Ipratropium Bromide Inhalation Solution, 0.02%

Prescribing Information

Rx Only

The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-; a synthetic quaternary ammonium compound, chemically related to atropine.

Chemical Structure

Ipratropium Bromide Monohydrate     C₂₀H₃₀BrNO₃•H₂O     Mol.Wt. 430.4

Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media.

Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.

Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.

Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature.

All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.

Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, and acute eye pain have been reported.Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg.

Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.

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 LD₅₀ 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.

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 0781-7157-86, 25 vials in a foil pouch.

NDC 0781-7157-64, 30 vials in a foil pouch.

NDC 0781-7157-29, 60 vials, two foil pouches of 30 each.

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

Vials are supplied in a 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
Sandoz Inc.
Princeton, NJ 08540

To report SUSPECTED ADVERSE
REACTIONS, contact Sandoz Inc. at
1-800-525-8747 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

January 2013

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
Sandoz Inc.
Princeton, NJ 08540

To report SUSPECTED ADVERSE
REACTIONS, contact Sandoz Inc. at
1-800-525-8747 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

January 2013

NDC 0781-7157-86

Ipratropium Bromide
Inhalation Solution

0.02%
(0.5 mg/2.5mL)

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.

STERILE
Rx only
25 x 2.5 mL Unit-Dose Vials

SANDOZ