Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Caraco Pharma, Inc.
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 80 mg in 15 mL
ORAL
PRESCRIPTION DRUG
Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. ELIXOPHYLLIN Elixir is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
ELIXOPHYLLIN Elixir is a clear red solution with a mixed fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. ELIXOPHYLLIN Elixir is available in bottles of 473 mL NDC 49708-644-90 RECOMMENDED STORAGE Store at 25o C (77o F); excursions permitted to 15o - 30o C (59o - 86o F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: SUN Pharmaceutical Industries, Inc. 705 East Mulberry Street Bryan, Ohio 43506 Distributed By: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202 Iss.: 11/2012 7231T01
Abbreviated New Drug Application
ELIXOPHYLLIN - THEOPHYLLINE ANHYDROUS LIQUID CARACO PHARMA, INC. ---------- RX ONLY DESCRIPTION Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7- dihydro-1,3 -dimethyl-, and is represented by the following structural formula: The molecular formula of anhydrous theophylline is C7H8N4O2 with a molecular weight of 180.17. ELIXOPHYLLIN Elixir is available as a liquid intended for oral administration, containing 80 mg of theophylline anhydrous and 20% alcohol in each 15 mL (tablespoonful). ELIXOPHYLLIN Elixir also contains the following inactive ingredients: anhydrous citric acid, glycerin, saccharin sodium, artificial tutti fruiti flavor #051880A, FD&C red #40 and purified water. ELIXOPHYLLIN Elixir has a pH of 3.0-4.0. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects). While the mechanisms of action of theophylline are not known with certainty, studies in animals suggest that bronchodilatation is mediated by the inhibition of two isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilator prophylactic actions are probably mediated through one or more different molecular mechanisms, that do not involve inhibition of PDE III or antagonism of adenosine receptors. Some of the adverse effects associated with theophylline appear to be mediated by inhibition of PDE III (e.g., hypotension, tachycardia, headache, and emesis) and adenosine receptor antagonism (e.g., alterations in cerebral blood flow). Theophylline increases the force of contraction of diaphragmatic muscles. This action appears to be due to enhancement of calcium uptake through an adenosine-mediated channel. SERUM CONCENTRATION-EFFEC Прочитать полный документ