Balzole Albendazole Tablets

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.

 

DESCRIPTION

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).

 

LABEL CLAIM

Each uncoated chewable tablet contains:

Albendazole BP 400mg

Excipients q.s.

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.

 

PHARMACOKINETICS

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.

 

INDICATIONS

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).

 

DOSAGE

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.

 

CONTRAINDICATION

Albendazole is absolutely contraindicated during pregnancy.

 

DRUG INTERACTION

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.

 

WARNING/PRECAUTION

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.

 

SIDE EFFECTS

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.

 

OVER DOSAGE

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.

 

STORAGE INSTRUCTIONS

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

Uttarakhand, INDIA

 

Marketed by

KRIS MEDIKS NIGERIA LTD.

Nigeria.

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