Metronidazole 0.75% Topical Crm 45g
It is used to treat rosacea.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-rosacea agent; Topical anti-infective
Pharmacologic Class
Nitroimidazole
Pregnancy Category
Category B
FDA Approved
Mar 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole topical cream is a medication applied to the skin to help reduce the redness, bumps, and pimples associated with rosacea, a common skin condition. 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 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 with your pharmacist. You may also want to check if there are 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 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 with your pharmacist. You may also want to check if there are 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
- Avoid triggers that worsen rosacea (e.g., hot beverages, spicy foods, alcohol, extreme temperatures, sun exposure, stress).
- Use a gentle, non-irritating cleanser and moisturizer.
- Apply sunscreen daily (SPF 30 or higher) to protect skin from UV radiation, which can exacerbate rosacea.
- Avoid abrasive skin products or harsh chemicals.
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 of the face twice daily, morning and evening.
Condition-Specific Dosing:
Rosacea:
Apply a thin layer to affected areas of the face twice daily (morning and evening) for 9 weeks or as directed by physician. Improvement usually seen within 3 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not 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 the treatment of rosacea is unknown, but it is believed to involve both anti-inflammatory and immunosuppressive effects, rather than direct antimicrobial action against skin flora. It may reduce reactive oxygen species and inhibit neutrophil chemotaxis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<10% systemic absorption after topical application)
Tmax:
Not well-defined for topical application; systemic peak concentrations are very low (typically <100 ng/mL)
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Not applicable for topical application due to minimal systemic absorption
ProteinBinding:
Not applicable for topical application due to minimal systemic absorption (systemic metronidazole is <20%)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application (systemic half-life is 6-11 hours)
Clearance:
Not applicable for topical application due to minimal systemic absorption
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not applicable for topical application (systemic metronidazole: ~20% unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 3 weeks
PeakEffect:
Optimal results often observed after 9 weeks of continuous use
DurationOfAction:
Maintained with continued use; symptoms may recur upon discontinuation
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
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, seek medical attention 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:
+ Abnormal burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Emotional 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 for advice:
Dry skin
Scaling
Itching
Burning or stinging sensations
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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, seek medical attention 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:
+ Abnormal burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Emotional 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 for advice:
Dry skin
Scaling
Itching
Burning or stinging sensations
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Numbness or tingling in extremities (rare, but possible with systemic absorption)
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. Therefore, 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 ensure your safety. They will help you determine if it is safe to take this medication with your other drugs and health conditions.
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. Therefore, 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 ensure your safety. They will help you determine if it is safe to take this medication with your other drugs and health conditions.
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. Discuss this potential risk 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 without consulting your doctor.
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.
Long-term use of metronidazole has been associated with an increased risk of cancer in animal studies, such as mice and rats. Discuss this potential risk 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 without consulting your doctor.
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. If large amounts are ingested orally, symptoms could include nausea, vomiting, diarrhea, metallic taste, ataxia, seizures, peripheral neuropathy.
What to Do:
For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US). Treatment is supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of rosacea symptoms (erythema, papules, pustules)
Frequency: Periodically during treatment (e.g., at 3 weeks, 9 weeks, and as needed)
Target: Reduction in lesion count and erythema
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment plan.
Symptom Monitoring
- Reduction in facial redness (erythema)
- Decrease in inflammatory papules and pustules
- Absence of burning, stinging, or irritation at application site
- Signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Metronidazole topical cream is generally considered low risk during pregnancy due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic absorption is minimal. Oral metronidazole is generally avoided in the first trimester if possible, but topical is different.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk.
Lactation
Metronidazole is excreted in breast milk after systemic administration. However, systemic absorption from topical application is minimal, making the amount transferred to breast milk very low. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal maternal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No specific dosage 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
- Advise patients that improvement may not be seen for several weeks, and full therapeutic effect may take up to 9 weeks.
- Emphasize the importance of consistent, twice-daily application.
- Remind patients that topical metronidazole is for external use only and should not be applied to the eyes or mucous membranes.
- Patients should avoid alcohol-containing products on the treated areas, as some topical formulations may contain alcohol.
- Sun protection is crucial for rosacea patients, regardless of metronidazole use.
Alternative Therapies
- Azelaic acid topical (cream, gel, foam)
- Brimonidine topical gel (for erythema)
- Oxymetazoline topical cream (for erythema)
- Ivermectin topical cream
- 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:
$30 - $100 per 45g tube
Generic Available:
Yes
Insurance Coverage:
Generally covered by most prescription drug plans (Tier 1 or 2 for generics)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.