Metrogel (metronidazole): FDA label

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Contraindications

Metronidazole Gel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Metronidazole Gel is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. ( 4 )

Warnings and precautions

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 reported with the post approval use of topical metronidazole. Immediately reevaluate Metronidazole Gel if abnormal neurologic signs appear. ( 5.1 ) Blood Dyscrasias: Metronidazole Gel is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.

( 5.2 ) Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. ( 5.3 ) Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes. ( 5.4 )

5.1Neurologic Disease

Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediately reevaluate Metronidazole Gel therapy if abnormal neurologic signs appear. Administer metronidazole with caution to patients with central nervous system diseases.

5.2Blood Dyscrasias

Metronidazole is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.

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 Precautions (5.3)] Eye Irritation [see Warnings and Precautions (5.4)] Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma, at 1-844-825-8500, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical 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 drug and may not reflect the rates observed in practice. In a controlled clinical trial, 557 subjects used Metronidazole Gel and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1% and at a higher rate than vehicle: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% and Higher Than Vehicle in Subjects Treated with Metronidazole Gel for Up to 10 Weeks Preferred Term Metronidazole Gel Gel Vehicle Influenza 8 (1.4) 1 (0.5) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Headache 12 (2.2) 1 (0.5) Contact dermatitis 7 (1.3) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline in Subjects Treated with Metronidazole Gel for Up to 10 Weeks Metronidazole Gel Gel Vehicle Sign/Symptom N= 544 N (%) N= 184 N (%) Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5) The following additional adverse experiences have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.

6.2Post Marketing 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 possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Nervous System Disorders: Peripheral neuropathy Ophthalmic Adverse Reactions: Tearing of the eyes

Metrogel

Indications

Contraindications

Warnings and precautions

5.1Neurologic Disease

5.2Blood Dyscrasias

Two medicines in one question?

5.3Contact Dermatitis Irritant

5.4Eye Irritation

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Post Marketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines