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Ipratropium (Inhalation-Local)


VA CLASSIFICATION
Primary: RE150

Commonly used brand name(s): Apo-Ipravent; Atrovent; Kendral-Ipratropium.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Bronchodilator—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Bronchitis, chronic (treatment) or
Emphysema, pulmonary (treatment) or
Pulmonary disease, chronic obstructive, other (treatment)—Ipratropium is indicated for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and pulmonary emphysema. Regular use of ipratropium results in at least as great an increase in airflow as that with use of other bronchodilators and fewer adverse effects. If additional bronchodilation is needed in these patients, an adrenergic bronchodilator may be used as an adjunct to ipratropium. {10} {14} {15} {16} {30} {40}{43}{44}{45}{46}
—[Ipratropium is indicated as an adjunct to adrenergic bronchodilators {09} for treatment of acute exacerbations of chronic obstructive pulmonary disease {03} {09} {19} {40}{46} .]

[Asthma (treatment adjunct) ]—Ipratropium is used as an adjunct to anti-inflammatory therapy or bronchodilators to prevent 1 exacerbations of asthma in patients who respond poorly to therapy {36} or as an alternative to other bronchodilators in patients who develop significant side effects with these medications {12} {14} {18}.
—Ipratropium is used as an adjunct to adrenergic bronchodilators for the treatment of acute exacerbations of asthma {04} {32} {39}. It is not used alone because it has a relatively slower onset of action and time to peak effect as compared with adrenergic bronchodilators {07} {36}.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    A synthetic quaternary ammonium compound, chemically related to atropine {01}
Molecular weight—
    430.38 {05}


Other characteristics
    Fairly stable in neutral solutions and in acid solutions; rapidly hydrolyzed in alkaline solutions {03}

Mechanism of action/Effect:

The bronchodilation produced by ipratropium is primarily a local, site-specific effect rather than a systemic effect. Ipratropium appears to produce bronchodilation by competitive inhibition of cholinergic receptors on bronchial smooth muscle. This effect antagonizes the action of acetylcholine at its membrane-bound receptor site and thereby blocks the bronchoconstrictor action of vagal efferent impulses. {10}

Absorption:

Systemic absorption is minimal following inhalation. Blood concentration and renal and fecal excretion studies have shown that ipratropium is poorly absorbed into the systemic circulation from both the surface of the lung and the gastrointestinal tract. {01} {02} At a dose of 14 times the recommended therapeutic inhalation dose, the peak plasma concentration is 0.06 nanograms/mL. Plasma concentrations after inhalation of usual doses are about 1000 times lower than equipotent oral or intravenous doses (15 and 0.15 mg, respectively) {03}.

Distribution:

Studies in rats have shown that ipratropium does not penetrate the blood-brain barrier {01}.

Biotransformation:

Hepatic, for the small amount of ipratropium systemically absorbed; metabolites have little or no anticholinergic activity {08}.

Onset of action:

Within 5 to 15 minutes {03}.

Time to peak effect:

About 90 minutes (range, 1 to 2 hours) {01} {02}.

Duration of action:

About 3 to 4 hours in the majority of patients, but up to 6 to 8 hours in some patients {01} {02}.

Elimination:
    Primarily fecal; up to 90% of inhaled dose is swallowed and eliminated as unchanged drug. Absorbed portion of dose is excreted primarily in the urine. {17}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to belladonna alkaloids may be sensitive to ipratropium also, since ipratropium is chemically related to atropine {01}. Although rare, allergic reactions to ipratropium metered-dose inhaler have been reported; however, the causative component has not been identified. Therefore, patients allergic to soybean protein or other legumes, such as peanuts, may be allergic to soya lecithin contained in the metered-dose inhaler as a suspending agent. {02} {33} {35} {37}

Carcinogenicity/Tumorigenicity

Two-year carcinogenicity studies in mice and rats have shown that ipratropium, at oral doses up to 1250 times the maximum recommended human daily dose, has no carcinogenic potential {02}. Also, studies in mice and rats have shown that ipratropium, at oral doses up to 6 mg per kg of body weight (mg/kg), does not have a carcinogenic or tumorigenic effect {01}.

