Ipratropium Bromide (Page 2 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.

HOW SUPPLIED

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

NDC 76204-100-25, 25 vials per carton / 25 vials per foil pouch

NDC 76204-100-30, 30 vials per carton / 30 vials per foil pouch

NDC 76204-100-01, 30 vials per carton / 1 vial per foil pouch

NDC 76204-100-60, 60 vials per carton / 30 vials per foil pouch

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

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 for
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203

To report SUSPECTED ADVERSE
REACTIONS, contact Ritedose
Pharmaceuticals, LLC
at 1-855-806-3300 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch

RPIN0044
JAN 2013

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).

    Figure 1

  2. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).

    Figure 2

  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.

    Figure 3

  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°). Protect from light. Store unused vials in the foil pouch.

ADDITIONAL INSTRUCTIONS:
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Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 for
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203

To report SUSPECTED ADVERSE
REACTIONS, contact Ritedose
Pharmaceuticals, LLC
at 1-855-806-3300 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch

JAN 2013

PRINCIPAL DISPLAY PANEL — RDP 25 ct Brick Carton

NDC 76204-100-25

Ipratropium Bromide Inhalation Solution, 0.02%
0.5 mg / 2.5 mL

FOR ORAL INHALATION ONLY

INGREDIENTS: Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid.
Usual Dosage: See accompanying prescribing information.
Store between 15° and 30°C (59° and 86°F). 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

25 x 2.5 mL Sterile Unit-Dose Vials

25 ct brick carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — RDP 30 ct Brick Carton

NDC 76204-100-30

Ipratropium Bromide Inhalation Solution, 0.02%
0.5 mg / 2.5 mL

FOR ORAL INHALATION ONLY

INGREDIENTS: Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid.
Usual Dosage: See accompanying prescribing information.
Store between 15° and 30°C (59° and 86°F). 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

30 x 2.5 mL Sterile Unit-Dose Vials

30 ct brick carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — RDP 60 ct Brick Carton

NDC 76204-100-60

Ipratropium Bromide Inhalation Solution, 0.02%
0.5 mg / 2.5 mL

FOR ORAL INHALATION ONLY

INGREDIENTS: Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid.
Usual Dosage: See accompanying prescribing information.
Store between 15° and 30°C (59° and 86°F). 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

60 x 2.5 mL Sterile Unit-Dose Vials

60 ct brick carton
(click image for full-size original)

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