| Customization: | Available |
|---|---|
| Application: | Paediatrics |
| Suitable for: | Children, Adult |
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Each Tablet contains:
Albendazole............. 400 mg
Albendazole is a Broad Spectrum anthelmintic for oral administration. The Chemical name is 5 - methyl - (propylthio) - 2 - bencimidazolcarbamato.
| Molecular formula | C12H15N3O2S |
| molecular weight | 265.34 |
| Color | White to Off White Powder |
It is soluble in dimetilsulfóxido, strong acids and strong bases. Slightly Soluble in methanol, chloroform, ethyl acetate and acetonitrilo.
Albendazole is practically insoluble in water.
The chemical structure of Albendazole is the following:
Therapeutic Indications: Albendazole is effective for the treatment of infestaciones caused by Ascaris lumbricoides, Hookworm and trichuris trichiura and Enterobius vermicularis, duodenale, Necator americanus, hymenolepis Nana Taenia sp, Strongyloides stercoralis, O. viverrini, C. sinensis, cutaneous Larva migrans and G. spinigerum.
It also has activity against Giardia lamblia.
Albendazole is indicated for
| 1 | the treatment of parenchymal neurocysticercosis, due to damage caused by active forms of porcine Taenia solium larval cestode. |
| 2 | the treatment of hydatid disease of liver, Lung and peritoneum caused by the larval form of the Dog Tapeworm Echinococcus granulosus. |
Contraindications: Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole compounds of type, or any component of the formulation of Albendazole, or suspicion of Pregnancy and Lactation.
Albendazole should not be used in children under one year of age.
Precautions: patients who are being treated for neurocisticercosis should receive the appropriate steroid and anticonvulsant Therapy needs. We must consider the oral or intravenous corticosteroids to prevent hypertensive cerebral episodes during the first week of treatment anticisticercosis.
Cysticercosis can rarely involve the retina. If the lesions are visualized, the therapy against Cisticerco must be weighed against the possibility of damage to the retina due to the Administration of Albendazole in the lesion of the retina.
Restrictions of use during pregnancy and Lactation:
Risk category X: it has been shown that albendazol is teratogenic (cause and embriotoxicidad Bone Malformations in rats and pregnant MICE.
Teratogenic response was observed in rats that received oral doses of 10 and 30 mg / kg / day (0.10 times and 0.32 times the recommended Human dose based on Body Surface Area in mg / m2, respectively) and in pregnant Rabbits that received oral doses of 30 mg / kg / day (0.60 times the recommended dose for Humans, based on Body Surface Area (mg / m2).
There have been no adequate and well controlled studies of the Administration of albendazol in pregnant women.
Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Albendazole is excreted in the Milk of Animals. It is not known whether Albendazole is excreted in human milk.
Because many drugs are excreted in human milk, Caution should be exercised when administering albendazol a woman lactante.
Adverse Reactions:
The Administration of Albendazole has been associated with Adverse reactions the following: abdominal Pain, nausea, vomiting, headache, dizziness, vertigo, epigastric Pain and diarrhea.
During the treatment of the disease hidatídica have reported increases in the levels of liver Enzymes.
Also, during the treatment of neurocisticercosis cases have been reported of intracraneal elevación pressure.
Other Adverse reactions related to the use of Albendazole are:
Hematologic: leukopenia.
Rare cases have been reported of granulocitopenia, pancytopenia, neutropenia, and thrombocytopenia.
Skin rash and Hives.
Hypersensitivity, Allergic reactions, Skin rash, itching and urticaria.
Drug interactions and other Gender:
Dexamethasone may increase the concentration of albendazol sulfoxide.
Praziquantel: approximately 50% increase in plasma levels in healthy volunteers.
Cimetidine: Increasing concentrations of Albendazole sulphoxide in Bile and in the Cystic Fluid (about twice).
Ritonavir increases the Serum concentrations of Albendazole.
Theophylline: although it has been shown that a Single Dose of Albendazole did not inhibit the Metabolism of Theophylline, Albendazole induces cytochrome P450 1a in human hepatocytes.
Therefore, it is recommended to monitor Theophylline Plasma concentrations during and After Treatment with Albendazole.
Food: Food increases the absorption of Albendazole.
Precautions in relation to effects of carcinogenesis, Mutagenesis, impairment of Fertility:
Albendazole is teratogenic and embryotoxic in rats and Rabbits. There were long term carcinogenicity studies in Mice and rats.
The study in Mice, Albendazole was administered in the Diet at a dose of 25, 100 and 400 mg / kg / day for 108 Weeks. In the study conducted in Rats, Albendazole was administered in the Diet at a dose of 3.5, 7 and 20 mg / kg / day for 117 Weeks.
In Mice and Rats treated compared with the control Group, there was no evidence of increased incidence of tumors.
In the Genotoxicity tests, albendazol was negative in the Ames Test of Mutation in Salmonella / microsoma Plate, with and without Activation metabólica; or in the test of Chromosomal Aberration in Chinese hamster ovary cells, mediated by prior Incubation with and without; and in the in Vivo Micronucleus Test in the mouse. Test of Balb / 3T3 cell Transformation in vitro, Albendazole exhibited a weak Metabolic activity in the presence but not exhibited Metabolic activity in absence. Albendazole did not adversely affect the Fertility of male or female rats by an oral dose of 30 mg / kg / day (0.32 times the recommended Human dose based on Body Surface Area (mg / m2).
Showed no tumor formation in rats and Mice with daily doses above 30 times the standard dose.
Dosage and Administration: The Route of Administration is oral.
The dose varies according to the disease:
Manifestations and Management of overdose or accidental ingestion have been reported only one case of overdose with Albendazole in one patient who took at least 16 grams in a 12 hour period.
No undesirable Effects were reported. In case of Overdose, it is recommended to apply symptomatic Therapy (e.g., gastric lavage and activated Charcoal) and General Supportive measures.
Recommendations on Storage:
Keep at room temperature to no more than 30°C in a Dry Place.
Legends of protection:
Dose: the doctor says.
Do not use in pregnant or lactating.
Do not Administer to children under one year of age.
Keep out of reach of Children.
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