Pirentel - instructions for use, doses, side effects, contraindications

Active substance: pyrantel 0.750 g (in the form of pyrantel embonate 2.1625 g). Auxiliary substances: sodium benzoate - 0.04500 g, carmellose sodium - 0.00625 g, sorbitol 70% (non-crystallizing) - 10,81350 g, glycerol - 0,91050 g, magnesium aluminosilicate 0.04500 g, polysorbate 80-0 , 0300 g, povidone 0.00900 g, simethicone emulsion 0.00750 g, citric acid monohydrate 0.00492 g, sodium hydroxide qs, apricot flavors 0.02000 g, purified water up to 15 ml.

Description:

Suspension of light yellow color with a characteristic fruit smell.

It is allowed to separate the liquid layer and the sediment, after stirring, a uniform suspension is formed.

Pharmacotherapeutic group:Anthelminthic remedy

ATX: & nbsp

P.02.C.C.01 Pirantele

Pharmacodynamics:

Pyrantel is an antihelminthic agent that acts on nematodes.

It causes neuromuscular blockade in sensitive helminths, which facilitates their removal from the digestive tract without stimulation and stimulation of migration of affected worms.

The drug acts on parasites in the early phase of development and on their mature forms, does not affect the larvae during their migration into tissues.

Pirantel is highly effective against infestations caused by pinworms (Enterobius vermicularis), hookworm (Ancylostoma doudenale, Necator americanus), against the causative agents of trichocephalosis (Trichostrongylus orientalis and Trichostrongylus colubriformis) and ascariasis (Ascaris lumbricoides).

Pharmacokinetics:

Pirantel is very poorly absorbed from the digestive tract.

Concentration of the drug in the blood plasma, after oral administration of a single dose of 10 mg / kg body weight, is 0.005-0.13 μg / ml for 3 hours.

There are no data on the penetration of the drug through the placenta and into the milk of the lactating woman, and also regarding the distribution of the drug in the tissues and body fluids (theoretically, the resorption of the drug is minimal).The minimum amount of the drug resorbed from the digestive tract is partially metabolized in the liver to N-methyl-1,3-propaidiamine.

About 93% of the oral dose of the drug is excreted unchanged with feces and not more than 7% with urine in unchanged form or in the form of a metabolite of N-methyl-1,3-propanedia.

Indications:

Ascaridosis
Enterobiosis
Ankylostomiasis
Nekatoroz
Trichocephalosis

Contraindications:

Hypersensitivity to pyrantel and other components of the drug; myasthenia gravis; liver failure; children up to 6 months; simultaneous application with piperazine and levamisole; In patients with a rare congenital intolerance to fructose.

Carefully:

Child age from b months to 6 years of age, with a body weight of less than 10 kg; depleted patients; anemia.

Pregnancy and lactation:

In studies on animals, there was no harmful effect of pyrantel on the fetus. However, controlled studies of the use of the drug in pregnant women are not available, so the use of the drug in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

There are no data on the safety of the drug in lactating women. If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

The drug is administered orally during or after a meal.

5 ml of the suspension contains 250 mg of pyrantel.

Before use, shake until a uniform suspension is obtained.

Depending on the age and weight of the patient, the following doses are recommended (based on K) mg / kg per day):

Patient's age	Dose of the preparation, mg	Number of measuring cups (1-dimensional ccup = 5 ml)
b months - 2 years	125	½ measuring cup = 2.5 ml
2-6 years	250	1 measuring cup = 5 ml
6-12 years old	500	2 measuring cups = 10 ml
older than 12 years and adults weighing up to 75 kg	750	3 measuring cups = 15 ml
adults weighing more than 75 kg	1000	4 measuring cups = 20 ml

To prevent re-infection, it is recommended to repeat the drug 3 weeks after the first dose.

With ascariasis and enterobiasis, as well as mixed infestations with these parasites, the dose intended for the entire course (at the rate of 10 mg / kg) is applied once.

With ankylostomiasis, a combination of non-katorosis with ascariasis or other combined helminthic lesions pirantele apply for 3 days to 10 mg / kg per day.

In massive invasions of Necator americanus, a dose of 20 mg / kg of body weight is recommended for 2 days.

Side effects:

Side effects are rare, they are short-lived and disappear after discontinuation of treatment.

The incidence of side effects is classified according to the recommendations of the World Health Organization (WHO): very often (> 10%); often (> 1%, <10%); infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%); very rarely (<0.01%); frequency is unknown (according to available data, it is not possible to establish the frequency of occurrence).

Disturbances from the nervous system: rarely - headache, dizziness, drowsiness, insomnia; frequency is unknown - hallucinations with confusion, paresthesia (the relationship of these symptoms with the drug is not proven). Hearing disorders and labyrinthine disturbances: frequency unknown - hearing impairment.

Disorders from the gastrointestinal tract: rarely - nausea, vomiting, pain and stomach cramps, diarrhea, decreased appetite.

Disorders from the liver and bile ducts: rarely - a transient increase in activity of aspartate aminotransferase (ACT) in the blood serum. Disturbances from the skin and subcutaneous tissues: rarely - rash, hives.

General disorders and disorders at the site of administration: rarely - weakness; frequency unknown - increased body temperature.

Overdose:

Symptoms: impaired vision, confusion, dizziness, orthostatic fainting, sweating, weakness, a feeling of irregular heartbeat, muscle cramps and tremors, hypoxia (difficulty breathing, loss of consciousness).

Treatment: In case of overdose, symptomatic therapy (gastric lavage, measures aimed at maintaining respiration and blood pressure) is recommended. There is no specific antidote.

Interaction:

Pyrantel should not be used together with piperazine. These funds act antagonistically.

Not recommended for use with levamisole.

Pirantel increases the concentration of theophylline in plasma.

Special instructions:

In case of liver disease, a doctor should be warned.

After taking pyrantel, laxatives are not prescribed. In the treatment of enterobiasis, all co-residents must be treated simultaneously. Careful hygiene (cleaning of living quarters and cleaning clothes for the destruction of helminth eggs) is a preventive measure of reinfection. 14 days after drug treatment Pirantele should conduct control parasitologic studies.

Because the drug contains sorbitol, it should not be used in patients with rare hereditary diseases, such as fructose intolerance. Sorbitol can have laxative effect.

Effect on the ability to drive transp. cf. and fur:

When unwanted reactions from the nervous system develop (for example, dizziness, drowsiness), one should refrain from managing transportation and taking other activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Suspension for oral administration 250 mg / 5 ml.

Packaging:

For 15 ml of the drug in bottles of dark glass with a screw cap made of polyethylene, equipped with a warranty ring.

1 bottle together with a measuring cup and instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 15 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014090 / 01

Date of registration:26.08.2009

The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland

Manufacturer: & nbsp

MEDANA PHARMA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp10.08.2015

Illustrated instructions

Instructions

Pirantele (Pyrantel)