দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
THEOPHYLLINE
BAUSCH HEALTH, CANADA INC.
R03DA04
THEOPHYLLINE
80MG
SOLUTION
THEOPHYLLINE 80MG
ORAL
500ML
Prescription
RESPIRATORY SMOOTH MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0103582001; AHFS:
APPROVED
2012-01-03
PRODUCT MONOGRAPH THEOLAIR (theophylline anhydrous) Theolair Liquid 80 mg/15 mL Bronchodilator Manufactured by: Valeant Canada LP 2150 St-Elzear Blvd., West Laval, Quebec H7L 4A8 Canada Date of Revision: February 13 th , 2013 Address Updated: September 4, 2014 CONTROL NO.: 162338 NAME OF DRUG THEOLAIR (theophylline anhydrous) Theolair Liquid (80 mg/15 mL) THERAPEUTIC CLASSIFICATION Bronchodilator DESCRIPTION Each 15 mL of citrus-berry flavoured, non-alcoholic liquid contains 80 mg of theophylline. ACTION Theophylline is a xanthine structurally related to theobromine and caffeine. Theophylline relaxes certain smooth muscles, including those of the bronchi, promotes dilation of blood vessels, other than cerebral vessels, increases cardiac output and acts as a mild diuretic. Theophylline stimulates central nervous system, cardiac muscles, skeletal muscles and causes an increase in gastric secretion. INDICATION AND CLINICAL USES Theolair is indicated for the symptomatic treatment of reversible bronchoconstriction associated with bronchial asthma, chronic obstructive pulmonary emphysema, chronic bronchitis and related bronchospastic disorders. CONTRAINDICATIONS Hypersensitivity to other theophylline derivatives of xanthines; peptic ulcer, in coronary artery disease when in the physician’s judgement myocardial stimulation might prove harmful. WARNINGS Theophylline has a relatively narrow margin of safety and patients should be carefully observed for signs of toxicity. Use with caution in the presence of severe hypertension and other cardiovascular diseases. Theolair Liquid is not recommended for children under 5 years of age. Children are very sensitive to theophylline and the margin of safety is small. Care should be taken to see that children receiving oral theophylline are not also being administered drug by the rectal route. PRECAUTIONS There is a marked variation in blood levels achieved in different patients given the same dose of theophylline. This may lead to serious side effects in some patients. This variab সম্পূর্ণ নথি পড়ুন