Metronidazole
Generic: METRONIDAZOLE
Basic Information
Manufacturer
Mayne Pharma Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
3c25a3f9-52fc-448e-a044-f63b9dadcd4a
Indications & Usage
1 INDICATIONS AND USAGE Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.
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Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.
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Adverse Reactions
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 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 6.1 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 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.
6.2 Post 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
( 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 6.1 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 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.
6.2 Post 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