THEOPHYLLINE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

PAI Holdings, LLC

INN (nemzetközi neve):

THEOPHYLLINE

Összetétel:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Theophylline is 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 Oral Solution USP is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Termék összefoglaló:

Theophylline Oral Solution USP is a clear red solution with a berry flavor.  Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous. Theophylline Oral Solution USP is available in the following oral dosage forms: NDC 0121-0820-04:  4 fl oz (118 mL) bottle NDC 0121-0820-16:  16 fl oz (473 mL) bottle NDC 0121-4820-15:  15 mL unit dose cup. Case contains 40 unit-dose cups of 15 mL (NDC 0121-4820-40), packaged in 4 trays of 10 unit-dose cups each. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R03/22

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

THEOPHYLLINE- THEOPHYLLINE SOLUTION
PAI HOLDINGS, LLC
----------
THEOPHYLLINE ORAL SOLUTION 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.
Theophylline Oral Solution USP is available as a liquid intended for
oral administration,
containing 80 mg of theophylline anhydrous and 20% alcohol in each 15
mL
(tablespoonful).
Theophylline Oral Solution USP also contains the following inactive
ingredients: citric acid,
FD&C Red No. 40, FD&C Yellow No. 6, flavor, purified water and
saccharin sodium. May
contain sodium citrate for pH adjustment. Theophylline Oral Solution
USP has a pH of 3.0
- 4.7.
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 bronchodilatation 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 cal