COMBIVENT RESPIMAT Inhalation spray (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Boehringer Ingelheim Pharmaceuticals Inc.

Λέξεις κλειδιά

0597-0024

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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 ...

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 ...

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. ...

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 ...

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 ...

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 ...

6.1. Clinical Trials Experience

COMBIVENT RESPIMAT 12-Week Clinical Trials The safety data described in Table 1 below are derived from one 12-week, randomized, multicenter, double-blind, double-dummy, parallel-group trial that compared ...

6.2. Postmarketing Experience

In addition to the adverse reactions reported during clinical trials, the following adverse reactions have been identified during post-approval use of CFC-propelled COMBIVENT Inhalation Aerosol. Since ...

7. Drug Interactions

COMBIVENT RESPIMAT has been used concomitantly with other drugs, including beta-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids, commonly used in the treatment of chronic obstructive ...

8.1. Pregnancy

Risk Summary There are no randomized clinical studies of COMBIVENT RESPIMAT, or its individual components, ipratropium bromide and albuterol sulfate, in pregnant women. Ipratropium is negligibly absorbed ...

8.2. Lactation

Risk Summary There are no available data on the presence of COMBIVENT RESPIMAT, or its components, ipratropium bromide or albuterol, in human milk, the effects on the breastfed infant, or the effects on ...

8.4. Pediatric Use

Safety and effectiveness of COMBIVENT RESPIMAT in pediatric patients have not been established. COMBIVENT RESPIMAT is indicated for use in patients with COPD on a regular aerosol bronchodilator who continue ...

8.5. Geriatric Use

In the 12-week trial in COPD, 48% of COMBIVENT RESPIMAT clinical trial patients were 65 years of age or over. In general, there were no marked differences between the proportion of patients with adverse ...

10. Overdosage

The effects of overdosage are expected to be related primarily to albuterol sulfate. Acute overdosage with ipratropium bromide by inhalation is unlikely since ipratropium bromide is not well absorbed systemically ...

11. Description

COMBIVENT RESPIMAT is a combination of ipratropium bromide (as the monohydrate) and albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1] ...

12.1. Mechanism of Action

COMBIVENT RESPIMAT is a combination of the anticholinergic ipratropium bromide and the beta2-adrenergic agonist albuterol sulfate. The mechanisms of action described below for the individual ...

12.2. Pharmacodynamics

Ipratropium bromide Cardiovascular effects At recommended doses, ipratropium bromide does not produce clinically significant changes in pulse rate or blood pressure. Ocular effects In studies without a ...

12.3. Pharmacokinetics

Ipratropium bromide Ipratropium bromide is a quaternary amine and hence, it is not readily absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Ipratropium bromide Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg/day (approximately 400 and 200 times the maximum recommended human ...

13.2. Animal Toxicology and/or Pharmacology

Preclinical Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma ...

14. Clinical Studies

The efficacy of COMBIVENT RESPIMAT (20/100 mcg) was evaluated in COPD patients in one randomized, double-blind, double-dummy parallel group trial. This was a 12-week trial in a total of 1460 adult patients ...

16.1. How Supplied

COMBIVENT RESPIMAT Inhalation Spray is supplied in a carton containing one COMBIVENT RESPIMAT cartridge and one COMBIVENT RESPIMAT inhaler. The COMBIVENT RESPIMAT cartridge is provided as an aluminum cylinder ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid freezing.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Paradoxical Bronchospasm Inform patients that COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. ...