theophylline- Theophylline, anhydrous capsule, 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:

Inwood Laboratories, Inc.

INN (International Name):

Theophylline, anhydrous

Pharmaceutical form:

CAPSULE, EXTENDED RELEASE

Composition:

125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Theophylline Extended-release capsules 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 capsules is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Product summary:

Theophylline Extended-release Capsules USP are available as 125 mg, 200 mg, or 300 mg and have the following identification characteristics: Theophylline Extended-release 125 mg clear/clear capsule, with off-white seeds, and imprint: IL/3638. Available in bottles of 100 (NDC 0258-3638-01). Theophylline Extended-release 200 mg clear/opaque white capsule, with off-white seeds, and imprint: IL/3634. Available in bottles of 100 (NDC 0258-3634-01). Theophylline Extended-release 300 mg opaque white/clear capsule, with off-white seeds, and imprint: IL/3625. Available in bottles of 100 (NDC 0258-3625-01). STORAGE: Store at controlled room temperature 15° - 30°C (59°- 86°F). Dispense in a tight container as defined in the USP. Keep this and all medications out of the reach of children. Inwood Laboratories, Inc. Subsidiary of FOREST LABORATORIES, INC. Inwood, New York 11096 MG #9933 (06) Rev. 03/05

Summary of Product characteristics

THEOPHYLLINE- THEOPHYLLINE, ANHYDROUS CAPSULE, EXTENDED RELEASE
INWOOD LABORATORIES, INC.
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THEOPHYLLINE
EXTENDED RELEASE CAPSULES, USP
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:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of 180.17.
Each extended-release capsule, for oral administration, contains 125
mg, 200 mg, or 300 mg anhydrous
theophylline in the form of long-acting beads within a dye-free hard
gelatin capsule. In addition, each
capsule contains the following inactive ingredients: black iron oxide,
butylparaben, castor oil, edetate
calcium disodium, ethylcellulose, gelatin, methylparaben,
pharmaceutical glaze, povidone,
propylparaben, sodium lauryl sulfate, sodium propionate, starch, sugar
spheres, and talc. The 200 mg,
and 300 mg capsules also contain titanium dioxide.
This extended-release capsule formulation can be administered with a
12-hour dosing interval for a
majority of patients and a 24-hour dosing interval for selected
patients (see DOSAGE AND
ADMINISTRATION).
These capsules comply with USP Drug Release Test 10.
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 anta