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| Product NDC Code | 51672-4164 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Metronidazole |
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| Type | Generic | ||||||||
| Pharm Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 577237 | ||||||||
| Application Number | ANDA204651 | ||||||||
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. | ||||||||
| Packages |
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Overdosage of Metronidazole
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE There are no reported human experiences with overdosage of metronidazole. Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 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 patients used metronidazole gel USP, 1% and 189 patients 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%: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% System Organ Class/Preferred Term Metronidazole Gel USP, 1% 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 Metronidazole Gel USP, 1% 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: skin irritation, 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: peripheral neuropathy. 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.
| System Organ Class/Preferred Term | Metronidazole Gel USP, 1% | Gel Vehicle |
|---|---|---|
| N=557 | N=189 | |
| | | |
| | | |
| 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) |
| | | |
| Back pain | 3 (0.5) | 2 (1.1) |
| | | |
| Basal cell carcinoma | 1 (0.2) | 2 (1.1) |
| | | |
| Headache | 12 (2.2) | 1 (0.5) |
| | | |
| Nasal congestion | 6 (1.1) | 3 (1.6) |
| | | |
| Contact dermatitis | 7 (1.3) | 1 (0.5) |
| Dry skin | 6 (1.1) | 3 (1.6) |
| | | |
| Hypertension | 6 (1.1) | 1 (0.5) |
| Metronidazole Gel USP, 1% | Gel Vehicle | |
|---|---|---|
| Sign/Symptom | N=544 | N=184 |
| | | |
| Mild | 93 (17.1) | 41 (22.3) |
| Moderate | 42 (7.7) | 20 (10.9) |
| Severe | 3 (0.6) | 2 (1.1) |
| | | |
| Mild | 88 (16.2) | 32 (17.4) |
| Moderate | 43 (7.9) | 27 (14.7) |
| Severe | 3 (0.6) | 1 (0.5) |
| | | |
| Mild | 53 (9.7) | 21 (11.4) |
| Moderate | 27 (5.0) | 13 (7.1) |
| Severe | 6 (1.1) | 1 (0.5) |
| | | |
| Mild | 39 (7.2) | 18 (9.8) |
| Moderate | 7 (1.3) | 9 (4.9) |
| Severe | 10 (1.8) | 1 (0.5) |
Metronidazole Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when metronidazole is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when metronidazole is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. ( 7 )
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 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. 12.3 Pharmacokinetics Topical administration of a one gram dose of metronidazole to the face of 13 patients with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0-24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (T max ) was 6 to 10 hours after topical application.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Topical administration of a one gram dose of metronidazole to the face of 13 patients with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0-24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (T max ) was 6 to 10 hours after topical application.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS Metronidazole Gel USP, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Metronidazole Gel USP, 1% is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Metronidazole Gel USP, 1% contains metronidazole, USP. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole- 1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds. Metronidazole is a colorless to slightly yellow gel; each gram contains 10 mg of metronidazole in a base of alcohol (10% w/w), disodium edetate, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, and purified water. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Apply and rub in a thin film of metronidazole once daily to affected area(s). A gentle cleanser should be used before the application of metronidazole. Cosmetics may be applied after the application of metronidazole. Not for oral, ophthalmic or intravaginal use. Not for oral, ophthalmic or intravaginal use. Apply and rub in a thin film of metronidazole once daily to affected area(s). ( 2 ) Treated areas should be cleansed before the application of metronidazole. ( 2 ) Cosmetics may be applied after the application of metronidazole. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Gel, 1%. Metronidazole is a colorless to slightly yellow gel. Each gram of metronidazole contains 10 mg (1%) of metronidazole. Gel, 1%.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel USP, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Metronidazole Metronidazole Metronidazole Metronidazole alcohol edetate disodium methylparaben polyethylene glycol, unspecified propylparaben propylene glycol water clear to yellow
