Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)
Tris Pharma Inc
THEOPHYLLINE ANHYDROUS
THEOPHYLLINE ANHYDROUS 80 mg in 15 mL
ORAL
PRESCRIPTION DRUG
Theophylline oral solution 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 oral solution is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
Theophylline Oral Solution, USP 80 mg/15 mL is an orange-flavored, clear, colorless to slightly yellow solution. Each 15 mL (one tablespoonful) contains 80 mg theophylline anhydrous. Theophylline Oral Solution, USP is available in bottles of 16 fl. oz. (473 mL) NDC 27808-033-01 Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted from 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child resistant containers. Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852 www.trispharma.com LB8063 Rev. 02 01/2020
Abbreviated New Drug Application
THEOPHYLLINE- THEOPHYLLINE SOLUTION TRIS PHARMA INC ---------- THEOPHYLLINE ORAL SOLUTION, USP 80 MG/15 ML 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: S TRUCTURE The molecular formula of anhydrous theophylline is C H N O with a molecular weight of 180.17. Theophylline Oral Solution, USP is available as a solution intended for oral administration, containing 80 mg of theophylline anhydrous per 15 mL (one tablespoonful). Theophylline Oral Solution is alcohol free. Theophylline Oral Solution also contains the following inactive ingredients: anhydrous citric acid, glycerin, methylparaben, orange oil, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol solution. Theophylline Oral Solution has pH of 4.3 to 4.7. 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 o Soma hati kamili