Instructions for use: Pyrantel oral suspension 250 mg/5 ml, 15 ml bottle
Composition
active ingredient: pyrantel;
5 ml of suspension contains pyrantel (as pyrantel pamoate) – 250 mg;
Excipients: sodium benzoate (E 211); carmellose sodium; sorbitol solution, non-crystallizing (E 420); glycerin; aluminum-magnesium silicate; polysorbate 80; polyvinylpyrrolidone; apricot flavoring (aromatic substances, isopropyl alcohol, ethanol 96%); simethicone emulsion; citric acid, monohydrate; sodium hydroxide; purified water.
Dosage form
Oral suspension.
Main physicochemical properties: light yellow suspension with a characteristic odor. There may be separation into a liquid layer and a precipitate, which after shaking form a homogeneous suspension.
Pharmacotherapeutic group
Anthelmintic agents.
ATX code P02C C01.
Pharmacological properties
Pharmacodynamics.
Pyrantel Polpharma is an anthelmintic agent. Active against Enterobius vermicularis, Ascaris lubricoides, Ancylostoma duodenale and Necator americanus. Pyrantel Polpharma causes neuromuscular blockade, paralyzing the helminths, as a result of which they are excreted by intestinal peristalsis together with the feces. Pyrantel Polpharma is active against sensitive sexually mature and immature forms of helminths. It does not affect helminth larvae migrating through tissues.
Pharmacokinetics.
Intestinal absorption is very low. After administration of the drug, plasma concentrations are very low (0.05-0.13 μg/ml) and are reached within 1-3 hours. Up to 93% of the drug is excreted unchanged in the feces. Less than 7% is found in the urine in unchanged and metabolized form.
Indication
Enterobiasis, ascariasis, hookworm.
Contraindication
Increased individual sensitivity to pyrantel or to any other components of the drug.
Concomitant use with piperazine.
Avoid using pyrantel during treatment of myasthenia gravis.
Interaction with other medicinal products and other types of interactions
May increase theophylline levels in blood plasma. Simultaneous use of piperazine inhibits the action of pyrantel.
Application features
It should be prescribed with caution in cases of impaired liver function (temporarily increases the level of aspartic aminotransferase). If necessary, the dose should be reduced.
There is no need to use laxatives during treatment.
For enterobiasis, it is recommended to prescribe Pirantel Polpharma to all family members.
14 days after taking the drug, it is necessary to undergo laboratory parasitological control.
To prevent re-infection, strict adherence to personal hygiene rules is recommended: daily toileting of the perianal area, cleaning nails several times a day. Children should keep their nails short. Regularly change underwear and pajamas. Prevent scratching of the perianal area.
Caution should be exercised when prescribing to malnourished patients or patients with anemia.
The medicinal product contains sorbitol solution and should not be used in patients with rare hereditary problems of fructose intolerance. Sorbitol solution may cause a mild laxative effect.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
Use during pregnancy or breastfeeding
Pregnancy.
In experimental studies on animals, there is no indication of a teratogenic effect of the drug. However, due to the lack of controlled studies on the use of pyrantel during pregnancy or breastfeeding, the drug is not recommended for use during this period. Treatment with the drug during pregnancy is possible only in case of extreme necessity and if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding period.
No studies have been conducted to study the penetration of the drug into breast milk, therefore the drug should not be used during breastfeeding. If treatment with Pirantel Polpharma is necessary, women who are breastfeeding should stop breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effect of the drug on the ability to drive a car or operate other mechanisms. In case of dizziness, drowsiness, weakness, hallucinations with disorientation, you should refrain from driving vehicles or operating other machines and complex mechanisms.
Method of administration and doses
Orally, during or after meals.
5 ml of suspension contain 250 mg of pyrantel.
Shake before use until a homogeneous suspension is obtained.
For adults, it is advisable to use pyrantel in tablet form, but if it is impossible to take tablets, the drug should be used in the form of a suspension.
Ascariasis and enterobiasis
for children weighing 10 kg or more – 2.5 ml of suspension per 10 kg of body weight once;
adults with a body weight of up to 75 kg – 15 ml of suspension once;
adults with a body weight of over 75 kg – 20 ml of suspension once.
In the case of enterobiasis, strict hygiene measures are necessary for all family members to completely get rid of the parasites. To avoid re-infection, it is recommended to take a second dose 3 weeks after the previous dose.
Hookworm infection caused by Ancylostoma duodenale or Necator americanus
For hookworm infection in case of severe infestation or in endemic areas, prescribe at a dose of 20 mg/kg per day in 1-2 doses for 2-3 days, i.e.:
for children weighing from 10 kg – 5 ml per 10 kg of body weight per day;
adults with a body weight of up to 75 kg – 30 ml per day;
adults with a body weight of over 75 kg – 40 ml per day.
In case of infection with Ancylostoma duodenale (occurring in non-endemic areas), a single dose of 10 mg/kg body weight may be sufficient.
A measuring cup (5 ml) with graduations is included in the package.
Children.
Assign to children weighing more than 10 kg.
Overdose
In case of an overdose of the drug, the following symptoms may occur: visual disturbances, disorientation in space, dizziness, loss of consciousness or dizziness when changing body position, sweating, feeling of fatigue or general weakness, arrhythmia, muscle spasm, tremor and muscle weakness; exhaustion, asphyxia (difficulty breathing, loss of consciousness); nausea, vomiting, lack of appetite, spastic abdominal pain, diarrhea, headache, drowsiness or insomnia, agitation, skin rashes, liver damage.
Treatment
There are no specific antidotes. In case of overdose, symptomatic and supportive treatment should be carried out (early gastric lavage, ensuring airway patency, maintaining blood pressure).
Side effects
When taking the drug in therapeutic doses, in some cases the following disorders are possible:
from the gastrointestinal tract: nausea, vomiting, loss of appetite, abdominal pain, diarrhea, constipation, tenesmus;
from the nervous system: headache, dizziness, insomnia, drowsiness, hallucinations with disorientation, paresthesia, ataxia;
Skin and subcutaneous tissue disorders: urticaria, skin rashes;
Hepatobiliary disorders: decrease or temporary increase in hepatic transaminase levels;
from the organs of hearing and balance: hearing impairment;
others: hyperthermia, nasal congestion, visual impairment, asthenia, weakness, increased fatigue.
Hypersensitivity reactions may occur.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
After opening the bottle, store with the lid tightly closed for 21 days.
The medicine should not be used after the expiry date stated on the packaging.
Packaging
Dark glass bottles of 15 ml with a polyethylene screw cap and a warranty ring.
1 bottle with a graduated measuring cup in a cardboard box.
Vacation category
Without a prescription.
Producer
Pharmaceutical Works POLPHARMA SA Medana Branch in Sieradz
Address
57, Polskiej Organizacji Wojskowej Str., 98-200 Sieradz, Poland.
