Albendacid^® (Tablets) Instructions for Use

Marketing Authorization Holder

Globalmedpharm, LLC (Russia)

Manufactured By

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

ATC Code

P02CA03 (Albendazole)

Active Substance

Albendazole (Rec.INN WHO registered)

Dosage Form

Albendacid®

Film-coated tablets, 400 mg: 1, 2, 3 or 5 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oval, biconvex; the cross-section shows two layers, the core is almost white.

Excipients: corn starch, croscarmellose sodium (sodium carboxymethylcellulose), crospovidone (type A), povidone K30, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose (type 101), Opadry II series 32 (F) code 280000 (white): (hypromellose, lactose monohydrate, macrogol 4000 (polyethylene glycol), titanium dioxide (E171)).

1 pc. – contour cell packaging (1) – cardboard packs.
1 pc. – contour cell packaging (2) – cardboard packs.
1 pc. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Anthelmintic drug

Pharmacotherapeutic Group

Anthelmintic agents; agents for the treatment of nematode infections; benzimidazole derivatives

Pharmacological Action

Broad-spectrum anthelmintic agent; a carbamate benzimidazole derivative. It selectively inhibits the polymerization of beta-tubulin, which leads to the destruction of the cytoplasmic microtubules of the helminths’ intestinal tract cells; causes irreversible impairment of glucose utilization in the helminth’s body and inhibits ATP synthesis; blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death.

It is most effective against the larval forms of cestodes – Echinococcus granulosus and Taenia solium; nematodes – Strongyloides stercoralis.

Pharmacokinetics

When taken orally, Albendazole is poorly absorbed from the gastrointestinal tract, is not detected unchanged in plasma, and has low bioavailability. Taking with fatty food increases absorption and C_max by 5 times. The time to reach C_max of albendazole sulfoxide is 2-5 hours. Plasma protein binding is 70%; it penetrates in significant amounts into bile, liver, cerebrospinal fluid, urine, and the wall and fluid of helminth cysts.

It is metabolized in the liver to form the primary metabolite (albendazole sulfoxide), which has anthelmintic activity. Albendazole sulfoxide is metabolized to albendazole sulfone (a secondary metabolite) and other oxidized products.

T_1/2 of albendazole sulfoxide is 8-12 hours. It is excreted with bile through the intestine in the form of the active metabolite albendazole sulfoxide, and only a small amount is excreted in the urine. In liver damage, bioavailability increases, while the C_max of albendazole sulfoxide increases by 2 times and the T_1/2 is prolonged. It is an inducer of the CYP1A2 isoenzyme in human liver cells.

Indications

Nematodoses: ascariasis, trichuriasis, ancylostomiasis, enterobiasis, trichinellosis, toxocariasis, giardiasis, strongyloidiasis; mixed helminthiases.

Tissue cestodoses: neurocysticercosis, hydatid echinococcosis of the liver, lungs, peritoneum; as an adjuvant in the surgical treatment of alveolar echinococcosis.

ICD codes

Dosage Regimen

Take tablets orally, with food, preferably a fatty meal to enhance absorption.

For adults and children over 1 year, the standard single dose is 400 mg (one tablet).

For intestinal nematodoses (ascariasis, trichuriasis, ancylostomiasis, enterobiasis), administer a single 400 mg dose. Repeat the same dose for enterobiasis after 14 days.

For strongyloidiasis and taeniasis, administer 400 mg once daily for 3 consecutive days.

For giardiasis in children, administer 400 mg once daily for 5 days.

For toxocariasis, administer 400 mg twice daily for 5 days. For patients weighing less than 60 kg, the dose is 15 mg/kg/day in two divided doses.

For cysticercosis and neurocysticercosis, administer 400 mg twice daily for 8 to 30 days. The dose is based on 15 mg/kg/day in two divided doses, not to exceed 800 mg daily.

For hydatid echinococcosis, administer 400 mg twice daily for 28 days, followed by a 14-day drug-free interval. Repeat this cycle for a total of 3 cycles. The dose is based on 15 mg/kg/day in two divided doses, not to exceed 800 mg daily.

For patients with impaired liver function, monitor closely and consider dose adjustment.

In all cases, consult a physician for precise dosing based on the specific helminth, patient weight, and clinical presentation.

Adverse Reactions

From the digestive system: abdominal pain, nausea, vomiting, increased activity of hepatic transaminases.

From the central nervous system: headache, dizziness, meningeal symptoms, increased intracranial pressure.

From the hematopoietic system: leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia.

Allergic reactions: skin rash, itching.

From the urinary system: impaired renal function, acute renal failure.

Other: hyperthermia, increased blood pressure, alopecia.

Contraindications

Retinal pathology, pregnancy, lactation (breastfeeding), children under 1 year of age (for all dosage forms); toxocariasis in adults and children over 14 years of age and with body weight less than 60 kg; hypersensitivity to albendazole and other benzimidazole derivatives.

With caution

Impaired liver function, bone marrow hematopoiesis suppression, liver cirrhosis.

Use in Pregnancy and Lactation

Albendazole is contraindicated for use during pregnancy and during lactation (breastfeeding).

Women of childbearing potential are advised to use non-hormonal methods of contraception during treatment. It is not known whether Albendazole and its active metabolite are excreted in breast milk.

In experimental studies on animals, the teratogenicity of albendazole has been shown.

Use in Hepatic Impairment

Albendazole should be prescribed with caution to patients with hepatic insufficiency, liver cirrhosis.

Use in Renal Impairment

In patients with impaired renal function, the clearance of albendazole does not change.

Pediatric Use

Contraindicated for use in children under 1 year of age (for all dosage forms).

In children over 1 year of age, appropriate dosage forms are used.

In children, the use of albendazole in high doses for a long time should be avoided.

Geriatric Use

There are no specific restrictions.

Special Precautions

Therapy should be discontinued if leukopenia develops.

In neurocysticercosis with eye involvement, an examination of the retina is necessary before starting treatment (the risk of worsening retinal pathology increases).

Patients receiving high doses should be under close supervision, with constant monitoring of blood counts and liver function.

In children, the use of albendazole in high doses for a long time should be avoided.

Drug Interactions

With simultaneous use with dexamethasone, praziquantel, an increase in the concentration of albendazole sulfoxide in blood plasma is possible.

An increase in the concentration of albendazole sulfoxide in bile and in the contents of an echinococcal cyst was found with the simultaneous use of albendazole and cimetidine, which may increase the effectiveness of echinococcosis treatment.

Simultaneous use with carbamazepine, phenytoin, phenobarbital and Panax ginseng may lead to a decrease in the concentration of albendazole in plasma.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.