Active Ingredient: Each tablet contains: Albendazole 200 mg.
Pharmacotherapeutic group: Anthelmintic.
Pharmacology: Pharmacodynamics: Mechanism of action: Albendazole is a benzimidazole carbamate anthelmintic drug similar to mebendazole. It is a broad-spectrum anthelmintic, which is highly effective against a wide range of intestinal helminths including a variety of intestinal nematodes, cestodes, and trematodes. It is also effective against tissue helminth infections, such as cutaneous larva migrans and has also been used in the high dose, long term treatment of tissue helminth infections including hydatid cysts and cysticercosis.
The anthelminthic action of albendazole is thought to be mainly intra-intestinal due to low absorption (less than 5%) after oral administration. However, at higher albendazole doses, sufficient amount is absorbed and metabolised to the active sulfoxide metabolite, to have a therapeutic effect against tissue parasites.
Albendazole exhibits larvicidal, ovicidal and vermicidal activity, and is thought to act via inhibition of tubulin polymerization. This causes a cascade of metabolic disruption, including energy depletion, which immobilizes and then kills the susceptible helminth.
Pharmacokinetics: Absorption: In man, the full extent of albendazole absorption following oral administration has not been established. However, it is known that albendazole is poorly absorbed (<5%) with most of an oral dose remaining in the gastrointestinal tract. The poor absorption is believed to be due to the low aqueous solubility of albendazole. Absorption is significantly enhanced (up to 5 fold) if albendazole is administrated with a fatty meal compared with fasted state.
Metabolism: Albendazole rapidly undergoes extensive first-pass metabolism in the liver, and is generally not detected in plasma or in urine. Albendazole sulfoxide is the primary metabolite, which is thought to be the active moiety in effectiveness against systemic tissue infections (anthelminthic activity). Peak plasma concentrations of albendazole sulfoxide attained 2 - 5 hours after a dose. Albendazole
sulfoxide is further metabolized to albendazole sulfone and other primary oxidative metabolites.
Distribution: Albendazole sulfoxide 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 sulfoxide 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 sulfoxide is 8 - 12 hours.
Special populations: Patients with extrahepatic obstruction: Increased albendazole sulfoxide serum concentration and prolonged half-life. Elimination half-life may be 31.7 hours.
Zenmox Chewable Tablet 200 mg is used for the treatment of common worm infections of the gut, such as conditions caused by the following organisms: 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).
Recommended Dose: Chewable tablets may be crushed, chewed, or swallowed whole.
For roundworm, whipworm, hookworm and pinworm: Adults and children above 24 months: 2 tablets (400 mg) as a single dose.
Children 12 - 24 months: 1 tablet (200 mg) as a single dose.
For threadworm and tapeworm: Adults and children above 24 months: 2 tablets (400 mg) as a single dose once a day for 3 consecutive days.
The maximum duration of treatment will vary according to the indication. Please refer to the info previously mentioned for maximum doses of each indication. Do not exceed the maximum daily doses and treatment durations recommended.
If the patient is still symptomatic after a single course of treatment, they must consult a Healthcare Professional for further treatment.
Not to be used in children aged under 1 year.
Route of Administration: For oral use.
Zenmox Chewable Tablet 200 mg are chewable and can also be crushed and mixed with food.
Overdose has not been observed in humans. Recommendations for treatment of overdose are the usual measures to remove the unabsorbed materials from the gastro-intestinal tract and supportive therapy for the evolving clinical syndrome.
Hypersensitivity to albendazole, other benzimidazole derivatives or to any of the excipients.
Pregnancy and lactation.
SHOULD NOT BE ADMINISTERED DURING CONFIRMED OR SUSPECTED PREGNANCY.
General precaution: Confirmation of eradication of many intestinal and tissue parasites is necessary after treatment.
Use in Systemic Helminth Infections (longer duration of treatment at higher doses): Hepatic Effects: Mild to moderate elevations of liver enzymes have been reported with albendazole. Elevations of liver enzymes increase risk of hepatotoxicity and bone marrow suppression. In prolonged higher dose albendazole therapy for hydatid disease, there have been rare reports of severe hepatic abnormalities associated with jaundice and histological hepatocellular damage, which may be irreversible. Case reports of hepatitis have also been received. Enzyme abnormalities usually normalize on discontinuation of treatment.
