Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Alembic Pharmaceuticals Inc.
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 300 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: 300 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP62” on one side and plain on other side. NDC 62332-025-30 Bottle of 30 NDC 62332-025-31 Bottle of 100 NDC 62332-025-71 Bottle of 500 NDC 62332-025-91 Bottle of 1000 450 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP63” on one side and plain on other side. NDC 62332-026-30 Bottle of 30 NDC 62332-026-31 Bottle of 100 NDC 62332-026-71 Bottle of 500 Dispense in a well-closed container, with child resistant closure [as defined in the USP]. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 08/2021
Abbreviated New Drug Application
THEOPHYLLINE - THEOPHYLLINE TABLET, EXTENDED RELEASE ALEMBIC PHARMACEUTICALS INC. ---------- THEOPHYLLINE EXTENDED-RELEASE TABLETS 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 1_H-_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 300 mg or 450 mg of anhydrous theophylline. 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 7 8 4 2 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 chan Citiți documentul complet