THEOPHYLLINE tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Chartwell RX, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Theophylline Extended-release Tablets: 300 mg: White to off-white, capsule shaped, biconvex, uncoated tablets debossed with 741 on one side and scored on the other side.  NDC 62135-457-90                                                           Bottle of 90  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71211 Revised 02/2023

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

THEOPHYLLINE- THEOPHYLLINE TABLET, EXTENDED RELEASE
CHARTWELL RX, LLC
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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 1H-
Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, 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 extended-release tablet for oral administration contains either
300 mg or 450 mg
of anhydrous theophylline. Tablets also contain as inactive
ingredients: hypromellose,
lactose anhydrous, 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-mediated
channel.
SERUM CONCENTRATION-EFFECT RELATIONSHIP:
Br