SENOPHYLLINE- theophylline anhydrous, choline kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Available from:

Physician Therapeutics LLC

INN (International Name):

THEOPHYLLINE ANHYDROUS

Composition:

THEOPHYLLINE ANHYDROUS 100 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 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. CONTRAINDICATIONS Theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product. Pediatric Use Theophylline is safe and effective for the approved indications in pediatric patients. The maintenance dose of theophylline must be selected with caution in pediatric patients since the rate of theophylline clearance is highly variable across the age range of neonates to adolescents (see CLINICAL PHARMACOLOGY, Table I, WARNINGS, and DOSAGE AND ADMINISTRATION, Table V). Geriatric Use Elderly patients are at significantly greater risk of experiencing serious toxicity from theophylline than younger patients due to pharmacokinetic and pharmacodynamic changes associated

Product summary:

HOW SUPPLIED Theophylline Extended-Release Tablets 100 mg – White to off white, round, biconvex, uncoated tablets debossed with PLIVA and 483 bisected by a score line on one side and unscored on the other side in bottles of 100 and 500. 200 mg – White to off white, Oval shaped, biconvex, uncoated tablets debossed with PLIVA and 482 on one side and scored on the other side in bottles of 100, 500 and 1000. 300 mg – White to off white, capsule shaped, biconvex, uncoated tablets debossed with PLIVA and 459 on one side and scored on the other side in bottles of 100, 500 and 1000. 450 mg – White to off white, capsule shaped, biconvex, uncoated tablets debossed with PLIVA and 518 on one side and scored on the other side in bottles of 100. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 6/2010 How Supplied  Sentra AM is supplied in opaque orange and white, size 0 capsules in bottles of 60 capsules.  Physician Supervision Sentra AM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.  U.S. patent pending.  Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225  Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com   Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved  NDC # 68405-1002-02

Authorization status:

unapproved drug other

Summary of Product characteristics

SENOPHYLLINE - THEOPHYLLINE ANHYDROUS, CHOLINE
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SENOPHYLLINE
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
100 mg, 200 mg, 300 mg or 450 mg
of anhydrous theophylline. Tablets also contain as inactive
ingredients: hypromellose, anhydrous
lactose, 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
bronchodilatation is mediated by the inhibition of
two isozymes of phosphodiesterase (PDE lll 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 lll or antagonism of adenosine
receptors. Some of the adverse effects
associated with theophylline appear to be mediated by inhibition of
PDE lll (e.g., hypotension,
tachycardia, headache, and emesis) and adenosine receptor antagonism
(e.g., alterations in cerebral
blood flow).
Theophylline increases the force of contraction