Terbutaline 5mg Tablets
WARNING: Severe and sometimes deadly side effects, like fast heartbeat, an abnormal heartbeat, high blood sugar, low potassium, fluid in the lungs, or heart attack, have happened when this drug was given during pregnancy. It may also cause fast heartbeat or low blood sugar in the fetus or newborn if given to during pregnancy. This drug is not approved to treat or prevent premature labor. Talk with the doctor. @ COMMON USES: It is used to open the airways in lung diseases where spasm may cause breathing problems. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Bronchodilator
Pharmacologic Class
Beta-2 Adrenergic Agonist
Pregnancy Category
Category B
FDA Approved
Sep 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
Terbutaline is a medication used to help you breathe easier by relaxing the muscles around your airways. It's often prescribed for conditions like asthma or emphysema to prevent or treat wheezing and shortness of breath.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to follow the dosage instructions carefully to ensure safe and effective treatment.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally friendly way to dispose of your medications.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to follow the dosage instructions carefully to ensure safe and effective treatment.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally friendly way to dispose of your medications.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
Lifestyle & Tips
- Take the medication exactly as prescribed by your doctor. Do not take more than the recommended dose or more often than prescribed.
- Do not use this medication for sudden, severe breathing problems (acute asthma attacks); it is not a rescue inhaler. Use your prescribed rescue inhaler for acute symptoms.
- Avoid triggers that worsen your breathing (e.g., smoke, allergens, cold air).
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, especially beta-blockers, diuretics, or antidepressants.
- Limit caffeine intake as it can worsen side effects like nervousness or tremor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg three times a day
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
initialDose:
2.5 mg three times a day, increased to 5 mg three times a day if needed and tolerated. Maximum 15 mg per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for oral tablets under 12 years of age.
Adolescent:
12-15 years: 2.5 mg three times a day. Maximum 7.5 mg per day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Consider dose reduction (e.g., 2.5 mg three times a day) and monitor for adverse effects due to renal excretion.
Severe:
Significant dose reduction (e.g., 2.5 mg two times a day or less) may be necessary; monitor closely for adverse effects.
Dialysis:
Not well studied; use with caution and monitor for adverse effects. Terbutaline is dialyzable to some extent.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, as hepatic metabolism is primarily conjugation, not oxidative.
Severe:
No specific adjustment recommended, but monitor for increased sensitivity to adverse effects.
Pharmacology
Mechanism of Action
Terbutaline is a direct-acting sympathomimetic amine with selective beta-2 adrenergic agonist activity. It stimulates beta-2 receptors in the bronchial smooth muscle, leading to relaxation of the smooth muscle and bronchodilation. It also inhibits the release of mediators from mast cells in the airways. At higher doses, it can stimulate beta-1 receptors, leading to cardiac effects.
Pharmacokinetics
Absorption:
Bioavailability:
30-50%
Tmax:
1-2 hours
FoodEffect:
Food may delay absorption but does not significantly affect bioavailability.
Distribution:
Vd:
Not available (large volume of distribution)
ProteinBinding:
Approximately 25%
CnssPenetration:
Limited
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 60% of an oral dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
30 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-8 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Chest pain or pressure
Fast or abnormal heartbeat
Seizures
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Feeling nervous or excitable
Shakiness
Restlessness
Headache
Dizziness or drowsiness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Chest pain or pressure
Fast or abnormal heartbeat
Seizures
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Feeling nervous or excitable
Shakiness
Restlessness
Headache
Dizziness or drowsiness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma symptoms or increased need for rescue inhaler
- Chest pain, rapid or irregular heartbeat
- Severe or persistent tremor, nervousness, or dizziness
- Muscle cramps or weakness
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you experience a fast or abnormal heartbeat.
If you are in preterm labor or are having a miscarriage.
This list is not exhaustive, and it is crucial to discuss all your health concerns and medications with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your existing health problems.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you experience a fast or abnormal heartbeat.
If you are in preterm labor or are having a miscarriage.
This list is not exhaustive, and it is crucial to discuss all your health concerns and medications with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your existing health problems.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Monitoring Your Condition and Dosage
Contact your doctor immediately if you experience any of the following:
- Your usual dose is not effective
- Your symptoms worsen
- You need to use this medication more frequently than prescribed
Safe Use and Dosage
Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount may increase your risk of severe side effects.
Interactions with Other Medications and Conditions
Before using any other medications or inhalers for breathing problems, consult with your doctor. If you have diabetes (high blood sugar), discuss your condition with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Special Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy, Breastfeeding, and Pediatric Use
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby. For children, different forms of this medication may be suitable for various age groups; therefore, consult with your doctor before administering this medication to a child.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Monitoring Your Condition and Dosage
Contact your doctor immediately if you experience any of the following:
- Your usual dose is not effective
- Your symptoms worsen
- You need to use this medication more frequently than prescribed
Safe Use and Dosage
Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount may increase your risk of severe side effects.
