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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 3 mL

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 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. 30 Vial Carton - 68788-9279-3 Store between 2°C and 25°C (36°F and 77°F). Protect from light. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Manufactured by: The Ritedose Corporation Columbia, SC 29203 Revised: August 2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
Preferred Pharmaceuticals, Inc.
----------
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 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
th

Summary of Product characteristics

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- IPRATROPIUM BROMIDE AND
ALBUTEROL
SULFATE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
----------
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE INHALATION SOLUTION
IPRATROPIUM BROMIDE
AND ALBUTEROL SULFATE
INHALATION SOLUTION
0.5 MG/3 MG PER 3 ML
RX 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* 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 Albu