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Terbutaline Sulfate Oral tablet

It helps open up the airways in your lungs to make it easier to breathe

Generic Name: terbutaline  |  Brand Name: Bricanyl

Brand Names: Brethine, Bricanyl, Brethaire

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 02/17/2011] ISSUE: FDA notified healthcare professionals that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns.

Death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.

BACKGROUND: Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.

The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information reviewed by the FDA, specifically postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary in Drug Safety Communication) as well as data from the medical literature. These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).

A Data Summary is provided in the Drug Safety Communication

RECOMMENDATION: Based on FDA review, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.

Healthcare professional and patients should follow the recommendations in the “Additional Information for Healthcare Professionals/Patients” sections of the Drug Safety Communication. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

TERBUTALINE (ter BYOO ta leen) is a bronchodilator. It helps open up the airways in your lungs to make it easier to breathe. This medicine is used to treat the symptoms of asthma, bronchitis, and emphysema.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:
  • diabetes
  • heart disease
  • high blood pressure
  • irregular heartbeat
  • seizures
  • an unusual or allergic reaction to terbutaline, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cocaine
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • probucol
  • procarbazine

This medicine may also interact with the following medications:

  • heart medicines
  • medicines for colds or breathing difficulties
  • medicines for high blood pressure
  • some medicines for mental depression or sleep
  • stimulants

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Tell your doctor if your symptoms do not improve. Do not take extra doses. If your asthma or bronchitis gets worse while you are using this medicine, call your doctor right away.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions such as skin rash or hives, swelling of the face, lips, or tongue
  • dizzy, lightheaded
  • hallucinations
  • irregular heartbeat or chest pain
  • muscle cramps
  • seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • anxious, nervous
  • drowsy
  • headache
  • nausea
  • sweating
  • tremor

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

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.


Last Updated: September 03, 2009
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