Country: United States
Language: English
Source: NLM (National Library of Medicine)
Theophylline, anhydrous (UNII: 0I55128JYK) (Theophylline, anhydrous - UNII:0I55128JYK)
FOREST PHARMACEUTICALS, INC.
Theophylline, anhydrous
LIQUID
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 0456-0644-16
ELIXOPHYLLINE- THEOPHYLLINE, ANHYDROUS LIQUID FOREST PHARMACEUTICALS, INC. ---------- ELIXOPHYLLIN® (BRAND OF THEOPHYLLINE ANHYDROUS) ELIXIR 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 C H N O 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: citric acid, FD&C Red #40, glycerin, saccharin sodium, imitation tutti frutti fruit flavor 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 Read the complete document