Piperazine adipinate-darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIPERAZINE ADIPINATE-DARNYTSIA (PIPERAZINE ADIPINATE-DARNYTSIA)

Composition:

Active substance: piperazine adipinate;

1 tablet contains 200 mg of piperazine adipinate;

Excipients: povidone, methylcellulose, microcrystalline cellulose, sodium croscarmellose, calcium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white-colored, flat cylindrical tablets with bevel and score line; marbling is permissible.

Pharmacotherapeutic group. Anthelmintics. ATC code P02CB01.

Pharmacological properties.

Pharmacodynamics.

Piperazine and its salts exert anthelmintic effects against various species of nematodes, particularly against Ascaris and pinworms. They act on both mature and immature helminths of either sex, causing paralysis of nematode muscles, after which the parasites are expelled by intestinal peristalsis. The degree of dehelmintization with the use of the drug is 90–95%, and with repeated administration, it reaches 100%. Since the drug does not kill Ascaris in the intestinal lumen but only paralyzes their musculature by which they are retained in the intestine, there is no risk of absorption of toxic biological degradation products.

Pharmacokinetics.

Piperazine adipinate is rapidly absorbed from the gastrointestinal tract and is primarily excreted by the kidneys. Complete elimination of a single administered dose occurs within 24 hours.

Clinical characteristics.

Indications.

Ascariasis, enterobiasis.

Contraindications.

Increased individual sensitivity to the active substance or to other components of the medicinal product, organic diseases of the central nervous system, epilepsy, nephritis, chronic hepatic insufficiency, chronic renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

Possible interactions when used concomitantly with other drugs:

with aminazine, phenothiazines (chlorpromazine) – enhancement of extrapyramidal disorders;

with pyrantel – antagonistic effect on helminths may occur.

Special precautions for use.

Treatment can be carried out on an outpatient basis.

Administration of the medicinal product does not require a special diet or patient preparation. Laxatives should be prescribed only in patients prone to constipation.

During treatment of enterobiasis, strict hygienic measures must be observed.

The medicinal product should be used with caution in debilitated patients and in patients with anemia.

Use during pregnancy or breastfeeding.

The medicinal product must not be used during pregnancy. If use is necessary, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery.

Caution is required when driving or operating machinery due to the possible occurrence of dizziness.

Method of Administration and Dosage.

Ascariasis: administer the drug orally twice daily, 1 hour before or 0.5–1 hours after meals, for 2 consecutive days. The single dose is as follows: for children 4–5 years of age – 500 mg; 6–8 years – 750 mg (use the drug in the appropriate dosage form); 9–12 years – 1 g; 13–15 years – 1.5 g; for adults and children aged 15 years and older – 1.5–2 g.

Enterobiasis: administer the drug in the same doses as for ascariasis. The treatment course lasts 5 days. Conduct 1–3 treatment cycles with 7-day intervals between them. To remove pinworms from the rectum between treatment courses, administer a nightly enema containing 1/2 teaspoon of sodium hydrocarbonate (baking soda) per 1 glass of water. Enema volume: for children – 1–3 glasses, for adults – 4–5 glasses.

Children.

The drug must not be administered to children under 4 years of age.

Overdose.

Symptoms: nausea, vomiting, tremor, muscle weakness, impaired motor coordination, spasmodic abdominal pain. In patients with impaired renal excretory function, neurotoxic effects may occur.

Treatment: gastric lavage, administration of activated charcoal or other enterosorbents, use of saline laxatives. If necessary, perform oxygen and transfusion therapy with hydration followed by administration of diuretics. In case of neurological symptoms, administer thiamine hydrochloride.

Side effects

Eye disorders: visual disturbances (including blurred vision).

Ear and labyrinth disorders: impaired coordination of movements.

Respiratory, thoracic and mediastinal disorders: bronchospasm.

Gastrointestinal disorders: abdominal pain of spasmodic nature, nausea, vomiting, diarrhea.

Nervous system disorders: headache, dizziness, drowsiness, ataxia, muscle weakness, tremor, euphoria, hallucinations, nystagmus, paresthesia, chorea, areflexia, seizures.

Immune system disorders: hypersensitivity reactions, including skin rashes (such as urticaria, erythema multiforme, purpura), pruritus, Stevens-Johnson syndrome and other allergic reactions.

Musculoskeletal and connective tissue disorders: arthralgia.

General disorders and administration site conditions: fever.

The risk of adverse reactions (especially neurotoxic complications) is higher in patients with renal impairment.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 tablets in a blister pack; 1 blister pack in a carton; 10 tablets in blister packs.

Prescription category. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borysplis'ka Street, Kyiv, 02093, Ukraine.