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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Theophylline Extended-release Tablets: 100 mg: White to off-white, Round shaped Tablets debossed with “N” above “T1” on one side.   NDC 29033-057-01      Bottle of 100 200 mg: White to off-white, Oval shaped Tablets debossed with “NT2” on one side.   NDC 29033-058-01      Bottle of 100 300 mg: White to off-white, Capsule shaped, Bisected Tablets (functional scoring) debossed with “N” Bisect “T3” on one side.   NDC 29033-059-01      Bottle of 100 450 mg: White to off-white, Capsule shaped, Bisected Tablets (functional scoring) debossed with “N” Bisect “T5” on one side.   NDC 29033-060-01      Bottle of 100 Dispense in a well-closed container, with a child resistant closure [as defined in the USP]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]  Manufactured by: Nostrum Laboratories Inc. Kansas City, MO 64120 Revised: 07/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
NOSTRUM LABORATORIES, INC.
----------
THEOPHYLLINE EXTENDED-RELEASE TABLETS
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
1_H-_Purine -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is
represented by the following
structural formula:
C H N O M.W. 180.17.
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 or 200 mg
or 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as
inactive
ingredients: hypromellose, lactose monohydrate, colloidal silicone
dioxide, 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 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
7
8
4
2
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 th