THEOPHYLLINE solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Tris Pharma Inc

SNN (starptautisko nepatentēto nosaukumu):

THEOPHYLLINE ANHYDROUS

Kompozīcija:

THEOPHYLLINE ANHYDROUS 80 mg in 15 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Theophylline oral solution 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 is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Produktu pārskats:

Theophylline Oral Solution, USP 80 mg/15 mL is an orange-flavored, clear, colorless to slightly yellow solution. Each 15 mL (one tablespoonful) contains 80 mg theophylline anhydrous. Theophylline Oral Solution, USP is available in bottles of 16 fl. oz. (473 mL) NDC 27808-033-01 Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted from 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child resistant containers. Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852 www.trispharma.com LB8063 Rev. 02 01/2020

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

THEOPHYLLINE- THEOPHYLLINE SOLUTION
TRIS PHARMA INC
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THEOPHYLLINE ORAL SOLUTION, USP
80 MG/15 ML
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:
S TRUCTURE
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 solution intended
for oral administration, containing
80 mg of theophylline anhydrous per 15 mL (one tablespoonful).
Theophylline Oral Solution is alcohol
free.
Theophylline Oral Solution also contains the following inactive
ingredients: anhydrous citric acid,
glycerin, methylparaben, orange oil, polysorbate 80, propylene glycol,
purified water, sodium
benzoate, sodium citrate, sodium saccharin, and sorbitol solution.
Theophylline Oral Solution has pH of
4.3 to 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 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 o