Mutagenicity

Various studies in mice and hamsters have shown that ipratropium is not mutagenic {01} {02}.

Pregnancy/Reproduction
Fertility—
Although studies in male and female rats have shown that ipratropium, at oral doses up to approximately 10,000 times the maximum recommended human daily dose, does not affect fertility, ipratropium has been shown to increase resorption and decrease conception rates when the medication was administered at doses above 18,000 times the maximum recommended human daily dose {02}.

Pregnancy—
Although adequate and well-controlled studies in humans have not been done, no increased risk of congenital malformation has been reported.

Reproduction studies with ipratropium in mice, rats, and rabbits given oral doses of 10, 100, and 125 mg per kg of body weight (mg/kg), respectively, and in rats and rabbits given inhalation doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose), respectively, have shown no evidence of teratogenic effects {01}.

FDA Pregnancy Category B {01}.

Breast-feeding

It is not known whether ipratropium is distributed into breast milk. However, problems in humans have not been documented. Although lipid-insoluble quaternary bases, such as ipratropium, are distributed into breast milk, it is unlikely that inhaled ipratropium would reach significant concentrations in maternal serum, and the concentration in breast milk would probably be undetectable. {01}

Pediatrics

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ipratropium in children {42}.


Geriatrics


Studies performed to date on patients over 65 years of age have not demonstrated geriatrics-specific problems that would limit the usefulness of ipratropium inhalation in the elderly {15} {19}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anticholinergics, other, or other medications with anticholinergic activity (see Appendix II )    (concurrent use of other anticholinergics, including ophthalmic preparations, or other medications with anticholinergic action with ipratropium may result in additive effects {03})


Tacrine    (because tacrine is thought to act by increasing effective acetylcholine concentrations, concurrent use may decrease the effects of either ipratropium {21} or tacrine {23})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Glaucoma, angle-closure    (an acute attack may be precipitated or condition may be exacerbated if ipratropium inhalation aerosol is sprayed directly into the eyes or if a poorly fitting face mask is used with nebulized ipratropium inhalation solution, alone or in combination with an adrenergic bronchodilator {01} {22} {26} {34})


Sensitivity to ipratropium or belladonna alkaloids{01} ; also, allergy to soya lecithin, soybean protein, or other legumes such as peanuts for patients using the metered-dose inhaler{02}{33}
Urinary retention    (rarely, condition may be aggravated {01} {06})




Side/Adverse Effects

Note: Usual therapeutic doses of ipratropium generally do not cause systemic side/adverse effects because of the low blood concentrations achieved with the inhalation; however, the potential for systemic side/adverse effects exists {14} {17}.
Although rare, cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported following use of ipratropium aerosol, and inhalation solution alone or in combination with an adrenergic bronchodilator, when the spray came into contact with the eyes {22} {26} {34}.
Acute overdose of ipratropium by inhalation is unlikely since the medication is not well absorbed systemically {01}.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Bronchospasm, increased {02}(increased wheezing; tightness in chest; difficulty in breathing)
    
dermatitis, hypersensitivity-induced {02}
angioedema (swelling of face, lips, or eyelids), skin rash
urticaria (hives)
    
eye pain, acute {01}{22}{26}{34}
    
paralytic ileus (continuing constipation; lower abdominal pain or distention){27}{28}{29}—especially in patients with cystic fibrosis{39}

Note: Increased bronchospasm may be due to sensitivity to benzalkonium chloride and edetate disodium present in the multiple-dose container of inhalation solution {08}.




Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Cough {02}{03}
    
dryness of mouth {02}
    
unpleasant taste {02}{03}

Incidence rare
    
Blurred vision or other changes in vision {03}
    
burning eyes {03}
    
dizziness {02}
    
headache {02}{03}
    
nausea {02}{03}
    
nervousness {02}
    
palpitations {02}{03}(pounding heartbeat)
    
sweating {03}
    
trembling {03}
    
urinary retention {01}{06}(difficult urination)





Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).

