Albendazole (Tablets, Suspension) Instructions for Use

Instructions
Dosage forms

ATC Code

P02CA03 (Albendazole)

Active Substance

Albendazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Anthelmintic drug

Pharmacotherapeutic Group

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

Pharmacological Action

Albendazole is a broad-spectrum anthelmintic agent; a benzimidazole carbamate derivative. It selectively inhibits the polymerization of beta-tubulin, which leads to the destruction of the cytoplasmic microtubules of the cells of the intestinal tract of helminths.

It causes an irreversible impairment of glucose utilization in the helminth’s body and inhibits ATP synthesis.

It 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; and nematodes – Strongyloides stercoralis.

Pharmacokinetics

When taken orally, Albendazole is poorly absorbed from the gastrointestinal tract, is not detected in the plasma in its unchanged form, 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 the bile, liver, cerebrospinal fluid, urine, and the wall and fluids 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.

The T_1/2 of albendazole sulfoxide is 8-12 hours.

It is excreted in the 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 impairment, bioavailability increases, with the C_max of albendazole sulfoxide increasing by 2 times and the T_1/2 prolonging.

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 agent in the surgical treatment of alveolar echinococcosis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A07.1	Giardiasis
B60.8	Other specified protozoal infections
B66.0	Opisthorchiasis
B67	Echinococcosis
B69	Cysticercosis
B76	Ancylostomiasis
B77	Ascariasis
B78	Strongyloidiasis
B80	Enterobiasis

ICD-11 code	Indication
1A31	Giardiasis
1F58	Microsporidiosis
1F5Z	Unspecified protozoal disease
1F62	Ascariasis
1F65	Enterobiasis
1F68	Hookworm diseases
1F6B	Strongyloidiasis
1F70.Z	Cysticercosis, unspecified
1F73.Z	Echinococcosis, unspecified
1F84	Opisthorchiasis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally with a fatty meal to significantly increase bioavailability.

For most intestinal nematode infections in adults and children over 1 year, a single 400 mg dose is standard.

For neurocysticercosis, administer 400 mg twice daily with meals for 8-30 days; base duration on cyst location and response.

For hydatid echinococcosis, administer 400 mg twice daily for 28-day cycles separated by a 14-day drug-free interval; repeat for three cycles.

In patients weighing less than 60 kg, use a reduced dose of 15 mg/kg/day, divided into two doses; do not exceed 800 mg total daily.

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

For giardiasis in children, administer a single 400 mg dose for one day or 200 mg daily for three days.

Select the tablet or suspension formulation based on patient age, ability to swallow, and excipient tolerance.

Crush tablets or use the suspension for children and patients with swallowing difficulties.

In cases of hepatic impairment, monitor plasma levels closely due to altered pharmacokinetics.

Prior to treatment for neurocysticercosis, conduct an ophthalmological examination to rule out retinal involvement.

During long-term, high-dose therapy, monitor liver function tests and complete blood counts every two weeks.

Discontinue therapy immediately if clinically significant leukopenia develops.

Adverse Reactions

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

From the CNS: 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 age are recommended 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, it is used in appropriate dosage forms.

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 must 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 the echinococcal cyst was found with 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Albendazole Velpharm [Velpharm-M, LLC (Russia)]
Film-coated tablets 200 mg
Film-coated tablets 400 mg

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Dosage Forms

	Albendazole Velpharm	Film-coated tablets 200 mg
		Film-coated tablets 400 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

