Terbutaline

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

GENERIC AVAILABLE: Yes

Terbutaline reduces uterine contractions and may inhibit labor. There are no adequate studies of terbutaline in pregnant women.

Terbutaline is found in small amounts in the breast milk of nursing women. The American Academy of Pediatrics considers terbutaline to be compatible with breastfeeding.

Terbutaline may be found in some form under the following brand names:

• Brethaire

• Brethine

• Bricanyl

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

Terbutaline is used to treat or prevent bronchospasm (wheezing, chest tightness, trouble breathing) in people with lung conditions such as asthma, bronchitis, or emphysema.

Terbutaline may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Asthma -- Maintenance:

Tablets: 5 mg orally 3 times a day at 6 hour intervals during waking hours. May decrease to 2.5 mg/dose if side effects are pronounced. Do not exceed 15 mg in 24 hours.

Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

Usual Adult Dose for Premature Labor:

Tablets: 2.5 to 7.5 mg orally every 6 hours. Therapy should be continued until 36 to 37 weeks gestation.

Continuous intravenous infusion: 10 to 25 mcg/min. Therapy should be continued until labor has been arrested. Maximum dose 80 mcg/min.

Subcutaneous injection: 0.25 mg every 6 hours. Subcutaneous therapy should be continued until labor has been arrested.

Usual Adult Dose for Asthma -- Acute:

Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

Subcutaneous Injection: 0.25 mg into the lateral deltoid area. A second 0.25 mg dose can be administered in 15 to 30 minutes if needed. Do not exceed 0.5 mg in 4 hours.

Continuous intravenous infusion: 0.08 to 6 mcg/kg/min.

Usual Pediatric Dose for Asthma -- Acute:

Subcutaneous Injection: 0.005 to 0.01 mg/kg/dose to a maximum dose of 0.4 mg every 15 to 20 minutes for 2 doses.

Nebulization: 0.01 to 0.03 mg/kg/dose with a minimum dose of 0.1 mg; maximum dose is 2.5 mg diluted with 1 to 2 mL of normal saline every 4 to 6 hours.

Continuous intravenous infusion: 0.08 to 6 mcg/kg/min.

> 12 years:
Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

Subcutaneous Injection: 0.25 mg into the lateral deltoid area. A second 0.25 mg dose can be administered in 15-30 minutes if needed. Maximum dose 0.5 mg in 4 hours.

Usual Pediatric Dose for Asthma -- Maintenance:

< 12 years:
Tablets: 0.05 mg/kg/day divided into three doses. Gradually increase to 0.15 mg/kg/day. Maximum dose is 5 mg per day.

>=12 years:
Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

>=12 =15 years:
Tablets: 2.5 mg to 5 mg orally every 6 to 8 hours. Do not exceed 15 mg in 24 hours.

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:

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

• 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

• 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:

• 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:

• Sleepiness or unusual drowsiness

• Anxiety
• lack or loss of strength

• 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.

Oral: 30 to 45 minutes; SubQ: 6 to 15 minutes; Inhalation: 5 minutes (maximum effect: 15 to 60 minutes)

Time to Peak

Serum: SubQ: 0.5 hours

For extravasation management (off-label use): Using vial for injection, dilute 1 mg in 10 mL (large extravasation site) or 1 mg in 1 mL (small/distal extravasation site) of 0.9% sodium chloride (Stier 1999).

IV: Use infusion pump.

Oral: Administer around-the-clock to promote less variation in peak and trough serum levels

Inhalation: Bricanyl Turbuhaler [Canadian product]: After removing lid, patient should hold inhaler upright and turn blue grip as far as it will go in one direction then turn it back to original position. Clicking sound indicates that inhaler is ready for use. Patient should exhale fully but not into the inhaler and then place mouthpiece gently between teeth, close lips around inhaler and inhale deeply. Inhaler should be removed from mouth prior to exhaling. Instruct patients to rinse mouth with water after each inhalation as some medication may stick to the inside of the mouth and throat. If inhaler is dropped or shaken, or if patient exhales into the inhaler after a dose is loaded, the dose will be lost and a new dose should be loaded and inhaled. Outside of mouthpiece should be cleaned once weekly with a dry tissue. Instruct patient to keep inhaler dry. First appearance of red mark in dose indicator (window underneath mouthpiece) indicates that 20 doses remain. When red mark reaches bottom of dose indicator no doses remain and Turbuhaler should be discarded.

inSubQ: Extravasation management, sympathomimetic vasopressors (off-label use): Stop vesicant infusion immediately and disconnect IV line (leave needle/cannula in place); gently aspirate extravasated solution from the IV line (do NOT flush the line); remove needle/cannula; elevate extremity. Infiltrate extravasation area with terbutaline solution 1 mg diluted with 10 mL (large extravasation site) or 1 mg diluted in 1 mL (small/distal extravasation site) of 0.9% sodium chloride into extravasation site (Stier 1999).

Store injection at room temperature; do not freeze. Protect from heat and light. Use only clear solutions. Store powder for inhalation (Bricanyl® Turbuhaler [Canadian availability]) at room temperature between 15°C and 30°C (58°F and 86°F).

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

• Serious effects/fatalities: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Disease-related concerns:

• Asthma: Appropriate use: When used as a bronchodilator, optimize anti-inflammatory treatment before initiating maintenance treatment with terbutaline. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest form of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias.

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia or taking concomitant drugs that cause hypokalemia; beta2-agonists may decrease serum potassium.

• Preterm labor: [US Boxed Warning]: Terbutaline is not FDA approved for and should not be used for prolonged tocolysis (>48 to 72 hours). Use for maintenance tocolysis should not be done in the outpatient setting. Adverse events observed in pregnant women include arrhythmias, increased heart rate, hyperglycemia (transient), hypokalemia, myocardial ischemia, and pulmonary edema. Heart rate may be increased in the fetus and hypoglycemia may occur in the neonate. Oral terbutaline is contraindicated for acute or chronic use in the management of preterm labor.

• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Other warnings/precautions:

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed.