Ipratropium Bromide (Page 2 of 2)

OVERDOSAGE

Acute systemic overdosage by inhalation is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD50 of ipratropium bromide ranged between 1,001 and 2,010 mg/kg in mice; between 1,667 and 4,000 mg/kg in rats; and between 400 and 1,300 mg/kg in dogs.

DOSAGE AND ADMINISTRATION

The usual dosage of Ipratropium Bromide Inhalation Solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium Bromide Inhalation Solution Unit-Dose Vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

HOW SUPPLIED

Ipratropium Bromide Inhalation Solution, USP is a clear, colorless solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as listed below:
NDC 47335-706-49 carton of 25 vials (5 vials per foil pouch)

NDC 47335-706-52 carton of 30 vials (5 vials per foil pouch)

NDC 47335-706-54 carton of 60 vials (5 vials per foil pouch)
Each vial is made from a low density polyethylene (LDPE) resin.
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. Store in pouch until time of use.
Dispense with Patient’s Instructions For Use available at: https://www.sunpharma.com/usa/products

Patient’s Instructions for Use


Ipratropium Bromide (IH-pruh-TROE-pee-uhm BROE-mide)
Inhalation Solution, USP 0.02%

Read complete instructions carefully before using.

1. Remove vial from the foil pouch.
figure-1


2. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1).

figure-2
3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).
4. Connect the nebulizer to the compressor.
figure-3

5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor. If a face mask is used, care should be taken to avoid leakage around the mask as temporary blurring of vision, pupil enlargement, precipitation or worsening of narrow-angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes.

6. Breathe as calmly, deeply, and evenly as possible 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).

Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

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. Store in pouch until time of use.

ADDITIONAL INSTRUCTIONS: __________________________________________

Dispense with Patient’s Instructions For Use available at: https://www.sunpharma.com/usa/products
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Medicare Limited

Baska Ujeti Road, Ujeti

Halol-389350, Gujarat, India

5230899

ISS. 4/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-706-54
Ipratropium Bromide Inhalation Solution, USP
0.02% (0.5 mg/2.5 mL)
For Oral Inhalation Only
Rx only
60 X 2.5 mL Sterile Unit-Dose Vials
(5 Unit-Dose Vials per pouch, 12 pouches per carton)
PHARMACIST: Dispense with “Patient’s Instructions For Use” to each patient.
SUN PHARMA

Snowbox-1.jpg
(click image for full-size original)

IPRATROPIUM BROMIDE ipratropium bromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-706
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE (IPRATROPIUM) IPRATROPIUM BROMIDE 0.5 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-706-49 5 POUCH in 1 CARTON contains a POUCH (47335-706-48)
1 NDC:47335-706-48 5 VIAL in 1 POUCH This package is contained within the CARTON (47335-706-49) and contains a VIAL
1 2.5 mL in 1 VIAL This package is contained within a POUCH (47335-706-48) and a CARTON (47335-706-49)
2 NDC:47335-706-52 6 POUCH in 1 CARTON contains a POUCH
2 5 VIAL in 1 POUCH This package is contained within the CARTON (47335-706-52) and contains a VIAL
2 2.5 mL in 1 VIAL This package is contained within a POUCH and a CARTON (47335-706-52)
3 NDC:47335-706-54 12 POUCH in 1 CARTON contains a POUCH
3 5 VIAL in 1 POUCH This package is contained within the CARTON (47335-706-54) and contains a VIAL
3 2.5 mL in 1 VIAL This package is contained within a POUCH and a CARTON (47335-706-54)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207903 02/04/2020
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Medicare Limited 725420835 ANALYSIS (47335-706), MANUFACTURE (47335-706)

Revised: 04/2022 Sun Pharmaceutical Industries, Inc.

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