	1 tab.
Albendazole	200 mg

1 pc. – jars – cardboard packs (1 pc.) – By prescription
1 pc. – blister packs – cardboard packs (1 pc.) – By prescription
1 pc. – blister packs (10 pcs.) – cardboard packs (10 pcs.) – By prescription
1 pc. – blister packs (2 pcs.) – cardboard packs (2 pcs.) – By prescription
1 pc. – blister packs (3 pcs.) – cardboard packs (3 pcs.) – By prescription
1 pc. – blister packs (4 pcs.) – cardboard packs (4 pcs.) – By prescription
1 pc. – blister packs (5 pcs.) – cardboard packs (5 pcs.) – By prescription
1 pc. – blister packs (6 pcs.) – cardboard packs (6 pcs.) – By prescription
1 pc. – blister packs (7 pcs.) – cardboard packs (7 pcs.) – By prescription
1 pc. – blister packs (8 pcs.) – cardboard packs (8 pcs.) – By prescription
1 pc. – blister packs (9 pcs.) – cardboard packs (9 pcs.) – By prescription
10 pcs. – jars – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – blister packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
2 pcs. – jars – cardboard packs (2 pcs.) – By prescription
2 pcs. – blister packs – cardboard packs (2 pcs.) – By prescription
2 pcs. – blister packs (10 pcs.) – cardboard packs (20 pcs.) – By prescription
2 pcs. – blister packs (2 pcs.) – cardboard packs (4 pcs.) – By prescription
2 pcs. – blister packs (3 pcs.) – cardboard packs (6 pcs.) – By prescription
2 pcs. – blister packs (4 pcs.) – cardboard packs (8 pcs.) – By prescription
2 pcs. – blister packs (5 pcs.) – cardboard packs (10 pcs.) – By prescription
2 pcs. – blister packs (6 pcs.) – cardboard packs (12 pcs.) – By prescription
2 pcs. – blister packs (7 pcs.) – cardboard packs (14 pcs.) – By prescription
2 pcs. – blister packs (8 pcs.) – cardboard packs (16 pcs.) – By prescription
2 pcs. – blister packs (9 pcs.) – cardboard packs (18 pcs.) – By prescription
20 pcs. – jars – cardboard packs (20 pcs.) – By prescription
3 pcs. – jars – cardboard packs (3 pcs.) – By prescription
3 pcs. – blister packs – cardboard packs (3 pcs.) – By prescription
3 pcs. – blister packs (10 pcs.) – cardboard packs (30 pcs.) – By prescription
3 pcs. – blister packs (2 pcs.) – cardboard packs (6 pcs.) – By prescription
3 pcs. – blister packs (3 pcs.) – cardboard packs (9 pcs.) – By prescription
3 pcs. – blister packs (4 pcs.) – cardboard packs (12 pcs.) – By prescription
3 pcs. – blister packs (5 pcs.) – cardboard packs (15 pcs.) – By prescription
3 pcs. – blister packs (6 pcs.) – cardboard packs (18 pcs.) – By prescription
3 pcs. – blister packs (7 pcs.) – cardboard packs (21 pcs.) – By prescription
3 pcs. – blister packs (8 pcs.) – cardboard packs (24 pcs.) – By prescription
3 pcs. – blister packs (9 pcs.) – cardboard packs (27 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
4 pcs. – jars – cardboard packs (4 pcs.) – By prescription
4 pcs. – blister packs – cardboard packs (4 pcs.) – By prescription
4 pcs. – blister packs (10 pcs.) – cardboard packs (40 pcs.) – By prescription
4 pcs. – blister packs (2 pcs.) – cardboard packs (8 pcs.) – By prescription
4 pcs. – blister packs (3 pcs.) – cardboard packs (12 pcs.) – By prescription
4 pcs. – blister packs (4 pcs.) – cardboard packs (16 pcs.) – By prescription
4 pcs. – blister packs (5 pcs.) – cardboard packs (20 pcs.) – By prescription
4 pcs. – blister packs (6 pcs.) – cardboard packs (24 pcs.) – By prescription
4 pcs. – blister packs (7 pcs.) – cardboard packs (28 pcs.) – By prescription
4 pcs. – blister packs (8 pcs.) – cardboard packs (32 pcs.) – By prescription
4 pcs. – blister packs (9 pcs.) – cardboard packs (36 pcs.) – By prescription
5 pcs. – jars – cardboard packs (5 pcs.) – By prescription
5 pcs. – blister packs – cardboard packs (5 pcs.) – By prescription
5 pcs. – blister packs (10 pcs.) – cardboard packs (50 pcs.) – By prescription
5 pcs. – blister packs (2 pcs.) – cardboard packs (10 pcs.) – By prescription
5 pcs. – blister packs (3 pcs.) – cardboard packs (15 pcs.) – By prescription
5 pcs. – blister packs (4 pcs.) – cardboard packs (20 pcs.) – By prescription
5 pcs. – blister packs (5 pcs.) – cardboard packs (25 pcs.) – By prescription
5 pcs. – blister packs (6 pcs.) – cardboard packs (30 pcs.) – By prescription
5 pcs. – blister packs (7 pcs.) – cardboard packs (35 pcs.) – By prescription
5 pcs. – blister packs (8 pcs.) – cardboard packs (40 pcs.) – By prescription
5 pcs. – blister packs (9 pcs.) – cardboard packs (45 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

Film-coated tablets

	1 tab.
Albendazole	400 mg

Albendazole Velpharm [Velpharm-M, LLC (Russia)]
Chewable tablets 400 mg

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Dosage Form

Albendazole Velpharm

Chewable tablets 400 mg

Dosage Form, Packaging, and Composition

Chewable tablets

Albendazole

400 mg

Albendazole-Alium [Aliym, JSC (Russia)]
Film-coated tablets, 400 mg: 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 16, 20, 30, or 40 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Albendazole-Alium

Film-coated tablets, 400 mg: 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 16, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oblong in shape with rounded ends, with a score on one side of the tablet; the core on the cross-section is white or almost white.

