ipratropium

Therapeutic Classification: allergy, cold and cough remedies, bronchodilators

Pharmacologic Classification: anticholinergics

REMS

Inhaln: Maintenance therapy of reversible airway obstruction due to COPD, including chronic bronchitis and emphysema.
Rhinorrhea associated with allergic and nonallergic perennial rhinitis (0.03% solution) or the common cold (0.06% solution).

Unlabeled Use:

Inhaln: Adjunctive management of bronchospasm caused by asthma.

Inhaln: Inhibits cholinergic receptors in bronchial smooth muscle, resulting in decreased concentrations of cyclic guanosine monophosphate (cGMP). Decreased levels of cGMP produce local bronchodilation.
Local application inhibits secretions from glands lining the nasal mucosa.

Therapeutic effects:

Inhaln: Bronchodilation without systemic anticholinergic effects.
Decreased rhinorrhea.

Absorption: Minimal systemic absorption (2% for inhalation solution; 20% for inhalation aerosol; <20% following nasal use).

Distribution: 15% of dose reaches lower airways after inhalation.

Metabolism/Excretion: Small amounts absorbed are metabolized by the liver.

Half-Life: 2 hr.

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Inhalation	1–3 min	1–2 hr	4–6 hr
Intranasal	15 min	unknown	6–12 hr

Contraindicated in:

Hypersensitivity to ipratropium, atropine, belladonna alkaloids, or bromide;
Acute bronchospasm.

Use Cautiously in:

Bladder-neck obstruction, prostatic hyperplasia, glaucoma, or urinary retention;
Lactation: Safety not established in breastfeeding;
Geri: Older adults may be more sensitive to effects.

CV: hypotension, palpitations

Derm: rash

EENT: blurred vision, sore throat, nasal onlyepistaxis, nasal dryness/irritation

GI: GI irritation, nausea

Neuro: dizziness, headache, nervousness

Resp: bronchospasm, cough

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

↑anticholinergic effects with other drugs having anticholinergic properties, including antihistamines, phenothiazines, and disopyramide.

Inhaln (Adults and Children >12 yr): Metered-dose inhaler (nonacute): 2 inhalations 4 times daily (not to exceed 12 inhalations/24 hr or more frequently than every 4 hr). Acute exacerbations: 4–8 puffs using a spacer device as needed. Via nebulization (nonacute): 500 mcg 3–4 times daily. Via nebulization (acute exacerbations): 500 mcg every 30 min for 3 doses, then every 2–4 hr as needed.
Inhaln (Adults and Children 5–12 yr): Metered-dose inhaler (nonacute): 1–2 inhalations every 6 hr as needed (not to exceed 12 inhalations/24 hr). Acute exacerbations: 4–8 puffs as needed. Via nebulization (nonacute): 250–500 mcg 4 times daily given every 6 hr. Acute exacerbations: 250 mcg every 20 min for 3 doses, then every 2–4 hr as needed.
Inhaln (Infants ): Nebulization: 125–250 mcg 3 times a day.
Inhaln (Neonates ): Nebulization: 25 mcg/kg/dose 3 times a day.
(Adults and Children >6 yr): 0.03% solution: 2 sprays in each nostril 2–3 times daily (21 mcg/spray).
Inhaln (Adults and Children >5 yr): 0.06% solution: 2 sprays in each nostril 3–4 times daily (42 mcg/spray).

(Generic available)

Aerosol inhaler (HFA) (chlorofluorocarbon-free): 17 mcg/inhalation in 12.9-g canister (200 inhalations)
Inhalation solution: 0.0125%; 0.02%; 0.025%
Nasal spray: 0.03% solution—21 mcg/spray in 30-mL bottle (345 sprays/bottle); 0.06% solution—42 mcg/spray in 15-mL bottle (165 sprays)
In combination with: albuterol (Combivent Respimat). See Appendix [not included in this PDA edition].

Assess for allergy to atropine and belladonna alkaloids; patients with these allergies may also be sensitive to ipratropium.
Inhaln: Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.
Nasal Spray: Assess patient for rhinorrhea.

Inhaln: See Medication Administration Techniques for administration of inhalation medications.
- When ipratropium is administered concurrently with other inhalation medications, administer adrenergic bronchodilators first, followed by ipratropium, then corticosteroids. Wait 5 min between medications.
- Solution for nebulization can be diluted with preservative-free 0.9% NaCl. Diluted solution should be used within 24 hr at room temperature or 48 hr if refrigerated. Solution can be mixed with preservative-free albuterol or cromolyn if used within 1 hr of mixing.

