Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Amneal Pharmaceuticals NY LLC
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 are supplied as a white to off-white, capsule shaped, uncoated tablet debossed with ‘AC’ and ‘78’ on either side of break line and plain on other side. They are available as follows: Bottles of 30 with child-resistant closure: NDC 60219-2045-3 Bottles of 100 with child-resistant closure: NDC 60219-2045-1 Bottles of 500: NDC 60219-2045-5 Bottles of 1000: NDC 60219-2045-7 Theophylline Extended-Release Tablets, 450 mg are supplied as a white to off-white, capsule shaped, uncoated tablet debossed with ‘AC’ and ‘79’ on either side of break line and plain on other side. They are available as follows: Bottles of 30 with child-resistant closure: NDC 60219-2046-3 Bottles of 100 with child-resistant closure: NDC 60219-2046-1 Bottles of 500: NDC 60219-2046-5 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, with child-resistant closure as defined in the USP. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2022-00
Abbreviated New Drug Application
THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE AMNEAL PHARMACEUTICALS NY LLC ---------- THEOPHYLLINE EXTENDED-RELEASE TABLETS RX ONLY DESCRIPTION Theophylline is structurally classified as a methylxanthine. Theophylline, USP occurs as a white crystalline powder. Anhydrous theophylline has the chemical name 1,3-dimethyl- 3,7-dihydro-1-H-purine-2,6-dione, and is represented by the following structural formula: Molecular Formula: C H N O Molecular Weight: 180.17 g/mol 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, 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-media Belgenin tamamını okuyun