Acute overdosage by inhalation is unlikely since ipratropium bromide is not well–absorbed systemically.{43}{44}

Treatment of overdose
Cholinesterase inhibitors may be used for serious anticholinergic toxicity {03}{45}{46}.

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric evaluation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Ipratropium (Inhalation).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to ipratropium or belladonna alkaloids; also, allergy to soya lecithin, soybean protein, or peanuts for patients using metered-dose inhaler
Other medical problems, especially angle-closure glaucoma

Proper use of this medication
» Helps control symptoms of lung disease; inhalation solution used only with other bronchodilators when treating acute asthma attacks

» Importance of not using more medication than the amount prescribed

» Avoiding contact with the eyes; closing eyes if necessary when inhaling; if accidentally sprayed into the eyes or if nebulized solution escapes into the eyes, irritation or blurring of vision may occur; rinsing eyes with cool water if necessary

Reading patient instructions carefully before using

» If using regularly, importance of using every day at regularly spaced times

» Proper dosing
If used regularly, using as soon as possible; using any remaining doses for that day at regularly spaced intervals

» Proper storage

For inhalation aerosol dosage form
Checking periodically with health care professional for proper use of inhaler to prevent improper technique and incorrect dosage

Testing or priming inhaler before using first time or first time in a while

Proper administration technique without spacer device

Proper administration technique with spacer device

Proper cleaning procedure for inhaler

For inhalation solution dosage form
Using only in nebulizer as instructed by physician

Preparing solution for nebulizer

Proper administration technique: using in a power-operated nebulizer with an adequate flow rate and equipped with a face mask or mouthpiece

Precautions while using this medication
» Checking with physician immediately if symptoms do not improve within 30 minutes after using this medication or if condition becomes worse

For patients using ipratropium inhalation solution
» If also using cromolyn inhalation solution, not mixing cromolyn inhalation solution with ipratropium inhalation solution containing the preservative benzalkonium chloride for use in a nebulizer {24} {25}


Side/adverse effects
Signs of potential side effects, especially increased bronchospasm, hypersensitivity-induced dermatitis, acute eye pain, and paralytic ileus


General Dosing Information
For nebulization of ipratropium bromide inhalation solution, a gas flow (oxygen or compressed air) of 6 to 10 liters per minute should be used. Nebulizers with either a face mask or mouthpiece have been used, although a mouthpiece may be preferable to a face mask because it reduces the risk of solution entering the eyes. {01} {03}

Patients should be advised to contact their physician immediately if they do not respond to the usual dose of ipratropium because this may be a sign of seriously worsening airflow obstruction or the development of concurrent illness requiring reassessment of therapy.

The contents of metered dose inhalers should generally not be floated in water to assess the contents since this method may not reliably predict the amount of medication remaining in the canister. A record should be kept of the number of inhalations used {13}.


Inhalation Dosage Forms

Note: Bracketed uses in the Dosage Forms section refers to indications that are not included in U.S. product labeling.

IPRATROPIUM BROMIDE INHALATION AEROSOL

Usual adult and adolescent dose
Bronchitis (treatment)
Emphysema, pulmonary (treatment) or
Pulmonary disease, chronic obstructive, other (treatment)
Oral inhalation, 2 to 4 inhalations (36 to 72 mcg) three or four times a day. Some patients may require up to 6 to 8 inhalations (108 to 144 mcg) three times a day. For severe exacerbations, 6 to 8 inhalations may be administered, using a spacer device, every three to four hours. {40}

[Asthma (treatment adjunct) ]
Oral inhalation, 1 to 4 inhalations (18 to 72 mcg) four times a day as necessary {41}.
{45}

Usual adult and adolescent prescribing limits
The U.S. manufacturer recommends a maximum of twelve inhalations in twenty–four hours. {43}The Canadian manufacturer recommends a maximum of 8 inhalations in twenty–four hours.{45}

Usual pediatric dose
[Asthma (treatment adjunct)]1
Children up to 12 years of age: Oral inhalation, 1 to 2 inhalations (18 to 36 mcg) every six to eight hours {11} as necessary.


