COMPOSITION:

Active substance:

Pyrantel pamoate;

1 tablet contains pyrantel pamoate equivalent to pyrantel 250 mg;

Excipients:

Povidone, maize starch, сroscarmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

INDICATIONS:

Treatment of helminthism:Ascariasis,enterobiasis,ankylostomiasis, necatoriasis, trichocephaliasis.

DOSAGE:

Administrate orally once in a day, in any time:

There is no need to abstain from eating or take purgative before Pyrantel administration.

During enterobiasis and combination of enterobiasis with ascariasis for adults and children the preparation is prescribed once in a dose 10 mg/kg of a body weight and in accordance with the following scheme:

During severe forms a double dose is prescribed – 20 mg/kg per day as 1 – 2 doses for 2 – 3 days.

To avoid autoinvasiona repeated treatment course in 3 weeks in a dose 10 mg/kg is recommended.

In case of isolated ascariasis – a single dose of 5 mg/kg in a day.

In case of ankylostomiasis, necatoriasis, combination of necatoriasis with ascariasis or in case of other combinations of helminthis invasions the preparation should be used in a dose 10 mg/kg per day during 3 days or 20 mg/kg per day during 2 days.

For children under 3 years the suspension type preparation for oral use is prescribed.

ADVERSE REACTIONS:

Gastrointestinal distress:

pain in the upper abdomen, nausea, vomiting, diarrhea, anorexia, epigastric spasms, tenesmus;

Hepatobiliary disorders:

overactivityof hepatic transaminases;

Neurological disorders:

headache, dizziness, somnolence, fatigue, insomnia, weakness;

Changes of skin and subcutaneous tissue:

skin rash, itching, hives.

Drug interactions:

Not Known.

Pregnancy and lactation:

In experimental studies a negative teratogenic influence of pyrantel on a fetus has not been observed. During pregnancy and lactation the drug is administered after a careful evaluation of the ratio benefit for a women/risk to a fetus (baby) determined by a doctor and a patient adheres strictly to the recommended doses.

Children:

It is more reasonable to prescribe the suspension type preparation for children under 6 years. In case of impossible strict dose determination or difficulty in swallowing for children older 3 years, the suspension type preparation for oral use is prescribed

PRECAUTIONS:

Administration.There is no need in special preparation and usage of laxatives. Pyrantel is used regardless of meal and time of the day, there is no necessity to refrain from eating.

Tablets before swallowing should be thoroughly chewed.

In case of enterobiasis, simultaneous treatment of all people, who live together, must be conveyed.

To achieve treatment effect in case of enterobiasisit is recommended a strict adherence to the rules of personal hygiene, especially for children, as well as rechellange of Pyrantel in 3 weeks.

After completion of the course control feces analysis on helminth eggs should be hold.

Overdose:

In case of preparation administration in a high dose adverse reactions become more severe, ataxia is possible.

In case of overdose gastric lavage must be performed, vital body functions should be monitored, symptomatic therapy has to be conducted. If there are any signs of anticholinesterase action, atropine must be introduced.

Ability to influence reaction velocity while driving or operating any other mechanisms.

In case of dizziness, somnolence, weakness occurrence you should refrain from driving and operating the machinery.

CONTRAINDICATIONS:

Hypersensitivity to any component of the preparation, hepatic failure.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:

Pyrantel pamoate is anticholinesterase agent.

Pyrantel depolarizing effect leads to symptomatic delivery disruption in the body of helminth (firstly, it leads to reinforcement, and then to inhibition), the development of neuromuscular blockade, and therefore to the spastic paralysis of the muscles of helminth, promoting their excretion in feces.Pyrantel is active against sensitive sexually mature and immature helminthes. Larvae, which migrate via tissues, are not affected.

Pharmacokinetics:

It is not practically absorbed in the gastrointestinal tract (less than 3.5%). After administration of thesingle dose 10 mg/kg of body weight concentration of the Pyrantel is insignificant – from 0,05 to 0,13 mg/ml during 1 – 3 hours. Pyrantel, which is absorbed into the systemic circulation, partially metabolized in the liver

The major metabolite is a N-methyl-1.3-propanediamine, which concentration in urine is 1.2 – 4.6%. Over 93% of the Pyrantel is excreted with feces intact.

PHARMACEUTICAL CHARACTERISTICS:

General physicO-chemical properties:

Film coated capsule-shaped pink tablets with etching “500” or “750” on one side.

Shelf-life:

3 years.

Storage:

Store below 25°С in the original pack and keep it out of reach of children.

Package:

3 tablets are in a blister, each blister is in a carton package. 10 packages are in a carton box.

Conditions of supply:

By prescription.