Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Mylan Pharmaceuticals Inc.
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 400 mg
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. Theophylline (anhydrous) extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
Theophylline (Anhydrous) Extended-Release Tablets are available containing 400 mg or 600 mg of theophylline, USP. The 400 mg tablet is a white, round, scored tablet, embossed with N over T4 . They are available as follows: NDC 0378-0486-01 bottles of 100 tablets The 600 mg tablet is a white, oblong, scored tablet embossed with NT6 . They are available as follows: NDC 0378-0487-01 bottles of 100 tablets 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 using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120 FEBRUARY 2016 NOS:THEOT:R1
Abbreviated New Drug Application
THEOPHYLLINE (ANHYDROUS)- THEOPHYLLINE TABLET, EXTENDED RELEASE MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Theophylline (anhydrous) extended-release tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients. Theophylline, USP 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. Each extended-release tablet for oral administration, contains 400 mg or 600 mg of anhydrous theophylline. Inactive ingredients: glyceryl behenate, silicified microcrystalline cellulose, silicon dioxide, and magnesium stearate. 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 adenosine-mediated channel. SERUM CONCENTRATION-EFFECT RELATIONSHIP Bron Pročitajte cijeli dokument