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:

Chartwell RX, LLC

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. FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER / COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER. A TYPICAL EXAMPLE IS SHOWN NEARBY. - Remove one vial from the foil pouch. Place remaining vials back into the pouch for storage. - Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer to the mouthpiece or face mask (Figure 2). 4. Connect the nebulizer to the compressor 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor. 6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5 - 15 minutes). At this point, the treatment is finished. 7. Clean the nebulizer (see manufacturer's instructions). L71928 Revised: 01/2024

Product summary:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below. NDC 62135-831-84: 6 foil pouches, each containing  5 vials, total 30 vials per carton Storage and Handling PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store between 2° and 25° C (36° and 77° F). Protect from light. Rx Only Manufactured for: Chartwell RX, LLC. Congers, NY 10920

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
CHARTWELL RX, LLC
----------
IPRATROPIUM BROMIDE 0.5 MG AND ALBUTEROL SULFATE 3 MG* INHALATION
SOLUTION
*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 β 2-adrenergic bronchodilator
chemically described as
α 1-[( _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’s recommended name for albuterol base is
salbutamol.
Ipratropium bromide is an anticholinergic bronchodilator chemically
described as 8-
azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-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.
Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation
Solution contains
3 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 and hydrochloric acid to adjust to pH 4.
13
21
3
2
2
4
20
30
3
2
containing sodium chloride and hydrochloric acid to adjust to pH 4.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a
clear, colorless
solution. It does not require dilution prior to administration by
nebulization. For
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, li