Terbutaline 2.5mg Tablets

Manufacturer LANNETT Active Ingredient Terbutaline Tablets(ter BYOO ta leen) Pronunciation ter BYOO ta leen
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.
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Drug Class
Bronchodilator
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Pharmacologic Class
Beta2-adrenergic agonist
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Pregnancy Category
Category B
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FDA Approved
Sep 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Terbutaline is a medication used to open up the airways in your lungs, making it easier to breathe. It's often prescribed for conditions like asthma or emphysema. It works by relaxing the muscles around your airways.
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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 your 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, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for safe and responsible disposal.

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 to make up for the missed one.
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Lifestyle & Tips

  • Take this medication exactly as prescribed by your doctor. Do not take more or less than directed.
  • Do not stop taking other asthma medications unless advised by your doctor.
  • Avoid smoking, as it can worsen lung conditions and reduce the effectiveness of the medication.
  • Report any worsening of breathing problems or increased need for the medication to your doctor immediately.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg three times a day, every 6 hours, while awake. May increase to 5 mg three times a day if needed and tolerated.
Dose Range: 2.5 - 5 mg

Condition-Specific Dosing:

maximumDailyDose: 15 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.075 mg/kg/dose three times a day, not to exceed 2.5 mg/dose. Maximum daily dose 7.5 mg.
Adolescent: 2.5 mg three times a day, every 6 hours, while awake. May increase to 5 mg three times a day if needed and tolerated. Maximum daily dose 15 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: Consider dose reduction (e.g., 50% of usual dose) or increased dosing interval.
Severe: Consider dose reduction (e.g., 50% of usual dose) or increased dosing interval.
Dialysis: Not well studied, use with caution. Terbutaline is partially dialyzable.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, monitor for adverse effects.
Severe: No specific adjustment recommended, monitor for adverse effects.

Pharmacology

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Mechanism of Action

Terbutaline is a selective beta2-adrenergic agonist. It stimulates beta2-adrenergic receptors in the smooth muscle of the bronchi, leading to relaxation of bronchial smooth muscle and bronchodilation. It also inhibits the release of mediators from mast cells in the airways.
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Pharmacokinetics

Absorption:

Bioavailability: 10-15%
Tmax: 1-2 hours
FoodEffect: Food may decrease the rate and extent of absorption.

Distribution:

Vd: 1.6 L/kg
ProteinBinding: 25%
CnssPenetration: Limited

Elimination:

HalfLife: 3-4 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as inactive sulfate conjugates, some unchanged drug)
Unchanged: Approximately 30-50% (oral dose)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-3 hours
DurationOfAction: 4-8 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal 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 and excitable
Shakiness
Restlessness
Headache
Feeling dizzy or sleepy

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or worsening shortness of breath
  • Chest pain or discomfort
  • Fast or irregular heartbeat (palpitations)
  • Severe dizziness or fainting
  • Muscle weakness or cramps (may indicate low potassium)
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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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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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.

Immediately contact your doctor if you experience any of the following:
- Your usual dose is not providing adequate relief
- Your symptoms worsen
- You need to use this medication more frequently than prescribed

Adhere strictly to the dosage instructions provided by your doctor. Taking more than the prescribed amount can significantly increase your risk of severe side effects.

Before using any other medications or inhalers for breathing problems, consult with your doctor to ensure safe and effective treatment.

If you have diabetes (high blood sugar), discuss this with your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar as directed by your healthcare provider.

For patients aged 65 and older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication for both you and your baby.

Special Considerations for Children
This medication is available in different forms, each suitable for specific age groups. Before administering this drug to a child, consult with their doctor to ensure the appropriate form and dosage are used.
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Overdose Information

Overdose Symptoms:

  • Exaggerated beta-adrenergic stimulation
  • Seizures
  • Angina
  • Hypertension or hypotension
  • Tachycardia (heart rate up to 200 bpm)
  • Arrhythmias
  • Nervousness
  • Headache
  • Tremor
  • Nausea
  • Dizziness
  • Dry mouth
  • Fatigue
  • Malaise
  • Insomnia
  • Hypokalemia
  • Hyperglycemia

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Treatment is supportive and symptomatic. Consider cautious use of a cardioselective beta-blocker for severe cardiac effects, but only under strict medical supervision due to risk of bronchospasm.