	1 tab.
Albendazole	400 mg

Excipients: lactose monohydrate, microcrystalline cellulose type 101, sodium carboxymethyl starch (sodium starch glycolate), corn starch, povidone K30, sodium lauryl sulfate, colloidal silicon dioxide (aerosil), croscarmellose sodium, magnesium stearate.

Shell composition hypromellose (hydroxypropyl methylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide.

1 pc. – blister packs – cardboard packs.
1 pc. – blister packs (2) – cardboard packs.
1 pc. – blister packs (3) – cardboard packs.
1 pc. – blister packs (4) – cardboard packs.
2 pcs. – blister packs – cardboard packs.
2 pcs. – blister packs (2) – cardboard packs.
2 pcs. – blister packs (3) – cardboard packs.
2 pcs. – blister packs (4) – cardboard packs.
4 pcs. – blister packs – cardboard packs.
4 pcs. – blister packs (2) – cardboard packs.
4 pcs. – blister packs (3) – cardboard packs.
4 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.

Albendazole-Edvansd [Advanced Pharma, LLC (Russia)]
Film-coated tablets, 200 mg: 2 pcs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Form

Albendazole-Edvansd

Film-coated tablets, 200 mg: 2 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Albendazole	200 mg

Excipients: corn starch – 108.65 mg, sodium lauryl sulfate – 4 mg, povidone K30 – 14.2 mg, purified talc – 6.7 mg, sodium carboxymethyl starch – 3.35 mg, croscarmellose sodium – 14.2 mg, colloidal silicon dioxide – 2 mg, magnesium stearate – 2 mg.

Shell composition: film coating “Wincoat WT-10019P white” – 6 mg (polyvinyl alcohol – 45%, soy lecithin – 3%, macrogol 4000 – 11%, titanium dioxide – 30%, talc – 11%).

2 pcs. – blisters (1) – cardboard packs.
2 pcs. – jars (1) – cardboard packs.

Albendazole-J [Jodas Expoim, LLC (Russia)]
Film-coated tablets, 200 mg: 2 pcs.
Film-coated tablets, 400 mg: 1 or 5 pcs.

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Forms

	Albendazole-J	Film-coated tablets, 200 mg: 2 pcs.
		Film-coated tablets, 400 mg: 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Albendazole	200 mg

Excipients: lactose monohydrate – 36 mg, pregelatinized starch – 17 mg, sodium carboxymethyl starch – 8.25 mg, sodium lauryl sulfate – 2.75 mg, povidone K30 – 5.5 mg, colloidal silicon dioxide – 2.75 mg, magnesium stearate – 2.75 mg.

Shell hypromellose – 4.95 mg, titanium dioxide – 1.65 mg, talc – 0.91 mg, polyethylene glycol-400 – 0.74 mg.

2 pcs. – blisters – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Albendazole	400 mg

Excipients: lactose monohydrate – 72 mg, pregelatinized starch – 34 mg, sodium carboxymethyl starch – 16.5 mg, sodium lauryl sulfate – 5.5 mg, povidone K30 – 11 mg, colloidal silicon dioxide – 5.5 mg, magnesium stearate – 5.5 mg.

Shell hypromellose – 9.9 mg, titanium dioxide – 3.3 mg, talc – 1.82 mg, polyethylene glycol-400 – 1.48 mg.

1 pc. – blisters – cardboard packs.
5 pcs. – blisters – cardboard packs.

Albendazole-Richter [Gedeon Richter, Plc. (Hungary)]
Suspension for oral administration 20 mg/1 ml: fl. 20 ml

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Manufactured By

Gedeon Richter Romania, S.A. (Romania)

Packaging and Quality Control Release

GEDEON RICHTER ROMANIA, S.A. (Romania)

GEDEON RICHTER-RUS, AO (Russia)

Dosage Form

Albendazole-Richter

Suspension for oral administration 20 mg/1 ml: fl. 20 ml

Dosage Form, Packaging, and Composition

Suspension for oral administration white or almost white, with a characteristic odor.

	1 ml
Albendazole	20 mg

Excipients: microcrystalline cellulose and sodium carmellose, sodium carmellose (high viscosity), sodium carmellose (low viscosity), sorbic acid, benzoic acid, potassium chloride, sorbitol (liquid non-crystallizing) 70%, polysorbate 80, glycerol, fruit flavor, purified water.

20 ml – HDPE bottles with a capacity of 25 ml (1) – cardboard packs.

Medixlife (Author)

View all posts Profile link