Translation of the instructions can be
PYRANTEL-Vishfa oral suspension 250 mg / 5 ml
Instruction
For medical use of the medicinal product
Composition:
Active ingredient: 5 ml of oral suspension contain pyrantel pamoate (as pyrantel) 250 mg;
excipients: sorbitol solution that does not crystallize (contains E 420); glycerin; polysorbate 80; sodium carboxymethylcellulose; sodium benzoate (E 211); aluminum-magnesium silicate; povidone; simethicone; Apricot MA / 1 137 flavoring (contains propylene glycol); citric acid monohydrate; sodium hydroxide; purified water.
Dosage form.
Oral suspension.
Pharmacotherapeutic group.
Antiparasitic agents. anthelmintic agents. ATS code R 02C C01.
Pharmaceutical characteristics.
Main physicochemical properties: light yellow suspension with a characteristic odor. During storage, stratification is possible, which is eliminated by shaking.
Pharmacological properties.
Pharmacodynamics.
The depolarizing effect of pyrantel causes the development of neuromuscular block, resulting in a spasm of the helminth muscles, and the latter is removed from the body by intestinal peristalsis. PYRANTEL-Vishfa acts on both sexually mature and immature individuals of parasites.
Pharmacokinetics.
Pyrantel pamoate is poorly absorbed from the gastrointestinal tract (less than 3.8%). After oral administration at a dose of 10 mg/kg, the plasma concentration is 0.005 - 1.13 μg/ml within 1 - 3 hours. The minimum amount of the drug is partially metabolized in the liver to N-methyl-1,3-propanediamine. More than 50% of the drug is excreted unchanged in the feces after oral administration, no more than 7% is excreted in the urine unchanged and in the form of N-methyl-1,3-propanediamine.
Clinical characteristics.
Indication.
Enterobiasis, ascariasis, hookworm, necatoriasis.
Contraindication.
Hypersensitivity to the components of the drug; impaired liver function; pregnancy and breastfeeding; children under 6 months of age.
Application features.
It is prescribed with caution to patients with impaired liver function. After using the drug, laxatives are not prescribed. In case of enterobiasis, it is necessary to simultaneously treat all persons living in the same room as the patient. After the end of the course of treatment, it is necessary to conduct control laboratory tests (stool tests for the presence of parasites).
Use during pregnancy or breastfeeding.
In experimental studies, teratogenic effects have not been established. Use during pregnancy and breastfeeding is possible if the expected benefit to the mother outweighs the possible risk to the fetus/child.
The ability to influence the reaction speed when driving or working with other mechanisms.
The drug may cause dizziness, drowsiness, and weakness, so it should be used with caution when driving vehicles and operating other mechanisms.
Interaction with other drugs and other types of interactions.
It is not recommended to use the drug together with levamisole (potentiation of the latter's toxicity) and with piperazine, which is an antagonist of the anthelmintic action of pyrantel. The drug may increase the concentration of theophylline.
Method of administration and doses.
Administer orally, during or after meals. There is no need to use laxatives or abstain from eating. Shake before use until a homogeneous suspension is obtained.
The recommended dose of the drug for adults and children is 10 mg of active substance per 1 kg of body weight. The maximum dose is 1000 mg orally once.
Depending on age and body weight, they prescribe:
- children aged 6 months to 2 years - 125 mg (2.5 ml);
- from 2 to 6 years - 250 mg (5 ml);
- from 6 to 12 years old - 500 mg (10 ml);
- over 12 years old and adults with a body weight of up to 75 kg - 750 mg (15 ml);
- adults with a body weight of more than 75 kg - 1000 mg (20 ml) once a day.
When treating enterobiasis, in order to improve the effect, it is recommended to strictly follow the rules of personal hygiene (especially for children) and repeat the drug 2-3 weeks after the previous one.
In severe forms of hookworm infection, a double dose of 20 mg per kilogram of body weight is prescribed in 1 or 2 doses for 2-3 days.
Children.
Do not use in children under 6 months of age.
Overdose.
Loss of appetite, nausea, vomiting, diarrhea, ataxia are possible, however, due to the minimal amounts of pyrantel absorbed, even a significant overdose causes signs of intoxication very rarely. Due to the lack of a specific antidote, in cases of overdose, symptomatic treatment (gastric lavage, laxatives) is recommended, if necessary, supportive therapy with cardiac and analeptic agents.
Adverse reactions.
On the part of the digestive system: nausea, vomiting, epigastric pain, anorexia, abdominal cramps, tenesmus, diarrhea, rarely - increased activity of hepatic transaminases.
From the side of the central and peripheral nervous system: headache, dizziness, feeling of fatigue, drowsiness, insomnia.
Skin: allergic rashes
Shelf life: 3 years.
Storage conditions: Store at a temperature not exceeding 25 °C, out of the reach of children.
Packaging: 15 ml in a bottle with a measuring spoon in a pack.
Release category: By prescription.
Producer.
Location of production and its address of place of business.
Ukraine, 12430, Zhytomyr region, Zhytomyr district, Stanyshivka village, Koroleva st., 4.
