Ectomethrin 5 Ointment

Description

Ectomethrin 5

Permethrin 5%

For adults

For Efficacy, Fast action and safety in scabies and pruritus 

DESCRIPTION

Ectomethrin (permethrin) 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in four forms

(Cream, ointment & emulsion)

ECTOMETHRIN 5% (cream, ointment & emulsion) is for topical use only.

 

 

 

 

Chemical Name: – The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.

Active Ingredient – Each 100 gm contains 5 gm permethrin.

CLINICAL PHARMACOLOGY

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% (cream, ointment &emulsion)

has not been determined precisely, data from studies with 14C-labeled permethrin and absorption studies of the (cream, ointment & emulsion) applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

INDICATIONS AND USAGE

ECTOMETHRIN 5% (cream, ointment & emulsion) is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).

CONTRAINDICATIONS

ECTOMETHRIN5% (cream, ointment & emulsion) is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

WARNINGS

If hypersensitivity to ECTOMETHRIN 5% (cream, ointment, lotion& emulsion) occurs, discontinue use.

PRECAUTION

FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.

Rx Only

General

Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with permethrin may temporarily exacerbate these conditions.

Information for Patients

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of permethrin. In clinical trials, approximately 75% of patients treated with permethrin who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. permethrin may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if permethrin gets in the eyes.

Pregnancy:-

Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: –

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, consideration should be given to

discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Geriatric Use: –

Clinical studies of Permethrin 5% did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

ADVERSE REACTIONS

 Permethrin preparation is well tolerated, only in exceptional cases mild and transient burning and stinging in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients.

Other adverse events reported since marketing permethrin 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Ectomethrin treatment.

OVERDOSAGE

No instance of accidental ingestion of Permethrin 5% has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION) may result in increased irritation and erythema.

DOSAGE AND ADMINISTRATION

Adults and children:-Thoroughly massage ECTOMETHRIN into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients.

The (cream, ointment & Emulsion) should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead.

ONE APPLICATION IS GENERALLY CURATIVE.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for treatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

General roles for effective treatment.

• Scabies

A-All adults individuals in the house are preferably treated simultaneously with Ectomethrin 5 %

b- Children below 10 years treated with ectomethrin 2.5 %. Permethrin is fase & effective in paediatric patients two month of age &older. Safety &effectiveness in infant less than two months of age have not been established.

c- Ectomethrin preparation should be applied from neck to toes.

After hot bath, the patient should well dry his skin thoroughly and Ectomethrin cream 5 % must be rubbed into the entire body from the neck to toes. The treatment should be repeated for 2 successive days, on the third day from the first application a cleansing bath should be taken, patients should use freshly washed or dry cleaned clothing in order to prevent reinfection

• pruritus:

The patients should rub the effective area 2 times daily for three days or until the itching stop. If itching still persists after the third day the patient should consult his doctor

HOW SUPPLIED

ECTOMETHRIN 5% (cream, ointment &emulsion) is available as follows:

Cream: white carton box containing white printed aluminium tube containing 20 gm cream with sealed orifice and white HDPE plastic cap + insert leaflet.

Ointment: Mauve carton box containing violet printed aluminium tube containing 20 gm ointment with sealed orifice and white HDPE plastic cap +insert leaflet.

Emulsion: white carton box containing brown glass bottle type Ⅲ containing 50 ml emulsion with golden aluminum cap and white LDPE foam liner + insert leaflet.

STORAGE

Store at temperature not exceeding 30ºC

Keep out of the reach of children.