BALZOLE (Albendazole Tablets 400 mg)
Description, Label claim, Mechanism of action (Pharmacodynamics), Pharmacokinetics: absorption, metabolism, distribution, elimination, Indications, Dosage, Contraindication, Drug interaction, Warning/precaution, Side effects, Overdosage, Storage instructions, Manufacturer and Marketer of Balzole Tablet Medicine for Gastrointestinal worms.
BALZOLE Tablet contain an active ingredient Albendazole. Its chemical name is Methyl [5-(propylsulphanyl)-1H-benzimidazol-2-y]carbamate. Which is an Anthelmintics. Albendazole is used for treating tapeworm infections. (e.g., neurocysticercosis).
Each uncoated chewable tablet contains:
Albendazole BP 400mg
Colour: Sunset Yellow
MECHANISM OF ACTION (PHARMACODYNAMICS)
Albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. The loss of the cytoplasmic microtubules leads to impaired uptake of glucose by the larval and adult stages of the susceptible parasites, and depletes their glycogen stores. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of Lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth. Due to diminished energy production, the parasite is immobilized and eventually dies.
Absorption: Albendazole is poorly absorbed (<5%) with most of an oral dose remaining in the gastrointestinal tract.
Metabolism: Albendazole rapidly undergoes extensive first-pass metabolism in the liver, and is generally not detected in plasma or in urine.
Distribution: Albendazole sulphoxide is widely distributed throughout the body including into urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). It is about 70% bound to plasma protein.
Elimination: Albendazole sulphoxide and its metabolites appear to be principally eliminated in bile, with only a small proportion (<1% of albendazole sulfoxide) appearing in the urine. The plasma half life of albendazole sulphoxide is 8-12 hours.
Albendazole is indicated in Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestation. Enterobiasis, Capillariassis, Cysticerocsis, and Coetaneous larva migrans. Hydatid disease Surgery as an adjunct therapy (either Pre-or-Post operatively).
The usual dose for adults and children aged 2 years or over with ascariasis (roundworm), hookworm infestations, trichuriasis (whipworm), enterobiasis (pinworm) abd cytabeiys karva nugrabs use 400mg as a single dose. In strongyloidiasis, 400mg is given daily for 3 consecutive days. This may be repeated after 3 weeks if necessary.
Albendazole is absolutely contraindicated during pregnancy.
Albendazole has been shown to induce liver enzymes of the cytochrome p450 system responsible for its own metabolism. There is therefore, a theoretical risk of interaction with theo-phylline, anticonvulsant, care should therefore be exercised during the introduction of Albendazole in patients receiving the above groups of compounds.
Elevation in hepatic enzyme levels and reversible reduction in total white cell count have occasionally been reported. These changes appear to be more common during treatment of Echinococcus multilocularis.
Gastrointestinal disturbances, headache and dizziness have been reported during treatment. These symptoms are usually mild and resolved without treatment. Rash, fever and rarely alopecia may occur during treatment.
There is no experience of overdosage. Gastric lavage may be per-formed in the first two to three hours after ingestion. No specific antidote is known. However, symptomatic treatment and general supportive measures should be undertaken as required.
Store at a temperature not exceeding 30°C.
KEEP OUT OF THE REACH OF CHILDREN.
Manufactured in India by
Rhydburg Pharmaceuticals Ltd.
C-2 & 3, S.I.E.L., Selaqui, Dehradun
KRIS MEDIKS NIGERIA LTD.