Metrolotion 0.75% Top Lotn 59ml

Manufacturer GALDERMA LABORATORIES 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
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Pharmacologic Class
Nitroimidazole
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Pregnancy Category
Category B
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FDA Approved
Mar 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metrolotion is a topical medication used to treat rosacea, a skin condition that causes redness and bumps on the face. It helps reduce inflammation and the number of pimple-like lesions.
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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 drugs or products on your skin, 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 about disposal, 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 continue with 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 before applying the lotion.
  • Apply a thin layer to the entire affected area, not just individual lesions.
  • Wash hands thoroughly after applying the medication.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Avoid known rosacea triggers such as sun exposure, hot beverages, spicy foods, alcohol, and extreme temperatures.
  • Use a broad-spectrum sunscreen daily.
  • Cosmetics can be applied after the lotion has dried.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected areas of the face once daily, in the morning.

Condition-Specific Dosing:

Rosacea: Apply a thin layer to affected areas of the face once daily, in the morning. Patients may use cosmetics after the application has dried.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

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 effects and possibly antimicrobial activity against *Demodex* mites or certain bacteria. It has been shown to reduce reactive oxygen species.
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Pharmacokinetics

Absorption:

Bioavailability: <10% (systemic absorption after topical application)
Tmax: Not clinically relevant for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

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

Elimination:

HalfLife: Not clinically relevant for topical application.
Clearance: Not clinically relevant for topical application.
ExcretionRoute: Not clinically relevant for topical application.
Unchanged: Not clinically relevant for topical application.
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Pharmacodynamics

OnsetOfAction: Several weeks (clinical improvement)
PeakEffect: Up to 9-12 weeks for maximal effect
DurationOfAction: Maintained with continued use

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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
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 sensations

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 that does not subside.
  • Excessive dryness or peeling of the skin.
  • Worsening of rosacea symptoms.
  • Signs of an allergic reaction such as rash, hives, swelling of the face/lips/tongue, or difficulty breathing (seek immediate medical attention).
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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. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter 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. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.
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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:

  • Overdose with topical metronidazole is highly unlikely due to minimal systemic absorption. Ingestion of the entire tube would be required for systemic effects, which could include nausea, vomiting, diarrhea, metallic taste, or seizures (rare).

What to Do:

If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of rosacea severity

Rationale: To establish baseline for treatment efficacy evaluation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical assessment of rosacea improvement (reduction in inflammatory lesions and erythema)

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

Target: Reduction in lesion count and erythema

Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of diagnosis or treatment.

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: Severe or persistent irritation may require temporary discontinuation or reduced frequency of application.

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Symptom Monitoring

  • Burning
  • Stinging
  • Dryness
  • Redness
  • Itching
  • Worsening of rosacea symptoms
  • Signs of allergic reaction (e.g., rash, swelling, severe itching)

Special Patient Groups

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Pregnancy

Metronidazole topical is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and human data are limited but do not suggest an increased risk of major birth defects. 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 into breast milk after systemic administration, but systemic absorption after topical application is minimal. Therefore, the amount transferred to breast milk is expected to be very low, and adverse effects in breastfed infants are unlikely. Considered L2 (safer).

Infant Risk: Low risk of adverse effects in breastfed infants.
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Pediatric Use

Safety and efficacy of metronidazole topical for the treatment of rosacea have not been established in pediatric patients. Rosacea is rare in children.

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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

  • Patients should be advised that therapy may take several weeks to show noticeable improvement.
  • Metronidazole topical is for external use only. Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Patients should continue to avoid known rosacea triggers while using metronidazole.
  • If irritation occurs, patients may temporarily reduce the frequency of application or discontinue use until irritation subsides, then resume as tolerated.
  • This medication does not cure rosacea but helps manage its symptoms.
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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
  • Oral antibiotics (e.g., doxycycline, minocycline) for more severe inflammatory rosacea
  • Laser or light therapy for persistent redness or telangiectasias
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Cost & Coverage

Average Cost: Varies widely (e.g., $50 - $300+) per 59ml lotion
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often covered by most prescription plans)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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.