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bitolterol inhalation

Generic Name: bitolterol inhalation (bye TOLE ter ole)
Brand Name: Tornalate

What is bitolterol inhalation?

Bitolterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Bitolterol inhalation is used to treat asthma. Bitolterol is not currently availabe for use in the United States.

Bitolterol inhalation may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about bitolterol inhalation?

It is very important that you use your bitolterol inhaler or nebulizer properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler and nebulizer use.

Slideshow: Flashback: FDA Drug Approvals 2013

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

What should I discuss with my healthcare provider before using bitolterol inhalation?

Before using this medication, tell your doctor if you have

  • heart disease or high blood pressure,

  • epilepsy or another seizure disorder,

  • diabetes,

  • an overactive thyroid (hyperthyroidism), or

  • any type of liver or kidney disease.

You may require a lower dose or special monitoring during therapy with bitolterol inhalation if you have any of the conditions listed above.

Bitolterol inhalation is in the FDA pregnancy category C. This means that it is not known whether bitolterol inhalation will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is not known whether bitolterol passes into breast milk. Do not use bitolterol inhalation without first talking to your doctor if you are breast-feeding a baby.

Bitolterol inhalation is not approved for use by children younger than 12 years of age.

How should I use bitolterol inhalation?

Use bitolterol inhalation exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the inhaler:

  • Shake the inhaler several times and uncap the mouthpiece. Breathe out fully and place your lips around the mouthpiece. Take a deep, slow breath as you push down on the canister. Hold your breath for several seconds, then exhale slowly.

  • If you take more than one dose at a time, wait for at least 1 full minute, then repeat the procedure.

  • Keep your inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. Clean your inhaler once a day by removing the canister and immersing the mouthpiece in warm water. Allow the parts to dry, then reassemble the inhaler.

To use the solution for nebulization:

  • Measure the correct amount of medication with the dropper provided or select the prescribed number of ampules. Transfer the liquid into the medication chamber of the nebulizer. If your medication has a dropper, do not allow the dropper to touch any surface including your hands or the chamber of the nebulizer. Dilute the medication with normal saline if prescribed by your doctor.

  • Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor. Sit upright, in a comfortable position, and put the mouthpiece into your mouth or put the face mask on, covering the nose and mouth. Breathe slowly and evenly until all of the medicine has been inhaled (usually 5 to 15 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

  • Clean the nebulizer after a treatment as directed by the manufacturer.

If you also use a steroid inhaler, use your bitolterol inhaler or nebulization solution first to open up your airways, then use the steroid inhaler as directed.

It is very important that you use your bitolterol inhaler or nebulizer properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with your inhaler. Talk to your doctor about proper inhaler and nebulizer use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Carry your inhaler or nebulizer and solution with you at all times in case of emergencies. Get a refill before you run out of medicine and before going on vacation.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a bitolterol overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while using bitolterol?

Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Bitolterol inhalation side effects

Stop using bitolterol and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

  • chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use bitolterol inhalation and talk to your doctor if you experience

  • headache, dizziness, lightheadedness, or insomnia;

  • tremor or nervousness;

  • sweating;

  • nausea, vomiting, or diarrhea; or

  • dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

See also: Side effects (in more detail)

Bitolterol inhalation dosing information

Usual Adult Dose for Asthma -- Acute:

Inhalation aerosol: 2 inhalations at an interval of at least 1 to 3 minutes followed by a third inhalation if needed. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.

Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Acute:

Inhalation aerosol: 2 inhalations at an interval of at least 1 to 3 minutes followed by a third inhalation if needed. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.

Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Adult Dose for Asthma -- Maintenance:

Inhalation aerosol: 2 inhalations every 8 hours. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.
Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

Inhalation aerosol: 2 inhalations every 8 hours. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.
Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Pediatric Dose for Asthma -- Acute:

>=12 years:

Inhalation aerosol: 2 inhalations at an interval of at least 1 to 3 minutes followed by a third inhalation if needed. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.

Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Pediatric Dose for Asthma -- Maintenance:

>=12:

Inhalation aerosol: 2 inhalations every 8 hours. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.
Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

>=12:

Inhalation aerosol: 2 inhalations every 8 hours. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.
Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

Continuous flow nebulization: 2.5 mg 3 times a day with a maximum daily dose of 14 mg. Treatments should be at least 4 hours apart.

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease -- Acute:

>=12 years:

Inhalation aerosol: 2 inhalations at an interval of at least 1 to 3 minutes followed by a third inhalation if needed. Do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours.

Inhalation solution:

Intermittent nebulization: 0.5 to 1.5 mg every 8 hours. Treatments may be increased to four times a day, however, the interval between treatments should not be less than 4 hours. In severely obstructed patients, a dose of 2 mg may be used with a maximum daily dose of 8 mg.

What other drugs will affect bitolterol?

Before using bitolterol inhalation, tell your doctor if you are taking any of the following medicines:

  • a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL), propranolol (Inderal), and others;

  • a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), and others;

  • a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);

  • another inhaled bronchodilator; or

  • caffeine, diet pills, or decongestants.

You may not be able to use bitolterol inhalation, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with bitolterol inhalation or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

  • Your pharmacist has additional information about bitolterol written for health professionals that you may read.

What does my medication look like?

Bitolterol is available under the brand name Tornalate. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is unfamiliar to you.

  • Tornalate 16.4 grams

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2/13/04 4:01:09 PM.

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