THEOPHYLLINE tablet, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Amneal Pharmaceuticals NY 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 are supplied as a white to off-white, capsule shaped, uncoated tablet debossed with ‘AC’ and ‘78’ on either side of break line and plain on other side. They are available as follows: Bottles of 30 with child-resistant closure:                  NDC 60219-2045-3 Bottles of 100 with child-resistant closure:                NDC 60219-2045-1 Bottles of 500:                                                            NDC 60219-2045-5 Bottles of 1000:                                                          NDC 60219-2045-7 Theophylline Extended-Release Tablets, 450 mg are supplied as a white to off-white, capsule shaped, uncoated tablet debossed with ‘AC’ and ‘79’ on either side of break line and plain on other side. They are available as follows: Bottles of 30 with child-resistant closure:                  NDC 60219-2046-3 Bottles of 100 with child-resistant closure:                NDC 60219-2046-1 Bottles of 500:                                                            NDC 60219-2046-5 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, with child-resistant closure as defined in the USP. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2022-00

Status de autorização:

Abbreviated New Drug Application

Características técnicas

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS NY LLC
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THEOPHYLLINE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Theophylline is structurally classified as a methylxanthine.
Theophylline, USP occurs as a
white crystalline powder. Anhydrous theophylline has the chemical name
1,3-dimethyl-
3,7-dihydro-1-H-purine-2,6-dione, and is represented by the following
structural
formula:
Molecular Formula: C H N O
Molecular Weight: 180.17 g/mol
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
300 mg or 450 mg
of anhydrous theophylline, USP. Tablets also contain as inactive
ingredients:
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 uptake through an
adenosine-media