Drug Interactions

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Contraindicated Interactions

  • Non-selective beta-blockers (e.g., propranolol, nadolol)
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Major Interactions

  • Other sympathomimetics (e.g., epinephrine, pseudoephedrine)
  • MAO inhibitors (MAOIs)
  • Tricyclic antidepressants (TCAs)
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Moderate Interactions

  • Diuretics (e.g., thiazides, loop diuretics)
  • Digoxin
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Baseline vital signs (heart rate, blood pressure)

Rationale: To establish baseline and identify pre-existing cardiovascular conditions.

Timing: Prior to initiation of therapy

Serum potassium

Rationale: Beta2-agonists can cause transient hypokalemia.

Timing: Prior to initiation of therapy, especially in patients at risk (e.g., on diuretics)

Blood glucose

Rationale: Beta2-agonists can cause transient hyperglycemia.

Timing: Prior to initiation of therapy, especially in diabetic patients

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Routine Monitoring

Heart rate and rhythm

Frequency: Regularly, especially during dose titration or if symptoms of palpitations occur.

Target: Within normal limits for the patient, without significant tachycardia or arrhythmias.

Action Threshold: Persistent tachycardia (>120 bpm) or new onset arrhythmias; consider dose reduction or discontinuation.

Blood pressure

Frequency: Regularly, especially during dose titration.

Target: Within normal limits for the patient.

Action Threshold: Significant hypertension or hypotension.

Pulmonary function (e.g., FEV1, PEFR)

Frequency: Periodically, as clinically indicated, to assess therapeutic response.

Target: Improvement in baseline values.

Action Threshold: Lack of improvement or worsening of pulmonary function.

Serum potassium

Frequency: Periodically, especially in patients at risk for hypokalemia or on high doses.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.0 mEq/L; consider potassium supplementation or dose adjustment.

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Symptom Monitoring

  • Worsening shortness of breath or wheezing
  • Increased frequency of rescue inhaler use (if applicable)
  • Palpitations or chest pain
  • Tremor or nervousness
  • Muscle cramps or weakness (suggestive of hypokalemia)
  • Headache
  • Dizziness

Special Patient Groups

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Pregnancy

Terbutaline is classified as Pregnancy Category B. While animal studies have shown some adverse effects at high doses, 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.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Generally considered safe for short-term use if needed for asthma control.
Third Trimester: May inhibit uterine contractions and cause transient maternal and fetal tachycardia, hyperglycemia, and hypokalemia. Neonatal hypoglycemia has been reported.
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Lactation

Terbutaline is excreted into breast milk. The amount is small, and adverse effects on the breastfed infant are unlikely, but theoretical risks of beta-adrenergic effects (e.g., tachycardia, tremor) exist. Use with caution, monitor infant for adverse effects.

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Oral terbutaline is generally not preferred for chronic asthma management in children due to systemic side effects and the availability of more effective inhaled therapies. If used, dosing must be carefully weight-based. Children may be more susceptible to CNS and cardiovascular side effects.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to the cardiovascular and CNS adverse effects of beta-agonists (e.g., tremor, nervousness, tachycardia, hypertension). Start with lower doses and titrate slowly. Monitor for underlying cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Oral terbutaline is less commonly used for asthma than inhaled beta-agonists due to a higher incidence of systemic side effects (e.g., tremor, tachycardia).
  • It is a long-acting oral bronchodilator, but its onset is slower than inhaled short-acting beta-agonists.
  • Patients should be advised not to exceed the prescribed dose due to the risk of serious cardiovascular adverse effects.
  • Educate patients on the difference between oral terbutaline and inhaled rescue medications.
  • Monitor for hypokalemia, especially in patients on concomitant diuretics or corticosteroids.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (e.g., albuterol, levalbuterol)
  • Inhaled long-acting beta-agonists (e.g., salmeterol, formoterol) - typically in combination with inhaled corticosteroids
  • Inhaled corticosteroids (e.g., fluticasone, budesonide)
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Theophylline (oral)
  • Anticholinergics (e.g., ipratropium, tiotropium)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.