Instructions for use: Pirantel tablets 250 mg, blister pack No. 30
Composition
active ingredient: pyrantel pamoate;
1 tablet contains pyrantel pamoate equivalent to pyrantel 250 mg;
Excipients: povidone, corn starch, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide.
Dosage form
Pills.
Main physicochemical properties: yellow capsule-shaped tablets with a score line on one side.
Pharmacotherapeutic group
Antiparasitic agents, insecticides and repellents. Anthelmintic agents. ATX code P02C C01.
Pharmacological properties
Pharmacodynamics.
Pyrantel is an anthelmintic agent. Active against Enterobius vermicularis, Ascaris lumbricoides, Ansulostoma duodenale and Necator americanus. Pyrantel causes neuromuscular blockade, paralyzing the helminths, as a result of which they are excreted by intestinal peristalsis together with the feces. Pyrantel is active against sensitive sexually mature and immature forms of helminths. It does not affect helminth larvae migrating through tissues.
Pharmacokinetics.
Intestinal absorption of pyrantel is very low. After administration of the drug, plasma concentration is very low (0.05-0.13 μg/ml) and reaches a maximum within 1-3 hours. Up to 93% of the drug is excreted unchanged in the feces. Less than 7% is found in the urine in an unchanged state and in the form of metabolites.
Indication
Enterobiasis, ascariasis, hookworm.
Contraindication
Hypersensitivity to any components of the drug.
Interaction with other medicinal products and other types of interactions
Do not use with piperazine, which is an antagonist of the anthelmintic action of pyrantel.
Application features
In case of liver failure, it is recommended to reduce the dose.
Enterobiasis: to prevent re-infection, it is necessary to take strict hygiene measures: daily toilet of the perianal area, clean the nails several times a day. Children should have their nails cut short. Change underwear and pajamas regularly. Prevent scratching. It is recommended to treat all family members at the same time, since the infection is often asymptomatic.
Use during pregnancy or breastfeeding
Due to the lack of teratogenic effects of pyrantel in animals, congenital malformations in humans are not expected. At present, there is no clinical evidence of congenital malformations or fetotoxic effects of pyrantel. However, monitoring of the use of pyrantel during pregnancy is insufficient to exclude all possible risks. Therefore, this drug can be used during pregnancy only if absolutely necessary after a careful assessment of the benefit to the woman/risk to the fetus, which is determined by the doctor.
Due to the lack of published studies on the undesirable effects of pyrantel on breastfed children, and also due to the very low absorption of pyrantel, the use of the drug is possible, if necessary, after consulting a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
Adverse reactions from the nervous system, which may sometimes be observed during treatment with pyrantel, may affect the speed of reaction when driving vehicles and the ability to work with other mechanisms.
Method of administration and doses
The drug can be taken at any time, there is no need to take the drug on an empty stomach or to use laxatives beforehand.
Enterobiasis and ascariasis.
In the treatment of enterobiasis and ascariasis, the usual dosage is 10 mg/kg to 12 mg/kg once.
Children over 6 years of age: 1 tablet per 20 kg of body weight once.
Adults weighing less than 75 kg: 3 tablets once.
Adults weighing more than 75 kg: 4 tablets once.
In the case of enterobiasis, to completely get rid of the parasites, it is necessary to follow strict hygiene measures and treat all family members at the same time. To avoid re-infection, it is recommended to take a second dose 3 weeks after the first dose.
Hookworm.
In endemic areas, in case of infection with Necator americanus or massive invasion of Ancylostoma duodenale, the dosage is 20 mg/kg per day (in 1 or 2 doses) for 2-3 days.
Children over 6 years of age: 1 tablet per 10 kg of body weight per day.
Adults weighing less than 75 kg: 6 tablets per day.
Adults weighing more than 75 kg: 8 tablets per day.
In case of moderate infection with Ancylostoma duodenale (which usually occurs in non-endemic areas), a single dose of 10 mg/kg may be sufficient.
Children
Prescribe to children aged 6 years and over. For children under 6 years of age, it is advisable to use the drug in
in the form of a suspension.
Overdose
Due to the low absorption rate, plasma concentrations of the drug are low. Overdose causes some gastrointestinal disorders (e.g. nausea, vomiting, diarrhea) and minor temporary disorders of the central nervous system (e.g. asthenia, dizziness, headache). Sometimes overdose leads to an increase in the level of hepatic transaminases (AST). Specific antidotes are unknown. Immediate gastric lavage is recommended, as well as monitoring of the functions of the respiratory and cardiovascular systems. Treatment is symptomatic.
Side effects
Gastrointestinal: epigastric pain, abdominal pain, nausea, vomiting, diarrhea, anorexia; abdominal cramps, tenesmus.
On the part of the hepatobiliary system: decrease or temporary increase in the level of hepatic transaminases.
From the nervous system: headache, dizziness, drowsiness, increased fatigue, insomnia, asthenia.
Skin and subcutaneous tissue disorders: skin rash, itching, urticaria,
Immune system disorders: hypersensitivity reactions.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
3 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Kusum Healthcare Pvt Ltd.
Address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
