Tanzol Albendazole Chewable Tablet and Oral Suspension

Tanzol™

(Albendazole Chewable Tablet /Albendazole Oral Suspension USP)

 

Composition

Tanzol tablet

Each uncoated chewable tablet contains:

Albendazole USP 400mg.

Colour: Sunset Yellow.

Flavour: Orange.

Excipients: Calcium Hydrogen Phosphate BP, Maize Starch BP, Gelatin BP, Sodium Benzoate BP, Saccharin Sodium BP, Magnesium Stearate BP and Purified Talc BP.

Tanzol suspension

Each 10ml contains:

Albendazole USP 400mg.

Colour: Sunset Yellow FCF.

Flavour: Banana.

Excipients: Citric Acid Monohydrate BP, Glycerol BP, Sodium Methyl Hydroxy Benzoate BP, Sodium Propyl Hydroxy Benzoate BP, Carmellose Sodium BP, Liquid Sorbitol (70%) BP, Sucrose, Polysorbate-80 BP, Purified Water BP.

 

Pharmacological Category

Tanzol is a benzimidazole anthelmintic drug.

 

Pharmacological Action

Tanzol selectively blocks me glucose uptake by adult helminthes in the intestine and their tissue dwelling larvae. Inhibition of glucose uptake leads to endogenous depletion of glycogen stored within the parasite. This in turn causes a decrease in the formation of adenosine triphosphate. By this mechanism, the drug slowly depletes the energy levels of the susceptible parasites.

 

Therapeutic Indications

Tanzol is indicated for the treatment of parasitic worm infestations (single or mixed) due to: Enterobius vermicularis (Pin worms), Trichuris trichuira (Whipworms), Ascaris lumbricoides (Large Roundworms), Ancylostoma duodenale (Hookworms), Necator americanus (Hookworms), Strongyloides stercoralis (Threadworms), Taenia spp (Tapeworms), Hymenolepis nana (Dwarf tapeworms), Taenia solium (Neurocysticercosis), Echinococcus granulosus (Hydatid cysts).

 

Contraindication

Tanzol is contraindicated in pregnancy and in patients with known hypersensitivity to albendazole.

 

Dosage and method of administration

The dose of Tanzol for adults and children above 2 years is one tablet or 10ml of suspension (400mg albendazole) as a single dose in suspected or confirmed infestations with Pin worms, Whipworms, Large Roundworms, Hookworms. In case of suspected or confirmed cases of Threadworms, Tapeworms, or Dwarf tapeworms, Tanzol should be used at a dose of one tablet or 10ml suspension once daily for 3 consecutive days. In cases of Dwarf Tapeworms, retreatment in 10-21 days is recommended. Tanzol 400mg twice daily for 3 consecutive days is effective in the treatment of patients with mixed worm infestation including infestation with Opisthorchis viverrini and Opisthorchis sinensis. For hydatid cysts: 10mg/kg of body weight/day for4-8weeks. For neurocysticercosis: 400mg twice a day for 30 days.

 

Pharmacokinetic Properties

Absorption: Oral absorption is low

Plasma half life: 8.5hrs

Mean plasma peak concentration: 0.46 to 1.58mcg/ml

Elimination: Via bile

 

Side effects of Tanzol

Include transient abdominal pain and diarrhea, dizziness, nausea, constipation, dry mouth etc.

 

Adverse Reaction

Use of large doses of Tanzol can cause adverse effects like allergic reactions, raised liver enzyme values, alopecia, bone marrow depression etc.

 

Warnings and Precautions

General

It has been noted that leucopaenia has occurred when used for periods longer than recommended. Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Cysticercosis may, in rare cases, involve the retina. If retinal lesions are visualized, the need for anticysticeral therapy should be weighed against the possibility of retinal damage caused by albendazole induced changes to the retinal lesion.

 

For use in special populations

Paediatrics

During albendazole therapy, because of the possibility of harm to the liver or bone marrow, routine (every 2 weeks) monitoring of blood counts and liver function tests should take place. Albendazole should be taken with food.

Pregnancy

Refer to contra-indication.

Lactation

Because of inadequate data breast feeding should be discontinued during and minimum 5 days after the treatment.

 

Effects on ability to drive and operate machinery

Not applicable.

 

Drugs interactions

Praziquantel, Cimetidine and Dexamethasone increases the drug level of Tanzol.

Theoretical risk of interaction with the theophylline, anticonvulsants, oral contraceptives and oral hypoglycaemics increases.

 

Symptoms of over dosage and 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 symptomatic supportive therapy be administered as appears indicated.

 

Storage condition

Do not store above 30°C.

Protect from sunlight.

Keep out of reach of children.

 

Presentation

Tanzol tablets: Pack of 1 tablet.

NAFDAC Reg. No.: 04-2927

Zambia Lic. No.: 075/046

Method of sale in Zambia: P

PPB Reg. No.: H2011/CTD1901357

Publication Date: 13/04/2016

 

Tanzol suspension: Pack of 10ml bottle.

NAFDAC Reg. No.: 04-8748

Zambia Lic. No.: 075/077

Method of sale in Zambia: P

PPB Reg. No.: H2013/CTD6381388