Interactions with Other Medications and Conditions
Before using any other medications or inhalers for breathing problems, consult with your doctor. If you have diabetes (high blood sugar), discuss your condition with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Special Considerations
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy, Breastfeeding, and Pediatric Use
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby. For children, different forms of this medication may be suitable for various age groups; therefore, consult with your doctor before administering this medication to a child.
Overdose Information
Overdose Symptoms:
- Tachycardia (rapid heart rate)
- Palpitations (pounding heart)
- Arrhythmias (irregular heartbeat)
- Tremor (shaking)
- Nervousness
- Headache
- Nausea
- Vomiting
- Dizziness
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Seizures (rare)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, nadolol) due to antagonism of bronchodilator effect and risk of severe bronchospasm.
Major Interactions
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of terbutaline, increasing risk of arrhythmias and hypertension.
- Other sympathomimetics: Additive cardiovascular effects and increased risk of adverse reactions.
Moderate Interactions
- Diuretics (loop or thiazide): May exacerbate hypokalemia, increasing risk of cardiac arrhythmias.
- Digoxin: Terbutaline may decrease serum digoxin levels; monitor digoxin levels.
- Theophylline: Increased risk of adverse effects (e.g., tremor, tachycardia) when used concurrently.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To assess baseline lung function and severity of bronchospasm.
Timing: Prior to initiation of therapy.
Vital Signs (Heart Rate, Blood Pressure)
Rationale: To establish baseline cardiovascular status and identify potential contraindications or risks.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: To establish baseline and identify patients at risk for hypokalemia, especially with concomitant diuretic use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom Control (e.g., shortness of breath, wheezing)
Frequency: Regularly, at each visit or as directed by physician.
Target: Improved or stable respiratory symptoms.
Action Threshold: Worsening symptoms or increased need for rescue medication indicates inadequate control or worsening condition, requiring re-evaluation.
Adverse Effects (e.g., tremor, palpitations, tachycardia, headache)
Frequency: Regularly, at each visit or as directed by physician.
Target: Absence or minimal, tolerable adverse effects.
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Heart Rate and Blood Pressure
Frequency: Periodically, especially during dose titration or if cardiovascular symptoms occur.
Target: Within normal limits or patient's baseline.
Action Threshold: Significant tachycardia, arrhythmias, or hypertension may require intervention.
Serum Potassium
Frequency: Periodically, especially in patients at risk for hypokalemia (e.g., concomitant diuretics, severe asthma exacerbation).
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L) may require potassium supplementation or dose adjustment.
Symptom Monitoring
- Worsening shortness of breath or wheezing
- Increased frequency of rescue inhaler use
- Chest pain or discomfort
- Palpitations or irregular heartbeat
- Severe or persistent tremor
- Dizziness or lightheadedness
- Muscle cramps or weakness (suggestive of hypokalemia)
Special Patient Groups
Pregnancy
Terbutaline was formerly Pregnancy Category B. Studies in animals have shown some adverse effects, but adequate and well-controlled studies in pregnant women are lacking. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral terbutaline is not recommended for the prevention or prolonged treatment of preterm labor due to serious maternal cardiac adverse reactions.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for cardiac effects on fetus if maternal systemic absorption is high.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
Can inhibit uterine contractions and cause maternal and fetal tachycardia, hypokalemia, and hyperglycemia. Not recommended for preterm labor.
Lactation
Terbutaline is excreted into breast milk. The amount is small, but potential for adverse effects on the infant (e.g., irritability, tremor, tachycardia) exists. Use with caution; monitor the infant for signs of beta-adrenergic stimulation.
Infant Risk:
Low to Moderate (L3)
Pediatric Use
Oral terbutaline tablets are not recommended for children under 12 years of age due to insufficient data on efficacy and safety. For adolescents (12-15 years), a lower dose is recommended. Inhaled beta-agonists are generally preferred for pediatric asthma.
Geriatric Use
Elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, arrhythmias, hypertension) and central nervous system effects (e.g., tremor, nervousness). Start with the lowest effective dose (2.5 mg three times a day) and titrate cautiously, monitoring closely for adverse reactions.
Clinical Information
Clinical Pearls
- Oral terbutaline is generally considered a second-line or alternative therapy for chronic asthma management due to systemic side effects compared to inhaled beta-agonists.
- It is not indicated for the relief of acute bronchospasm; a short-acting inhaled beta-agonist should be used for rescue.
- Tolerance to the bronchodilator effect may develop with prolonged use.
- Patients should be advised to report any worsening of asthma symptoms or increased need for rescue medication, as this may indicate deterioration of their condition.
- Monitor for hypokalemia, especially in patients with severe asthma or those receiving concomitant medications that can lower potassium (e.g., diuretics, corticosteroids).
Alternative Therapies
- Inhaled Short-Acting Beta-Agonists (SABAs) for rescue (e.g., albuterol, levalbuterol)
- Inhaled Long-Acting Beta-Agonists (LABAs) (e.g., salmeterol, formoterol) - often in combination with inhaled corticosteroids (ICS)
- Inhaled Corticosteroids (ICS) (e.g., fluticasone, budesonide)
- Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
- Methylxanthines (e.g., theophylline)
- Oral corticosteroids (for severe exacerbations or refractory asthma)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.