Ratio-Ipra Sal Udv

Generic Name: ipratropium and albuterol (Inhalation route)

ip-ra-TROE-pee-um BROE-mide, al-BUE-ter-ol SUL-fate

Commonly used brand name(s):

In the U.S.

• Combivent
• Duoneb

In Canada

• Ratio-Ipra Sal Udv

Available Dosage Forms:

• Aerosol Powder
• Solution
• Aerosol Liquid

Therapeutic Class: Bronchodilator

Pharmacologic Class: Ipratropium

Uses For Ratio-Ipra Sal Udv

Ipratropium and albuterol combination is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis, and emphysema. It is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD) in patients who need another medicine.

Ipratropium and albuterol belong to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Ratio-Ipra Sal Udv

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

No information is available on the relationship of age to the effects of ipratropium and albuterol combination in geriatric patients.

Interactions with Medicines

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.

• Acebutolol
• Alprenolol
• Arotinolol
• Atenolol
• Atomoxetine
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Brofaromine
• Bucindolol
• Bupranolol
• Carteolol
• Carvedilol
• Celiprolol
• Clorgyline
• Dilevalol
• Esmolol
• Furazolidone
• Iproniazid
• Isocarboxazid
• Labetalol
• Landiolol
• Lazabemide
• Levobetaxolol
• Levobunolol
• Linezolid
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Nipradilol
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Rasagiline
• Selegiline
• Sotalol
• Talinolol
• Tertatolol
• Timolol
• Toloxatone
• Tranylcypromine

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

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:

• Blood circulation problems or
• Blood vessel and heart disease or
• Heart rhythm problems or
• Hypertension (high blood pressure)—Use with caution. May increase risk for serious side effects.

• Diabetes or
• Difficult urination or
• Enlarged prostate or
• Glaucoma, narrow-angle or
• Hypokalemia (low potassium in the blood) or
• Overactive thyroid or
• Seizures or
• Urinary bladder blockage—Use with caution. May make these conditions worse.

Proper Use of ipratropium and albuterol

This section provides information on the proper use of a number of products that contain ipratropium and albuterol. It may not be specific to Ratio-Ipra Sal Udv. Please read with care.

This medicine usually comes with patient directions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the inhaler or nebulizer, ask your doctor to show you how to use it.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may cause your lung condition to become worse.

When you use the inhaler for the first time, or if you have not used it for more than 24 hours, the inhaler may not give the right amount of medicine with the first puff. Before using the inhaler, prime it by spraying the medicine into the air, and pointed away from people, 3 times. The inhaler will now be ready to give the right amount of medicine when you use it.

When you use the inhalation solution, make sure you use a jet nebulizer that is connected to an air compressor with a good air flow. Use a face mask or mouthpiece to inhale the medicine.

Keep the spray away from your eyes. This medicine may cause eye pain or discomfort, irritation, or blurred vision. If it does come into contact with your eyes, check with your doctor right away.

To use the inhaler:

• Insert the metal canister firmly and fully into the clear end of the Combivent® Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other inhaled medicines.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Shake the inhaler for at least 10 seconds and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for awhile.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.
• Hold your breath for about 10 seconds, then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.
• When you have finished all of your doses, rinse your mouth with water.
• Clean the inhaler mouthpiece every day with hot water. Dry it thoroughly before use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation aerosol dosage form (used with an inhaler):
  • For symptoms of chronic obstructive pulmonary disease (COPD):
    • Adults—2 puffs four times a day and as needed. A total of 12 puffs can be used in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.

• For inhalation solution dosage form (used with a nebulizer):
  • For symptoms of chronic obstructive pulmonary disease (COPD):
    • Adults—Use one 3 milliliter (mL) vial in the nebulizer 4 times a day. You may use 2 additional treatments per day if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ratio-Ipra Sal Udv

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.

Check with your doctor at once if difficulty with breathing continues after using a dose of this medicine or if your condition gets worse.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ratio-Ipra Sal Udv Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• cough
• cough producing mucus
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• shortness of breath
• sneezing
• sore throat
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Chest pain
• congestion
• diarrhea
• general feeling of discomfort or illness
• hoarseness
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• noisy breathing
• pain
• pain or tenderness around the eyes and cheekbones
• shivering
• sweating
• tender, swollen glands in the neck
• trouble with swallowing
• trouble with sleeping
• voice changes
• vomiting

• Fast or irregular heartbeat
• skin rash or hives
• swelling of the face, lips, eyelids, mouth, or throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in sense of taste
• dizziness
• dryness of the mouth
• nervousness
• tremor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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