Ambroxol + Flavoured Mentholated base + Guaifenesin + Terbutaline

Usage

This combination medication is primarily prescribed for the symptomatic relief of productive cough associated with various respiratory conditions, including:

• Bronchitis (acute and chronic)
• Bronchial asthma
• Emphysema
• Chronic Obstructive Pulmonary Disease (COPD)
• Other bronchopulmonary disorders where bronchospasm, mucus plugging, and difficulty expectorating coexist
• Upper respiratory tract infections

Pharmacological Classification: This combination drug falls under multiple classifications due to its components:

• Mucolytic: (Ambroxol)
• Expectorant: (Guaifenesin)
• Bronchodilator: (Terbutaline)
• Topical Anesthetic/Demulcent: (Menthol/Flavoured Mentholated base)

Mechanism of Action:

• Ambroxol breaks down mucopolysaccharides in the mucus, reducing its viscosity and making it easier to expectorate.
• Guaifenesin increases respiratory tract fluid volumes, further thinning the mucus and promoting its removal.
• Terbutaline, a beta-2 adrenergic agonist, relaxes the smooth muscles in the airways, leading to bronchodilation and improved airflow.
• Menthol provides a cooling sensation and soothes throat irritation.

Alternate Names

There isn’t a single, universally recognized alternate name for this specific combination. However, depending on the region and specific formulation, similar combinations may exist under different generic names. The medication is marketed under various brand names, depending on the manufacturer and country. Some examples include “Tussquit XP Expectorant” and “Lavicof-T.” A doctor or pharmacist can confirm whether a particular brand contains this specific drug combination.

How It Works

Pharmacodynamics:

• Ambroxol decreases mucus viscosity and promotes its clearance from the airways.
• Guaifenesin enhances respiratory secretions, making the mucus less sticky and easier to cough out.
• Terbutaline relaxes bronchial smooth muscle, causing bronchodilation and relieving bronchospasm.
• Menthol provides a soothing and cooling effect on the irritated throat mucosa.

Pharmacokinetics:

• Absorption: All components are absorbed orally. Specific absorption rates can vary depending on the formulation.
• Metabolism: Primarily hepatic (liver) metabolism, specifically through CYP450 enzymes for Terbutaline.
• Elimination: Primarily renal (kidney) excretion. Ambroxol metabolites may accumulate in patients with severe renal impairment.

Mode of Action (Cellular/Molecular Level):

• Ambroxol stimulates the secretion of surfactant by type II pneumocytes, which reduces surface tension within the alveoli, preventing their collapse.
• Guaifenesin acts by irritating gastric vagal receptors, triggering a reflex increase in respiratory tract fluid production.
• Terbutaline binds to beta-2 adrenergic receptors on bronchial smooth muscle cells, activating intracellular signaling cascades that lead to muscle relaxation and bronchodilation.

Dosage

Standard Dosage

Adults: The typical adult dosage is 10 mL of syrup three times daily. However, this can vary based on the specific formulation. Always consult the product labeling.

Children: Dosing in children varies by age and formulation. For syrup formulations, children 2-6 years may receive 2.5 mL three times daily, and children 6-12 years may receive 5 mL three times daily. Drops may be used in children 6 months and older, but the dosing should be adjusted based on weight or age as per the product information.

Special Cases:

• Elderly Patients: Start with the lower end of the adult dose range and monitor closely for adverse effects.
• Patients with Renal Impairment: Dose reduction and/or increased dosing intervals may be necessary depending on the degree of impairment.
• Patients with Hepatic Dysfunction: Close monitoring is advised. Dose adjustments may be necessary for terbutaline and ambroxol due to their hepatic metabolism.
• Patients with Comorbid Conditions: Pre-existing heart disease (especially ischemic heart disease), diabetes mellitus, hyperthyroidism, gastric ulceration, and epilepsy require caution. Dose adjustments and close monitoring may be necessary.

Clinical Use Cases

Dosing in specialized medical settings like intubation, surgical procedures, mechanical ventilation, or ICU is generally guided by the standard dosing guidelines and adjusted based on the patient’s specific needs and condition. Always consult with the product information and/or senior colleagues.

Dosage Adjustments

Dose adjustments must be made in cases of renal or hepatic dysfunction, metabolic disorders, or genetic polymorphisms affecting drug metabolism. The specific adjustment depends on the severity of the impairment and the individual patient response.

