METROGEL Gel (2023)

Βιβλιογραφική αναφορά

Συγγραφείς

Galderma Laboratories, L.P.

Λέξεις κλειδιά

0299-3820

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1. Indications and Usage

METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.

2. Dosage and Administration

Cleanse treated areas before the application of METROGEL. Apply and rub in a thin film of METROGEL once daily to affected area(s). Cosmetics may be applied after the application of METROGEL. For topical ...

3. Dosage Forms and Strengths

Gel, 1%. METROGEL is a clear, colorless to pale yellow gel. Each gram of METROGEL contains 10 mg (1%) of metronidazole.

4. Contraindications

METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.

5. Warnings and Precautions

5.1 Neurologic Disease Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Neurologic Disease [see Warnings and Precautions (5.1)] Contact Dermatitis [see Warnings and ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reaction has been identified during post-approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always ...

7. Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when prescribing for patients who are ...

8.1. Pregnancy

Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity ...

8.2. Lactation

Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. ...

8.4. Pediatric Use

Safety and effectiveness of METROGEL have not been established in pediatric patients.

8.5. Geriatric Use

Sixty-six subjects aged 65 years and older were treated with METROGEL in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, ...

11. Description

METROGEL (metronidazole) topical gel, 1% is a nitroimidazole for topical use. METROGEL is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole ...

12.1. Mechanism of Action

The mechanism of action of metronidazole in the treatment of rosacea is unknown.

12.2. Pharmacodynamics

The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology The effect of METROGEL on the QTc interval has not been adequately characterized. ...

12.3. Pharmacokinetics

Topical administration of a one-gram dose of METROGEL to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean + SD Cmax of metronidazole of 32 + 9 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Metronidazole has shown evidence of carcinogenic activity in studies involving chronic oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, ...

14. Clinical Studies

In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with METROGEL or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 (moderate) on the 5-point ...

16.1. How Supplied

METROGELis clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0299-3820-60 Marketed by: Galderma Laboratories, L.P., Dallas, TX 75201 USA

16.2. Storage and Handling

Store at controlled room temperature: 20˚ to 25˚C (68˚ to 77˚F), excursions permitted between 15˚ and 30˚C (59˚ and 86˚F).