Pyrantel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIRANTEL (PIRANTEL)

Composition:

5 ml of oral suspension contains:

Active substance: pyrantel pamoate (calculated as pyrantel) 250 mg;

Excipients: sorbitol solution, non-crystallizing (E 420); glycerol; polysorbate 80; sodium carboxymethylcellulose; sodium benzoate (E 211); aluminum-magnesium silicate; povidone; simethicone; flavoring agent "Apricot" (contains propylene glycol); citric acid monohydrate; sodium hydroxide; purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical characteristics: light yellow suspension with a characteristic odor. Stratification may occur upon storage, which is eliminated by shaking.

Pharmacotherapeutic group. Antihelminthic agents.

ATC code P02C C01.

Pharmacological properties.

Pharmacodynamics.

Pyrantel is an anthelmintic agent. It is active against Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, and Necator americanus. Pyrantel causes neuromuscular blockade, paralyzing helminths, resulting in their elimination via intestinal peristalsis along with fecal masses. Pyrantel is effective against sensitive mature and immature forms of helminths. It has no effect on migrating tissue-stage larvae.

Pharmacokinetics.

Gut absorption of pyrantel is very low. After administration, plasma concentration is very low (0.05–0.013 mcg/mL) and reaches maximum levels within 1–3 hours. Up to 93% of the drug is excreted unchanged in feces. Less than 7% is found in urine, both unchanged and as metabolites.

Clinical characteristics.

Indications.

Enterobiasis, ascariasis, ancylostomiasis.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of pyrantel with levamisole is not recommended (potentiation of the latter's toxicity) or with piperazine, which is an antagonist of pyrantel's anthelmintic effect. The drug may increase the concentration of theophylline.

Special precautions for use.

In case of hepatic insufficiency, dose reduction is recommended.

Enterobiasis: to prevent reinfection, strict hygiene measures should be observed: daily perianal toilet, cleaning of nails several times a day. Children should have their nails kept short. Underwear and nightwear should be changed regularly. Scratching should be avoided. Simultaneous treatment of all family members is recommended, as infection often occurs asymptomatically.

This medicinal product contains sorbitol. It should not be used in patients with hereditary fructose intolerance (a rare genetic disorder). Sorbitol may have a mild laxative effect.

If intolerance to certain sugars is known, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

Due to the absence of teratogenic effects in animals, congenital malformations in humans are not expected. Currently, congenital malformations or fetotoxic effects have not been clinically confirmed. However, monitoring of pyrantel use during pregnancy is insufficient to exclude all possible risks. Therefore, this drug should be used during pregnancy only if absolutely necessary, after careful assessment of the benefit-to-risk ratio for mother and fetus, as determined by a physician.

Due to the lack of published studies on the adverse effects of pyrantel on breastfed infants, and considering the very low absorption of pyrantel, the use of Pyrantel may be possible, if necessary, after consultation with a physician.

Ability to affect reaction speed when driving vehicles or operating machinery.

The drug may cause dizziness, drowsiness, and weakness; therefore, it should be used with caution when driving vehicles or operating machinery.

Method of Administration and Dosage

The medication can be taken at any time; there is no need to take it on an empty stomach or to use laxatives beforehand.

Enterobiasis and Ascariasis.

For the treatment of enterobiasis and ascariasis, the usual dose is a single dose of 10 mg/kg to 12 mg/kg.

Children: 2.5 mL of suspension per 10 kg body weight as a single dose.

Adults with body weight less than 75 kg: 15 mL of suspension as a single dose.

Adults with body weight over 75 kg: 20 mL of suspension as a single dose.

In cases of enterobiasis, to achieve complete elimination of parasites, strict hygiene measures must be followed and all family members should be treated simultaneously. To prevent reinfection, a repeat dose should be administered 3 weeks after the first dose.

Hookworm Infection.

In endemic areas, for infection with Necator americanus or heavy infestation with Ancylostoma duodenale, the dosage is 20 mg/kg per day (in 1 or 2 divided doses) for 2–3 days.

Children: 5 mL of suspension per 10 kg body weight per day.

Adults with body weight less than 75 kg: 30 mL of suspension per day.

Adults with body weight over 75 kg: 40 mL of suspension per day.

In cases of mild infection with Ancylostoma duodenale (which typically occurs in non-endemic areas), a single dose of 10 mg/kg may be sufficient.

Children.

Should be prescribed to children with body weight of at least 10 kg.

Overdose.

Due to the low absorption coefficient of the drug, plasma concentrations remain low. Even in cases of overdose, including large overdoses, symptoms are generally limited to mild gastrointestinal disturbances (nausea, vomiting, diarrhea) and minor transient central nervous system effects (asthenia, dizziness, headache). Occasionally, elevated levels of liver transaminases (AST) may occur. Specific antidotes are not known. Immediate gastric lavage is recommended, along with monitoring of respiratory and cardiovascular functions. Treatment is symptomatic.

Adverse reactions.

Gastrointestinal system: nausea, vomiting, epigastric pain, anorexia, abdominal cramps, tenesmus, diarrhea, rarely – increased liver transaminase activity.

Central and peripheral nervous system: headache, dizziness, fatigue, somnolence, insomnia, asthenia, weakness.

Skin and subcutaneous tissue: rash, urticaria.

Hypersensitivity reactions are possible.

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 25 °C in a place inaccessible to children.

Packaging. 15 ml in a bottle No. 1 with a dosing cup in a carton.

Prescription status. Prescription only.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's location and address of business activity:
4 Korolyova St., Stanishevska village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.