DRUTAZOLE® CHEWABLE TABLET
(Albendazole 400mg Chewable Tablet)
Composition:
Each chewable tablets contains 400mg Albendazole.
CLINICAL PHARMACOLOGY
Pharmacodynamic Properties
Albendazole causes selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and larvae; glycogen is depleted, glucose uptake and cholinesterase secretion are impaired and desecratory substances accumulate intracellularly. ATP production decreases causing energy depletion, immobilization and worm death.
Pharmacokinetics
Absorption of albendazole from the gastrointestinal tract is poor but may be enhanced by a fatty meal. Albendazole rapidly undergoes extensive first-pass metabolism. It principal metabolite albendazole sulfoxide has antihelmintic activity and a plasma half-life of about 8.5hours. Albendazole sulfoxide is widely distributed throughout the body including into the bile and the cerebrospinal fluid. It is about 70% bound to plasma protein. Albendazole sulfoxide is eliminated in the bile. Only a small amount appears to be excreted in the urine.
INDICATIONS
Albendazole is used
– In the treatment of single and mixed intestinal nematode infections including ascariasis, enterobiasis, hookworm, strongyloidiasis and trichuriasis.
– It may be used in the treatment of capillariasis, gnasthosomiasis and trichos strongyhasis.
– Albendazole may be effective in the treatment of the tissue nematode infections cutaneous larva migrants, toxocariasis and trichinosis.
– In combination with other antihelmintics, in the management of the filarial nematode infection, lymphatic filariasis.
– It is used in relatively high doses in the treatment of the cestode infections cysticercosis and echinococcosis (hydatid disease)
CONTRAINDICATIONS
Hypersensitivity to albendazole or any component of the formulation
INTERACTIONS
– Albendazole serum levels are increased when taken with dexamethasone, praziquantel.
– Cimetidine may increase albendazole metabolism
– Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by 4-5times)
WARNINGS/PRECAUTIONS:
Corticosteroids should be administered 1-2 days before albendazole therapy in patients with neurocysticercosis to minimize inflammatory reactions and steroid and anticonvulsant therapy should be use concurrently during the first week of patients with neurocyticercosis to prevent cerebral hypertension.
PREGNANCY AND LACTATION
Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy; if at all possible.
LACTATION:
For women of childbearing age (15 – 40years), Drutazole should be administered within 7days of the start of normal menstruation.
SIDE EFFECTS/ADVERSE REACTIONS
Gastrointestinal discomfort, headache, dizxiness, vertigo, fever, alopecia (reversible), nausea and vomiting.
ANTIDOTE IN THE EVENT OF OVER DOSAGE
In case of over dosage symptomatic therapy and general supportive measures are recommended.
DOSAGE AND ADMINISTRATION
– Ascaris, hookworm infections, enterobiasis and tricho strongyliasis;
ADULT AND CHILDREN OVER 2 YEARS: 400mg (one chewable tablet) as a single dose.
Children 12 months – 2 years; 200mg as a single dose.
– Trichuriasis;
Adult and Children over 2 Years 400mg (one chewable tablet) as a single dose (for moderate infections or 400mg daily for 3days (severe infections).
Children 12 months – 2 years; 200mg as a single dose (for moderate infections) or 200mg initially then 100mg twice daily for 3 days (severe infections).
– Strongyloidiasis;
Adult and children over 2 years 400mg once or twice daily for 3 days.
– Capillariasis:
Adult and children over 2 years 400mg daily for 10days.
STORAGE CONDITION
Store in a cool dry place below 30OC. Protect from light.
PRESENTATION
Drutazole® is presented as 400mg albendazole chewable tablet in a blister of 1’s per pack.