www.rxlist.com Open in urlscan Pro
104.18.32.6  Public Scan

Form analysis
0 forms found in the DOM

Text Content

 * Drugs & Vitamins
   
   * Drugs A-Z
   * Generic Drugs A-Z
   * Drugs by Classification
   * Drugs Comparison (Drug Vs. Drug)
   * Vitamins & Supplements
   * Drug Interaction Checker
   * Pill Identifier
 * Tools & Resources
   
   * Medical Dictionary
   * Slideshows
   * Images
   * Quizzes
     
 * Privacy & Other Trust Info
   
   * Privacy Policy
   * About Us
   * Contact Us
   * Terms of Use
   * Advertising Policy


Search




NORITATE

 * Generic Name: metronidazole
 * Brand Name: Noritate
 * Drug Class: Topical Antimicrobials

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/11/2022

home drugs a-z list noritate (metronidazole) drug

   
   
 * Related Drugs
   ClindaMax Epsolay Finacea Foam MetroGel Oracea Rhofade Soolantra
   
   
 * Noritate User Reviews


DRUG SUMMARY

WHAT IS NORITATE?

Noritate (metronidazole) is a topical (for the skin) antibiotic used to treat
skin lesions caused by rosacea.

WHAT ARE SIDE EFFECTS OF NORITATE?

Noritate may cause serious side effects including:

 * hives,
 * difficulty breathing,
 * swelling of your face, lips, tongue, or throat, and
 * severe stinging or burning after applying the medication

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Noritate include:

 * stinging or burning when the medication is applied,
 * skin irritation/dryness/redness,
 * metallic taste in the mouth,
 * nausea,
 * headache,
 * numbness or tingly feeling in your hands or feet,
 * cough,
 * stuffy nose,
 * sore throat,
 * cold symptoms,
 * vaginal itching or discharge, or
 * scaly or itchy skin

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheadedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR NORITATE

Areas to be treated should be cleansed before application. Apply and rub in a
thin film dose of Noritate once daily to entire affected area(s).

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH NORITATE?

Noritate may interact with blood thinners such as warfarin. It is not likely
other drugs you take orally or inject will have an effect on topically applied
Noritate.

NORITATE DURING PREGNANCY OR BREASTFEEDING

But many drugs can interact with each other. Tell your doctor all medications
and supplements you use. Noritate should be used only when prescribed during
pregnancy. This drug passes into breast milk. Consult your doctor before
breastfeeding.

ADDITIONAL INFORMATION

Our Noritate (metronidazole) Side Effects Drug Center provides a comprehensive
view of available drug information on the potential side effects when taking
this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications & Dosage
 * Side Effects & Drug Interactions
 * Warnings & Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)


DESCRIPTION FOR NORITATE

NORITATE™ (metronidazole cream) Cream, 1%, contains metronidazole, USP.
Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol.

The molecular formula for metronidazole is C6H9N3O3.

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 a solubility in
water of 10 mg/mL at 20°C. Metronidazole is a member of the imidazole class of
anti-bacterial agents and is classified as an antiprotozoal and anti-bacterial
agent.

NORITATE (metronidazole) is an emollient cream; each gram contains 10 mg
micronized metronidazole USP, in a base of purified water USP, stearic acid NF,
glyceryl monostearate NF, glycerin USP, methylparaben NF, trolamine NF and
propylparaben NF.




USES FOR NORITATE

Noritate is indicated for the topical treatment of inflammatory lesions and
erythema of rosacea.


DOSAGE FOR NORITATE

Areas to be treated should be cleansed before application of Noritate. Apply and
rub in a thin film of Noritate once daily to entire affected area(s). Patients
may use cosmetics after application of Noritate.


HOW SUPPLIED

Cream - 60 g aluminum tube - NDC 0187-5202-60.

Keep out of reach of children.

STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada.
Revised Jun 2020.


SIDE EFFECTS FOR NORITATE

Safety data from 302 patients who used Noritate (n=200) or vehicle control
(n=102) once daily in clinical trials and experienced an adverse event
considered to be treatment related include: application site reaction (Noritate
1, vehicle 1), condition aggravated (Noritate 1, vehicle 0), paresthesia
(Noritate 0, vehicle 1), acne (Noritate 1, vehicle 0), dry skin (Noritate 0,
vehicle 2). The majority of adverse reactions were mild to moderate in severity.

Two patients treated with Noritate once daily discontinued treatment because of
adverse events: one for a severe flare of comedonal acne and one for rosacea
aggravated.

Additional clinical adverse effects reported spontaneously since the drug was
marketed are uncommon and include tingling or numbness of extremities, allergic
reactions, skin and eye irritation, rash, headache, nausea and dry mouth.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at
1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


DRUG INTERACTIONS FOR NORITATE

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 Noritate is prescribed for patients who
are receiving anticoagulant treatment, although they are less likely to occur
with topical metronidazole administration because of low absorption. (See
CLINICAL PHARMACOLOGY and Pharmacokinetics)


WARNINGS FOR NORITATE

No Information Provided


PRECAUTIONS FOR NORITATE

GENERAL

If a reaction suggesting local skin irritation occurs, patients should be
directed to discontinue use of the medication. Conjunctivitis associated with
topical use of metronidazole on the face has been reported. Contact with the
eyes should be avoided. Metronidazole is a nitroimidazole and should be used
with care in patients with evidence of, or history of, blood dyscrasia.

