IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Ipratropium Bromide (IH-pruh-TROE-pee-uhm BROE-mide) and Albuterol Sulfate (al-BUE-ter-ol) Inhalation  Solution, USP 0.5 mg/3 mg *Equivalent to 2.5 mg albuterol base Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again. Ipratropium bromide and albuterol sulfate inhalation solution should only be used under the direction of a physician. Your physician and pharmacist have more information about ipratropium bromide and albuterol sulfate inhalation solution and the condition for which it has been

Product summary:

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. Store in pouch until time of use. Supplied in bags as listed below. NDC 71205-726-15    bag of 1 foil pouch (5 x 3 mL vials per foil pouch) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°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 solution is not colorless.   Dispense with Patient's Instructions For Use available at: https://www.sunpharma.com/usa/products

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
PROFICIENT RX LP
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION, USP
0.5 MG/3 MG
*EQUIVALENT TO 2.5 MG ALBUTEROL BASE
DESCRIPTION
The active components in ipratropium bromide and albuterol sulfate
inhalation solution
are albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively
selective β2-adrenergic
bronchodilator chemically described as α
-[(tert-butylamino)methyl]-4-hydroxy-m‑-
xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of
576.7 and the molecular
formula is (C
H
NO ) •H SO . It is a white or practically white 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 molecular formula is C
H
BrNO •H O. It is a white to off-white crystalline
substance, freely soluble in water and lower alcohols, and insoluble
in lipophilic solvents
such as ether, chloroform, and fluorocarbons.
1
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 contains 3
mg (0.1%) of albuterol sulfate USP (equivalent to 2.5 mg (0.083%) of
albuterol base) and
0.5 mg (0.017%) of ipratropium bromide USP in an isotonic, sterile,
aqueous solution
containing sodium chloride, hydrochloric acid to adjust to pH 4,
edetate disodium, USP
(a chelating agent) and water for injection.
Ipratropium bromide and albuterol sulfate inhalation solution is a
clear, colorless solution.