Usage
Ambroxol + Terbutaline is prescribed for the relief of productive cough associated with respiratory diseases where bronchospasm, mucus plugging, and difficulty in expectoration coexist. These conditions include bronchitis, bronchial asthma, emphysema, and other bronchopulmonary disorders.
Pharmacological Classification:
- Ambroxol: Mucolytic, Expectorant
- Terbutaline: Bronchodilator, Beta2-adrenergic agonist
Mechanism of Action: Ambroxol works by breaking down the structure of mucus, making it less viscous and easier to expel. Terbutaline relaxes the smooth muscles of the airways, widening them and facilitating breathing. The combination facilitates expectoration and improves airflow in the respiratory tract.
Alternate Names
There are no widely recognized alternate names for this specific combination. However, the individual components have alternate names:
- Ambroxol: Ambroxol hydrochloride
- Terbutaline: Terbutaline sulfate
Brand names vary regionally and internationally. Examples of brand names include “Trump A”, “SANCOFF-A”, and others. Always verify the composition of a particular brand before prescribing.
How It Works
Pharmacodynamics: Ambroxol increases the production of serous secretions in the respiratory tract and improves mucociliary clearance. Terbutaline stimulates beta-2 adrenergic receptors in the lungs, leading to bronchodilation.
Pharmacokinetics:
- Ambroxol: Well absorbed orally. Metabolized primarily in the liver and excreted renally.
- Terbutaline: Administered orally, it is metabolized by conjugation with sulfate and glucuronide. Elimination is primarily renal.
Mode of Action: Ambroxol reduces the viscosity of mucus by breaking down mucopolysaccharide fibers. Terbutaline relaxes bronchial smooth muscle through beta-2 receptor stimulation.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Terbutaline acts as a beta-2 adrenergic receptor agonist. Ambroxol does not have significant receptor binding or enzyme inhibition activity related to its mucolytic action.
Elimination Pathways: Both drugs are primarily eliminated through renal excretion.
Dosage
Standard Dosage
Adults:
- Syrup: 10-20 ml three times daily
- Tablets: Ambroxol 30 mg tablets 1-4 tablets in 2 to 3 divided doses; Terbutaline 2.5-5mg, three times daily.
Children: Dosage should be determined by a physician based on age and weight.
- Children (6-12 years): 5-10 ml of syrup three times daily.
- Children (under 6 years): 5 ml of syrup three times daily or as directed by the physician.
- Oral drops for children (6 months – 2 years): 1ml twice a day or 0.5ml three times a day.
Special Cases:
- Elderly Patients: Dose adjustment may be necessary due to potential age-related decline in renal and hepatic function. Close monitoring is recommended.
- Patients with Renal Impairment: Reduce dosage or increase dosing interval. Closely monitor renal function.
- Patients with Hepatic Dysfunction: Use with caution and consider dose adjustment.
- Patients with Comorbid Conditions: Careful evaluation is needed for patients with hypertension, cardiovascular disease, diabetes, hyperthyroidism, or seizures.
Clinical Use Cases
Dosage in clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be individualized based on patient needs and closely monitored.
Dosage Adjustments
Dose modifications are necessary based on individual patient factors, including renal and hepatic function, comorbidities, and potential drug interactions. Closely monitor for efficacy and adverse effects.
Side Effects
Common Side Effects:
Nausea, vomiting, dizziness, headache, tremor, nervousness, sweating, muscle cramps, gastrointestinal upset, drowsiness, tachycardia, palpitations.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, angioedema), paradoxical bronchospasm, arrhythmias, myocardial ischemia, hypotension, seizures, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Long-Term Effects:
Potential for tolerance to the bronchodilator effects of terbutaline with prolonged use.
Contraindications
- Hypersensitivity to any component of the formulation.
- Pre-existing ischemic heart disease or significant risk factors for it.
- Thyrotoxicosis
- Gastric ulcer
- Hypertrophic cardiomyopathy
- Pheochromocytoma
- Hypersensitivity to ambroxol, terbutaline, guaiphenesin.