Instruct patient in proper use of inhaler, nebulizer, or nasal spray and to take medication as directed. Take missed doses as soon as remembered unless almost time for the next dose; space remaining doses evenly during day. Do not double doses.
- Advise patient that rinsing mouth after using inhaler, good oral hygiene, and sugarless gum or candy may minimize dry mouth. Health care professional should be notified if stomatitis occurs or if dry mouth persists for more than 2 wk.
- Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Inhalation: Caution patient not to exceed 12 doses within 24 hr. Patient should notify health care professional if symptoms do not improve within 30 min after administration of medication or if condition worsens.
- Explain need for pulmonary function tests prior to and periodically during therapy to determine effectiveness of medication.
- Caution patient to avoid spraying medication in eyes; may cause blurring of vision or irritation.
- Advise patient to inform health care professional if cough, nervousness, headache, dizziness, nausea, or GI distress occurs.
Nasal Spray: Instruct patient in proper use of nasal spray. Clear nasal passages gently before administration. Do not inhale during administration, so medication remains in nasal passages. Prime pump initially with 7 actuations. If used regularly, no further priming is needed. If not used in 24 hr, prime with 2 actuations. If not used for >7 days, prime with 7 actuations.
- Advise patient to contact health care professional if symptoms do not improve within 1–2 wk or if condition worsens.

Decreased dyspnea.
- Improved breath sounds.
Decrease in rhinorrhea from perennial rhinitis or the common cold.

NDC Code

0054- West-Ward Pharmaceuticals Corp.
- 0054-0045- Ipratropium Bromide
  - 0054-0045-44- 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) > 345 SPRAY in 1 BOTTLE, SPRAY

0054- West-Ward Pharmaceuticals Corp.
- 0054-0046- Ipratropium Bromide
  - 0054-0046-41- 1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) > 165 SPRAY in 1 BOTTLE, SPRAY

0378- Mylan Pharmaceuticals Inc.
- 0378-7970- Ipratropium Bromide
  - 0378-7970-52- 1 POUCH in 1 CARTON (0378-7970-52) > 25 AMPULE in 1 POUCH (0378-7970-62) > 2.5 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-7970- Ipratropium Bromide
  - 0378-7970-55- 30 POUCH in 1 CARTON (0378-7970-55) > 1 AMPULE in 1 POUCH (0378-7970-31) > 2.5 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-7970- Ipratropium Bromide
  - 0378-7970-91- 2 POUCH in 1 CARTON (0378-7970-91) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-7970- Ipratropium Bromide
  - 0378-7970-93- 1 POUCH in 1 CARTON (0378-7970-93) > 30 AMPULE in 1 POUCH (0378-7970-64) > 2.5 mL in 1 AMPULE

0487- Nephron SC Inc.
- 0487-9801- Ipratropium Bromide
  - 0487-9801-01- 30 POUCH in 1 CARTON (0487-9801-01) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

0487- Nephron SC Inc.
- 0487-9801- Ipratropium Bromide
  - 0487-9801-02- 30 BAG in 1 BOX (0487-9801-02) > 1 POUCH in 1 BAG > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

0487- Nephron SC Inc.
- 0487-9801- Ipratropium Bromide
  - 0487-9801-25- 1 POUCH in 1 CARTON (0487-9801-25) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

0487- Nephron SC Inc.
- 0487-9801- Ipratropium Bromide
  - 0487-9801-30- 1 POUCH in 1 CARTON (0487-9801-30) > 30 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

0487- Nephron SC Inc.
- 0487-9801- Ipratropium Bromide
  - 0487-9801-60- 2 POUCH in 1 CARTON (0487-9801-60) > 30 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

0591- Actavis Pharma, Inc.
- 0591-3798- Ipratropium Bromide
  - 0591-3798-30- 1 POUCH in 1 CARTON (0591-3798-30) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

0591- Actavis Pharma, Inc.
- 0591-3798- Ipratropium Bromide
  - 0591-3798-60- 2 POUCH in 1 CARTON (0591-3798-60) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

0591- Actavis Pharma, Inc.
- 0591-3798- Ipratropium Bromide
  - 0591-3798-83- 1 POUCH in 1 CARTON (0591-3798-83) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

