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:

Cipla USA Inc.

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 and Albuterol Sulfate Inhalation Solution 0.5 mg / 3 mg per 3 mL Patient's Instructions for Use 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 prescribed. Contact them if you have additional questions. Storing your Medicine Store Ipratropium Bromide and Albuterol Sulfate Inhalation Solution between 2°C and 25°C (36°F and 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton. Dose Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial for each nebulizer treatment. FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER/COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER. A TYPICAL EXAMPLE IS SHOWN BELOW. Instructions for Use 1.Remove one vial from the foil pouch. Place remaining vials back into pouch for storage. 2.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 mouth piece 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). Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203 Distributed by: Cipla USA Inc. 10 Independence Boulevard , Suite 300, Warren , NJ 07059 9 /2020

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 in pouch until time of use. Supplied in cartons as listed below. NDC 69097-840-53                           30 vials per carton/ 1 vial per foil pouch NDC 69097-840-87                            30 vials per carton / 30 vials per foil pouch NDC 69097-840-64                            60 vials per carton / 30 vials per foil pouch Store between 2°C and 25°C (36°F and 77°F). Protect from light. Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203 Distributed By: Cipla USA Inc. 10 Independence Boulevard Suite 300, Warren, NJ 07059 9/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE - IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
CIPLA USA INC.
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION 0.5 MG /
3 MG
PER 3 MLRX ONLY
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
-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 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
1
13
21
3 2
2
4
20
30
3
2
Figure 3.1-2. Chemical structure of ipratropium bromide.
Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium
bromide (0.017%) and 3
mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in
an isotonic, sterile,
aqueous solution containing sodium chloride and 1 N hydrochloric acid
to adjust to pH 4
*Equivalent to 2.5 mg albuterol base
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 Solutio