METROGEL

METROGEL — metronidazole gel
Galderma Laboratories, L.P.

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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

For topical use only, not for oral, ophthalmic, or intravaginal use
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.

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 reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of METROGEL therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.

5.2 Blood Dyscrasias

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

5.3 Contact Dermatitis

Irritant and allergic contact dermatitis have been reported with METROGEL. If dermatitis occurs, patients may need to discontinue use.

5.4 Eye Irritation

Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.

6 ADVERSE REACTIONS

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.

Table 1: Adverse Reactions That Occurred at a Rate of ≥1%
System Organ Class/Preferred Term METROGEL Gel Vehicle
N= 557 N= 189
Patients with at least one AE Number (%) of Patients 186 (33.4) 51 (27.0)
Infections and infestations 76 (13.6) 28 (14.8)
Bronchitis 6 (1.1) 3 (1.6)
Influenza 8 (1.4) 1 (0.5)
Nasopharyngitis 17 (3.1) 8 (4.2)
Sinusitis 8 (1.4) 3 (1.6)
Upper respiratory tract infection 14 (2.5) 4 (2.1)
Urinary tract infection 6 (1.1) 1 (0.5)
Vaginal mycosis 1 (0.2) 2 (1.1)
Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6)
Back pain 3 (0.5) 2 (1.1)
Neoplasms 4 (0.7) 2 (1.1)
Basal cell carcinoma 1 (0.2) 2 (1.1)
Nervous system disorders 18 (3.2) 3 (1.6)
Headache 12 (2.2) 1 (0.5)
Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6)
Nasal congestion 6 (1.1) 3 (1.6)
Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3)
Contact dermatitis 7 (1.3) 1 (0.5)
Dry skin 6 (1.1) 3 (1.6)
Vascular disorders 8 (1.4) 1 (0.5)
Hypertension 6 (1.1) 1 (0.5)
Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline
METROGEL Gel Vehicle
Sign/Symptom N= 544 N= 184
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.

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