Duovent - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Class:||Bronchodilator combinations, Bronchodilators|
|Form:||Liquid solution, Inhaler, Nebulizer|
|Ingredients:||ipratropium bromide, fenoterol hydrobromide, hydrochloric acid, sodium chloride|
Ipratropium Bromide/Fenoterol Hydrobromide Nebulizer Solution
About this medication
What the medication is used for
Your doctor has prescribed DUOVENT UDV for your medical condition. It can relieve wheezing, coughing, chest tightness and/or shortness of breath if you have an acute attack of asthma or COPD (Chronic Obstructive Pulmonary Disease) which includes chronic bronchitis and emphysema.
It is important to know that the treatment of asthma and COPD may be different for each patient. Your doctor will discuss with you the best plan for the treatment of your particular condition. This plan may include taking other medication(s) in addition to DUOVENT UDV. It is necessary that you follow your doctor’s directions for the treatment of your condition. If you have any questions about how you should treat your condition at home, you should consult your doctor.
What it does
DUOVENT UDV belongs to a group of medicines known as “bronchodilators” which works by relaxing the muscles surrounding the bronchioles (airways in the lungs) and therefore helps to ease breathing problems.
If you have asthma and you find that you need to use DUOVENT UDV on a regular, daily basis, but you are not taking other medication(s) that control the inflammation of the airways called Inhaled Corticosteroids (ICS), you should contact your doctor so that your treatment can be re-evaluated.
If DUOVENT UDV does not relieve your symptoms within 10 minutes after the nebulization is finished, if the dosage of medication(s) recommended by your doctor does not provide relief for longer than 3 hours, or if you experience a change of your symptoms, for example, more coughing, chest tightness, waking up at night, or increased usage of other relief medication (for example Ventolin), you should contact your doctor or go to the nearest hospital. These are signs that your condition may be worsening, and that you need to be re-assessed by a doctor.
If you have COPD and DUOVENT UDV does not relieve your symptoms within 10 minutes after the nebulization is finished, or if the dosage of medication(s) recommended by your doctor does not provide relief for longer than 3 hours, you should contact your doctor or go to the nearest hospital. These are signs that your condition may be worsening, and that you need to be re-assessed by a doctor.
When it should not be used
DUOVENT UDV should not be used if you
- are allergic to ipratropium bromide, fenoterol hydrobromide, atropine, any other sympathomimetic amines or to any non-medicinal ingredient in the formulation
- have the following heart conditions:
- hypertrophic obstructive cardiomyopathy
- DO NOT use a higher dose of DUOVENT UDV than your doctor has recommended
- DO NOT use your nebulizer more often than your doctor has recommended
- Contact your doctor if you feel that you need more medication than he/she has recommended
- DUOVENT UDV contains a beta agonist, and the taking of additional doses in the form of other single agent, beta agonists (fenoterol, salbutamol [Ventolin] etc.) could lead to poor heart related effects. If these medications need to be taken together, it should only be under the supervision of your doctor.
What the medicinal ingredients are
ipratropium bromide and fenoterol hydrobromide
What the non-medicinal ingredients are
hydrochloric acid, sodium chloride
What dosage forms it comes in
DUOVENT UDV is a combination of two bronchodilators (airway openers) in a solution that is inhaled using a nebulizer. Each plastic unit dose vial (UDV) contains 0.5 mg of ipratropium bromide and 1.25 mg fenoterol hydrobromide in four milliliters (4 mL) of sodium chloride solution.
Warnings and precautions
Before you use DUOVENT UDV talk to your doctor or pharmacist if
- you are pregnant or intend to become pregnant.
- you are breast feeding.
- you have eye problems such as glaucoma or eye pain.
- you are taking other medications, including those you can buy without a prescription and including eye drops, or herbal medicines.
- you have special allergies or reactions to foods or drugs.
- you have other health problems such as difficult urination, enlarged prostate, blood vessel disease, high blood pressure, diabetes mellitus.
- you have a history of heart disease, irregular heart rhythm (heart skips a beat) or angina (chest pain).
Your doctor will recommend when and how often you should use DUOVENT UDV. You must follow any other directions that your doctor has given you for the treatment and/or monitoring of your condition. This may include taking other medication(s) in addition to DUOVENT UDV.
DUOVENT UDV may cause dizziness, tremor, difficulty in focusing the eye, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.
The use of DUOVENT UDV may test positive for performance enhancement (doping) in athletic competition.
Interactions with this medication
Drugs that may interact with DUOVENT UDV include: Other beta adrenergic agents, anticholinergics, xanthine derivatives (such as theophylline) and corticosteroids may enhance the effect of DUOVENT UDV nebulizer solution. The concurrent administration of other beta mimetics, systemically available anticholinergics and xanthine derivatives (e.g. theophyline) may increase the side effects.
Proper use of this medication
Treatment with DUOVENT UDV is to be initiated and administered under medical supervision (e.g. in the hospital setting). Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician. Administration should be stopped when sufficient symptom relief is achieved
Since DUOVENT UDVs contain no preservatives, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged UDVs should be discarded. In most cases, dilution of the DUOVENT UDV dose with sterile preservative-free saline is not necessary. However, volumes of DUOVENT solution less than 2 mL are not appropriate for nebulization and must be diluted with saline or another suitable nebulizer solution to make-up a total fill volume of 2-5 mL. Dilute your dose immediately before you plan to use the solution.
