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NDC 00781-7080-35 Metronidazole 10 mg/g Details
Metronidazole 10 mg/g
Metronidazole is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc.. The primary component is METRONIDAZOLE.
MedlinePlus Drug Summary
Metronidazole is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Related Packages: 00781-7080-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metronidazole Topical
Product Information
| NDC | 00781-7080 |
|---|---|
| Product ID | 0781-7080_327f4ef7-b4c7-4e46-8ee4-e4a78f95ff76 |
| Associated GPIs | 90060040004020 |
| GCN Sequence Number | 059325 |
| GCN Sequence Number Description | metronidazole GEL (GRAM) 1 % TOPICAL |
| HIC3 | L5G |
| HIC3 Description | ROSACEA AGENTS, TOPICAL |
| GCN | 24926 |
| HICL Sequence Number | 004157 |
| HICL Sequence Number Description | METRONIDAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Metronidazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Metronidazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | METRONIDAZOLE |
| Labeler Name | Sandoz Inc. |
| Pharmaceutical Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090903 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00781-7080-35 (00781708035)
| NDC Package Code | 0781-7080-35 |
|---|---|
| Billing NDC | 00781708035 |
| Package | 1 TUBE in 1 CARTON (0781-7080-35) / 60 g in 1 TUBE |
| Marketing Start Date | 2013-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.80815 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | METRONIDAZOLE TOPICAL 1% GEL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL caaf1b7f-eaab-4fb6-a955-b7d881038fef Details
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use metronidazole gel USP, 1% safely and effectively. See full prescribing information for metronidazole gel USP, 1%.
Metronidazole Gel USP, 1% for topical use.
Initial U.S. Approval: 1963
INDICATIONS AND USAGE
Metronidazole gel USP, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. (1)
DOSAGE AND ADMINISTRATION
● Not for oral, ophthalmic, or intravaginal use. (2)
● Cleanse treated areas before the application of metronidazole gel USP, 1%. (2)
● Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s). (2)
● Cosmetics may be applied after the application of metronidazole gel USP, 1%. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1%. (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
- 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 metronidazole gel USP, 1% therapy. (5.1)
- Blood Dyscrasias: Metronidazole gel USP, 1% is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. (5.2)
- Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. (5.3)
- Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, avoid contact with the eyes. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
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 administering metronidazole gel USP, 1% concomitantly to patients who are receiving anticoagulant treatment. (7)
USE IN SPECIFIC POPULATIONS
- Lactation: Breastfeeding not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2022
Table Of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Neurologic Disease
5.2 Blood Dyscrasias
5.3 Contact Dermatitis
5.4 Eye Irritation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
14 CLINICAL STUDIES
16 HOW SUPPLIED
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
For topical use only, not for oral, ophthalmic, or intravaginal use.
Cleanse treated areas before the application of metronidazole gel USP, 1%.
Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s).
Cosmetics may be applied after the application of metronidazole gel USP, 1%.
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
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 metronidazole gel USP, 1% therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.
5.2 Blood Dyscrasias
Metronidazole gel USP, 1% is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.
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.
In a controlled clinical trial, 557 subjects used metronidazole gel USP, 1% 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%:
Table 1: Adverse Reactions That Occurred at a Rate of ≥1%
| System Organ Class/Preferred Term | Metronidazole Gel USP, 1% | 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% | 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.
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 [see Warnings and Precautions (5.1)]
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 gel USP, 1% is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data have not established an association with 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 metronidazole gel USP, 1%.
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 to 4% and 15 to 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 reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. 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 metronidazole gel USP, 1%.
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.
11 DESCRIPTION
Metronidazole gel USP, 1% contains metronidazole, USP. It is intended for topical use. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-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.
Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel; each gram contains 10 mg of metronidazole in a base of ceteth-20, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.
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 metronidazole gel USP, 1% on the QTc interval has not been adequately characterized.
12.3 Pharmacokinetics
Topical administration of a one-gram dose of metronidazole gel USP, 1% to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD Cmax of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC(0-24) was 595 ± 154 ng*hr/mL. The mean Cmax 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 (Tmax) was 6 to 10 hours after topical application.
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/m2/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/m2/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.
14 CLINICAL STUDIES
In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel USP, 1% 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 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.
16 HOW SUPPLIED
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.
Cleanse treated areas before the application of metronidazole gel USP, 1%
Advise patients to report any adverse reaction to their healthcare providers.
Lactation
Advise women not to breastfeed during treatment with metronidazole gel USP, 1% [see Use in Specific Populations (8.2)].
Rx Only
Manufactured by
Tolmar, Inc.
Fort Collins, CO 80526 for
Sandoz Inc.
Princeton, NJ 08540
44445 Rev. 2 04/22
PATIENT INFORMATION
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PATIENT INFORMATION Metronidazole Gel USP, 1% (me troe ni’ da zole) |
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Important: Metronidazole gel USP, 1% is for use on the skin only (topical use). Do not use metronidazole gel USP, 1% in your mouth, eyes, or vagina. |
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What is metronidazole gel USP, 1%? Metronidazole gel USP, 1% 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 metronidazole gel USP, 1% is safe and effective in children. |
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Do not use metronidazole gel USP, 1% if you are allergic to metronidazole or any of the ingredients in metronidazole gel USP, 1%. See the end of this leaflet for a complete list of ingredients in metronidazole gel USP, 1%. |
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Before using metronidazole gel USP, 1%, tell your healthcare provider about all your medical conditions, including if you:
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. |
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How should I use metronidazole gel USP, 1%?
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What are the possible side effects of metronidazole gel USP, 1%?
Tell your healthcare provider if you get any side effects during treatment with metronidazole gel USP, 1%. These are not all of the possible side effects of metronidazole gel USP, 1%. 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 Sandoz Inc. at 1-800-525-8747. |
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How should I store metronidazole gel USP, 1%?
Keep metronidazole gel USP, 1% and all medicines out of the reach of children. |
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General information about the safe and effective use of metronidazole gel USP, 1%. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use metronidazole gel USP, 1% for a condition for which it was not prescribed. Do not give metronidazole gel USP, 1% 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 metronidazole gel USP, 1% that is written for health professionals. |
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What are the ingredients in metronidazole gel USP, 1%? Active ingredient: metronidazole Inactive ingredients: betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 For more information, call 1-866-735-4137. |
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 04/2022
44445 Rev. 2 04/22
INGREDIENTS AND APPEARANCE
| METRONIDAZOLE
metronidazole gel |
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| Labeler - Sandoz Inc. (005387188) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TOLMAR Inc. | 791156578 | analysis(0781-7080) , label(0781-7080) , manufacture(0781-7080) , pack(0781-7080) | |