Metronidazole 0.75% Topical Lotion
It is used to treat rosacea.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiacne agent; Antiprotozoal
Pharmacologic Class
Nitroimidazole
Pregnancy Category
Category B
FDA Approved
Feb 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole topical is a medication applied to the skin to treat rosacea, a common skin condition that causes redness and bumps on the face. It helps reduce inflammation and the number of bumps.
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. Continue using the medication 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 of the medication 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 the 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. Continue using the medication 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 of the medication 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 the 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 skin gently before applying.
- Apply a thin layer to the affected areas, avoiding eyes, nose, and mouth.
- Wash hands thoroughly after application.
- Avoid alcohol-containing products, astringents, or abrasive cleansers on treated areas.
- Protect skin from sun exposure (use sunscreen and protective clothing) as rosacea can be worsened by sun.
- Be patient; it may take several weeks to see improvement.
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 layer to affected areas twice daily, morning and evening.
Condition-Specific Dosing:
rosacea:
Apply a thin layer to affected areas (e.g., face) twice daily, morning and evening, after washing. Rub in gently and completely.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for rosacea; use for other conditions (e.g., perioral dermatitis) is off-label and based on clinical judgment.
Adolescent:
Same as adult dosing for rosacea, if indicated.
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 adjustment needed 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 exact mechanism by which topical metronidazole reduces inflammatory lesions and erythema of rosacea is unknown, but it is believed to involve anti-inflammatory and immunosuppressive effects. Metronidazole has demonstrated anti-inflammatory activity by inhibiting neutrophil chemotaxis and reactive oxygen species production. It also has antiprotozoal and antibacterial activity, which may contribute to its effect, although rosacea is not primarily an infection.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% of applied dose)
Tmax:
Not clinically significant due to minimal systemic absorption
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically significant due to minimal systemic absorption
ProteinBinding:
Not clinically significant due to minimal systemic absorption
CnssPenetration:
Limited (not clinically significant)
Elimination:
HalfLife:
Not clinically significant due to minimal systemic absorption
Clearance:
Not clinically significant due to minimal systemic absorption
ExcretionRoute:
Not clinically significant due to minimal systemic absorption
Unchanged:
Not clinically significant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 3 weeks for initial improvement)
PeakEffect:
Up to 9 weeks for maximal effect
DurationOfAction:
Maintained with continued use; effects may diminish upon discontinuation
Confidence:
Medium
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 burning, stinging, or irritation at the application site
- Worsening of rosacea symptoms
- New skin rash or hives (signs of allergic reaction)
- Swelling of face, lips, or tongue
- Difficulty breathing
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 within 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 medications 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
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting 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 within 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 medications 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
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 animal studies, such as mice and rats; therefore, it is crucial to discuss this with your doctor. This medication has been prescribed for 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:
- Unlikely with topical application due to minimal systemic absorption. If large amounts are ingested, symptoms could resemble systemic metronidazole overdose (e.g., nausea, vomiting, diarrhea, ataxia, seizures, peripheral neuropathy).
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). Treatment is supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of rosacea symptoms (erythema, papules, pustules)
Frequency: Periodically (e.g., at follow-up visits)
Target: Reduction in lesion count and erythema
Action Threshold: Lack of improvement after 3 months, or worsening symptoms
Local skin irritation (e.g., dryness, redness, stinging, burning)
Frequency: Daily, by patient self-monitoring
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation requiring dose reduction or discontinuation
Symptom Monitoring
- Reduction in facial redness (erythema)
- Decrease in inflammatory papules and pustules
- Improvement in skin texture
- Local skin irritation (dryness, redness, stinging, burning, itching)
- Allergic reactions (rare)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Category B.
Trimester-Specific Risks:
First Trimester:
Low risk; systemic absorption is minimal.
Second Trimester:
Low risk; systemic absorption is minimal.
Third Trimester:
Low risk; systemic absorption is minimal.
Lactation
Considered low risk (L2) for nursing infants due to minimal systemic absorption. Amount excreted in breast milk is negligible.
Infant Risk:
Low risk of adverse effects in breastfed infants.
Pediatric Use
Safety and efficacy for rosacea in pediatric patients have not been established. Use in children for other conditions (e.g., perioral dermatitis) is off-label and should be done with caution and clinical judgment.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact safety or efficacy.
Clinical Information
Clinical Pearls
- Topical metronidazole is a first-line treatment for inflammatory lesions (papules and pustules) of rosacea, but it has limited efficacy for erythema (redness).
- Patients should be advised that improvement is gradual and may take several weeks to months.
- Emphasize the importance of consistent, long-term use for maintenance of effect.
- Advise patients to avoid applying the product near the eyes, as it can cause tearing.
- Patients should be educated on general rosacea triggers (e.g., sun, hot beverages, spicy foods, alcohol, stress) and lifestyle modifications.
- If irritation occurs, advise reducing frequency of application or temporarily stopping use, then gradually reintroducing.
Alternative Therapies
- Azelaic acid (topical)
- Ivermectin (topical)
- Brimonidine (topical, for erythema)
- Oxymetazoline (topical, for erythema)
- Sulfacetamide/sulfur (topical)
- Oral antibiotics (e.g., doxycycline, minocycline, for severe inflammatory rosacea)
- Laser or light therapy (for persistent erythema or telangiectasias)
Cost & Coverage
Average Cost:
$50 - $200 per 45g tube/bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic); Tier 3 (brand)
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 this 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 occurred.