Each gram contains:
active ingredient: permethrin – 50 mg;
excipients: ceteareth-12, ceteareth-20, cetostearyl alcohol, liquid paraffin, propylene glycol, dimethicone, methylparaben, propylparaben,glycerol monostearate, water purified.
Products
Permethrin, 5 % cream
Drug formSoft
ATC categoryAntiparasitic agents
ATC subcategoryAgents for the treatment of scabies
Brand namePermethrin
Generic namePermethrin
Composition
Pharmacological group and ATC code
Pediculicide; ATC CODE – P03AC04.
Pharmacology
Following absorption through the chitinous exoskeleton of arthropods, permethrin stimulates the nervous system, apparently by competitively interfering with cationic conductances in the lipid layer of nerve cells, thereby blocking nerve impulse transmissions. Paralysis and death follow.
Spectrum and Resistance
Permethrin is toxic to the parasitic arthropods Pediculus capitis (head louse), Pediculus corporis (body louse), and Phthirus pubis (crab louse), and possibly their nits. Resistance to permethrin may develop rarely in strains of Pediculus corporis. Some lice resistant to chlorophenothane (DDT) have been reported to be cross-resistant to permethrin. Permethrin is also toxic to house-flies, fleas, chiggers, and mosquitoes.
Pharmacokinetics
Absorption
Permethrin is absorbed through intact skin when applied topically.
Permethrin is absorbed through intact skin when applied topically.
Distribution and Elimination
The highest levels of excretion are detectable within 48 hours but very low levels of metabolite are still detectable in the urine of some individuals 28 days after treatment. The overall pattern of excretion indicates a mean of approximately 0.5% of applied permethrin is absorbed during the first 48 hours. In animals, Permethrin are rapidly metabolized to water soluble, inactive compounds.
Permethrin is reportedly inactivated in the GI tract following: ingestion.
Uses
- Scab (infection caused by Sarcoptes Scabiei).
- Pediculosis pubis.
Dosage and administration
The preparation is intended for topical use.
The drug is carefully rubbing massaged into the skin from the head to the soles of the feet – for adults and children. All members of the affected household should be treated simultaneously. Treatment for children necessarily should be applied scalp, temples and forehead area. For the treatment of adult patients is usually sufficient 30 g. After 8-14 h after the procedure it is necessary to wash off the cream (in the shower, in the bath).
It is now recommended that permethrin should be applied twice, one week apart.
Patients with hyperkeratotic scabies may require 2 or 3 applications of acaricide on consecutive days to ensure that enough penetrates the skin crusts to kill all the mites.
After the treatment, the skin should use only clean linen (including bed). Hands after handling should not be washed for 3 hours; subsequently put the cream on your hands after each wash. It is important to warn users to reapply treatment to the hands if they are washed.
Contraindications
- Hypersensitivity to the ingredients of the preparation.
- Pregnancy,
- Breast-feeding.
- Children up to age 5 years.
Adverse effects
Pruritus, erythema, and stinging; rarely rashes and oedema.
Precautions
Be wary appoint patients with concomitant diseases of the skin.
Treatment of complications of scabies (dermatitis, eczema, pyoderma, postscabiotic limfoplasia) should be carried out simultaneously with the treatment of scabies and continue after its completion. Saving itching after treatment is not an indication for further course of specific therapy. Itching is the body’s reaction to the mite killed and products of its life and disappears in the appointment of antihistamines.Contact with the face, eyes, mucous membranes, and urethral meatus should be avoided. If accidental contact with the eyes occurs, the eyes should be flushed thoroughly with water, Permethrin cream should not be applied to acutely inflamed skin or raw, weeping surfaces.
The preparation should not be applied more than once per day.
If primary irritation or hypersensitivity occurs in patients using Permethrin cream, treatment should be discontinued, the drug washed off, and а physician consulted.
Treatment of patients and contacts should be carried out simultaneously in order to avoid re-infection.
All linen should be carefully treated. Bedding, towels, underwear boiled in a solution of detergent for 5-10 minutes. Outerwear must be heat treated iron. Things that can not be heat treated are posted outdoors for 3 days.
Overdosage
Due to the low absorption into the systemic circulation overdose is unlikely.
Drug interactions
Prescribed drug interaction has not been describe
Identification
White homogenous odorless cream.
Presentation
50 g of cream is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).
Expiry date
3 years. Do not use after the expiration date.
Prescription status
To be dispensed without prescription.
Storage conditions
Store at a room temperature, in a dry place, out of the reach of children. Protect from light.