Metrogel 1% Topical Gel (pump) 55gm

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-acne agent; Anti-rosacea agent
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Pharmacologic Class
Nitroimidazole antibiotic; Antiprotozoal
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Pregnancy Category
Category B
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metrogel is a topical medication used to treat a skin condition called rosacea. It helps reduce the redness, bumps, and pimples associated with rosacea by calming inflammation in the skin.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Before and after applying the medication, wash your hands thoroughly.

Use the medication as directed, even if your symptoms improve. It is essential to apply this medication only to your skin and avoid taking it by mouth. Keep the medication away from your mouth, nose, and eyes, as it may cause burning.

Before applying the medication, clean the affected area and dry it well. Then, 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.

Before using any other medications or products on your skin, including soaps, consult with your doctor.

Storing and Disposing of Your Medication

Store the medication at room temperature, avoiding freezing. 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 about disposing of medications, consult with your pharmacist. You may also want to check if there are drug take-back programs in your area.

What to Do If You Miss a 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.
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Lifestyle & Tips

  • Apply a thin layer to the affected areas of the face once daily, after cleansing. Avoid contact with eyes, nose, and mouth.
  • Wash hands thoroughly after applying the gel.
  • Avoid alcohol consumption, especially if you experience any systemic absorption (though rare with topical use), due to a theoretical disulfiram-like reaction.
  • Protect skin from sun exposure, as rosacea can be exacerbated by UV light. Use sunscreen and protective clothing.
  • Avoid other skin irritants, harsh cleansers, or abrasive products on the treated areas.
  • Be patient; it may take several weeks to see noticeable improvement, and full results can take 2-3 months.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected areas of the face once daily.

Condition-Specific Dosing:

rosacea: Apply a thin film to affected areas of the face once daily, in the morning or evening, for 9-12 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (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

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. While metronidazole is an antimicrobial, its efficacy in rosacea is thought to be primarily due to its ability to reduce reactive oxygen species and inhibit neutrophil chemotaxis, thereby reducing inflammation.
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Pharmacokinetics

Absorption:

Bioavailability: <10% (systemic absorption from topical application)
Tmax: Not well-defined for systemic absorption from topical application; peak plasma concentrations are very low (typically <25 ng/mL)
FoodEffect: Not applicable for topical formulation

Distribution:

Vd: Not applicable for topical formulation (minimal systemic distribution)
ProteinBinding: Not applicable for topical formulation (minimal systemic protein binding)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Approximately 6-8 hours (systemic, if absorbed)
Clearance: Not well-defined for topical application
ExcretionRoute: Renal and fecal (if systemically absorbed)
Unchanged: Approximately 20% (systemic, if absorbed)
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Pharmacodynamics

OnsetOfAction: Several weeks (clinical improvement typically seen within 3 weeks, but full effect may take 9-12 weeks)
PeakEffect: 9-12 weeks
DurationOfAction: Varies after discontinuation; maintenance therapy may be needed

Safety & Warnings

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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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 burning, stinging, or irritation at the application site
  • Worsening of rosacea symptoms
  • New or unusual skin reactions (e.g., rash, itching, swelling)
  • Eye irritation if gel accidentally gets into eyes
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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. Be sure to describe the allergic reaction and its symptoms.
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 list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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 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 you should not use it 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.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts could theoretically lead to systemic metronidazole overdose symptoms such as nausea, vomiting, diarrhea, metallic taste, dizziness, ataxia, seizures, or peripheral neuropathy.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. 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 use due to minimal absorption)
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Confidence Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of rosacea symptoms (erythema, papules, pustules)

Rationale: To establish baseline severity and track treatment response.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical assessment of rosacea symptoms

Frequency: Every 4-6 weeks or as clinically indicated

Target: Reduction in inflammatory lesions and erythema

Action Threshold: Lack of improvement after 9-12 weeks may warrant re-evaluation of diagnosis or treatment plan; significant irritation may require temporary discontinuation or reduced frequency.

Skin irritation (e.g., dryness, redness, burning, stinging)

Frequency: At each follow-up visit and patient self-monitoring

Target: Minimal to no irritation

Action Threshold: Persistent or severe irritation may require dose reduction, temporary discontinuation, or use of emollients.

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Symptom Monitoring

  • Reduction in facial redness (erythema)
  • Decrease in inflammatory papules and pustules
  • Improvement in overall skin appearance
  • Monitoring for local adverse reactions such as dryness, redness, burning, stinging, itching, or worsening of rosacea

Special Patient Groups

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Pregnancy

Metrogel (metronidazole topical) is classified as Pregnancy Category B. Studies in animals have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, the risk to the fetus is considered low.

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.
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Lactation

Metronidazole is excreted in breast milk following oral administration. However, systemic absorption from topical application is minimal, making the amount transferred to breast milk negligible. It is considered compatible with breastfeeding (L1).

Infant Risk: Low risk; no adverse effects on breastfed infants are expected.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use in children is generally not recommended unless specifically directed by a physician for off-label use.

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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

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Clinical Pearls

  • Advise patients that improvement in rosacea symptoms is gradual and may take 9-12 weeks for full effect. Encourage adherence to the daily regimen.
  • Emphasize the importance of gentle skin care and sun protection for rosacea patients, as these factors can exacerbate the condition.
  • Metrogel 1% is applied once daily, which may improve patient adherence compared to twice-daily formulations.
  • If patients experience significant dryness or irritation, suggest using a non-comedogenic moisturizer after the gel has dried.
  • While systemic interactions are rare, caution patients about alcohol consumption, especially if they have a history of disulfiram-like reactions with oral metronidazole, though the risk is extremely low with topical use.
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Alternative Therapies

  • Azelaic acid topical (e.g., Finacea, Azelex)
  • Ivermectin topical (e.g., Soolantra)
  • Brimonidine topical (e.g., Mirvaso) for erythema
  • Oxymetazoline topical (e.g., Rhofade) for erythema
  • Topical retinoids (e.g., tretinoin, adapalene) for acneiform rosacea (use with caution)
  • Oral antibiotics (e.g., doxycycline, minocycline) for severe inflammatory rosacea
  • Laser or light therapy for persistent erythema or telangiectasias
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Cost & Coverage

Average Cost: Check current market prices (typically $100-$300+ for brand, less for generic) per 55gm pump
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (brand may require prior authorization)
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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'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 medication taken, the amount, and the time it happened.