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| Product NDC Code | 0299-3820 | ||||
|---|---|---|---|---|---|
| Drug Name | Metrogel |
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| Type | Brand | ||||
| 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, 605730 |
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| Application Number | NDA021789 | ||||
| Labeler Name | Galderma Laboratories, L.P. | ||||
| Packages |
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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 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 Galderma Laboratories, L.P. at 1-866-735-4137, 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 METROGEL 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 METROGEL for Up to 10 Weeks Preferred Term METROGEL Vehicle (N= 557) N (%) (N= 189) N (%) 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 METROGEL for Up to 10 Weeks METROGEL 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 reactions 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
| 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) |
| 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) |
METROGEL 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. Use caution when prescribing for patients who are receiving anticoagulant treatment. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when administering METROGEL concomitantly to patients who are receiving anticoagulant treatment. ( 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. Cardiac Electrophysiology: The effect of METROGEL on the QTc interval has not been adequately characterized. 12.3 Pharmacokinetics Topical administration of a one-gram dose of METROGEL to the face of 13 subjects 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 6-10 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. Cardiac Electrophysiology: The effect of METROGEL on the QTc interval has not been adequately characterized.
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 METROGEL to the face of 13 subjects 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 6-10 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 METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. METROGEL 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 METROGEL (metronidazole) topical gel, 1% is a nitroimidazole for topical use. METROGEL is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole is 2-methyl-5-nitro-1 Himidazole- 1-ethanol. The molecular formula for metronidazole is C6H9N3O3. 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. The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water. Structural Formula
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 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. For topical use only, not for oral, ophthalmic, or intravaginal use. Cleanse treated areas before the application of METROGEL. ( 2 ) Apply and rub in a thin film of METROGEL once daily to affected area(s). ( 2 ) Cosmetics may be applied after the application of METROGEL. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 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%. METROGEL is a clear, colorless to pale yellow gel. Each gram of METROGEL 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 METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. METROGEL, 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.METROGEL metronidazole METRONIDAZOLE Metronidazole betadex edetate disodium methylparaben niacinamide phenoxyethanol propylene glycol propylparaben water 60g carton image
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 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 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. 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.
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 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 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. 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.
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.PACKAGE LABEL - 60g Tube metrogel 1% (metronidazole) Gel 1% For topical use only NDC 0299-3820-60 Rx Only NET WT. 60 g For topical use only. Not for oral, ophthalmic or intravaginal use. Store at controlled room temperature, 68° to 77°F (20° - 25°C), excursions permitted between 59° to 86°F (15° - 30°C). Keep out of reach of children. Usual dosage: Apply a thin film once a day to the affected areas. See package insert for complete prescribing instructions. Each gram contains: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparben, and purified water. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, TX 76177 USA All trademarks are the property of their respective owners. Made in Canada. P50741-6
METROGEL: 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 Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Use as directed. Avoid contact with the eyes [ see Warnings and Precautions ( 5.4) ]. Cleanse treated areas before the application of METROGEL [ see Dosage and Administration ( 2 ) ] Advise patients to report any adverse reaction to their healthcare providers. Neurologic Disease Advise patients to immediately report any abnormal neurologic signs to their healthcare provider [ see Warnings and Precautions ( 5.1 ) ]. Lactation Advise women not to breastfeed during treatment with METROGEL [ see Use in Specific Populations ( 8.2 ) ]. Rx Only US Patent No. 6,881,726 and 7,348,317 Marketed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA P5XXXX-X Made in Canada All trademarks are the property of their respective owners.
Patient medication information
Information or instructions to patients about safe use of the drug product, sometimes including a reference to a patient medication guide or counseling materials.PATIENT INFORMATION METROGEL® (MET-TRO-GEL) (metronidazole) Gel Important: METROGEL is for use on the skin only (topical use). Do not use METROGEL in your mouth, eyes, or vagina. What is METROGEL? METROGEL is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if METROGEL is safe and effective in children. Do not use METROGEL if you are allergic to metronidazole or any of the ingredients in METROGEL. See the end of this leaflet for a complete list of ingredients in METROGEL. Before using METROGEL, tell your healthcare provider about all your medical conditions, including if you: have tingling or numbness in your hands or feet have or have had a blood disorder or disease are pregnant or plan to become pregnant. It is not known if METROGEL will harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if METROGEL passes into your breast milk. Do not breastfeed during treatment with METROGEL. Talk to your healthcare provider about the best way to feed your baby during treatment with METROGEL. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use METROGEL? Use METROGEL exactly as your healthcare provider tells you to. Cleanse the treated area before applying METROGEL. Apply and rub in a thin film of METROGEL 1 time a day to the affected area(s). You can apply cosmetics after applying METROGEL. Avoid contact of METROGEL with your eyes. What are the possible side effects of METROGEL? METROGEL may cause serious side effects, including: Peripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with METROGEL. Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with METROGEL. Eye irritation. Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with METROGEL. The most common side effects of METROGEL include: sore throat and nasal congestion upper respiratory tract infections headache Tell your healthcare provider if you get any side effects during treatment with METROGEL. These are not all of the possible side effects of METROGEL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137. How should I store METROGEL? Store METROGEL at room temperature between 68°F to 77°F (20°C to 25°C). Keep METROGEL and all medicines out of the reach of children. General information about the safe and effective use of METROGEL. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use METROGEL for a condition for which it was not prescribed. Do not give METROGEL to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about METROGEL that is written for health professionals. What are the ingredients in METROGEL? Active ingredient: metronidazole Inactive ingredients : betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water Marketed by: Galderma Laboratories, Dallas, Texas 75201 USA P5XXXX-X Made in Canada US Patent No. 6,881,726 and 7,348,317 For more information, call 1-866-735-4137. This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 11/2023
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 METROGEL or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 (“moderate”) on the 5-point Investigator Global Assessment (IGA) scale, with 8 to 50 inflammatory lesions and no more than two nodules at baseline. The co-primary efficacy endpoints were the percent reduction in inflammatory lesion counts and percentage of subjects with success on IGA, defined as an IGA score of 0 (“clear”) or 1 ( “almost clear”) at Week 10. The efficacy results are shown in the following table: Table 3: Inflammatory Lesion Counts and Global Scores in Subjects with Rosacea at Week 10 in a Clinical Trial METROGEL 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 METROGEL 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.
| METROGEL | 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 METROGEL 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.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with METROGEL.
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 of METROGEL have not been established in pediatric patients.
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 Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of METROGEL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
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 Lactation: Breastfeeding not recommended. (8.2 ) 8.1 Pregnancy Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of METROGEL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with METROGEL. 8.4 Pediatric Use Safety and effectiveness of METROGEL have not been established in pediatric patients. 8.5 Geriatric Use Sixty-six subjects aged 65 years and older were treated with METROGEL 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 How Supplied METROGEL®is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0299-3820-60 Storage and Handling Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
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