Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Teva Pharmaceuticals USA, Inc.
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 100 mg
ORAL
PRESCRIPTION DRUG
Theophylline extended-release tablets are 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. Theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
Theophylline Extended-Release Tablets 100 mg – White to off white, round, biconvex, uncoated tablets debossed with PLIVA and 483 bisected by a score line on one side and unscored on the other side in bottles of 100 and 500. 200 mg – White to off white, Oval shaped, biconvex, uncoated tablets debossed with PLIVA and 482 on one side and scored on the other side in bottles of 100, 500 and 1000. 300 mg – White to off white, capsule shaped, biconvex, uncoated tablets debossed with PLIVA and 459 on one side and scored on the other side in bottles of 100, 500 and 1000. 450 mg – White to off white, capsule shaped, biconvex, uncoated tablets debossed with PLIVA and 518 on one side and scored on the other side in bottles of 100. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 6/2010
Abbreviated New Drug Application
THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE TEVA PHARMACEUTICALS USA, INC. ---------- THEOPHYLLINE EXTENDED-RELEASE TABLETS 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: C H N O M.W. 180.17 This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 100 mg, 200 mg, 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, anhydrous lactose, magnesium stearate and povidone. 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 lll 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 lll or antagonism of adenosine receptors. Some of the adverse effects associated with theophylline appear to be mediated by inhibition of PDE lll (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. SER Les hele dokumentet