Permethrin 5% Cream 60gm

Manufacturer PERROGO Active Ingredient Permethrin Cream(per METH rin) Pronunciation per-METH-rin
It is used to treat scabies.
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Drug Class
Scabicides; Pediculicides
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Pharmacologic Class
Pyrethroid
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Pregnancy Category
Category B
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FDA Approved
Dec 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Permethrin 5% cream is a medicine applied to the skin to treat scabies, a condition caused by tiny mites that burrow into the skin and cause intense itching. It works by killing these mites and their eggs.
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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. It is essential to use this medication as directed.

Application Instructions

Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Wash your hands before and after applying the medication.
Apply a thin layer of the medication to your skin, covering the area from the neck to the toes. Be sure to include the skin folds, creases, spaces between the fingers and toes, and the soles of the feet.
Trim your fingernails short before applying the medication.
Use a toothbrush to apply the cream under your nails. Dispose of the toothbrush after use to prevent reuse.

Precautions and Safety Measures

Wear light, loose-fitting clothing while the medication is on your skin.
Avoid direct skin-to-skin contact with others while wearing the cream.

Removing the Medication

After 8 to 14 hours, wash the medication off your skin using warm, soapy water.
Launder all bedding, towels, and recently worn clothing in hot water or have them dry cleaned.

Storage and Disposal

Store the medication at room temperature.
Discard any unused portion of the medication after use.

Missed Dose

* If you forget to apply a dose, do so as soon as you remember.
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Lifestyle & Tips

  • Wash all clothing, bedding, and towels used by the infested person and household contacts in hot water and dry them in a hot dryer, or dry clean them. Items that cannot be washed should be sealed in a plastic bag for at least 72 hours.
  • Vacuum carpets and upholstered furniture.
  • Treat all household members and close contacts simultaneously, even if they don't have symptoms, to prevent re-infestation.
  • Trim fingernails and toenails to reduce mite hiding places and prevent scratching-induced skin damage.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer of 5% cream to all skin surfaces from the neck to the soles of the feet. Leave on for 8-14 hours, then wash off thoroughly. A single application is usually curative. Re-treatment may be necessary in 7-14 days if live mites are observed or new lesions appear.

Condition-Specific Dosing:

scabies: Apply a thin layer of 5% cream to all skin surfaces from the neck to the soles of the feet. Leave on for 8-14 hours, then wash off thoroughly. A single application is usually curative. Re-treatment may be necessary in 7-14 days if live mites are observed or new lesions appear.
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Pediatric Dosing

Neonatal: Not established (safety and efficacy in infants <2 months of age have not been established, but often used off-label under medical supervision).
Infant: For infants â‰Ĩ2 months of age: Apply a thin layer of 5% cream to all skin surfaces from the neck to the soles of the feet. Leave on for 8-14 hours, then wash off thoroughly. A single application is usually curative. Re-treatment may be necessary in 7-14 days if live mites are observed or new lesions appear.
Child: Same as adult for children â‰Ĩ2 months of age.
Adolescent: Same as adult.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Permethrin is a synthetic pyrethroid that acts as a neurotoxin on the parasites (Sarcoptes scabiei mites). It disrupts the sodium channel current in the neuronal membranes of arthropods, leading to delayed repolarization and subsequent paralysis and death of the parasite.
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Pharmacokinetics

Absorption:

Bioavailability: <2% (systemic absorption after topical application)
Tmax: Not well-defined due to minimal systemic absorption; metabolites detected within 48 hours.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not well-defined due to minimal systemic absorption.
ProteinBinding: Not well-defined due to minimal systemic absorption.
CnssPenetration: Limited (due to minimal systemic absorption).

Elimination:

HalfLife: Not well-defined due to minimal systemic absorption; metabolites cleared within 48 hours.
Clearance: Not well-defined due to minimal systemic absorption.
ExcretionRoute: Primarily renal (as inactive metabolites).
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Rapid (paralysis of mites occurs quickly after exposure).
PeakEffect: Not applicable (direct parasiticidal effect).
DurationOfAction: Residual activity for up to 14 days after application, providing continued protection against newly hatched mites.

