ETIBI Tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
ETIBI Ethambutol Hydrochloride Tablets, USP, 100 & 400 mg.
Indications and clinical use
ETIBI (ethambutol) is indicated in combination with other antituberculosis medications in the treatment of all forms of tuberculosis, including tuberculous meningitis, caused by Mycobacterium tuberculosis. ...
Contraindications
ETIBI (ethambutol) is contraindicated in patients with optic neuritis unless clinical judgment deems it necessary that the drug be used. ETIBI is also contraindicated in patients with known hypersensitivity ...
Warnings and precautions
Susceptibility / Resistance Development of Drug Resistant Bacteria Prescribing ETIBI Tablets in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient ...
Adverse reactions
The most important adverse effect of ethambutol is optic neuritis with decreases in visual acuity, constriction of visual fields, central and peripheral scotomas, and loss of red-green color discrimination. ...
Dosage and administration
ETIBI (ethambutol) may be taken with food if gastrointestinal irritation occurs. Since daily administration in divided doses may not result in therapeutic serum concentrations, it is recommended that ETIBI ...
Overdosage
Usually ETIBI (ethambutol) is well tolerated. However, optical disturbances, as noted above, are reversible when the drug is discontinued. This may require a period of weeks to months. Any unusual sign ...
Action and clinical pharmacology
Action Ethambutol is bacteriostatic in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit the synthesis of one or more metabolites in susceptible ...
Storage and stability
Keep away from light, moisture, and excessive heat. Store in well-closed container at controlled room temperature (15-30°C).
Dosage forms, composition and packaging
Each blue, film coated, single-scored on one side ETIBI 100 mg tablet contains 100 mg of ethambutol hydrochloride, USP. Bottles of 100. Each blue, film coated, single-scored on one side and engraved ICN ...
Pharmaceutical information
Drug Substance: Ethambutol hydrochloride Chemical Name: (1) 1-Butanol,2,2'-(1,2-ethanediyldiimino) bis-,dihydrochloride (2) (+)- 2,2'-(Ethylenediimino)-di-1-butanol dihydrochloride Structural Formula: ...
Detailed pharmacology
A single 25 mg/kg dose of ETIBI (ethambutol) was administered to each of twenty (20) human volunteers, and plasma concentration and urinary recovery rate determinations were performed. In 12 subjects the ...
Microbiology
In vitro tests were carried out on 100 strains of M. tuberculosis isolated from patients previously not treated with ETIBI, and on 20 strains isolated from patients unsuccessfully treated. In these studies, ...
Toxicology
Two species were used to determine the Acute Oral Toxicity of ETIBI. In albino mice, a test dose of 10,000 mg/kg did not cause immediate or delayed mortality in animals of either sex. At this high dose ...
Marketing authorization holder
Bausch Health, Canada Inc., 2150 St-Elzéar Blvd., West, Laval, Quebec, H7L 4A8
Submission control number
228021
Date of revision
July 9, 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
