Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Avera McKennan Hospital
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 300 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
THEO-24- THEOPHYLLINE ANHYDROUS CAPSULE, EXTENDED RELEASE AVERA MCKENNAN HOSPITAL ---------- THEO-24 (THEOPHYLLINE ANHYDROUS) EXTENDED-RELEASE CAPSULES RX ONLY DESCRIPTION THEOPHYLLINE 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: The molecular formula of anhydrous theophylline is C H N O with a molecular weight of 180.17. Theo-24 is available as capsules intended for oral administration, containing 100 mg, 200 mg, 300 mg, or 400 mg of anhydrous theophylline per capsule, in an extended-release formulation which allows a 24-hour dosing interval for appropriate patients. Inactive ingredients are edible ink (which contains synthetic black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Red No. 40), ethylcellulose, gelatin, pharmaceutical glaze, colloidal silicon dioxide, starch, sucrose, talc, titanium dioxide, and coloring agents: 100 mg - includes FD&C Yellow No. 6; 200 mg - FD&C Red No. 3 and D&C Yellow No. 10; 300 mg - FD&C Blue No. 1 and FD&C Red No. 40; 400 mg - FD&C Red No. 40 and D&C Red No. 28. Theo-24 Extended-release capsules meet Drug Release Test 6 as published in the current USP monograph for Theophylline Extended-release Capsules. 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 ® 7 8 4 2 isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilator prophylactic actions are probably mediated Prečítajte si celý dokument