Tube (Net wt. 45 g)
1-
Rehyla ™ Wash
Moisturizing Daily Wash
Bottle (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.

Principal Display Panel - Kit Carton
ROSADAN 
metronidazole gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-182
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
edetate disodium  
methylparaben  
propylene glycol  
propylparaben  
water  
sodium hydroxide  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:43538-182-45 1 in 1 CARTON
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078178 04/15/2012
ROSADAN 
metronidazole kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-183
Packaging
# Item Code Package Description
1 NDC:43538-183-45 1 in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 45 g
Part 2 1 BOTTLE, PUMP 454 g
Part 1 of 2
ROSADAN 
metronidazole gel
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
edetate disodium  
methylparaben  
propylene glycol  
propylparaben  
water  
sodium hydroxide  
Packaging
# Item Code Package Description
1 1 in 1 CARTON
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078178 04/15/2012
Part 2 of 2
REHYLA WASH 
cleansing (cold creams, cleansing lotions, liquids, and pads)
Product Information
Route of Administration TOPICAL DEA Schedule     
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR water  
INGR glyceryl monostearate  
INGR glycerin  
INGR cetyl alcohol  
INGR disodium oleamido mipa-sulfosuccinate  
INGR cholesterol  
INGR disodium laureth sulfosuccinate  
INGR caprylyl glycol  
INGR propylene glycol  
INGR phenoxyethanol  
INGR sodium cocoyl isethionate  
INGR cocamidopropyl betaine  
INGR sodium methyl cocoyl taurate  
INGR C13-14 isoparaffin  
INGR sodium chloride  
INGR niacinamide  
INGR edetate disodium  
INGR hexylene glycol  
INGR laureth-7  
INGR chamaemelum nobile flower  
INGR hyaluronate sodium  
Packaging
# Item Code Package Description
1 1 in 1 CARTON
1 454 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078178 08/01/2011
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
Name Address ID/FEI Business Operations
G&W Laboratories 001271188 MANUFACTURE

Revised: 04/2012
 
Medimetriks Pharmaceuticals, Inc.

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