0597- Boehringer Ingelheim Pharmaceuticals Inc.
- 0597-0087- Atrovent HFA
  - 0597-0087-17- 1 CANISTER in 1 CARTON (0597-0087-17) > 200 AEROSOL, METERED in 1 CANISTER

24208- Bausch and Lomb Incorporated
- 24208-398- Ipratropium bromide
  - 24208-398-30- 1 BOTTLE, SPRAY in 1 CARTON (24208-398-30) > 345 SPRAY, METERED in 1 BOTTLE, SPRAY

24208- Bausch and Lomb Incorporated
- 24208-399- Ipratropium Bromide
  - 24208-399-15- 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) > 165 SPRAY, METERED in 1 BOTTLE, SPRAY

50090- A-S Medication Solutions
- 50090-0961- Atrovent HFA
  - 50090-0961-0- 1 CANISTER in 1 CARTON (50090-0961-0) > 200 AEROSOL, METERED in 1 CANISTER

50090- A-S Medication Solutions
- 50090-2566- Ipratropium Bromide
  - 50090-2566-0- 1 POUCH in 1 CARTON (50090-2566-0) > 25 mL in 1 POUCH

50090- A-S Medication Solutions
- 50090-4185- Ipratropium Bromide
  - 50090-4185-0- 1 POUCH in 1 CARTON (50090-4185-0) > 25 mL in 1 POUCH

53002- RPK Pharmaceuticals, Inc.
- 53002-8410- Atrovent HFA
  - 53002-8410-1- 1 CANISTER in 1 CARTON (53002-8410-1) > 200 AEROSOL, METERED in 1 CANISTER

53217- Aidarex Pharmaceuticals LLC
- 53217-008- Ipratropium Bromide
  - 53217-008-01- 2 POUCH in 1 CARTON (53217-008-01) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

55154- Cardinal Health
- 55154-4351- Ipratropium Bromide
  - 55154-4351-5- 5 POUCH in 1 BAG (55154-4351-5) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

60687- American Health Packaging
- 60687-394- Ipratropium Bromide
  - 60687-394-83- 30 POUCH in 1 CARTON (60687-394-83) > 1 AMPULE in 1 POUCH (60687-394-79) > 2.5 mL in 1 AMPULE

63187- Proficient Rx LP
- 63187-188- Ipratropium Bromide
  - 63187-188-25- 1 POUCH in 1 CARTON (63187-188-25) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

65862- Aurobindo Pharma Limited
- 65862-905- Ipratropium bromide
  - 65862-905-03- 30 POUCH in 1 CARTON (65862-905-03) > 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) > 2.5 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-905- Ipratropium bromide
  - 65862-905-25- 1 POUCH in 1 CARTON (65862-905-25) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-905- Ipratropium bromide
  - 65862-905-30- 1 POUCH in 1 CARTON (65862-905-30) > 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) > 2.5 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-905- Ipratropium bromide
  - 65862-905-60- 2 POUCH in 1 CARTON (65862-905-60) > 30 VIAL, SINGLE-DOSE in 1 POUCH > 2.5 mL in 1 VIAL, SINGLE-DOSE

68071- NuCare Pharmaceuticals,Inc.
- 68071-1550- Ipratropium Bromide
  - 68071-1550-6- 2.5 mL in 1 VIAL (68071-1550-6)

68071- NuCare Pharmaceuticals,Inc.
- 68071-1737- Ipratropium Bromide
  - 68071-1737-2- 2.5 mL in 1 VIAL (68071-1737-2)

68788- Preferred Pharmaceuticals Inc.
- 68788-6897- Ipratropium Bromide
  - 68788-6897-2- 1 POUCH in 1 CARTON (68788-6897-2) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

70518- REMEDYREPACK INC.
- 70518-1070- Ipratropium Bromide
  - 70518-1070-0- 2 POUCH in 1 CARTON (70518-1070-0) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

76204- Ritedose Pharmaceuticals, LLC
- 76204-100- Ipratropium Bromide
  - 76204-100-01- 30 POUCH in 1 CARTON (76204-100-01) > 1 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-100- Ipratropium Bromide
  - 76204-100-25- 1 POUCH in 1 CARTON (76204-100-25) > 25 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-100- Ipratropium Bromide
  - 76204-100-30- 1 POUCH in 1 CARTON (76204-100-30) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-100- Ipratropium Bromide
  - 76204-100-60- 2 POUCH in 1 CARTON (76204-100-60) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

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