The Order of Ministry of Health of Ukraine 20.08.2015 № 537
Order of the Ministry of Health of Ukraine 21.03.2019 № 629
for medical use РYRANTEL
active substance: pyrantel;
5 ml of suspension contain pyrantel pamoate equivalent to pyrantel 250 mg;
excipients: xanthan gum, sucrose, citric acid, monohydrate; sodium citrate, glycerol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), polysorbate 80, pineapple flavor, purified water.
Pharmaceutical form. Oral suspension.
Basic physico-chemical properties: yellow suspension with a characteristic odor.
Pyrantel is an anthelmintic agent. It is active against Enterobius vermicularis, Ascaris lumbricoіdes, Anсylostoma duodenale and Necator americanus. Pyrantel causes neuro-muscular blockade paralyzing the helminthes, so that they are excreted by means of intestinal peristalsis with stool. Pyrantel is active against sensitive and mature and immature forms of helminthes. It has no effect on larvae of helminthes that migrate through tissues.
Intestinal resorption of pyrantel is very low. After taking the drug, plasma concentration is very low (0.05-0.13 µg/l) and reaches its maximum within 1-3 hours. Up to 93% of the dose is excreted unchanged with the feces. Less than 7% are detected in the urine unchanged and in the form of metabolites.
Enterobiasis, ascariasis, ankylostomiasis.
Hypersensitivity to any components of the drug.
Interaction with other medicinal products and other forms of interaction.
Do not use with piperazine, which is an antagonist to the anthelminthic effect of pyrantel.
In case of hepatic insufficiency, the dose should be reduced.
Enterobiasis: to prevent reinfection, it is necessary to take strict hygienic measures: clean perianal area every day, clean nails several times per day. Children’s nails should be cut short. The underwear and pyjamas should be changed regularly. Prevent scratching. It is recommended to treat all the family members, since the infection is often asymptomatic.
This medicinal product contains sucrose. If you have detected intolerance to some sugars, consult your doctor before taking this medicinal product.
This medicinal product contains methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate; therefore, it may cause allergic reactions (possiblydelayed).
Use during pregnancy or breast-feeding.
Due to the absence of teratogenic effect in animals, congenital malformations in humans are not expected. Currently, congenital malformations or fetotoxic effects have not been proved clinically. However, monitoring of the use of pyrantel during pregnancy is not sufficient to rule out all the possible risks. Thus, this preparation may be used during pregnancy only if absolutely necessary, after careful evaluation of the benefit for the woman/risk for the fetus ratio, which is determined by the physician.
In the absence of published studies about the undesired effect of pyrantel in breastfed children, and also taking into account very low absorption of pyrantel, the use of Pyrantel is possible if necessary, after consultation with the doctor.
Effect on reaction rate when driving motor transport or operating other mechanisms.
In cases, where during the drug treatment dizziness or drowsiness is observed, one should refrain from driving vehicles and working with machinery.
Dosage and administration.
Shake before using. Use orally.
The drug may be taken at any time, there’s no need to take the drug on an empty stomach or to use laxative previously.
Enterobiasis and ascariasis.
During treatment of ascariasis the usual dosage is 10 mg/kg to 12 mg/kg taken as a single dose. Children: a single dose of 2.5 ml per 10 kg of body weight.
Adults with body weight less than 75 kg: a single dose of 15 ml of suspension. Adults with body weight more than 75 kg: a single dose of 20 ml of suspension.
In case of enterobiasis, for complete elimination of parasites it is necessary to use strict hygienic measures and treat all the family members at one time. To avoid recurrent autoinfection, it is necessary to take repeated dose in 3 weeks after the first dosing.
In endemic areas, in case of infection with Necator americanus or massive invasion of Anсylostoma duodenale, the dosage is 20 mg/kg per day (taken in 1 or 2 doses) during 2-3 days.
Children: 5 ml per 10 kg of body weight per day.
Adults with body weight less than 75 kg: 30 ml of suspension per day. Adults with body weight more than 75 kg: 40 ml of suspension per day.
In case of moderate infection with Anсylostoma duodenale (which usually takes place in non-endemic areas), a single dose of 10 mg/kg may be enough.
For adult patients, it is appropriate to use the drug in the form of tablets, but in case if taking tablets is impossible, it is recommended to use the drug in the form of suspension.
Prescribe for children with body weight at least 10 kg.
Due to the low absorption coefficient of the drug, its plasma concentrations are low. Overdoses, even insignificant, cause some gastrointestinal tract disorders (nausea, vomiting, diarrhea) and insignificant temporary central nervous system disorders (asthenia, dizziness, headache). Sometimes overdose leads to an increased level of liver transaminases (AST). Specific antidotes are unknown. Immediate gastric lavage is recommended, as well as monitoring of the respiratory and cardiovascular systems functions. The treatment is symptomatic.
Nervous system disorders: dizziness, somnolence, insomnia, headache.
Immune system disorders: hypersensitivity reactions.
Skin and subcutaneous tissue disorders: skin rash, urticaria.
Digestive tract disorders: anorexia, nausea, vomiting, abdominal cramps, abdominal pain, diarrhea, tenesmus.
Hepatobiliary system disorders: increase or temporary decrease in the level of transaminases.
Other: weakness, asthenia, increased fatigability.
Store in the original package at the temperature not more than 25 С. Keep it out of reach of children.
15 ml of the drug are in the bottle or a jar. Each bottle or jar is in a carton package together with a measuring spoon.
Conditions of supply.
“KUSUM PHARM” LLC.
40020, Ukraine, Sumy region, Sumy, Skryabina str., 54.
Date of last revision.
21.03.2019 № 629