clear
Composition: Each BENZATOL contains 400 mg Albendazole.
Excipients: Lactose, starch, aerosol, microcrystalline cellulose, magnesium stearate.
Pharmacodynamic:
Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against the intestinal and tissue worm infections.
Pharmacokinetic:
Absorption & Metabolism of albendazole from the gastrointestinal tract is poor but may be enhanced by a fatty meal. Albendazole rapidly undergoes extensive first-pass
metabolism. Its principal metabolite albendazole sulfoxide has anthelmintic activity and a plasma half-life of about 8.5 hours.
Distribution: Albendazole sulfoxide is widely distributed throughout the body including into the bile and the CSF. It is about 70% bound to plasma protein.
Excretion: Albendazole sulfoxide is eliminated in the bile; only a small amount appears to be excreted in the urine.
Indications:
ALBENDAZOLE is used for the treatment of common worm infections such as the following conditions:
– Pinworm infection (enterobiasis)
– Hookworm disease (ancylostomiasis and necatoriasis)
– Dwarf tapeworm infection (hymenolepsiasis)
– Pork/beef tapeworm infections (taeniasis)
– Threadworm infection (strongyloidiasis)
– Roundworm infection (ascariasis)
– Whipworm infection (trichuriasis)
– Liver fluke infections (clonorchiasis and opisthorchiasis)
– Hookworm (animal origin) causing skin disease (cutaneous larva migrans)
– Giardia infection (giardiasis in children)
Contraindications:
ALBENDAZOLE is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components, and in children aged under 1 year.
Warnings and Precautions:
If you develop severe headache, nausea and vomiting, fits and/or problems with your vision after taking this medicine, consult a Healthcare Professional immediately.
ALBENDAZOLE may cause liver problems. Please consult a Healthcare Professional if you experience yellowing of the skin or eyes, dark coloured urine and/or light coloured stools. Patients diagnosed with hepatic or renal impairment (liver or kidney problems) must seek advice from a Healthcare Professional before taking this medicine
When driving vehicles or operating machinery it should be taken into account that dizziness has been reported after using ALBENDAZOLE.
Drug Interaction:
ALBENDAZOLE interacts with the following drugs: Praziquantel, Antiepileptics as phenytoin, carbamazepine, phenobarbital
appear to induce the metabolism of ALBENDAZOLE, Corticosteroids and Histamine H2-antagonists: plasma concentrations of the active metabolite of albendazole were reported to be raised by about 50% resulting in reduced concentration of ALBENDAZOLE.
Pregnancy and lactation:
ALBENDAZOLE is contraindicated in pregnancy, patients who think they are or may be pregnant should not take this preparation. Patients who are breast feeding must seek advice from a Healthcare Professional prior to taking this medicine.
Undesirable effects: Uncommon side effects are headache, dizziness, stomach pain, nausea, vomiting and diarrhoea.
Rare side effects are hypersensitivity reactions including rash, pruritus and urticaria, and changes in liver blood test. Please consult a Healthcare Professional if you experience yellowing of the skin or eyes, dark coloured urine and/or light coloured stools.
Very rare side effects are serious blistering skin rashes with swelling and peeling
Dosage and method of administration:
The recommended dose of ALBENDAZOLE is as follows:
Adults and children over 2 years of age 400 mg as a single dose.
Children 1-2 years of age 200 mg as a single dose.
ALBENDAZOLE should not to be used in children aged under 1 year.
| Indications | Age | Dose | Period | Maximum Dose Recommended |
| Pinworm infection *
Hookworm disease Roundworm infection Whipworm infection |
adults and children over 2 years of age | 400 mg [two 200 mg tablet(s) or 10 ml 4% suspension]# | single dose (to be taken on an empty stomach) | Single dose, 400 mg |
| children 1-2 years of age | 200 mg (one 200 mg tablet or 5 ml 4% suspension) | single dose (to be taken on an empty stomach) | Single dose, 200 mg | |
| Threadworm infection
Pork/beef tapeworm infection Dwarf tapeworm infection ** |
adults and children over 2 years of age | 400 mg or 10 ml | one dose per day for 3 days (to be taken on an empty stomach) | 400 mg per day (1200 mg for 3 consecutive days) |
| Liver fluke infections *** | adults and children over 2 years of age | 400 mg or 10 ml | two doses per day for 3 days (to be taken with food) | 800 mg per day (2400 mg over a 3 day period) |
| Cutaneous larva migrans | adults and children over 2 years of age | 400 mg | Once daily for 1 to 3 days (to be taken with food) | 400 mg per day (Up to 1200 mg over a 3 day period) |
| Giardia infection | children 2 – 12 years of age only | 400 mg or 10 m | one dose per day for 5 days (to be taken on an empty stomach) | 400 mg per day (2000 mg over a 5 day period) |
In order to obtain a complete cure in the case of pin-worm infestation, measures should be taken to maintain strict hygiene. Relatives and individuals sharing the same housing should also take a course of treatment.
**In cases of proven dwarf tapeworm infection (Hymenolepiasis), a repeat course of the medicine in 10-21 days is recommended
Overdose:
Please consult a Healthcare Professional for advice in the event of overdose
Storage conditions:
Store in a dry place, at temperature below 25°. Protect from light.
Packaging:
A carton box containing 1 or 10 Tab. BENZATOL.
