Combivent Respimat
COMBIVENT RESPIMAT- ipratropium bromide and albuterol sulfate spray, metered
Boehringer Ingelheim Pharmaceuticals Inc.
1 INDICATIONS AND USAGE
COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta2 -adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
2 DOSAGE AND ADMINISTRATION
The recommended dose of COMBIVENT RESPIMAT is one inhalation four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed six in 24 hours.
Prior to first use, the COMBIVENT RESPIMAT cartridge is inserted into the COMBIVENT RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17) ].
Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond six inhalations/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT RESPIMAT have not been studied.
3 DOSAGE FORMS AND STRENGTHS
COMBIVENT RESPIMAT consists of a COMBIVENT RESPIMAT inhaler and an aluminum cylinder (COMBIVENT RESPIMAT cartridge) containing a combination of ipratropium bromide (as the monohydrate) and albuterol sulfate. The COMBIVENT RESPIMAT cartridge is only intended for use with the COMBIVENT RESPIMAT inhaler.
Each actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) from the mouthpiece.
4 CONTRAINDICATIONS
COMBIVENT RESPIMAT is contraindicated in the following conditions [see Warnings and Precautions (5.6)]:
- Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT
- Hypersensitivity to atropine or any of its derivatives
5 WARNINGS AND PRECAUTIONS
5.1 Paradoxical Bronchospasm
COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, therapy with COMBIVENT RESPIMAT should be discontinued immediately and alternative therapy instituted.
5.2 Cardiovascular Effects
The albuterol sulfate contained in COMBIVENT RESPIMAT, like other beta‑adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. If these symptoms occur, COMBIVENT RESPIMAT may need to be discontinued. There is some evidence from postmarketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol. In addition, beta‑adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, COMBIVENT RESPIMAT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension [see Drug Interactions (7.2)].
5.3 Ocular Effects
Ipratropium bromide, a component of COMBIVENT RESPIMAT, is an anticholinergic and may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, COMBIVENT RESPIMAT should be used with caution in patients with narrow-angle glaucoma [see Drug Interactions (7.1)].
Patients should avoid spraying COMBIVENT RESPIMAT into the eyes. If a patient sprays COMBIVENT RESPIMAT into their eyes they may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjunctival or corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using COMBIVENT RESPIMAT.
5.4 Urinary Retention
Ipratropium bromide, a component of COMBIVENT RESPIMAT, is an anticholinergic and may cause urinary retention. Therefore, caution is advised when administering this medication to patients with prostatic hyperplasia or bladder-neck obstruction [see Drug Interactions (7.1)].
5.5 Do Not Exceed Recommended Dose
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected [see Drug Interactions (7.2)].
5.6 Hypersensitivity Reactions Including Anaphylaxis
Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after administration of ipratropium bromide or albuterol sulfate. In clinical trials and postmarketing experience with ipratropium containing products, hypersensitivity reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported [see Adverse Reactions (6.1, 6.2)]. If such a reaction occurs, therapy with COMBIVENT RESPIMAT should be stopped at once and alternative treatment should be considered [see Contraindications (4)].
5.7 Coexisting Conditions
COMBIVENT RESPIMAT contains albuterol sulfate, a beta2 -adrenergic sympathomimetic amine and, therefore, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines.
5.8 Hypokalemia
Beta2 ‑adrenergic agonists may produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation [see Drug Interactions (7.2)].
6 ADVERSE REACTIONS
Use of albuterol, a beta2 -adrenergic agonist, may be associated with the following:
- Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
- Cardiovascular effects [see Warnings and Precautions (5.2)]
- Hypersensitivity reactions including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.6)]
- Hypokalemia [see Warnings and Precautions (5.8)]
Albuterol is a component of COMBIVENT RESPIMAT.
Use of ipratropium bromide, an anticholinergic, may result in the following:
- Ocular effects [see Warnings and Precautions (5.3)]
- Urinary retention [see Warnings and Precautions (5.4)]
Ipratropium bromide is a component of COMBIVENT RESPIMAT.
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