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Eskazole 400mg SUSP INF 10 ml, Albendazole
THIS IS THE BRAND MEDICATION
INDICATIONS: Zentel Dosage Forms is a benzimidazole carbamate with anthelmintic activity and polyvalent against protozoan, which is effective in the treatment of the following intestinal parasites and tissues: Ascaris lumbricoides, Enterobius vermicularis, Necator americanus, Ancylostoma duodenale, whipworm, Strongyloides stercoralis, Taenia sp, Hymenolepis nana (only if associated parasitism), Chlonorchis sinensis, Opisthorchis cutaneous larva migrans and viverrini. Giardiasis (Giardia lamblia, Giardia, Giardia intestinalis, lamblia intestinalis) in children. Gnathostomiasis (caused by Gnathostoma spinigerum and related species).
HUMAN Pharmacokinetics: After oral administration, albendazole is absorbed in small amounts (less than 5%).
The pharmacological effect of albendazole increases when given with fatty foods, which increases about 5 times its absorption.
Distribution: Following administration of a single dose of 400 mg of albendazole, it has been reported that the pharmacologically active metabolite albendazole sulfoxide, maximum concentrations of 1.6 to 6.0 micromol / ml, when taken with breakfast.
Metabolism: Albendazole rapidly undergoes extensive first pass metabolism in the liver and is not detected in plasma. The primary metabolite albendazole sulfoxide is active and effective molecule against systemic infections.
Elimination: The elimination half-life is 8½ hours. Albendazole sulfoxide and its metabolites are excreted in the bile, only a small portion is excreted in the urine. Removing cysts occurs several weeks after the high and prolonged dose.
Special patient populations:
Elderly: Although not investigated the effect of age on the pharmacokinetics of albendazole sulfoxide, data in 26 hydatid cyst patients up to 79 years suggest that is similar to that of young people. The number of elderly patients treated either hydatid disease or neurocysticercosis is limited, but there were no problems associated with the elderly population.
CONTRAINDICATIONS: Do not administer during pregnancy or when there is suspicion thereof, or in patients with hypersensitivity to the components of the formula.
PRECAUTIONS: To avoid use during early pregnancy, women of childbearing age should start their administration during the first week of menstruation or when you have a negative pregnancy test result.
Zentel Dosage Forms Suspension contains benzoic acid that can irritate the skin, eyes and mucous membranes. You can increase the risk of jaundice in the newborn.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING
Pregnancy Albendazole should not be administered during pregnancy or in women who suspected they might be pregnant (see CONTRAINDICATIONS).
Lactation It is not known whether albendazole or its metabolites are excreted in human breast milk. Therefore, Zentel Dosage Forms should not be used during lactation unless it is considered that the potential benefits outweigh the potential risks associated with treatment.
ADVERSE REACTIONS: Data from large clinical trials were used to determine the frequency of very common to rare adverse events. The frequencies assigned to all other adverse events (eg, <1 / 1,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency of reports.
Very common: = 1/10, common: the following classification was used = 1/100 and <1/10, uncommon: 1/1 = 000 and <1/100, rare: = 1 / 10,000 to <1 / 1,000, very rare <1 / 10,000.
Alterations of the immune system:
Rare: hypersensitivity reactions, including erythema, pruritus and urticaria.
Aletraciones nervous system:
No communes: headache and dizziness.
Gastrointestinal disorders:
Uncommon: upper gastrointestinal tract symptoms (eg, epigastric or abdominal pain, nausea, vomiting) and diarrhea.
Hepatobiliary Altreaciones:
Rare: elevations of liver enzymes.
Disorders of skin and subcutaneous tissue:
Very rare: erythema multiforme, Stevens-Johnson syndrome.
DRUG INTERACTIONS: praziquantel has been reported to increase plasma levels of the active metabolite of albendazole.
CHANGES IN RESULTS OF LABORATORY TESTS: At low doses and brevity in treatment, has not been reported changes in laboratory parameters that establish a causal relationship with albendazole.
PRECAUTIONS IN RELATION TO EFFECTS OF Carcinogenesis, Mutagenesis, Impairment of Fertility: Albendazole has embryotoxic and teratogenic effects in rats and rabbits. It was no evidence of mutagenicity and genotoxicity in vitro and in vivo tests (including the Ames test). In studies of long-term toxicity in rats and mice with daily doses above 30 times the recommended dose for humans, no tumor formation related to treatment was observed.
DOSAGE AND ADMINISTRATION: Oral.
Indications
Age
Dose
Period
ascariasis
enterobiasis *
hookworm
whipworm
Adults and children over 2 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Single dose
Children aged 1 to 2 years
200 mg
(1 tablet of 200 mg or
5 ml of suspension)
Single dose
estrongiloidosis
intestinal tapeworm
hymenolepiasis **
Adults and children over 2 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Once daily for 3 days
clonorchiasis
opisthorchiasis
Adults and children over 2 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Twice daily for 3 days
giardiasis
Children 2 to 12 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Once a day for 5 days
Cutaneous Larva migrans
Adults and children over 2 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Once daily for 1 to 3 days
gnathostomiasis
Adults and children over 2 years
400 mg
(2 tablets of 200 mg,
One 400 mg tablet or 10 ml
Suspension)
Once a day for 12 to 14 days
* To achieve a complete cure of cases of infestation enterobios, prescribe strict hygiene and the same treatment to families and persons living with the patient.
** It is recommended retreatment 10-21 days later, given the life cycle of the parasites.
If patients do not heal after three weeks, a second treatment is indicated. No need for special procedures such as fasting or laxative use.
The tablets may be swallowed, chewed or crushed or taken with water.
REPRESENTATIONS AND MANAGEMENT Overdosage: In case of overdose symptomatic measures should be adopted (gastric lavage) and general treatment support.
Active substances: Albendazole
Presentation: SUSP
Concentration: 200mg
Extended-release tablets: No
Laboratory: Armstrong Laboratories, S.A. de C.V.
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