COMPOSITION :
Permethrin:                                  5%w/v
Preservatives:
Methyl Paraben   I.P.                    0.2%w/v
Propyl Paraben   I.P.                    0.1%w/v
In an oil in water emulsion
base                                             q.s


CLINICAL PHARMACOLOGY :
Pharmacodynamics :
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.
Pharmacokinetics :
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% Lotion has not been determined precisely, data from studies with 14 C-labeled permethrin and absorption studies of the Lotion  applied to patients with moderate to severe scabies indicate that it is 2% or less of the amount applied.

INDICATIONS :
ZEROSCAB LOTION 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

DOSAGE AND ADMINISTRATION :
Adults and Children :
Thoroughly massage ZEROSCAB (permethrin) LOTION into the skin from the head to the soles of the feet. Scabies rarely infests the skull of adults, although the hairline, neck, temple and forehead may be infested in infants and geriatric patients. Usually 30 ml is sufficient for an average adult. The Lotion should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple and forehead.
Children is under 2 months : not recommended
2 months – 1 year : up to 4 ml
1 – 5 years : up to 7.5 ml
5 – 12 years : up to 15 ml
12 years & above : entire content
One ml – approximately equal to area covered by a Rs. 1 coin
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 retreatment. Demonstable living mites after 14 days indicate that retreatment is necessary.

CONTRAINDICATIONS :
Permethrin Lotion is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

WARNINGS AND PRECAUTIONS :
Warnings :
If hypersensitivity to permethrin occurs, discontinue use. Precautions
General :
Scabies infestations is often accompanied by pruritus, edema and erythema. Treatment with permethrin Lotion  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. If irritation persists, they should consult their physician. Permethrin Lotion  may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during applications and to flush with water immediately if permethrin gets in the eyes.
Pregnancy :
There are, 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 Mother :
It is not known whether this drug is excreted in human milk because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.
Paediatric Use :
Permethrin is safe and effective in paediatric patients two months of age and older. Safety and effectiveness in paediatric patients less than two months of age have not been established.

ADVERSE REACTIONS :
Generally mild and transient burning and stinging follows application with permethrin. If ingested accidentally, gastric lavage and general supportive measures should be employed.

STORAGE INSTRUCTIONS :
Store at a temperature not exceeding 250C. Do not freeze.