Myelosuppression: Can cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with or without underlying hepatic dysfunction. Reversible leukopenia has occurred in <1% of patients receiving the drug; granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia reported rarely. Rare fatalities reported due to granulocytopenia or pancytopenia.
Albendazole has been shown to cause bone marrow suppression and therefore blood counts should be monitored at the start of each 28-day cycle and every two weeks during treatment. Closer monitoring of blood counts is recommended in patients with liver disease, including hepatic echinococcosis, since these individuals may be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia. Albendazole should be discontinued if clinically significant decreases in blood cell counts occur.
Precautions Related to Treatment of Neurocysticercosis: Destruction of cysticercosis lesions by albendazole may cause irreparable retinal damage, even when corticosteroids are given. Prior to treatment of neurocysticercosis, examine patient for cysticercosis retinal lesions. In those with such lesions, weigh the need for treatment against the possibility of irreparable retinal damage.
Symptoms associated with an inflammatory reaction following death of the parasite within the brain may occur in patients receiving albendazole treatment for neurocysticercosis (e.g. seizures, raised intracranial pressure, hydrocephalus, focal signs). These should be treated with appropriate corticosteroid and anticonvulsant therapy. Oral or intravenous corticosteroids are recommended during the first week of treatment to prevent cerebral hypertension. Pre-existing neurocysticercosis may also be uncovered in patients treated with albendazole for other conditions. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.
There is a risk that treatment of Taenia solium infections may be complicated by cysticercosis, and appropriate measures should be taken to minimise this possibility.
Effects on Ability to Drive and Use Machine: When driving vehicles or operating machinery it should be taken into account that dizziness has been reported after using Zenmox Chewable Tablet 200 mg.
Use in Impaired Renal or Hepatic Function: The use in patients with impaired renal or hepatic function has not been studied. However, caution should be used in patients with pre-existing liver disease, since albendazole is metabolised by the liver and has been associated with idiosyncratic hepatotoxicity.
Use in Children: There is limited experience in children under 2 years of age, therefore use in this age group is not recommended.
Pregnancy: SHOULD NOT BE ADMINISTERED DURING CONFIRMED OR SUSPECTED PREGNANCY.
Breast-feeding: Adequate human and animal data on use during lactation are not available. Therefore breast feeding should be discontinued during and for a minimum of 5 days after treatment.
Adverse effects are usually mild and resolve without treatment.
Dermatologic Effects: Reversible alopecia (thinning of hair, and moderate hair loss), itchiness and/or skin rashes, erythema multiforme and Stevens-Johnson syndrome.
Gastrointestinal Effects: Abdominal pain, diarrhoea, nausea, vomiting.
Hematologic Effects: Low red cell count, leucopenia, pancytopenia, aplastic anaemia and agranulocytosis.
Hepatic Effects: Transiently raised hepatic enzymes, hepatitis, acute liver failure, jaundice, hepatocellular damage.
Immunologic Effects: Hypersensitivity reactions including rash, pruritus and urticaria.
Neurologic Effects: Dizziness, headache, symptoms associated with treatment for neurocysticercosis (e.g. seizures, raised intracranial pressure, hydrocephalus, focal signs).
Ophthalmic Effects: Albendazole induced retinal damage in patients with pre-existing cysticercosis retinal lesions.
Renal Effects: Proteinuria.
Others: Bone pain and fever.
Cimetidine, praziquantel and dexamethasone have been reported to increase the plasma levels of the albendazole active metabolite.
Grapefruit juice may increase the bioavailability of albendazole but less than the increase observed after a fatty meal.
Phenytoin, carbamazepine, and phenobarbital appear to induce the oxidative metabolism of albendazole, resulting in significantly reduced concentrations of albendazole sulfoxide. This interaction is likely to be clinically significant when albendazole is used to treat systemic worm infections. The interaction is probably not clinically significant when albendazole is used for intestinal worm infections.
Chinese Ginseng may theoretically reduce the intestinal concentration of albendazole active metabolite.
Albendazole may theoretically inhibit theophylline metabolism and increase toxicity.
Store at temperature below 30°C.
Shelf Life: 2 years.
P02CA03 - albendazole ; Belongs to the class of benzimidazole derivative agents. Used as antinematodal.
Zenmox chewable tab 200 mg
1 × 2's
Sign Out
