IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E), IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Commercializzato da:

Cipla USA Inc.

INN (Nome Internazionale):

ALBUTEROL SULFATE

Composizione:

ALBUTEROL 2.5 mg in 3 mL

Via di somministrazione:

RESPIRATORY (INHALATION)

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Dettagli prodotto:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP  is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Each 3-mL vial contains 3 mg albuterol sulfate (0.083%)* and 0.5 mg ipratropium bromide (0.017%). Store in pouch until time of use. Supplied in cartons as listed below. *Equivalent to 2.5 mg albuterol base NDC 69097-173-53            30 vials per carton/5 vials per foil pouch NDC 69097-173-64            60 vials per carton/5 vials per foil pouch Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]. Protect from light. Unit-dose vials should remain stored in the protective foil pouch at all times. Once removed from the foil pouch, the individual vials should be used within one week. Discard if the solution is not colorless. Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India.   Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 2/2020

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
CIPLA USA INC.
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION, USP
DESCRIPTION
The active components in Ipratropium Bromide and Albuterol Sulfate
Inhalation Solution, USP are
albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively
selective β -adrenergic bronchodilator
chemically described as
α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate
(2:1) (salt).
It has a molecular weight of 576.7 and the empirical formula is (C
H NO ) •H SO . It is a white
crystalline powder, soluble in water and slightly soluble in ethanol.
The World Health Organization
recommended name for albuterol base is salbutamol.
Figure 3 1-1. Chemical structure of albuterol sulfate.
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8 -azoniabicyclo
[3.2.1]-octane,
3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-,
bromide,
monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium
compound, chemically related to
atropine. It has a molecular weight of 430.4 and the empirical formula
is C
H BrNO •H O. It is a
white crystalline substance, freely soluble in water and lower
alcohols, and insoluble in lipophilic
solvents such as ether, chloroform, and fluorocarbons.
2
13
21
3 2
2
4
20
30
3
2
Figure 3. 1-2. Chemical structure of ipratropium bromide.
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation
Solution, USP contains 3.0 mg
(0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of
albuterol base) and 0.5 mg (0.017%) of
ipratropium bromide in an isotonic, sterile, aqueous solution
containing sodium chloride, hydrochloric
acid to adjust to pH 4, and edetate disodium, USP (a chelating agent).
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a
clear, colorless solution. It
does not require dilution prior to administration by nebulization. For
Ipratropium Bromide