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METROGELŪ …
Tags: ethanol, global assessment, imidazole, inflammatory lesions, locf, metrogel, metronidazole, molecular formula, molecular weight, ophthalmic, structural formula, topical use, usp,Pages: 2
Language: english
Created: Fri Jul 1 13:41:36 2005
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METROGELŪ Week-10, mean count 8.9 12.8
(metronidazole gel), 1% Reduction 50.7% 32.6% 885 mg/m2/day (144 times the human dose).
4 Severe Severe erythema. Numerous small and/or large papules/pustules, Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a
up to several nodules dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An
increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease
The results are shown in the following table: who were treated with 200 to1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no
increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn's disease treat-
Inflammatory Lesion Counts and Global Scores in a Clinical Trial for Rosacea ed with the drug for 8 months.
In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45
METROGELŪ 1% Vehicle p-value mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in
ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies
N Results N (%) N Results N (%)
have been performed with METROGELŪ (metronidazole gel), 1% or any marketed metronidazole formulations.
Inflammatory lesions 557 189 Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the
use of METROGELŪ (metronidazole gel), 1% in pregnant women.
Baseline, mean count 18.3 18.4
Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after The following table summarizes the highest scores of local cutaneous signs and symptoms of irritation that were
oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. worse than baseline:
However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not
always predictive of human response, METROGELŪ (metronidazole gel), 1% should be used during pregnancy only if Metronidazole Gel, 1% Gel Vehicle
clearly needed. Sign/Symptom N= 544 N=184
Nursing Mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to
those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly Dryness 138 (25.4) 63 (34.2)
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 and the risk to the infant. Mild 93 (17.1) 41 (22.3)
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: While specific clinical trials in the geriatric population have not been conducted, sixty-six patients aged Moderate 42 (7.7) 20 (10.9)
65 years and older treated with METROGELŪ (metronidazole gel), 1% over ten weeks showed comparable safety and Severe 3 (0.6) 2 (1.1)
efficacy as compared to the general study population.
ADVERSE REACTIONS Scaling 134 (24.6) 60 (32.6)
In a controlled clinical trial, 557 patients used METROGELŪ (metronidazole gel), 1% and 189 patients used the gel
vehicle once daily. The following table summarizes adverse reactions that occur at a rate of 1% in the clinical trials: Mild 88 (16.2) 32 (17.4)
System Organ Class/Preferred Term Metronidazole Gel, 1% Gel Vehicle Moderate 43 (7.9) 27 (14.7)
N= 557 N=189 Severe 3 (0.6) 1 (0.5)
Patients with at least one AE Number (%) of Patients 186 (33.4) 51 (27.0) Pruritus 86 (15.8) 35 (19.0)
Infections and infestations 76 (13.6) 28 (14.8) Mild 53 (9.7) 21 (11.4)
Bronchitis 6 (1.1) 3 (1.6) Moderate 27 (5.0) 13 (7.1)
Influenza 8 (1.4) 1 (0.5) Severe 6 (1.1) 1 (0.5)
Nasopharyngitis 17 (3.1) 8 (4.2) Stinging/burning 56 (10.3) 28 (15.2)
Sinusitis 8 (1.4) 3 (1.6) Mild 39 (7.2) 18 (9.8)
Upper respiratory tract infection 14 (2.5) 4 (2.1) Moderate 7 (1.3) 9 (4.9)
Urinary tract infection 6 (1.1) 1 (0.5) Severe 10 (1.8) 1 (0.5)
Vaginal mycosis 1 (0.2) 2 (1.1) The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation,
transient redness, metallic taste, tingling or numbness of extremities, and nausea.
Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6) OVERDOSAGE: There are no reported human experiences with overdosage of METROGELŪ (metronidazole gel), 1%.
Back pain 3 (0.5) 2 (1.1) Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects.
DOSAGE AND ADMINISTRATION: Areas to be treated should be cleansed before application of METROGELŪ (metron-
Neoplasms 4 (0.7) 2 (1.1) idazole gel), 1%. Apply and rub in a thin film of METROGELŪ (metronidazole gel), 1% once daily to entire affected
area(s). Patients may use cosmetics after application of METROGELŪ (metronidazole gel), 1%.
Basal cell carcinoma 1 (0.2) 2 (1.1) HOW SUPPLIED: METROGELŪ (metronidazole gel), 1% is available in a 45-gram tube.
Nervous system disorders 18 (3.2) 3 (1.6) 45 gram tube NDC 0299-3820-45
Keep out of the reach of children.
Headache 12 (2.2) 1 (0.5) Storage Conditions: Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between
59° and 86°F (15°-30°C).
Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6) Prescribing Information as of June 2005.
Nasal congestion 6 (1.1) 3 (1.6) Rx Only
US Patent No. 6,881,726
Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3) Manufactured by:
Contact dermatitis 7 (1.3) 1 (0.5) Galderma Production Canada Inc.
Montreal, QC H9X 3N7 Canada
Dry skin 6 (1.1) 3 (1.6) Made in Canada.
Vascular disorders 8 (1.4) 1 (0.5) Marketed by:
Galderma Laboratories, L.P.
Hypertension 6 (1.1) 1 (0.5) Fort Worth, Texas 76177 USA
P50696-0 0705