Ukraine Product

Pyrantel Tablets

Pyrantel Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Enterobiasis, ascaridiasis, ancylostomiasis.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Gastrointestinal tract: epigastric pain, abdominal pain, nausea, vomiting, diarrhea, anorexia; abdominal cramps, tenesmus.
Hepatobiliary system: decreased or temporary increased liver transaminase level.
Nervous system: headache, dizziness, somnolence, increased fatigue, insomnia, fatigue.
Skin and subcutaneous tissue: skin rash, itching, urticaria.
Immune system: hypersensitivity reactions.


What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

In case of hepatic failure it is recommended to reduce the dosage.
Enterobiasis: to prevent reinfection, strict hygienic measures should be taken: the perianal area should be cleaned daily, the fingernails should be cleaned several times a day. Children’s fingernails should be cut short. The underwear and pyjamas should be changed regularly. Prevent scratching. It is recommended to treat the whole family simultaneously, because the infection is often without symptoms.

What to do if you accidentally take too much (overdose) of the medicine?

Due to the low coefficient of absorption, plasma drug concentrations are low. Overdose causes some gastrointestinal disorders (such as nausea, vomiting, diarrhea) and minor temporary disorders of the central nervous system (such as asthenia, dizziness, headache). Sometimes overdose increases the level of liver transaminases. Specific antidotes are unknown. Immediate gastric lavage is recommended, as well as monitoring of functions of the respiratory and cardiovascular systems. The treatment is symptomatic.

Is it safe in pregnancy and breast-feeding?

In the absence of teratogenic effects in animals Pyrantel congenital malformations in humans are not expected. Currently, congenital malformations or fetotoxicity effects of pyrantel is not confirmed clinically . However, monitoring the use of pyrantel during pregnancy is insufficient to exclude all possible risks. Thus, the drug can be used during pregnancy only if it is absolutely necessary after careful evaluation of the benefit for female/risk to the fetus, which is determined by the physician. Therefore the absence of published studies about the undesired effect of pyrantel on children who are breastfed and despite on the very low absorption of the drug pyrantel, the use of the drug is possible, if it is necessary, after consultation with the physician.

Storage Conditions:

Store below 25 °С in the original pack.
Keep it out of reach of children. 

Drug Description

Composition:
Each tablet contains:
pyrantel pamoate equivalent to pyrantel 250 mg;
Description:
Capsule-shaped yellow tablets with the breakline on one side


Indications and dosage.

Indications
Enterobiasis, ascaridiasis, ancylostomiasis.
Dosage:
 The drug may be taken at any time, there is no need to abstain from food and take purgative agents before taking the drug.
Enterobiasis and ascaridiasis.
While the treatment of enterobiasis and ascaridiasis usually the dosage is 10 mg/kg to 12 mg/kg single-use.
Children from 6 years: 1 tablet per 20 kg of body weight as single dose.
Adults with body weight less than 75 kg: 3 tablets as single dose.
Adults with body weight more than 75 kg: 4 tablets as single dose.
In case of enterobiasis, to full excreted parasites, strict hygienic measures should be taken, and the whole family should be treated simultaneously. To avoid repeated autoinfection it is recommended to take repeated dose 3 weeks after the first intake.
Ancylostomiasis.
In endemic areas in case of contamination Necator americanus or massive invasion Ancylostoma duodenale the dosage is 20 mg/kg per day (1 or 2 doses) during 2-3 days.
Children from 6 years: 1 tablet per 10 kg of body weight per day.
Adults with body weight less than 75 kg: 6 tablets per day.
Adults with body weight more than 75 kg: 8 tablets per day.
In case of temper contamination with Ancylostoma duodenale (which usually occurs in non-endemic areas), it may be enough to take 10 mg/kg as single dose.

Children.
Prescribe to children aged 6 years. Children under 6 years is desirable to use the drug in the form of suspension.

Side effects and drug interactions.

Side effect
Gastrointestinal tract: epigastric pain, abdominal pain, nausea, vomiting, diarrhea, anorexia; abdominal cramps, tenesmus.
Hepatobiliary system: decreased or temporary increased liver transaminase level.
Nervous system: headache, dizziness, somnolence, increased fatigue, insomnia, fatigue.
Skin and subcutaneous tissue: skin rash, itching, urticaria.
Immune system: hypersensitivity reactions.
Drug interactions

Do not use with piperazine, which is an antagonist of anthelmintic action of pyrantel.

Warnings and precautions

In case of hepatic failure it is recommended to reduce the dosage.Enterobiasis: to prevent reinfection, strict hygienic measures should be taken: the perianal area should be cleaned daily, the fingernails should be cleaned several times a day. Children’s fingernails should be cut short. The underwear and pyjamas should be changed regularly. Prevent scratching. It is recommended to treat the whole family simultaneously, because the infection is often without symptoms.


Overdosage and Contraindications

Overdose
Due to the low coefficient of absorption, plasma drug concentrations are low. Overdose causes some gastrointestinal disorders (such as nausea, vomiting, diarrhea) and minor temporary disorders of the central nervous system (such as asthenia, dizziness, headache). Sometimes overdose increases the level of liver transaminases. Specific antidotes are unknown. Immediate gastric lavage is recommended, as well as monitoring of functions of the respiratory and cardiovascular systems. The treatment is symptomatic.

Clinical pharmacology.

Pharmacotherapeutic group:
Antiparasitic products, insecticides and repellents Anti-helminthics.
АТC Code Р02С С01.
Pharmacological properties.
Pharmacodynamics:
Pyrantel is an antihelmint agent. Active against Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus. Pyrantel causes neuro-muscular blockade paralyzing the helmints so that they are excreted through the intestinal peristalsis with stool. Pyrantel is an active against sensitive and mature forms of immature helmints. There is no effect on larvae of helmints that migrate through tissues.
Pharmacokinetics:
Intestinal absorption of pyrantel is very low. After using the drug, plasma concentration is very low (0,05-0,13 mg / ml) and reaches its maximum within 1-3 hours. Up to 93% of the drug is excreted unchanged in the stool. Less than 7% found in the urine in unchanged form and as metabolites.
Shelf life 3 years.
Storage condition
Store below 25 °С in the original pack.
Keep it out of reach of children. 
Package
Store below 25 °С in the original pack.
Keep it out of reach of children. 
Conditions of supply
On prescription.

Manufacturer
KUSUM HEALTHCARE PVT LTD.

Address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575