Terbutaline (Oral)

Terbutaline is used to prevent bronchospasm in patients who are 12 years old and older with asthma, bronchitis, emphysema, and other lung diseases.

Terbutaline is part of a group of medicines called bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They help relieve cough, wheezing, shortness of breath, and trouble breathing by increasing the flow of air through the bronchial tubes.

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

It is very important that your doctor checks on you or your child regularly. This will help your doctor see if the medicine is working correctly and to look for any side effects.

Using this medicine to prevent or treat preterm labor can be harmful to pregnant women. This medicine may raise the risk of heart problems and other serious side effects when given to a pregnant woman for a long time. Use an effective form of birth control to avoid getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if you have trouble breathing after taking a dose of this medicine or if your condition worsens.

You may also be taking an anti-inflammatory medicine (e.g., corticosteroids) for asthma along with this medicine. Do not stop taking the anti-inflammatory medicine even if your asthma seems better, unless your doctor tells you to do so.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using it and contact your doctor right away.

Hypokalemia may occur with this medicine. Check with your doctor immediately if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

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

Pediatric

Use of terbutaline in children younger than 12 years of age is not recommended.

Geriatric

No information is available on how age affects the effects of terbutaline in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranylcypromine

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

• Acebutolol
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Esmolol
• Iobenguane I 123
• Labetalol
• Landiolol
• Levobunolol
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Talinolol
• Tertatolol
• Timolol

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizures—Use with caution. May worsen these conditions.

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:

More common

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Less common

• Extra heartbeat
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• sweating

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• excessive muscle tone
• muscle stiffness
• muscle tension or tightness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• convulsions
• decreased urine
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• general feeling of discomfort or illness
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seizures
• shortness of breath
• sleeplessness
• slow or fast heartbeat
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness

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:

More common

• Sleepiness or unusual drowsiness

Less common

• Anxiety
• lack or loss of strength

Rare

• Fever
• rash
• redness, soreness, or itching skin
• seeing, hearing, or feeling things that are not there
• sores, welting, or blisters

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.

In the U.S.

• Brethine

Available Dosage Forms:

• Tablet

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change or stop using this medicine without checking first with your doctor.

You may be taking other medicines for asthma together with terbutaline. Do not stop taking these medicines and do not reduce the dose, even if your asthma seems better, unless you are told to do so by your doctor.

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 oral dosage form (tablets):For prevention of bronchospasm: Adults and teenagers—5 milligrams (mg) three times a day. This medicine is taken only during the hours the patient is usually awake. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per 24 hours. Children and teenagers 12 to 15 years of age—2.5 mg three times a day. Your doctor may adjust your dose as needed up. However, the dose is usually not more than 7.5 mg per 24 hours. Children younger than 12 years of age—Use is not recommended.

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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.