Ipratropium Bromide (Page 3 of 3)

OVERDOSAGE

Acute systemic overdosage by inhalation solution 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 LD 50 of ipratropium bromide ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 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.

Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL.

NDC: 70518-1070-00

PACKAGING: 2 in 1 CARTON, 30 in 1 POUCH, 2.5 mL in 1 VIAL, TYPE 0

Each vial is made from a low density polyethylene (LDPE) resin.

Vials are supplied in a foil pouch.

Store between 59°F (15°C) and 86°F (30°C).

Protect from light.

Store unused vials in the foil pouch.

ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.

Rx Only

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Patient’s Instructions for Use

IPRATROPIUM BROMIDE
INHALATION SOLUTION 0.02%

Read complete instructions carefully before using.

  1. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1).
    Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir.
  2. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).
    Connect the nebulizer reservoir to the mouth piece or face mask
  3. Connect the nebulizer to the compressor.
  4. 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.
    Sit in a comfortable, upright position; place the mouthpiece in your mout
  5. 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.
  6. 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 the nebulizer have not been established.

Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

ADDITIONAL INSTRUCTIONS:
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Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Ipratropium Bromide

GENERIC: Ipratropium Bromide

DOSAGE: SOLUTION

ADMINSTRATION: RESPIRATORY (INHALATION)

NDC: 70518-1070-0

PACKAGING: 2.5 mL in 1 VIAL

OUTER PACKAGING: 30 in 1 POUCH

OUTER PACKAGING: 2 in 1 CARTON

ACTIVE INGREDIENT(S):

  • IPRATROPIUM BROMIDE 0.5mg in 2.5mL

INACTIVE INGREDIENT(S):

  • WATER
  • SODIUM CHLORIDE
  • HYDROCHLORIC ACID
Remedy_Label
(click image for full-size original)
IPRATROPIUM BROMIDE ipratropium bromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1070(NDC:0591-3798)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE (IPRATROPIUM) IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1070-0 2 POUCH in 1 CARTON contains a POUCH
1 30 VIAL in 1 POUCH This package is contained within the CARTON (70518-1070-0) and contains a VIAL
1 2.5 mL in 1 VIAL This package is contained within a POUCH and a CARTON (70518-1070-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075693 03/19/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 04/2021 REMEDYREPACK INC.

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