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m 2 /day or greater (approximately 37 times the human topical dose on a mg/m 2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a 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 who were treated with 200 to 1200 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 treated with the drug for 8 months. In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m 2 /day (approximately 7 times the human topical dose on a mg/m 2 basis) was associated with an increase in ultraviolet radiation induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with metronidazole gel USP, 1% or any marketed metronidazole formulations.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m 2 /day or greater (approximately 37 times the human topical dose on a mg/m 2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a 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 who were treated with 200 to 1200 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 treated with the drug for 8 months. In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at a dose of 45 mg/m 2 /day (approximately 7 times the human topical dose on a mg/m 2 basis) was associated with an increase in ultraviolet radiation induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with metronidazole gel USP, 1% or any marketed metronidazole formulations.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 51672-4164-6 45 g Metronidazole Gel USP, 1% FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: November 2018 20419-1118-2 782
Metronidazole: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Patients using Metronidazole Gel USP, 1% should receive the following information and instructions: This medication is to be used as directed. It is for external use only. Avoid contact with the eyes. Cleanse affected area(s) before applying Metronidazole Gel USP, 1%. This medication should not be used for any condition other than that for which it is prescribed. Keep out of reach of children. Patients should report any adverse reaction to their physicians.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel USP, 1% or gel vehicle once daily for 10 weeks. Most subjects had "moderate" rosacea at baseline. Efficacy was determined by recording reduction in inflammatory lesion counts and success rate in the Investigator Global Assessment (percentage of subjects "clear" and "almost clear" of rosacea at the end of the study). The scale is based on the following definitions: Table 3: Investigator Global Assessment Scale Score Grade Definition 0 Clear No signs or symptoms present; at most, mild erythema 1 Almost Clear Very mild erythema present. Very few small papules/pustules 2 Mild Mild erythema. Several small papules/pustules 3 Moderate Moderate erythema. Several small or large papules/pustules, and up to 2 nodules 4 Severe Severe erythema. Numerous small and/or large papules/pustules, up to several nodules The results are shown in the following table: Table 4: Inflammatory Lesion Counts and Global Scores in a Clinical Trial of Rosacea Metronidazole Gel USP, 1% Vehicle N Results N (%) N Results N (%) Inflammatory lesions 557 189 Baseline, mean count 18.3 18.4 Week-10, mean count 8.9 12.8 Reduction 9.4 (50.7) 5.6 (32.6) Investigator Global Assessment 557 189 Subject clear or almost clear 214 (38.42) 52 (27.51) Subject with no change 159 (28.5) 77 (40.7) Subjects treated with metronidazole gel USP, 1% experienced a mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to a reduction of 5.6 for those treated with vehicle, or a difference in means of 3.8 lesions. The contribution to efficacy of individual components of the vehicle has not been established.
| Score | Grade | Definition |
|---|---|---|
| | Clear | No signs or symptoms present; at most, mild erythema |
| | Almost Clear | Very mild erythema present. Very few small papules/pustules |
| | Mild | Mild erythema. Several small papules/pustules |
| | Moderate | Moderate erythema. Several small or large papules/pustules, and up to 2 nodules |
| | Severe | Severe erythema. Numerous small and/or large papules/pustules, up to several nodules |
| Metronidazole Gel USP, 1% | Vehicle | |||
|---|---|---|---|---|
| N | Results N (%) | N | Results N (%) | |
| | 557 | 189 | ||
| Baseline, mean count | 18.3 | 18.4 | ||
| Week-10, mean count | 8.9 | 12.8 | ||
| Reduction | 9.4 (50.7) | 5.6 (32.6) | ||
| | 557 | 189 | ||
| Subject clear or almost clear | 214 (38.42) | 52 (27.51) | ||
| Subject with no change | 159 (28.5) | 77 (40.7) | ||
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel USP, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.8.3 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 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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of metronidazole in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of metronidazole in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of metronidazole in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed. 8.3 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 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. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel USP, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING Metronidazole Gel USP, 1% is colorless to slightly yellow in color, and supplied as follows: 45 g tube - (NDC 51672-4164-6) 60 g tube - (NDC 51672-4164-3) 55 g pump - (NDC 51672-4164-9) Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Storage and handling
Information about safe storage and handling of the drug product.Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API