Adults and adolescents (12 years of age or older)
The usual dose is 4 mL of DUOVENT UDV.
It is not recommended for use in children under 12 years of age.
|Detach one plastic unit dose vial (UDV) by pulling it firmly from the strip|
|Open the unit dose vial (UDV) by twisting off the top. It is important that you use the contents of the vial as soon as possible after opening it.|
|Squeeze the plastic unit dose vial(UDV) to empty its contents intoyour nebulizer chamber. If yourdoctor has instructed you to useless than the contents of onecomplete vial, use a syringe totransfer the necessary amountfrom the vial to the nebulizerchamber.|
|Any solution left in the plastic vial must be thrown away.|
|If you have been directed by yourpharmacist or doctor to add sterilepreservative free 0.9% sodiumchloride to the chamber, add thissolution by means of a syringe.|
|Gently swirl the nebulizerchamber to mix the liquid,and connect it to themouthpiece or face mask.Then connect the nebulizertube to the air pump oroxygen supply.|
|Begin therapy. Sit upright in acomfortable position. Breathe calmly and deeply through the mask or mouthpiece until no more mist is formed in the nebulizer chamber. This usually takes 10-15 minutes.
It is very important to adjust the face mask, if required, to prevent the mist from getting in your eyes.
|7)Follow the instructions provided by the nebulizer and air pump manufacturers for the proper care, maintenance and cleaning of the equipment. Keep the nebulizer, nebulizer tube and face mask clean to minimize microbial contamination.|
|8)Store the unit dose vials (UDV) at room temperature (15-25°C) and protect from light and heat.|
You must remember
- DUOVENT UDV has been prescribed to treat your current condition. Do not give this medication to other people.
- DO NOT take any other medication without your doctor’s advice. Tell any other doctor, dentist, or pharmacist with whom you consult that you are using DUOVENT UDV.
The solution is to be administered only using a nebulizer. DO NOT inject it or drink it.
- Do not let the nebulized mist get into your eyes. Patients with glaucoma should use a mouthpiece or swimming goggles to prevent nebulizer solution from getting into the eyes.
- Keep this medication out of the reach of children.
|In case of an overdose, contact your doctor, or the Regional Poison Control Center, or go to the nearest hospital emergency department (do not drive yourself). Always take the labelled medicine container with you.|
If you forget to take your dose, don’t worry. Take your next dose as usual. Do not double your dose.
Side effects and what to do about them
If you experience a dry mouth or bad taste, sucking a sour candy or rinsing your mouth may help. Check with your doctor if the dry mouth or bad taste persists, or if you experience constipation.
Like any medication, DUOVENT UDV may cause unwanted effects along with the good effects. The most common side effects of DUOVENT UDV are cough, tremor (shakiness), dry mouth, headache, sore throat, nausea, dizziness, hoarseness/impaired voice, vomiting, changes in blood pressure, feeling nervous, increased heart rate and a feeling that your heart is beating fast. If you experience any unusual or unwanted effects while you are using DUOVENT UDV, you should contact your doctor.
Other side effects include: decreased blood flow to the heart, heart problems such as fast or irregular heart beat or rate, eye disorders such as difficulty in focusing the eye, seeing halos, swelling of the cornea, build up or increased pressure in the eye, dilated pupils, swelling of the blood vessels in the conjunctiva (outermost layer of the eye and inner surface of the eyelids), blurred vision, eye pain; muscle problems such as muscle spasms, muscle weakness, muscle pain; agitation, mental disorder; difficulty in passing urine; increased sweating; low potassium levels in the blood; breathing problems such as difficulty in breathing, coughing bouts, swelling of the throat, and choking due to swelling of the muscles around the voice box; irritation of throat, dry throat, wheezing after inhalation, swelling of the mouth, tongue and throat, tightness of the chest associated with coughing, wheezing, or breathlessness immediately after inhalation (bronchospasm) and digestive problems like constipation, diarrhoea and vomiting.
Stop taking the medication and tell your doctor immediately if you notice any of the following:
- you are wheezy or have any other difficulties in breathing;
- you are having an allergic reaction – the signs may include rash, itching and nettle rash. In severe cases the signs include swelling of your tongue, lips and face, sudden difficulties in breathing and reduction of your blood pressure.
DUOVENT UDV is a combination of two bronchodilators. Excessive use of bronchodilators may cause unwanted side effects (increased heart rate, low blood pressure, and/or irregular heart beat). Therefore do not take additional bronchodilators by inhalation with DUOVENT UDV unless instructed to do so by your doctor or pharmacist.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor or pharmacist||Stop
|Only if severe||In all cases|
|Uncommon||Fast or irregular heart beat/Chest pain||√|
|Rare||Increased /Sudden wheezing or tightness in the chest||√|
|Swelling of eyelids, face, lips, tongue or throat||√|
|Difficulty in swallowing||√|
|Blurred vision or pain in the eyes||√|
|Difficult or painful urination||√|
|Lumpy skin rash or “hives” anywhere on the body||√|
This is not a complete list of side effects. For any unexpected effects while taking DUOVENT UDV, contact your doctor or pharmacist.
How to store it
Unopened unit dose vials of DUOVENT UDV should be stored at room temperature (15-25°C) and protected from heat and light. If necessary, the solution may be diluted with preservative-free sterile sodium chloride solution 0.9% and used immediately. Any solution remaining in the vial must be discarded.
Reporting suspected side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103 Ext. 84633 (Medical Information).
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