Label: METROGEL- metronidazole gel

  • NDC Code(s): 0299-3820-00, 0299-3820-01, 0299-3820-03, 0299-3820-60, view more
    0299-3820-99
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 27, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use METROGEL, 1% safely and effectively. See full prescribing information for METROGEL, 1% 
    METROGEL® (metronidazole) topical gel 
    Initial U.S. Approval 1963

    INDICATIONS AND USAGE

    METROGEL, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. (1)

    DOSAGE AND ADMINISTRATION

    • 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

    Gel, 1% (3)

    CONTRAINDICATIONS

    METROGEL 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. Immediate reevaluate METROGEL therapy if abnormal neurologic signs appear. (5.1)
    • Blood Dyscrasias: METROGEL is a nitroimidazole; use 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. Avoid contact with the eyes. (5.4)

    ADVERSE REACTIONS

    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

    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 METROGEL 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: 11/2023

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    3 DOSAGE FORMS AND 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/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. 

  • 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.
  • 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. Immediately reevaluate METROGEL therapy if abnormal neurologic signs appear. Administer metronidazole 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

    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)]

    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 TermMETROGELVehicle
    (N= 557) N (%)(N= 189) N (%)
    Influenza8 (1.4)1 (0.5)
    Upper respiratory tract infection14 (2.5)4 (2.1)
    Urinary tract infection6 (1.1)1 (0.5)
    Headache12 (2.2)1 (0.5)
    Contact dermatitis7 (1.3)1 (0.5)
    Hypertension6 (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
    METROGELVehicle
    Sign/Symptom(N= 544) N (%)(N= 184) N (%)
    Dryness138 (25.4)63 (34.2)
       Mild93 (17.1)41 (22.3)
       Moderate42 (7.7)20 (10.9)
       Severe3 (0.6)2 (1.1)
    Scaling134 (24.6)60 (32.6)
       Mild88 (16.2)32 (17.4)
       Moderate43 (7.9)27 (14.7)
       Severe3 (0.6)1 (0.5)
    Pruritus86 (15.8)35 (19.0)
       Mild53 (9.7)21 (11.4)
       Moderate27 (5.0)13 (7.1)
       Severe6 (1.1)1 (0.5)
    Stinging/burning56 (10.3)28 (15.2)
       Mild39 (7.2)18 (9.8)
       Moderate7 (1.3)9 (4.9)
       Severe10 (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

  • 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.

  • 8 USE IN SPECIFIC POPULATIONS


    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.

  • 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:

    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.

  • 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 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 6-10 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 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
     METROGELVehicle
    NResults N (%)NResults N (%)
    Inflammatory lesions557 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 Assessment557 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.


  • 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).

  • 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 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

  • PACKAGE LABEL - 60g Tube

    60g carton image

    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

  • INGREDIENTS AND APPEARANCE
    METROGEL 
    metronidazole gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0299-3820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METRONIDAZOLE (UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E) METRONIDAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    betadex (UNII: JV039JZZ3A)  
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    niacinamide (UNII: 25X51I8RD4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-3820-6060 g in 1 TUBE; Type 0: Not a Combination Product08/29/200605/31/2026
    2NDC:0299-3820-0155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/19/201112/01/2019
    3NDC:0299-3820-033 g in 1 TUBE; Type 0: Not a Combination Product06/30/200501/01/2019
    4NDC:0299-3820-9955 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/19/201112/01/2019
    5NDC:0299-3820-003 g in 1 BLISTER PACK; Type 0: Not a Combination Product06/30/200501/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02178906/30/200505/31/2026
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-3820)
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