ALBENDAZOLtablets

ALBENDAZOL<span>tablets

Trade name

Albendazol

 

Drug description

Circular, white or yellowish tablets, with a compact and homogeneous structure, with "BP" embossed on one side of the tablet.

 

Main Active Ingredient

Albendazole

 

Pharmaceutical form:

Tablets

 

PHARMACOLOGICAL CLASSIFICATION:

A12 Anthelmintics.

PHARMACOLOGICAL ACTION:

Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal, ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth. In man, after oral administration, albendazole is absorbed and completely metabolized. At a dose of 6,6 mg/kg of albendazole the plasma concentration of its main metabolite, the sulfoxide, attains a maximum of 0,25 to 0,30 micrograms/mL after approximately 2½ hours. The half-life of the sulfoxide in the plasma is 8% hours. The metabolite is essentially eliminated via the urine,

 

WARNINGS:

It has been noted that leucopaenia has occurred when used for periods longer than recommended.

In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.

 

INDICATIONS:

Albendazol is indicated in the treatment of single or mixed intestinal parasites. Clinical studies have shown albeneffective in the treatment of Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis.

Albendazol has been shown to be effective in the treatment of Giardia (duodenalis or intestinalis or lamblia) infections in children.

 

CONTRA-INDICATIONS:

Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and Albendazol should not be taken by pregnant women at any stage of their pregnancy or by women who are likely to become pregnant, during or shortly after the course of therapy. Albendazol is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.

 

DOSAGE AND DIRECTIONS FOR USE:

Usual Dose:

400 mg (two Albendazol 200 mg tablets) or 20 mL (400 mg) of Albendazol suspension as a single dose in both adults and children over two years of age. The tablets may be chewed, swallowed or crushed and mixed with food. The usual dose in children between one and two years of age is 10 mL (200 mg) of Albendazol suspension as a single dose. In heavy mixed infestation involving Strongyloides or Taeniasis, a single daily dose may be inadequate and the dose may be given for three consecutive days.

Note:

If the patient is not cured after three weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required.

Albendazole has not been adequately studied in children under one year of age.

Giardiasis (dose in children over 2 years of age):

A single 400 mg daily dose (two 200 mg tablets or 20 mL suspension) for five days.

The tablets may be chewed, swallowed or crushed and they should be taken with food.

 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported.

Hypersensitivity reactions including rash. pruritus and urticaria have been reported less frequently.

Interactions:

Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.

Shelf Life

3 years. Do not use after the expiry date.

 

Special Precautions For Storage

Store in the original package, in a dry, dark place, away from the reach of the children, at a temperature not exceeding25°C.

 

Nature And Contents Of Package

Tablets 200 and 400 mg. 10 tablets in each blister. 1, 2 or 3 blisters in every package.

 

Name and address of the manufacturer

SC “Balkan Pharmaceuticals” SRL

4 Gradescu str.

Chisinau,RepublicofMoldova