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/m2/day
or greater (approximately 37 times the human topical dose on a mg/m2 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/m2/day (144 times the topical 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/m2/day (approximately 7 times
the human topical dose on a mg/m2 basis) was associated with an increase in
ultraviolet radiation-induced skin carcinogenesis. Neither dermal
carcinogenicity nor photocarcinogenicity studies have been performed with
Noritate or any marketed metronidazole formulations.

PREGNANCY

TERATOGENIC EFFECTS

There are no adequate and well-controlled studies with the use of Noritate in
pregnant women. Metronidazole crosses the placental barrier and enters the fetal
circulation rapidly. No fetotoxicity was observed after oral administration of
metronidazole to 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, Noritate should be used during pregnancy only if clearly needed.

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

Safety and effectiveness in pediatric patients have not been established.


OVERDOSE INFORMATION FOR NORITATE

No specific information available.


CONTRAINDICATIONS FOR NORITATE

NORITATE (metronidazole) is contraindicated in those patients with a history of
hypersensitivity to metronidazole or to any other ingredient in this
formulation.

 


CLINICAL PHARMACOLOGY FOR NORITATE

PHARMACOKINETICS

When a one gram dose of Noritate Cream, 1%, was applied in a single application
to the face of 16 healthy volunteers, low concentrations of metronidazole were
detected in the plasma of 7 of the volunteers. The mean±SD Cmax of metronidazole
was 27.6±7.3 ng/mL, which is about 1% of the value reported for a single 250 mg
oral dose of metronidazole. The time to maximum plasma concentration (Tmax) in
the volunteers with detectable metronidazole was 8-12 hours after topical
application.

PHARMACODYNAMICS

The mechanisms by which metronidazole acts in reducing inflammatory lesions of
rosacea are unknown.

CLINICAL STUDIES

Safety and efficacy of Noritate were evaluated in two randomized
vehicle-controlled clinical studies for the treatment of rosacea, which excluded
patients who had nodules, moderate or severe rhinophyma, dense telangiectases,
plaque-like facial edema or ocular involvement and those who had a history of
not responding to metronidazole therapy for rosacea. Of the patients included in
the efficacy database (n=416), there were 142 men and 274 women. Endpoint
efficacy data comparisons for patients treated with daily Noritate or vehicle
applications are listed below.

Inflammatory Lesion Counts and Erythema Severity Scores in Two Clinical Trials
for Rosacea

Noritate Vehicle Study 1 Study 2 Study 1 Study 2 N Result N Result N Result N
Result Papules + Pustules Count Baseline 89 15 92 19 50 18 49 17 Week 10 80 7*
82 8 45 15 41 12   Reduction 49%* 58%* 17% 30% Papules Count Baseline 89 13 92
17 50 15 49 15 Week 10 80 7* 82 7 45 12 41 11   Reduction 41%* 55%* 14% 28%
Erythema Score Baseline 89 2.2 92 2.3 50 2.2 49 2.2 Week 10 80 1.3* 82 1.4* 45
1.7 41 1.8   Reduction 42%* 40%* 25% 19% *Statistically significant differences
between Noritate and vehicle groups with p≤0.05. Erythema scores: 0=none,
1=mild, 2=moderate and 3=severe.



SAFETY STUDIES

Studies of contact sensitization (n=258), phototoxicity (n=21), and photocontact
sensitization (n=29) of Noritate were conducted. No evidence of sensitization or
phototoxicity was seen in these studies.


PATIENT INFORMATION FOR NORITATE

Patients using Noritate should receive the following information and
instructions:

 1. This medication is to be used as directed.
 2. It is for external use only.
 3. Avoid contact with the eyes.
 4. Cleanse affected area(s) before applying Noritate.
 5. This medication should not be used for any disorder other than that for
    which it is prescribed.
 6. Patients should report any adverse reaction to their physician.


FROM

SKIN CARE RESOURCES

 * 18 Common Rosacea Triggers
 * Causes of Rosacea

FEATURED CENTERS

 * What Are the Best PsA Treatments for You?
 * Understanding Biologics
 * 10 Things People With Depression Wish You Knew


REPORT PROBLEMS TO THE FOOD AND DRUG ADMINISTRATION

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit the website or call 1-800-FDA-1088.FDA MedWatch
Close modal
You are about to visit a website outside of medicinenet. Please familiarize
yourself with this other website's Privacy Policy as it differs from ours.
continue

Pill Identifier Tool Quick, Easy, Pill Identification

Drug Interaction Tool Check Potential Drug Interactions

Pharmacy Locator Tool Including 24 Hour, Pharmacies


 * 
 * 

DRUG CATEGORIES

 * Drugs & Medications
 * Pill Identification Tool
 * Vitamins, Herbs, & Dietary Supplements
 * Dictionary

RXLIST

 * About Us
 * Consumer Contact RxList
 * Terms of Use
 * Privacy Policy
 * Sponsor Policy

Your Privacy Choices

Copyright © 2024 by RxList Inc. An Internet Brands company. RxList does not
provide medical advice, diagnosis or treatment. See additional information.