Metrogel 1% Topical Gel 60gm

Manufacturer GALDERMA Active Ingredient Metronidazole Cream, Gel, and Lotion(met roe NYE da zole) Pronunciation MET-roe-NYE-da-zole
It is used to treat rosacea.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anti-rosacea agent, Anti-infective
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Pharmacologic Class
Nitroimidazole antibiotic, Antiprotozoal, Anti-inflammatory
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Pregnancy Category
Category B
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FDA Approved
Feb 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metrogel is a topical gel used to treat rosacea, a skin condition that causes redness and bumps on the face. It helps reduce the redness and the number of pimple-like bumps.
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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.
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Lifestyle & Tips

  • Cleanse affected areas gently before applying the gel.
  • Apply a thin layer of gel to the entire affected area, not just individual bumps.
  • Wash hands thoroughly after applying the gel.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Avoid excessive sun exposure and use sunscreen, as rosacea can be worsened by UV light.
  • Avoid irritating cosmetics or skin products.
  • Limit or avoid alcoholic beverages, as they can trigger rosacea flares (though systemic interaction with topical metronidazole is unlikely).

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected areas once or twice daily, in the morning and/or evening.

Condition-Specific Dosing:

rosacea: Apply a thin film to affected areas (e.g., face) once or twice daily, after washing. Patients may use cosmetics after application.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for rosacea. Safety and efficacy not established in pediatric patients.
Adolescent: Not established for rosacea. Safety and efficacy not established in pediatric patients.
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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

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Mechanism of Action

While the exact mechanism of action of metronidazole in the treatment of rosacea is unknown, it is believed to involve both anti-inflammatory and immunosuppressive effects, rather than direct antimicrobial action against skin flora. Metronidazole is known to inhibit cell-mediated immunity and to have anti-inflammatory properties by scavenging reactive oxygen species. For its antimicrobial action (relevant for other indications), metronidazole is a nitroimidazole that enters the cell, is reduced by electron transport proteins to form reactive nitro radicals, which then damage DNA and other macromolecules, leading to cell death.
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Pharmacokinetics

Absorption:

Bioavailability: <1% (systemic absorption from topical application)
Tmax: Not well-defined for topical; systemic levels are negligible.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not applicable for topical due to minimal systemic absorption.
ProteinBinding: Not applicable for topical due to minimal systemic absorption.
CnssPenetration: Limited (due to minimal systemic absorption)

Elimination:

HalfLife: Not applicable for topical due to minimal systemic absorption (systemic half-life is ~8 hours).
Clearance: Not applicable for topical due to minimal systemic absorption.
ExcretionRoute: Renal (for systemically absorbed drug)
Unchanged: Not applicable for topical due to minimal systemic absorption.
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Pharmacodynamics

OnsetOfAction: Several weeks (for clinical improvement in rosacea)
PeakEffect: Typically 3-9 weeks for maximal effect in rosacea.
DurationOfAction: Effects persist as long as treatment is continued; rosacea is a chronic condition requiring ongoing management.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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:
+ Abnormal burning, numbness, or tingling sensations
+ 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

This is not an exhaustive list of possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin irritation, burning, or stinging that does not subside
  • Worsening of redness or bumps
  • Dryness or peeling of the skin
  • Numbness or tingling in hands or feet (very rare with topical use, but report if experienced)
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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 medications and health conditions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Do not start, stop, or change the dose of any medication without first consulting your doctor.
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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. Be sure to discuss this with your doctor. This medication has been prescribed for a specific health condition, and you should not use it to treat other health problems without consulting your doctor.

If you are pregnant or planning to become pregnant, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. If ingested, symptoms could include nausea, vomiting, diarrhea, metallic taste, dizziness, headache, peripheral neuropathy, seizures.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). Treatment is supportive.

Drug Interactions

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Moderate Interactions

  • Warfarin (theoretical risk of increased anticoagulant effect due to minimal systemic absorption, monitor INR if co-administered)
  • Alcohol (theoretical disulfiram-like reaction, though highly unlikely with topical due to minimal absorption)
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Confidence Interactions

Monitoring

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Routine Monitoring

Clinical assessment of rosacea symptoms (e.g., erythema, papules, pustules)

Frequency: Periodically (e.g., every 4-8 weeks initially, then as needed)

Target: Reduction in inflammatory lesions and erythema

Action Threshold: Lack of improvement after 8-12 weeks, or worsening symptoms, may require re-evaluation of treatment.

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Symptom Monitoring

  • Local irritation (redness, dryness, burning, stinging)
  • Pruritus
  • Worsening of rosacea symptoms
  • Numbness or tingling in extremities (rare, indicative of peripheral neuropathy, usually with systemic use)

Special Patient Groups

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Pregnancy

Metronidazole is classified as Pregnancy Category B. While systemic absorption from topical application is minimal, caution is advised. Use only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Generally considered low risk due to minimal systemic absorption, but some clinicians prefer to avoid during the first trimester if possible.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Metronidazole is excreted in breast milk following systemic administration. However, systemic absorption from topical application is minimal, making the risk to the infant low. L3 (Moderately Safe) classification. Consider applying after feeding or wiping off any residue before nursing.

Infant Risk: Low risk of adverse effects due to minimal maternal systemic absorption and low transfer into breast milk.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for the treatment of rosacea. Use in children is generally not recommended for this indication.

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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

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Clinical Pearls

  • Patients should be advised that therapy may take several weeks (e.g., 3-9 weeks) to show significant improvement.
  • Metrogel is for external use only. Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Patients should continue to use gentle skin care products and avoid known rosacea triggers (e.g., hot beverages, spicy foods, alcohol, extreme temperatures, stress).
  • Cosmetics can be applied after the gel has dried.
  • Some patients may experience temporary worsening of rosacea symptoms or local irritation at the start of treatment; this often subsides with continued use.
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Alternative Therapies

  • Azelaic acid topical (Finacea, Azelex)
  • Brimonidine topical (Mirvaso) for erythema
  • Oxymetazoline topical (Rhofade) for erythema
  • Ivermectin topical (Soolantra)
  • Oral antibiotics (e.g., doxycycline, minocycline) for severe inflammatory rosacea
  • Oral metronidazole (for severe cases or other indications)
  • Laser or light therapy for persistent erythema or telangiectasias
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Cost & Coverage

Average Cost: $100 - $300 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand)
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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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.