IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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.

Product summary:

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg/3 mg per 3 mL is a clear, colorless solution. Practically free from visible particles and foreign matters packed in natural BFS LDPE vial and is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Supplied in cartons as listed below. NDC 65862-906-30 30 x 3 mL unit dose vials per carton (6 pouches, each containing 5 vials per foil pouch) NDC 65862-906-60 60 x 3 mL unit dose vials per carton (12 pouches, each containing 5 vials per foil pouch) NDC 65862-906-03 30 x 3 mL unit dose vials per carton (30 pouches, each containing 1 vial per foil pouch) 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. Store between 2º to 25ºC (36º to 77ºF). All brands listed are the trademarks of their respective owners and are not trademarks of Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 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 2º and 25ºC (36º and 77ºF). 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 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 to 15 minutes). At this point, the treatment is finished. 7. Clean the nebulizer (see manufacturer’s instructions).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL SULFATE SOLUTION
AUROBINDO PHARMA LIMITED
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION, USP
0.5 MG/3 MG PER 3 ML
RX ONLY
DESCRIPTION
The active components in ipratropium bromide and albuterol sulfate
inhalation solution,
USP are albuterol sulfate USP and ipratropium bromide USP.
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 molecular
formula is (C
H
NO
)
•H
SO
. It is a white to practically white crystalline powder,
freely soluble in water and slightly soluble in alcohol, chloroform
and ether. The World
Health Organization 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)-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
powder, soluble in water, freely soluble in methanol and slightly
soluble in ethanol,
insoluble in isopropyl alcohol, chloroform, methylene chloride and
benzene.
2
1
13
21
3
2
2
4
20
30
3
2
Each 3 mL vial of ipratropium bromide and albuterol sulfate inhalation
solution,
USP 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 edetate disodium (a chelating agent),
sodium chloride
and hydrochloric acid to adjust to pH 4.
Ipratropium bromide and albuterol sulfate inhalation solution, USP is
a clear, colorless
solution. Practically free from visible particles and foreign matters
packed