Drug Interactions
- Beta-blockers (e.g., propranolol): May antagonize the bronchodilator effects of terbutaline.
- Sympathomimetic agents: Additive effects on the cardiovascular system.
- MAO inhibitors or tricyclic antidepressants: Potentiate the effects of terbutaline on the vascular system.
- Halogenated anesthetics: Increased risk of cardiac arrhythmias.
- Diuretics (loop or thiazide): May increase the risk of hypokalemia.
- Certain antibiotics (e.g., amoxicillin, cefuroxime, erythromycin): Ambroxol may increase the concentration of these antibiotics in bronchial secretions.
- Antitussives: May lead to mucus accumulation.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C (Terbutaline). Ambroxol should be avoided, especially during the first trimester.
- Fetal risks: Potential for tachycardia and other cardiovascular effects in the fetus. Terbutaline is contraindicated for preventing premature labor.
- Breastfeeding: Terbutaline is likely safe in breastfeeding mothers. Ambroxol passes into breast milk; use with caution.
Drug Profile Summary
- Mechanism of Action: Ambroxol reduces mucus viscosity; Terbutaline dilates bronchi.
- Side Effects: Nausea, tremor, tachycardia, headache, dizziness. Serious side effects are rare but possible.
- Contraindications: Hypersensitivity, ischemic heart disease, thyrotoxicosis, gastric ulcer.
- Drug Interactions: Beta-blockers, sympathomimetics, MAO inhibitors, diuretics.
- Pregnancy & Breastfeeding: Terbutaline is Pregnancy Category C, Ambroxol use with caution while breastfeeding.
- Dosage: Adult and pediatric dosages vary; adjust for renal/hepatic impairment.
- Monitoring Parameters: Respiratory rate, heart rate, blood pressure, potassium levels.
Popular Combinations
Frequently combined with other medications for respiratory conditions, including corticosteroids and other bronchodilators. The rationale is to achieve better management of inflammation and bronchospasm.
Precautions
- Assess for allergies, renal/hepatic dysfunction, and cardiovascular disease.
- Monitor potassium levels, especially with concomitant use of diuretics.
- Avoid concomitant use with beta-blockers.
- Caution in patients with diabetes, hypertension, and seizure disorders.
- May impair ability to drive or operate machinery.
- Ensure adequate hydration.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Terbutaline?
A: Adult dosage varies by formulation (syrup, tablet) and individual factors. Consult dosage section for specific guidelines. Pediatric dosage needs careful calculation based on age and weight.
Q2: What are the main side effects?
A: Common side effects include nausea, vomiting, tremor, dizziness, headache, nervousness. Serious side effects are rare.
Q3: Can this combination be used during pregnancy?
A: Terbutaline is Pregnancy Category C and ambroxol should be avoided especially in the first trimester. It is crucial to consult a doctor about using this combination during pregnancy as the drug should only be used if the potential benefit justifies the potential risk to the fetus.
Q4: What are the contraindications?
A: Contraindications include hypersensitivity, ischemic heart disease, thyrotoxicosis, gastric ulcer, and pheochromocytoma.
Q5: How does this combination interact with other drugs?
A: It can interact with beta-blockers, sympathomimetics, MAO inhibitors, tricyclic antidepressants, diuretics, some antibiotics, and antitussives. Refer to drug interaction section for details.
Q6: Can patients operate machinery while taking this medication?
A: Caution should be exercised as this combination may cause dizziness or drowsiness.
Q7: What precautions are necessary for elderly patients?
A: Dose adjustment is often necessary and close monitoring is crucial due to age-related changes in renal and hepatic function.
Q8: Are there any specific dietary restrictions with this medication?
A: No specific dietary restrictions, but adequate fluid intake is recommended to aid in mucus thinning and clearance. Avoid caffeine.
Q9: Should patients with diabetes take any precautions?
A: Yes, patients with diabetes should monitor their blood glucose regularly while taking this medication and inform their doctor if they notice any significant changes.