Side Effects

Common Side Effects:

Nausea, diarrhea, vomiting, stomach discomfort, dizziness, headache, rash, tremor, increased heart rate, palpitations, sweating, muscle cramps, drowsiness.

Rare but Serious Side Effects:

Allergic reactions (rash, itching, swelling, difficulty breathing), hypokalemia, changes in blood pressure, myocardial ischemia.

Long-Term Effects: Chronic terbutaline use may lead to tolerance and decreased effectiveness, and potentially to cardiovascular complications.

Adverse Drug Reactions (ADR): Clinically significant ADRs requiring immediate intervention include severe allergic reactions, significant changes in blood pressure or heart rate, and hypokalemia.

Contraindications

• Hypersensitivity to any of the components
• Pre-existing ischemic heart disease
• Gastric ulceration
• Hypertrophic cardiomyopathy
• Thyrotoxicosis (use with caution)

Drug Interactions

• Beta-blockers (may reduce terbutaline’s effectiveness)
• Sympathomimetic agents (additive effects on the cardiovascular system)
• Halogenated anesthetics (increased risk of cardiac arrhythmias with terbutaline)
• Digoxin, safinamide, rasagiline, propranolol, ondansetron, promethazine, budesonide, xanthines, aminophylline, formoterol, furosemide, antidepressants, corticosteroids, and some antibiotics.

Pregnancy and Breastfeeding

Use with caution during pregnancy and breastfeeding. Although limited data suggest no significant risk, potential fetal risks and neonatal exposure should be considered. Consult with a specialist and weigh the potential benefits against risks if prescribing to pregnant or breastfeeding women.

Drug Profile Summary

• Mechanism of Action: Ambroxol (mucolytic), Guaifenesin (expectorant), Terbutaline (bronchodilator), Menthol (soothing agent).
• Side Effects: Nausea, dizziness, headache, tremor, increased heart rate, allergic reactions.
• Contraindications: Hypersensitivity, ischemic heart disease, gastric ulcer.
• Drug Interactions: Beta-blockers, sympathomimetics, various other medications (see Drug Interactions section).
• Pregnancy & Breastfeeding: Use with caution. Limited data, but potential risks exist.
• Dosage: Adults: 10mL TID. Pediatric and special adjustments exist. See Dosage section.
• Monitoring Parameters: Respiratory rate, oxygen saturation, heart rate, blood pressure, potassium levels.

Popular Combinations

This combination is already a commonly used multi-drug therapy. Individual components may be combined with other drugs to address specific patient needs, but this should be done with caution, considering potential interactions.

Precautions

• Pre-screen patients for allergies, metabolic disorders, organ dysfunction.
• Pregnant women and Breastfeeding mothers: Use with caution. Discuss benefits and risks with a specialist.
• Children and elderly: Use age-appropriate formulations and dosing. Start with lower doses and monitor closely. Monitor blood glucose in diabetic patients. Avoid alcohol, as it may potentiate side effects like dizziness and drowsiness.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Ambroxol + Flavoured Mentholated base + Guaifenesin + Terbutaline?

A: The standard adult dosage is 10 mL TID, but this can vary based on the formulation. Pediatric and special population dosing exists. Refer to the Dosage section.

Q2: What are the common side effects?

A: Common side effects include nausea, vomiting, stomach discomfort, dizziness, headache, tremor, and increased heart rate.

Q3: Is it safe during pregnancy and breastfeeding?

A: Use with caution. Limited data is available, but potential risks to the fetus and neonate should be considered. Discuss with a specialist.

Q4: What are the major drug interactions?

A: Beta-blockers, sympathomimetics, and a variety of other drugs can interact. Consult the detailed Drug Interactions section.

Q5: Can this combination be used in patients with renal impairment?

A: Use with caution. Dose adjustments are generally necessary based on the degree of impairment.

Q6: Can this combination be used in patients with hepatic impairment?

A: Use with caution. Close monitoring is essential. Dose adjustments may be necessary.

Q7: What are the contraindications for this drug combination?

A: Hypersensitivity, ischemic heart disease, gastric ulceration are absolute contraindications.

Q8: What are the monitoring parameters for patients on this medication?

A: Monitor respiratory rate, oxygen saturation, heart rate, blood pressure, and potassium levels.

Q9: Can this medication be used in children?

A: Yes, but age-appropriate formulations and dosing should be used. Drops are available for younger children.

Q10: What should patients be advised regarding lifestyle while taking this medication?

A: Patients should avoid alcohol and driving, as the medication may cause dizziness and drowsiness. Smoking should also be avoided.