Terbutaline (Oral route)
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration .
Uses of This Medicine:
Terbutaline is used to prevent bronchospasm in patients 12 years of age and older with asthma, bronchitis, emphysema, and other lung diseases.
Terbutaline belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Use of terbutaline in children younger than 12 years of age is not recommended.
No information is available on the relationship of age to the effects of terbutaline in geriatric patients.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
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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:
- 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 make these conditions worse.
Proper Use of This Medicine:
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.
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.
- For prevention of bronchospasm:
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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
Using this medicine to prevent or treat preterm labor can harm pregnant women. This medicine may increase 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 keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor at once if difficulty with breathing continues after using a dose of this medicine or if your condition gets worse.
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 you are told to do so by your doctor.
If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor right away.
Hypokalemia may occur with this medicine. Check with your doctor right away 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 they have been discussed 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.
Side Effects of This Medicine:
- 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
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- excessive muscle tone
- muscle stiffness
- muscle tension or tightness
- Symptoms of overdose
- Arm, back, or jaw pain
- blurred vision
- chest pain or discomfort
- chest tightness or heaviness
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- 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
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- shortness of breath
- slow or fast heartbeat
- trouble sleeping
- unable to sleep
- unusual tiredness or weakness
- More common
- Sleepiness or unusual drowsiness
- Less common
- lack or loss of strength
- redness, soreness, or itching skin
- seeing, hearing, or feeling things that are not there
- sores, welting, or blisters
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 9/4/2017