Mupirocin 2% Ointment 15gm

Manufacturer TARO Active Ingredient Mupirocin(myoo PEER oh sin) Pronunciation myoo PEER oh sin
It is used to treat skin infections.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Topical antibacterial
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Pharmacologic Class
Isoleucyl-tRNA synthetase inhibitor
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Pregnancy Category
Category B
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FDA Approved
Dec 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mupirocin is an antibiotic ointment used to treat certain skin infections, like impetigo, caused by bacteria. It works by stopping the growth of bacteria.
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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. Continue using the medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, eyes, or other sensitive areas, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean and dry the affected area before applying the medication.
Use a gauze pad or cotton swab to apply a small amount of the medication to the affected skin.
If recommended by your doctor, you may cover the treated area with a dressing.

Storage and Disposal

Store this medication at room temperature, avoiding refrigeration or freezing.
Keep all medications in a safe location, 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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed Dose

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands before and after applying the ointment.
  • Clean the affected area before applying the ointment.
  • Apply a thin layer of ointment to cover the entire affected area.
  • You may cover the treated area with gauze if directed by your doctor.
  • Do not use in the eyes, nose, or mouth.
  • Do not use for longer than prescribed, even if the infection seems to clear up, to prevent recurrence and antibiotic resistance.
  • Avoid getting the ointment in your eyes; if it happens, rinse thoroughly with water.
  • Do not use on large areas of skin or on severe burns without consulting a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a small amount to the affected area 3 times daily
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

impetigo: Apply a small amount to the affected area 3 times daily for 5 to 10 days.
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Pediatric Dosing

Neonatal: Not established (safety and efficacy in neonates <2 months not established)
Infant: Apply a small amount to the affected area 3 times daily for 5 to 10 days (for infants â‰Ĩ2 months).
Child: Apply a small amount to the affected area 3 times daily for 5 to 10 days.
Adolescent: Apply a small amount to the affected area 3 times daily for 5 to 10 days.
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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

Mupirocin is an antibacterial agent that inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-tRNA synthetase. This prevents the incorporation of isoleucine into bacterial proteins, leading to bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: <0.2% (intact skin), 3-5% (abraded skin)
Tmax: Not applicable (topical, minimal systemic absorption)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not available (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: 0.5-1 hour (monic acid)
Clearance: Not available
ExcretionRoute: Renal (as monic acid)
Unchanged: <0.2%
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within 3-5 days.
PeakEffect: Not applicable (topical)
DurationOfAction: Not applicable (applied frequently)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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, 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
Severe irritation at the site where the medication was applied
Dizziness
Fast or abnormal heartbeat
A severe form of diarrhea called C. diff-associated diarrhea (CDAD), which can be life-threatening. This may occur during or after treatment with the antibiotic. If you experience:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
seek medical help immediately. Do not attempt to treat diarrhea without consulting your doctor first.

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 symptoms that bother you or persist, contact your doctor:

Burning or stinging
Short-term pain after use
Itching
Headache
Upset stomach

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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the skin infection (e.g., increased redness, swelling, pain, pus)
  • Development of a new rash, itching, or severe irritation at the application site
  • Signs of an allergic reaction (e.g., hives, difficulty breathing, swelling of your face, lips, tongue, or throat)
  • Severe or persistent diarrhea, especially if bloody (may be a sign of C. difficile infection)
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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 allergic reaction you experienced, including any symptoms that occurred.
If a large area of your skin needs to be treated with this medication.
If your skin is damaged or has open wounds, as this medication should not be applied to damaged skin or open wounds.

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 existing health problems

Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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. Adhere to the prescribed duration of use, as prolonged use may increase the risk of a second infection. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. Avoid applying this medication near areas where intravenous drugs are administered; if you have any concerns, discuss them with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to weigh the benefits and risks to both you and your baby. If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before nursing your child.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts may cause gastrointestinal upset.

What to Do:

If accidental ingestion occurs, contact a poison control center or seek medical attention. For topical overdose, wipe off excess ointment. Call 1-800-222-1222.

Drug Interactions

Monitoring

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Routine Monitoring

Clinical response of infection

Frequency: Daily

Target: Resolution of lesions, reduction in redness/swelling

Action Threshold: No improvement after 3-5 days, worsening symptoms, or signs of allergic reaction.

Local adverse reactions (e.g., burning, stinging, itching)

Frequency: Daily

Target: Absence or mild, transient reactions

Action Threshold: Severe or persistent irritation, rash, or signs of contact dermatitis.

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Symptom Monitoring

  • Worsening of skin infection (increased redness, swelling, pain, pus)
  • Development of new skin rash or itching
  • Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Diarrhea (especially if severe or persistent, may indicate C. difficile infection)

Special Patient Groups

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Pregnancy

Mupirocin is Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Due to minimal systemic absorption, risk to the fetus is considered low.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Mupirocin is considered low risk during breastfeeding (Lactation Risk Category L2). Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Apply to areas not accessible to the infant, and avoid application to the nipple/areola area.

Infant Risk: Low risk
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Pediatric Use

Safety and effectiveness in pediatric patients 2 months to 16 years of age have been established. Safety and effectiveness in neonates less than 2 months of age have not been established. Dosing is similar to adults for children â‰Ĩ2 months.

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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. However, due to minimal systemic absorption, no age-related differences in safety or efficacy are expected.

Clinical Information

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Clinical Pearls

  • Mupirocin ointment is for external use only. Do not use in the eyes, nose (unless specifically for nasal formulation), or mouth.
  • The polyethylene glycol base of the ointment may be absorbed from open wounds and damaged skin and is renally excreted. Use with caution in patients with moderate to severe renal impairment, especially if applied to large areas or damaged skin.
  • Discontinue use and consult a healthcare provider if irritation, sensitization, or severe allergic reactions occur.
  • Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi.
  • Not effective for fungal or viral infections.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence and development of resistance.
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Alternative Therapies

  • Topical retapamulin
  • Topical fusidic acid (where available)
  • Oral antibiotics (e.g., cephalexin, dicloxacillin) for more severe or widespread infections
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Cost & Coverage

Average Cost: Varies, typically $15-$50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 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 substance taken, the amount, and the time it occurred.