Metronidazole 1% Topical Gel Pump
It is used to treat rosacea.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-rosacea agent; Anti-acne agent
Pharmacologic Class
Nitroimidazole antibiotic; Antiprotozoal
Pregnancy Category
Category B
FDA Approved
Feb 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole topical gel is an antibiotic medicine applied to the skin to treat rosacea, a skin condition that causes redness, bumps, and pimples on the face. It helps reduce inflammation and the number of lesions.
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 and Precautions
Before using other medications or skin products, 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 Instructions
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 and Precautions
Before using other medications or skin products, 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 Instructions
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 skin gently before applying the gel.
- Apply a thin layer of gel to the affected areas, avoiding the eyes, nose, and mouth.
- Wash hands thoroughly after application.
- Be patient; it may take several weeks to see significant improvement.
- Avoid known rosacea triggers such as sun exposure, hot beverages, spicy foods, alcohol, and stress.
- Use sunscreen daily and wear protective clothing when outdoors.
- Use gentle, non-irritating skin care products.
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 once or twice daily.
Condition-Specific Dosing:
rosacea:
Apply a thin film to affected areas (e.g., face) once or twice daily, after cleansing. Rub in gently.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for rosacea; use off-label for other conditions should be carefully considered.
Adolescent:
Similar to adult dosing for rosacea, if indicated, but safety and efficacy not specifically established.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
The exact mechanism of action of metronidazole in rosacea is unknown, but it is believed to involve both anti-inflammatory and antimicrobial effects. It reduces reactive oxygen species, inhibits neutrophil chemotaxis, and may have activity against certain bacteria (e.g., *Propionibacterium acnes*) and *Demodex* mites, which are implicated in rosacea pathogenesis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% of applied dose)
Tmax:
Variable and low (e.g., 6-10 hours for 0.75% gel, but systemic levels are very low)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not applicable for topical with minimal systemic absorption
ProteinBinding:
Not applicable for topical with minimal systemic absorption
CnssPenetration:
Limited (due to minimal systemic absorption)
Elimination:
HalfLife:
Systemic half-life is approximately 6-11 hours (if absorbed)
Clearance:
Not applicable for topical with minimal systemic absorption
ExcretionRoute:
Renal and fecal (if systemically absorbed)
Unchanged:
Not applicable for topical with minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 3 weeks
PeakEffect:
Maximal benefit usually seen by 9 weeks of treatment
DurationOfAction:
Effects persist with continued use; relapse occurs upon discontinuation
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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:
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance or eyesight
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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:
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance or eyesight
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 skin irritation, redness, or burning that worsens after application
- Rash or hives
- Swelling of the face, lips, or tongue
- Difficulty breathing (signs of allergic reaction - 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 allergic reaction you experienced, including any symptoms that occurred.
If you have taken disulfiram within the past 2 weeks, as this may interact with this medication.
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, so 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 health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health problems.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have taken disulfiram within the past 2 weeks, as this may interact with this medication.
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, so 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 health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health problems.
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 that contain 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 animal studies, such as 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 you should not use it for any other health issues. 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:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts could theoretically lead to systemic symptoms like nausea, vomiting, diarrhea, metallic taste, dizziness, or seizures.
What to Do:
If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Skin assessment (erythema, papules, pustules)
Rationale: To establish baseline severity of rosacea symptoms
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in lesions, erythema)
Frequency: Every 3-4 weeks initially, then as needed
Target: Reduction in inflammatory lesions and erythema
Action Threshold: Lack of improvement after 6-9 weeks may warrant re-evaluation of diagnosis or treatment
Local adverse reactions (dryness, irritation, burning, stinging)
Frequency: At each follow-up visit
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation may require temporary discontinuation or reduced frequency
Symptom Monitoring
- Skin irritation
- Dryness
- Redness
- Itching
- Burning sensation
- Stinging sensation
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 with topical use suggest minimal systemic absorption, making the risk to the fetus low. Use during pregnancy should be considered if clearly needed.
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 following systemic administration. However, systemic absorption from topical application is minimal. Therefore, the amount transferred to breast milk is expected to be very low. Considered L3 (moderately safe). Caution is advised, and benefits should outweigh potential risks.
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal systemic absorption by the mother.
Pediatric Use
Safety and efficacy in pediatric patients for the treatment of rosacea have not been established. Use in children for other conditions (e.g., perioral dermatitis) is off-label and should be done with caution.
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
- Metronidazole topical gel is a first-line treatment for inflammatory lesions and erythema of rosacea.
- Patients should be advised that improvement may not be seen for several weeks, and full therapeutic effect may take up to 9 weeks.
- It is important to apply the gel to clean, dry skin and to avoid contact with eyes and mucous membranes.
- Patients should be encouraged to continue using the medication as prescribed, even after symptoms improve, for maintenance therapy.
- Advise patients to avoid alcohol consumption if they experience any systemic absorption, though this is rare with topical use.
- Sun protection is crucial for rosacea patients, and metronidazole does not provide sun protection.
Alternative Therapies
- Azelaic acid topical (gel, foam, cream)
- Ivermectin topical (cream)
- Brimonidine topical (gel) for erythema
- Oxymetazoline topical (cream) for erythema
- Oral sub-antimicrobial dose doxycycline
- Oral metronidazole (for severe cases)
Cost & Coverage
Average Cost:
$30 - $150 per 45g tube/pump
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 information about the medication taken, the amount, and the time it happened.