THEOPHYLLINE tablet, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

THEOPHYLLINE (UNII: C137DTR5RG) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Disponível em:

Leading Pharma, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Theophylline Extended-release Tablets: 300 mg: White to off-white, capsule-shaped scored tablet, debossed with "LP" and "226" on one side and plain on the   other side. NDC 69315-226-01      Bottle of 100 450 mg: White to off-white, capsule-shaped scored tablet, debossed with "LP" and "227" on one side and plain on the     other side. NDC 69315-227-01      Bottle of 100 Dispense in a well-closed container, with child resistant closure [as defined in the USP]. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Manufactured and Distributed by: Leading Pharma, LLC 3 Oak Rd, Fairfield, New Jersey (NJ) 07004 United States (USA) Rev. 02 02/22

Status de autorização:

Abbreviated New Drug Application

Características técnicas

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
LEADING PHARMA, LLC
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION:
Theophylline is structurally classified as a methylxanthine. It occurs
as a white, practically
odorless, crystalline powder with a bitter taste. Anhydrous
theophylline has the chemical
name 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione, 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 theophylline extended-release tablet for oral administration
contains either 300 mg
or 450 mg of anhydrous theophylline. Theophylline extended-release
tablets also contain
as inactive ingredients: colloidal silicon dioxide, hypromellose,
lactose monohydrate,
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 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 of diaphragmatic
muscles. This action
appears to be due to enhancement of calcium uptak