Strength(s) usually available
U.S.—


18 mcg per metered spray (Rx) [Atrovent (dichlorodifluoromethane ) (dichlorotetrafluoroethane) ( trichloromonofluoromethane) (soya lecithin)]

Canada—


20 mcg per metered spray (Rx) [Atrovent (dichlorodifluoromethane ) (dichlorotetrafluoroethane) ( trichloromonofluoromethane) (soya lecithin)]

Note: In Canada, metered dose inhalers are labeled according to the amount of ipratropium delivered at the valve; in the U.S., metered dose inhalers are labeled according to the amount of ipratropium delivered at the mouthpiece or actuator. Therefore, 20 mcg of ipratropium delivered at the valve is equivalent to 18 mcg delivered at the mouthpiece.


Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For oral inhalation only.
   • Shake well before using.
   • Store away from heat and direct sunlight.

Note: Include patient instructions when dispensing.
Demonstrate inhalation technique to patient when dispensing.


Additional information:
Each canister contains medication for about 200 inhalations.


IPRATROPIUM BROMIDE INHALATION SOLUTION

Usual adult and adolescent dose
Bronchitis (treatment)
Emphysema, pulmonary (treatment) or
Pulmonary disease, chronic obstructive, other (treatment)
Oral inhalation, 250 to 500 mcg (0.25 to 0.5 mg), diluted, if necessary; dose is administered via nebulization three or four times a day, every six to eight hours. {01} {03} For severe exacerbations of COPD, 500 mcg may be administered every four to eight hours. {40}

[Asthma (treatment adjunct) ]
Oral inhalation, 500 mcg (0.5 mg), diluted, if necessary; dose is administered via nebulization three or four times a day, every six to eight hours as necessary {41}.
{46}

Usual adult and adolescent prescribing limits
2 mg per twenty–four hours.{46}

Usual pediatric dose
[Asthma (treatment adjunct)]1
Children up to 5 years of age: Safety and efficacy have not been established {03}.

Children 5 to 12 years of age: Oral inhalation, 125 to 250 mcg (0.125 to 0.25 mg), diluted, if necessary, to three to five mL with preservative-free sterile sodium chloride inhalation solution 0.9%; dose is administered via nebulization every four to six hours as necessary {03}.


Strength(s) usually available
U.S.—



Single-dose vial


0.02% (200 mcg per mL [2.5 mL]) (Rx) [Atrovent][Generic]

Canada—



Single-dose vial


0.0125% (125 mcg per mL [2 mL]) (Rx) [Atrovent]


0.025% (250 mcg per mL [1 or 2 mL]) (Rx) [Atrovent]



Multiple-dose vial


0.025% (250 mcg per mL) (Rx) [Apo-Ipravent (benzalkonium chloride) (EDTA-disodium)] [Atrovent (benzalkonium chloride) (EDTA-disodium )] [Kendral-Ipratropium]

Packaging and storage:
Prior to opening container, store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. Protect from light.

Preparation of dosage form:
Ipratropium inhalation solution can be diluted with preservative-free sterile 0.9% sodium chloride {03}.

Stability:
Solutions of ipratropium containing the preservative benzalkonium chloride may be diluted with preservative-free sterile sodium chloride inhalation solution 0.9%. The solution should be used within twenty-four hours from time of dilution when stored at room temperature and within forty-eight hours when stored in the refrigerator. {03}

Preservative-free albuterol inhalation solution can be mixed in the nebulizer with ipratropium inhalation solution {01} {24}, if used within one hour {01}.

Preservative-free ipratropium inhalation solution is recommended when combining ipratropium with cromolyn inhalation solution. This combination is compatible for up to one hour. Mixing ipratropium inhalation solution containing the preservative benzalkonium chloride with cromolyn in a nebulizer results in cloudiness of the solution, which is due to complexation between cromolyn sodium and benzalkonium chloride. No precipitation or significant decrease in the concentration of cromolyn or ipratropium occurs. {24}

Auxiliary labeling:
   • For oral inhalation only.

Note: Include patient instructions for preparation of solution when dispensing.




Revised: 12/29/1999



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