Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Heritage Pharmaceuticals Inc. d/b/a Avet 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, capsule shaped, biconvex, uncoated tablets debossed with 741 on one side and scored on the other side. 450 mg: White to off-white, Capsule shaped, biconvex uncoated tablets debossed with 742 on one side and scored on the other side. 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. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUGS (3784) 51U000000387US02 Revised: 12/2021
Abbreviated New Drug Application
THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE HERITAGE PHARMACEUTICALS INC. D/B/A AVET 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 1H- Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula: 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 anhydrous, 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. Կարդացեք ամբողջական փաստաթուղթը