Metronidazole 0.75% Topical Gel 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
Pharmacologic Class
Nitroimidazole
Pregnancy Category
Category B
FDA Approved
Mar 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole topical gel 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 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 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
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 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
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 before applying the gel.
- Apply a thin layer of gel to the entire affected area (e.g., face) and rub in gently.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Wash hands thoroughly after applying the gel.
- Avoid or minimize exposure to sunlight and artificial UV light (tanning beds) as metronidazole can cause photosensitivity. Use sunscreen and protective clothing.
- Identify and avoid rosacea triggers such as hot beverages, spicy foods, alcohol, extreme temperatures, and stress.
- Cosmetics may be applied after the gel has dried.
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 once or twice daily, in the morning and/or evening.
Condition-Specific Dosing:
rosacea:
Apply a thin layer to affected areas of the face once or twice daily, in the morning and/or evening, after cleansing. Rub in gently and completely.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established for rosacea in pediatric patients.)
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 specific considerations for topical application due to 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 immunomodulatory effects, rather than direct antimicrobial action against skin flora. Metronidazole has been shown to scavenge reactive oxygen species, which may contribute to its anti-inflammatory activity. It also exhibits some activity against *Demodex folliculorum* mites, which are implicated in rosacea pathogenesis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<10% of applied dose)
Tmax:
Not clinically relevant for topical application due to minimal systemic absorption. Systemic Tmax for oral metronidazole is 1-2 hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption. For systemic, ~0.5-1.1 L/kg.
ProteinBinding:
Not clinically relevant for topical application. For systemic, <20%.
CnssPenetration:
Limited (minimal systemic absorption from topical application).
Elimination:
HalfLife:
Not clinically relevant for topical application. For systemically absorbed drug, ~8 hours.
Clearance:
Not clinically relevant for topical application. For systemic, ~10 mL/min/kg.
ExcretionRoute:
Renal (primarily for systemically absorbed drug)
Unchanged:
Not clinically relevant for topical application. For systemic, ~20%.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 3 weeks.
PeakEffect:
Maximal effect may take up to 9 weeks.
DurationOfAction:
Maintained with continued use.
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
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
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
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
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 that does not subside.
- Signs of an allergic reaction such as rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Numbness or tingling in the hands or feet (very rare with topical use, but report if experienced).
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 in 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 nursing while taking this medication.
This medication may interact with other medications or 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 medical history, including any health problems you have
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 medications 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 allergic reaction you experienced, including any symptoms that occurred.
If you have taken disulfiram in 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 nursing while taking this medication.
This medication may interact with other medications or 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 medical history, including any health problems you have
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 medications 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. Be sure 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 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. Be sure 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 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:
- Unlikely with topical application due to minimal systemic absorption.
- If accidentally ingested in large quantities, symptoms could include nausea, vomiting, diarrhea, metallic taste, dizziness, ataxia, seizures, peripheral neuropathy.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of rosacea severity (e.g., erythema, papules, pustules)
Rationale: To establish baseline for treatment efficacy evaluation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (reduction in erythema, papules, pustules)
Frequency: Periodically, during follow-up visits (e.g., every 4-8 weeks initially, then as needed)
Target: Improvement in rosacea symptoms
Action Threshold: Lack of improvement after 9-12 weeks may warrant re-evaluation of diagnosis or treatment plan.
Local skin reactions (e.g., burning, stinging, dryness, pruritus, irritation)
Frequency: Daily by patient, periodically by clinician
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduction in frequency.
Symptom Monitoring
- Burning
- Stinging
- Dryness
- Pruritus (itching)
- Erythema (redness)
- Skin irritation
- Numbness or tingling in extremities (rare, if systemic absorption occurs)
Special Patient Groups
Pregnancy
Metronidazole topical gel is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Considered low risk based on animal data and minimal systemic absorption.
Second Trimester:
Considered low risk.
Third Trimester:
Considered low risk.
Lactation
Metronidazole is excreted in human milk following oral administration. While systemic absorption from topical application is minimal, caution should be exercised when metronidazole topical gel is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for metronidazole topical gel and any potential adverse effects on the breastfed infant from metronidazole topical gel or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk). Low systemic absorption suggests low infant exposure, but potential for gastrointestinal upset or candidiasis in the infant exists if significant exposure occurs. Monitor infant for diarrhea or thrush.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for the treatment of rosacea. Use is generally not recommended in this population for this indication.
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. However, due to minimal systemic absorption, age-related changes in renal or hepatic function are unlikely to significantly impact safety or efficacy.
Clinical Information
Clinical Pearls
- Patients should be advised that therapy may take up to 9 weeks to show maximal benefit.
- Metronidazole topical gel is for external use only. Avoid ophthalmic, oral, or intravaginal use.
- Some patients may experience a temporary worsening of rosacea symptoms (e.g., redness, stinging) at the start of treatment; this usually subsides with continued use.
- Can be used in conjunction with other topical or oral rosacea treatments, but consult a healthcare provider for combination therapy guidance.
- Advise patients to use a mild cleanser and moisturizer suitable for sensitive skin to avoid exacerbating rosacea.
Alternative Therapies
- Azelaic acid topical (cream, gel, foam)
- Ivermectin topical cream
- Brimonidine topical gel (for erythema)
- Oxymetazoline topical cream (for erythema)
- Sodium sulfacetamide and sulfur topical
- Oral antibiotics (e.g., doxycycline, minocycline - for inflammatory lesions)
- Oral isotretinoin (for severe, refractory cases)
- Laser and light-based therapies (for erythema and telangiectasias)
Cost & Coverage
Average Cost:
$50 - $200 per 45g tube
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 promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.