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ALZO 1

Quick Overview

 Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our Anti-infective range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Alzo 1 which contains Albendazole USP… 400 mg.


 


 

ALZO 1

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Details

Each uncoated chewable tablet contains:

Albendazole USP… 400 mg

Excipients     q.s.

CHEMICAL NAME: Carbamic acid, [5-(propylthio)-1H benzimidazol-2-y1], methyl ester.

Methyl 5-(propylthio)-2-benzimidazolecarbamate

CATEGORY: Anthelmintic and antiprotozoal

DESCRIPTION: White to off white Caplet Shape biconvex uncoated tablet, break line on one side and plain on other side.

CLINICAL PHARMACOLOGY

Mechanism of Action:

Albendazole is a Benz imidazole 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 2'A hours. The half-life of the sulfoxide in the plasma is 8% hours. The metabolite is essentially eliminated via the urine be administered as indicated. Albendazole inhibits colchicine binding by tubulin derived from Trichinella spiralis with an inhibition constant of about 10M. The morphological effects produced by known microtubule inhibitors in Giardiatrophozoite detachment and distortion of morphology, are very similar to those resulting from exposure to benzimidazole. There is a good correlation between the binding constant to Haemonchus contortus tubulin and the known anthelmintic potency of various benzimidazoles.

Pharmacokinetic Actions

Absorption:

Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide.

Maximal plasma concentrations of albendazole sulfoxide are typically achieved 2 to 5 hours after dosing and are on average 1.31 mcg/ml (range 0.46 to 1.58 mcg/m1) following oral doses of albendazole (400 mg) in six hydatid disease patients, when administered with a fatty meal. The mean apparent terminal elimination half-life of albendazole sulfoxide typically ranges from 8 to 12 hours.

Distribution:

Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebral spinal fluid (CSF). Concentrations in plasma were 3 to 10- fold and 2 to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively.

Metabolism:

Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine.

Excretion: Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma.

 

Indications:

ALZO-1 is indicated in the treatment of single or mixed intestinal parasites. Reported clinical studies have shown albendazole effective 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. It also 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 ALZO-1 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. ALZO-1 is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.

Dosage:

Usual Dose: (400 mg) of ALZO-1 as a single dose in both adults and children over two years of age. The tablets may be chewed with food. The usual dose in children between one and two years of age is 200 mg of ALZO-1 tablet 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.

Giardiasis (dose in children over 2 years of age): A single 400 mg daily dose forfive days.

Tablet should be chewed before swallowing.

Pregnancy and Lactation:

There are no adequate and well controlled studies of albendazole administration in pregnancy only if the potential benefits justify the potential risk to the fetus.

Albendazole is excreted in animals milk. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised while administering albendazole to a nursing woman.

Effect to drive and use the machine: None

Adverse Effects:

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

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

Drug Interactions:

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

Precautions and Warnings:

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

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

Overdose:

If poisoning or excessive over dosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy

Packing: Blister of 1 Tablet.

Storage: Store in a cool and dry place below 30°C. Protect from light.

Keep out of reach of children.

Shelf Life: 24 months from the date of manufacturing.

 

 

 
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