Combivent

Name: Combivent

Uses

This product is used to treat and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). This product contains 2 medications: ipratropium and albuterol (also known as salbutamol). Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

Storage

Store at room temperature away from light, heat, and moisture. Do not store in the bathroom. Do not puncture the canister or use or store near an open flame. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Reviewed on 4/16/2014 References

Side Effects of Combivent

Serious side effects have been reported with Combivent. See the “Combivent Precautions” section.

Common side effects of Combivent include the following:

  • headache
  • respiratory tract infection
  • cough
  • shortness of breath

This is not a complete list of ipratropium/albuterol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Combivent and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Combivent crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Combivent.

Before Using Combivent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ipratropium and albuterol combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Combivent® Respimat® spray in the elderly.

No information is available on the relationship of age to the effects of Combivent® in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Atomoxetine
  • Clomipramine
  • Desipramine
  • Dibenzepin
  • Doxepin
  • Imipramine
  • Iobenguane I 123
  • Levalbuterol
  • Lofepramine
  • Melitracen
  • Nortriptyline
  • Opipramol
  • Protriptyline
  • Tianeptine
  • Tiotropium
  • Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Betel Nut
  • Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to soya lecithin, soybean, or peanuts, history of—Combivent® brand should not be used in patients with this condition.
  • Blood circulation problems or
  • Heart or blood vessel disease or
  • Heart rhythm problems (eg, arrhythmia) or
  • Hypertension (high blood pressure)—Use with caution. May increase risk for serious side effects.
  • Diabetes or
  • Difficult urination or
  • Enlarged prostate or
  • Hyperthyroidism (an overactive thyroid) or
  • Hypokalemia (low potassium in the blood) or
  • Narrow-angle glaucoma or
  • Seizures or
  • Urinary bladder blockage—Use with caution. May make these conditions worse.

Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol

ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with the product.

Bronchodilator Aerosol
For Oral Inhalation Only

Prescribing Information

Contraindications

Combivent Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut. Combivent Inhalation Aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.

Warnings

1. Paradoxical Bronchospasm: Combivent Inhalation Aerosol can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

2. Cardiovascular Effect: The albuterol sulfate contained in Combivent Inhalation Aerosol, 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, discontinuation of the drug may be indicated. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol. In addition, beta-adrenergic agents 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 Inhalation Aerosol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.

3. 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.

4. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide or albuterol sulfate, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

If such a reaction occurs, therapy with Combivent Inhalation Aerosol should be stopped at once and alternative treatment should be considered.

5. Storage Conditions: The contents of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw the container into a fire or incinerator. Keep out of reach of children.

Before taking this medicine

You should not use Combivent if you are allergic to albuterol (Proventil, Ventolin), ipratropium (Atrovent), or atropine.

To make sure Combivent Respimat is safe for you, tell your doctor if you have ever had:

  • heart disease, high blood pressure, coronary artery disease, or heart rhythm disorder;

  • a seizure disorder such as epilepsy;

  • diabetes;

  • overactive thyroid;

  • glaucoma;

  • liver or kidney disease; or

  • enlarged prostate, problems with urination.

It is not known whether Combivent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Albuterol and ipratropium inhalation can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Combivent Respimat is not approved for use by anyone younger than 18 years old.

For Healthcare Professionals

Applies to albuterol / ipratropium: inhalation aerosol, inhalation solution

General

The combination of ipratropium and albuterol has been generally well tolerated. Systemic effects have occurred with albuterol; however, due to the poor oral and mucosal absorption of ipratropium, it typically has not exhibited systemic effects when administered by oral inhalation.[Ref]

Respiratory

Respiratory side effects have included bronchitis (up to 12.3%), upper respiratory tract infection (up to 10.9%), lung disease (6.4%), cough (up to 6.4%), dyspnea (up to 4.5%), pharyngitis (up to 4.4%), nasopharyngitis (up to 4%), respiratory disorders (2.5%), sinusitis (2.3%), pneumonia (up to 1.4%), rhinitis (1.1%), and voice alterations (more than 1%). Dysphonia, increased sputum, pharyngolaryngeal pain, wheezing, and bronchospasm have been reported in less than 2% of patients. Hoarseness, throat irritation, bronchospasm (including paradoxical bronchospasm), wheezing, exacerbation of COPD symptoms, upper respiratory tract infection, sinusitis, sore throat, nasal congestion, and pharyngeal edema have been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included headache (up to 5.6%). Dizziness, paresthesia, tremor, taste perversion, and insomnia have been reported in less than 2% of patients. Drowsiness, coordination difficulty, and taste perversion have been reported during postmarketing experience.[Ref]

Other

Other side effects have included chest pain (up to 2.6%), pain (up to 2.5%), and influenza (1.4%). Asthenia, influenza-like illness, chest discomfort, edema, and fatigue have been reported in less than 2% of patients. Mucosal ulcers, irritation from aerosol, flushing, edema, back pain, aching, and asthenia have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included hypertension, palpitations, tachycardia, angina, and arrhythmia in less than 2% of patients. Palpitations, hypotension, elevated heart rate, myocardial ischemia, decreased diastolic blood pressure, and increased systolic blood pressure have been reported during postmarketing experience. Postmarketing experience has included a 5-year placebo-controlled trial, in which hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ipratropium inhalation aerosol.[Ref]

Hypersensitivity

Hypersensitivity side effects associated with the inhalation solution have included immediate hypersensitivity reactions as demonstrated by rare cases of rash, urticaria, angioedema, pruritus, bronchospasm, anaphylaxis, and oropharyngeal edema. Allergic-type reactions such as skin reactions including rash, pruritus, urticaria (including giant urticaria), angioedema (including that of tongue, lips, and face), laryngospasm, and anaphylactic reaction have been reported with the inhalation aerosol. Hypersensitivity has been reported during postmarketing experience.[Ref]

Ocular

Ocular side effects have included eye pain (less than 2%), acute angle-closure glaucoma, and aggravation of narrow-angle glaucoma. Glaucoma, precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, conjunctival hyperemia, halo vision, accommodation disorder, ocular irritation, corneal edema, increased intraocular pressure, and mydriasis have been reported during postmarketing experience.[Ref]

There are numerous case reports in the literature of precipitation of glaucoma with the use of ipratropium and albuterol via nebulized solution. This is thought to occur through direct contact with the eyes, and is seen with the combination since both beta agonists and anticholinergics can increase intraocular pressure. There is one report of glaucoma associated with the use of nebulized albuterol and ipratropium aerosol in an emergency department. Caution is warranted when the combination is used in patients predisposed to glaucoma. Extra care should be taken to avoid contact with the eyes.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (greater than or equal to 2%). Diarrhea, dry mouth, constipation, dyspepsia, and vomiting have been reported in less than 2% of patients. Drying of secretions, gastrointestinal motility disorder, stomatitis, dry throat, heartburn, gastrointestinal distress (diarrhea, nausea, vomiting), constipation, and mouth edema have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, muscle spasms, and myalgia in less than 2% of patients. Leg cramps (1.4%) have been reported. Muscle spasms, muscular weakness, and myalgia have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included nervousness (less than 2%). Central nervous system stimulation and mental disorder have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypokalemia (less than 2%). Hypokalemia and metabolic acidosis have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included pruritus and rash in less than 2% of patients. Angioedema, hyperhidrosis, alopecia, and skin reaction have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included urinary tract infection and dysuria in less than 2% of patients. Urinary retention has been reported during postmarketing experience.

Some side effects of Combivent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)