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
Eye irritation

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 that bother you or do not go away, contact your doctor:

Itching or redness
Burning or stinging

Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 (e.g., intense burning, stinging, redness, swelling, blistering) after application.
  • Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat).
  • Persistent or worsening itching or new lesions after 2-4 weeks, which may indicate treatment failure or re-infestation.
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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 you are allergic to ragweed, as this medication may trigger breathing difficulties or an asthma attack.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
All of your health problems, as this medication may not be suitable for individuals with certain conditions.

To ensure your safety, it is vital to verify that this medication can be taken with all of your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with 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. If you ingest this drug orally and experience any adverse effects, seek immediate medical attention or contact a poison control center. This medication is not recommended for children under 2 months of age unless explicitly advised by a doctor. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to increased local irritation (redness, swelling, burning, stinging).
  • Accidental ingestion may cause nausea, vomiting, abdominal pain, dizziness, headache, and in severe cases, seizures or loss of consciousness (rare).

What to Do:

For topical overdose, wash off the cream thoroughly with soap and water. For accidental ingestion, seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical diagnosis of scabies

Rationale: To confirm the presence of Sarcoptes scabiei mites and guide treatment.

Timing: Prior to initiation of treatment.

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Routine Monitoring

Resolution of symptoms (e.g., itching, rash)

Frequency: Daily/weekly post-treatment

Target: Gradual decrease in itching and rash over several weeks (itching may persist for up to 4 weeks post-treatment due to allergic reaction to dead mites).

Action Threshold: Persistent or worsening symptoms after 2-4 weeks, or appearance of new lesions, may indicate treatment failure or re-infestation, requiring re-evaluation and potential re-treatment.

Skin irritation/adverse reactions

Frequency: Daily post-treatment

Target: Minimal to no irritation beyond initial application.

Action Threshold: Severe redness, swelling, blistering, or increased itching beyond expected post-treatment pruritus; discontinue use and consult physician.

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Symptom Monitoring

  • Persistent or worsening itching
  • New skin lesions (burrows, papules, vesicles)
  • Signs of secondary bacterial infection (e.g., pus, fever)
  • Severe skin irritation (redness, swelling, blistering)

Special Patient Groups

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Pregnancy

Permethrin is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and limited human data suggest a low risk. It is generally considered safe for use during pregnancy when indicated for scabies.

Trimester-Specific Risks:

First Trimester: Low risk, generally considered safe.
Second Trimester: Low risk, generally considered safe.
Third Trimester: Low risk, generally considered safe.
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Lactation

Permethrin is classified as L1 (safest) for lactation. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in significant amounts. It is generally considered compatible with breastfeeding.

Infant Risk: Low risk; unlikely to cause adverse effects in a breastfed infant.
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Pediatric Use

Approved for use in infants â‰Ĩ2 months of age. Safety and efficacy in infants <2 months have not been established, but it is often used off-label under medical supervision due to its favorable safety profile compared to alternatives. Careful application to avoid contact with eyes, mouth, and mucous membranes is crucial.

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Geriatric Use

No specific dose adjustments are needed for geriatric patients. The safety and efficacy profile is similar to that in younger adults. Use with caution in elderly patients with very sensitive or compromised skin, as they may be more prone to local irritation.

Clinical Information

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Clinical Pearls

  • Itching may persist for up to 2-4 weeks after successful treatment due to an allergic reaction to dead mites. This does not necessarily mean treatment failure.
  • Re-treatment is typically only recommended if live mites are observed or new burrows/lesions appear 7-14 days after the initial treatment.
  • Ensure the cream is applied to ALL skin surfaces from the neck down, including between fingers and toes, under nails, and in skin folds. For infants and elderly, also apply to the scalp, face, and ears, avoiding eyes and mouth.
  • Treat all close contacts and household members simultaneously to prevent re-infestation, even if asymptomatic.
  • Advise patients to wash off the cream thoroughly after the recommended application time (8-14 hours).
  • Permethrin is not effective against head lice when used as a 5% cream; a 1% lotion/cream is used for head lice.
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Alternative Therapies

  • Ivermectin (oral, for resistant or widespread scabies)
  • Crotamiton (cream/lotion, less effective than permethrin)
  • Sulfur (ointment, older treatment, strong odor)
  • Benzyl benzoate (lotion, not available in all regions, can be irritating)
  • Lindane (lotion, rarely used due to neurotoxicity risk, especially in children and those with compromised skin)
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Cost & Coverage

Average Cost: $20 - $50 per 60gm tube of 5% cream
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 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.