Terbutaline 1mg/ml Inj, 1ml

Manufacturer FRESENIUS KABI Active Ingredient Terbutaline Injection(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
Selective Beta-2 Adrenergic Agonist
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Pregnancy 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 injection is a medicine used to quickly open up the airways in your lungs, making it easier to breathe during severe asthma attacks or other breathing problems. 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. It is essential to follow the instructions carefully. This medication is administered via injection into the fatty tissue under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid known triggers for your breathing problems (e.g., allergens, smoke, cold air).
  • Follow your doctor's instructions for other asthma medications (e.g., inhaled corticosteroids) for long-term control.
  • Do not use this injection for routine, long-term breathing control; it is for acute relief only.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.25 mg subcutaneously into the lateral deltoid area. May repeat in 15-30 minutes if no significant improvement.
Dose Range: 0.25 - 0.5 mg

Condition-Specific Dosing:

maximumDose: 0.5 mg in a 4-hour period
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 12-15 years: 0.25 mg subcutaneously, may repeat in 15-30 minutes (max 0.5 mg in 4 hours). For children <12 years: 0.01 mg/kg subcutaneously (max 0.25 mg), may repeat in 15-20 minutes if needed (max 0.03 mg/kg or 0.5 mg in 4 hours). Use with caution and generally not preferred over inhaled therapy.
Adolescent: For children 12-15 years: 0.25 mg subcutaneously, may repeat in 15-30 minutes (max 0.5 mg in 4 hours).
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Dose Adjustments

Renal Impairment:

Mild: Adjustment may be necessary; monitor for increased adverse effects.
Moderate: Consider dose reduction; monitor for increased adverse effects.
Severe: Consider significant dose reduction; monitor closely for increased adverse effects.
Dialysis: Consider dose reduction; monitor closely. Terbutaline is dialyzable.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: No specific adjustment recommended, but use with caution.

Pharmacology

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Mechanism of Action

Terbutaline is a selective beta-2 adrenergic agonist. It stimulates beta-2 receptors in bronchial smooth muscle, leading to activation of adenyl cyclase, increased intracellular cyclic AMP (cAMP), and subsequent relaxation of bronchial smooth muscle, resulting in bronchodilation. It also inhibits the release of mediators from mast cells.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (for SC, generally high)
Tmax: 0.5-1 hour (subcutaneous)
FoodEffect: Not applicable (parenteral)

Distribution:

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

Elimination:

HalfLife: 3-4 hours
Clearance: Not available
ExcretionRoute: Renal (primarily)
Unchanged: Approximately 60% (renal)
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (subcutaneous)
PeakEffect: 30-60 minutes (subcutaneous)
DurationOfAction: 4-6 hours (subcutaneous)

Safety & Warnings

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BLACK BOX WARNING

Terbutaline Sulfate Injection is not approved for prolonged tocolysis (beyond 48-72 hours) in pregnant women. In particular, it should not be used for maintenance tocolysis. Serious adverse reactions, including maternal death, have been reported after administration of terbutaline to pregnant women. In the setting of preterm labor, the risk of serious maternal adverse reactions should be weighed against the potential benefits.
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Side Effects

Serious Side Effects: Seek Medical Attention 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 help 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, excessive 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
Rapid 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

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 chest pain or discomfort
  • Very rapid or irregular heartbeat (palpitations)
  • Severe tremor or shakiness
  • Worsening shortness of breath or wheezing after injection (paradoxical bronchospasm)
  • Dizziness or fainting
  • Unusual weakness or muscle cramps (signs of 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 you experienced, including any symptoms that occurred.
If you have a history of irregular or rapid heartbeat.
* If you are currently experiencing preterm labor or having a miscarriage.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe use of this medication.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that this medication can be taken safely with all your other medications and health conditions.
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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.

Patients aged 65 and older should exercise caution when using this medication, as they 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 to 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 effects: tachycardia, palpitations, arrhythmias, tremor, nervousness, headache, dizziness, nausea, muscle cramps, hypokalemia, hyperglycemia, and in severe cases, seizures or cardiac arrest.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive. In severe cases, a cardioselective beta-blocker may be considered, but use with extreme caution due to risk of bronchospasm. Monitor serum potassium and provide replacement if needed.

Drug Interactions

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Major Interactions

  • Non-selective beta-blockers (e.g., propranolol): May antagonize the bronchodilating effect of terbutaline and cause severe bronchospasm.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of terbutaline, leading to increased risk of arrhythmias, tachycardia, or hypertension.
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Moderate Interactions

  • Other sympathomimetics: Additive cardiovascular effects (e.g., increased heart rate, blood pressure).
  • Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia induced by beta-agonists, especially at higher doses.
  • Digoxin: May decrease serum digoxin levels.

