Drug Approvals
(British Approved Name, rINN)
International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):
Pharmacopoeias. In British, China, and US.
British Pharmacopoeia 2008 (Choline Theophyllinate). A white crystalline powder, odourless or with a faint amine-like odour. It contains between 41.9% and 43.6% of choline and between 61.7% and 65.5% of theophylline, each calculated with reference to the dried substance. Very soluble in water soluble in alcohol very slightly soluble in chloroform and in ether. Store at a temperature not exceeding 25°. Protect from light.
The United States Pharmacopeia 31, 2008 (Oxtriphylline). A white crystalline powder, having an amine-like odour. It contains not less than 61.7% and not more than 65.5% of anhydrous theophylline. Soluble 1 in 1 of water freely soluble in alcohol very slightly soluble in chloroform. A 1 % solution in water has a pH of about 10.3. Store in airtight containers.
Profile
Choline theophyllinate is a theophylline salt that liberates theophylline in the body choline theophyllinate 1.57 mg is equivalent in theophylline content to about 1 mg of anhydrous theophylline. It is used as a bronchodilator for reversible airways obstruction. The usual oral maintenance dose for adults is 800 mg daily, in 4 divided doses. The daily dose should be adjusted according to clinical response and serum-theophylline concentrations (see Uses and Administration of Theophylline). For details of doses in children see Administration in children, below.
Administration in children.
Choline theophyllinate can be given to children in oral doses of 10 to 20 mg/kg daily, in 3 or 4 divided doses.
Preparations
British Pharmacopoeia 2008: Choline Theophyllinate Tablets
The United States Pharmacopeia 31, 2008: Oxtriphylline Delayed-release Tablets Oxtriphylline Extended-release Tablets Oxtriphylline Oral Solution Oxtriphylline Tablets.
Proprietary Preparations
Australia:: Brondecon Elixir
Canada: Choledyl
Germany: Euspirax
Greece: Choledyl
Sweden: Teovent
USA: Choledyl
Multi-ingredient
Canada: Choledyl Expectorant
New Zealand: Broncelix Brondecon Pharmacycare Cough Expectorant
Portugal: Vitasma
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