THEOPHYLLINE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Chartwell RX, LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Theophylline Oral Solution, USP is a clear red solution with a fruit flavor. Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous.  Theophylline Oral Solution, USP is available in bottles of 473 mL (16 fl oz) NDC 62135-556-47 RECOMMENDED STORAGE Store at 20° to 25°C (68° to 77°); [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 10/2022 Part number: L71058

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

THEOPHYLLINE- THEOPHYLLINE SOLUTION
CHARTWELL RX, LLC
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THEOPHYLLINE ORAL SOLUTION, USP 80 MG/ 15 ML
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 clear red
color liquid with a
fruit flavor intended for oral administration, containing 80 mg of
theophylline anhydrous
in each 15 mL (tablespoonful).Theophylline Oral Solution, USP also
contains the following
inactive ingredients: citric acid, sodium saccharin, sodium benzoate,
glycerin, propylene
glycol, FD&C Red #40, natural and artificial fruity flavor and
purified water. Theophylline
Oral Solution, USP has a pH of 4.3 - 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
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 b