Metronidazole 1% Topical Gel Tube
It is used to treat rosacea.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent; Anti-rosacea agent; Topical anti-infective
Pharmacologic Class
Nitroimidazole antibiotic; Antiprotozoal
Pregnancy Category
Category B
FDA Approved
Mar 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole topical gel is an antibiotic medication applied to the skin to help reduce the redness, bumps, and pimples associated with rosacea. It works by reducing inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after applying the medication. Use it as directed, even if your symptoms improve.
Application Instructions
Do not take this medication by mouth. It is for skin use only. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer to the affected skin and gently rub it in.
You can apply makeup after the skin has dried.
Important Interactions
Before using other medications or products on your skin, including soaps, consult with your doctor.
Storage and Disposal
Store this medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
* Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after applying the medication. Use it as directed, even if your symptoms improve.
Application Instructions
Do not take this medication by mouth. It is for skin use only. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer to the affected skin and gently rub it in.
You can apply makeup after the skin has dried.
Important Interactions
Before using other medications or products on your skin, including soaps, consult with your doctor.
Storage and Disposal
Store this medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
* Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Cleanse affected areas gently before applying the gel.
- Apply a thin layer of gel to the entire affected area, not just individual lesions.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Wash hands thoroughly after applying the gel.
- Avoid alcohol-containing products on treated areas, as they may cause dryness or irritation.
- Protect skin from sun exposure, as rosacea can be worsened by UV light. Use sunscreen and protective clothing.
- Identify and avoid rosacea triggers (e.g., hot beverages, spicy foods, alcohol, extreme temperatures, stress).
Available Forms & Alternatives
Available Strengths:
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 250mg Tablets
- Metronidazole 0.75% Topical Lotion
- Metron/nacl 500mg Pb Inj, 100ml
- Metronidazole 0.75% Vaginal Gel 70g
- Metronidazole 500mg Tablets
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 0.75% Topical Gel 45g
- Metronidazole 375mg Capsules
- Metronidazole 500mg Tablets
- Metronidazole 250mg Tablets
- Metronidazole 1% Topical Gel Pump
- Metronidazole 1% Topical Gel Tube
- Metronidazole 500mg/100ml Inj,100ml
- Metronidazole 0.75% Vaginal Gel 70g
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to affected areas of the face once or twice daily, in the morning and/or evening.
Condition-Specific Dosing:
rosacea:
Apply a thin film to affected areas of the face once or twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established for rosacea in pediatric patients.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations for topical formulation due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
The mechanism of action of metronidazole in the treatment of rosacea is unknown, but it is thought to involve both anti-inflammatory and immunomodulatory effects, rather than its antimicrobial properties. It may reduce reactive oxygen species and inhibit neutrophil chemotaxis. For its general antimicrobial action, metronidazole is a nitroimidazole that is reduced by susceptible organisms to form reactive cytotoxic compounds that damage DNA and other macromolecules.
Pharmacokinetics
Absorption:
Bioavailability:
<10% (systemic absorption from topical application)
Tmax:
Not well-defined for systemic levels; local skin concentrations peak within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not significant systemically from topical application.
ProteinBinding:
Not significant systemically from topical application.
CnssPenetration:
No significant CNS penetration from topical application.
Elimination:
HalfLife:
Not significant systemically from topical application.
Clearance:
Not significant systemically from topical application.
ExcretionRoute:
Not significant systemically from topical application.
Unchanged:
Not significant systemically from topical application.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 3 weeks.
PeakEffect:
Maximal effect may take up to 9 weeks of continuous therapy.
DurationOfAction:
Effects persist with continued application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Nervous system problems, including:
+ Abnormal burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mental health changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dry skin
Scaling
Itching
Burning or stinging sensations
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Nervous system problems, including:
+ Abnormal burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mental health changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dry skin
Scaling
Itching
Burning or stinging sensations
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation at the application site.
- Worsening of rosacea symptoms despite consistent use.
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing - seek immediate medical attention).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have taken disulfiram in the past 2 weeks.
If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.
This medication can interact with other drugs and health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your existing health problems.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have taken disulfiram in the past 2 weeks.
If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.
This medication can interact with other drugs and health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your existing health problems.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before consuming alcohol or using products containing alcohol, consult with your doctor, as you may need to avoid them during treatment and for a period after your last dose. If you are using a product that contains propylene glycol, discuss this with your doctor. Long-term use of metronidazole has been associated with an increased risk of cancer in mice and rats; therefore, it is crucial to discuss this with your doctor. This medication has been prescribed to treat a specific health condition, and it should not be used to treat other health problems. If you are pregnant or planning to become pregnant, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Overdose with topical metronidazole is highly unlikely due to minimal systemic absorption. Ingestion of the entire tube would be required for systemic effects, which could include nausea, vomiting, diarrhea, metallic taste, dizziness, or seizures (rare).
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). Treatment is supportive.
Drug Interactions
Moderate Interactions
- Warfarin (theoretical potentiation of anticoagulant effect, but clinically insignificant with topical use due to minimal systemic absorption)
Confidence Interactions
Monitoring
Baseline Monitoring
Skin assessment (rosacea severity)
Rationale: To establish baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (erythema, dryness, irritation, burning, stinging)
Frequency: Periodically during treatment, especially during the first few weeks.
Target: Minimal to no irritation.
Action Threshold: If severe irritation or worsening of symptoms occurs, discontinue use and consult a healthcare provider.
Symptom Monitoring
- Worsening of rosacea symptoms (e.g., increased redness, papules, pustules)
- Severe skin irritation (e.g., burning, stinging, dryness, itching, erythema)
- Allergic reactions (e.g., rash, swelling, difficulty breathing - rare)
Special Patient Groups
Pregnancy
Metronidazole topical gel is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data from topical use suggest minimal systemic absorption, making it generally considered safe for use during pregnancy when clinically indicated.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Metronidazole is excreted in breast milk after systemic administration, but topical application results in very low maternal plasma concentrations. Therefore, the risk to a breastfed infant is considered low. Use with caution and apply to areas where the infant will not come into direct contact.
Infant Risk:
Low risk (L2)
Pediatric Use
Safety and efficacy have not been established for the treatment of rosacea in pediatric patients. Use in children should be under the guidance of a specialist.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but no overall differences in safety or effectiveness have been observed.
Clinical Information
Clinical Pearls
- Patients should be advised that therapy may take several weeks to show noticeable improvement.
- Metronidazole topical gel is for external use only. Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Some patients may experience temporary worsening of rosacea symptoms or skin irritation (e.g., dryness, redness, burning, stinging) at the start of treatment. This often subsides with continued use.
- It is important to use a gentle, non-comedogenic cleanser and moisturizer while using metronidazole topical gel to minimize skin irritation.
- This medication does not cure rosacea but helps control its symptoms. Continued use as prescribed is necessary to maintain improvement.
Alternative Therapies
- Azelaic acid topical (cream, gel, foam)
- Ivermectin topical cream
- Brimonidine topical gel (for erythema)
- Oxymetazoline topical cream (for erythema)
- Oral doxycycline (sub-antimicrobial dose)
- Oral isotretinoin (for severe cases)
Cost & Coverage
Average Cost:
$20 - $100 per 45g tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generics are usually preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.