Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Camber Pharmaceuticals, Inc.
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: 300 mg: White to off- white colored, capsule shaped, bevel edged, biconvex tablets, debossed with ‘T’ and score line on one side and ‘V’ on the other side. Bottle of 100 NDC 31722-077-01 450 mg: White to off- white colored, capsule shaped, bevel edged, biconvex tablets, debossed with ‘T’ and ‘1’ separated by a score line on one side and ‘V’ on the other side. Bottle of 100 NDC 31722-078-01 Dispense in a well-closed container, with child resistant closure [as defined in the USP]. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 08/2023
Abbreviated New Drug Application
THEOPHYLLINE - THEOPHYLLINE TABLET, EXTENDED RELEASE CAMBER PHARMACEUTICALS, INC. ---------- THEOPHYLLINE EXTENDED-RELEASE TABLETS RX ONLY DESCRIPTION: Theophylline is structurally classified as a methylxanthine. It occurs as a crystalline powder, white, practically odourless. Theophylline anhydrous USP has the chemical name 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione 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 ADMINISTRATIONsection for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of theophylline anhydrous USP. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, 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 bronchodilation 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 CONCE Прочетете целия документ