Monitoring

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Baseline Monitoring

Heart Rate

Rationale: To assess baseline cardiovascular status and monitor for tachycardia.

Timing: Prior to administration

Blood Pressure

Rationale: To assess baseline cardiovascular status and monitor for hypertension/hypotension.

Timing: Prior to administration

Respiratory Rate and Effort

Rationale: To assess baseline respiratory status and monitor response to bronchodilation.

Timing: Prior to administration

Oxygen Saturation

Rationale: To assess baseline oxygenation and monitor improvement.

Timing: Prior to administration

Serum Potassium

Rationale: Beta-agonists can cause transient hypokalemia.

Timing: Prior to administration, especially in patients at risk or on diuretics

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Routine Monitoring

Heart Rate and Rhythm

Frequency: Every 15-30 minutes during acute use, then as clinically indicated.

Target: Within patient's normal range or improving from baseline.

Action Threshold: Persistent tachycardia (>120 bpm) or arrhythmias; notify provider.

Blood Pressure

Frequency: Every 15-30 minutes during acute use, then as clinically indicated.

Target: Within patient's normal range.

Action Threshold: Significant hypertension or hypotension; notify provider.

Respiratory Status (rate, effort, breath sounds)

Frequency: Every 15-30 minutes during acute use, then as clinically indicated.

Target: Decreased respiratory rate, less effort, improved breath sounds (less wheezing).

Action Threshold: Worsening dyspnea, increased wheezing, paradoxical bronchospasm; notify provider.

Serum Potassium

Frequency: As clinically indicated, especially with prolonged use or concomitant diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L; consider supplementation and notify provider.

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Symptom Monitoring

  • Tremor
  • Palpitations
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Muscle cramps
  • Worsening dyspnea or wheezing (paradoxical bronchospasm)

Special Patient Groups

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Pregnancy

Category B. While animal studies have not shown harm, human data are limited. Terbutaline injection is NOT approved for prolonged tocolysis due to serious maternal adverse events, including death. For acute bronchospasm in pregnancy, use only if the potential benefit justifies the potential risk to the mother and fetus. Monitor for maternal tachycardia, hyperglycemia, and hypokalemia.

Trimester-Specific Risks:

First Trimester: Limited data, generally avoided unless essential.
Second Trimester: Use with caution, monitor maternal and fetal heart rate.
Third Trimester: Use with caution, monitor maternal and fetal heart rate, and for maternal adverse effects (tachycardia, hypokalemia, hyperglycemia). Not for prolonged tocolysis.
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Lactation

L3 (Moderately safe). Terbutaline is excreted into breast milk. While adverse effects in breastfed infants are generally not expected with typical therapeutic doses, monitor the infant for signs of irritability, tremor, or tachycardia.

Infant Risk: Low to moderate; potential for mild beta-adrenergic effects (e.g., irritability, tremor, tachycardia) in the infant, especially with higher maternal doses.
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Pediatric Use

Use with caution, especially in children under 12 years of age. The subcutaneous route is generally reserved for severe acute bronchospasm when inhaled therapy is insufficient or not feasible. Dosing must be carefully calculated based on weight. Children may be more susceptible to adverse effects.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the cardiovascular and central nervous system effects of beta-agonists. Start with lower doses and titrate slowly. Monitor closely for adverse effects such as tachycardia, tremor, and hypokalemia.

Clinical Information

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Clinical Pearls

  • Terbutaline injection is typically reserved for acute, severe bronchospasm when inhaled beta-agonists are ineffective or cannot be administered.
  • It is not indicated for long-term maintenance therapy of asthma or other chronic respiratory conditions.
  • Always monitor heart rate, blood pressure, and respiratory status closely after administration.
  • Be aware of the Black Box Warning regarding its use for prolonged tocolysis, even if prescribing for bronchospasm, as this is a significant safety concern associated with the drug.
  • Hypokalemia can occur, especially with concomitant use of diuretics or corticosteroids; monitor serum potassium levels if clinically indicated.
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Alternative Therapies

  • Albuterol (inhaled, oral, IV)
  • Levalbuterol (inhaled)
  • Epinephrine (subcutaneous, IM)
  • Ipratropium (inhaled, often in combination with albuterol)
  • Systemic corticosteroids (e.g., methylprednisolone, prednisone) for severe exacerbations
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Cost & Coverage

Average Cost: Low cost per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about your medication, discuss them with 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. Be prepared to provide information about the medication taken, the amount, and the time it happened, as this will aid in receiving appropriate care.