THEOPHYLLINE (ANHYDROUS)- theophylline tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nostrum Laboratories, Inc.

INN (International Name):

THEOPHYLLINE ANHYDROUS

Composition:

THEOPHYLLINE ANHYDROUS 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Theophylline (Anhydrous) Extended-Release Tablets 400 mg are supplied as white, round, bisected tablets debossed with "N" above the bisect and "T4" below the bisect,   available in bottles of 100 tablets (NDC 29033-001-01). Theophylline (Anhydrous) Extended-Release Tablets 600 mg are supplied as white, oblong, bisected tablets on one side and debossed with "NT6" on the other side,  available in bottles of 100 tablets (NDC 29033-002-01). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120 March 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE (ANHYDROUS)- THEOPHYLLINE TABLET, EXTENDED RELEASE
NOSTRUM LABORATORIES, INC.
----------
THEOPHYLLINE (ANHYDROUS) EXTENDED-RELEASE TABLETS
400 MG AND 600 MG
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).
7
8
4
2
Theophylline increases the force of contraction of diaphragmatic
muscles. This action
appears to be due to enhancement of calcium uptake through