Usage
This combination medication is primarily used for the symptomatic relief of cough and cold symptoms, especially dry cough associated with upper respiratory tract infections (URTIs). It is important to note that it does not treat the underlying infection, only the symptoms.
Pharmacological Classifications:
- Bromhexine: Mucolytic, expectorant
- Dextromethorphan Hydrobromide: Antitussive (cough suppressant)
- Phenylpropanolamine: Decongestant (Nasal decongestant)
Mechanism of Action:
- Bromhexine works by breaking down the thick mucus secretions in the airways, making it easier to expectorate.
- Dextromethorphan suppresses the cough reflex by acting on the cough center in the brain.
- Phenylpropanolamine acts as a decongestant by constricting blood vessels in the nasal passages, reducing swelling and congestion.
Alternate Names
This combination doesn’t have a universally recognized international nonproprietary name (INN). It is often referred to by the combination of its components. Brand names vary depending on the manufacturer and region. Some examples mentioned in the source include Tuxiril X Syrup, Kofnok, P Dex syrup, and Mucobron Forte. It is important to note that Mucobron Forte also contains other ingredients, so is not strictly an alternative name for Bromhexine + Dextromethorphan Hydrobromide + Phenylpropanolamine.
How It Works
Pharmacodynamics:
- Bromhexine: Decreases the viscosity of mucus by breaking down mucopolysaccharide fibers. This facilitates easier expectoration and improves airway clearance.
- Dextromethorphan: Acts centrally on the cough center in the medulla to suppress the cough reflex. It does not have analgesic or addictive properties like opioid cough suppressants.
- Phenylpropanolamine: Stimulates alpha-adrenergic receptors in the nasal mucosa causing vasoconstriction, which reduces blood flow and nasal congestion.
Pharmacokinetics:
All three components are absorbed orally. They are metabolized in the liver, specifically dextromethorphan undergoes metabolism through the CYP2D6 and CYP3A4 enzyme systems. Elimination occurs mainly through renal excretion, especially for phenylpropanolamine.
Mode of Action:
- Bromhexine: Depolymerizes mucopolysaccharides.
- Dextromethorphan: NMDA receptor antagonist (at high doses), sigma-1 receptor agonist.
- Phenylpropanolamine: Alpha-adrenergic receptor agonist.
Elimination Pathways: Primarily renal excretion, with hepatic metabolism playing a role, especially for dextromethorphan.
Dosage
Dosage varies depending on the specific product formulation and the patient’s age, weight, and medical condition. Always refer to the manufacturer’s prescribing information for detailed dosing instructions. However, phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke, and many regulatory bodies advise against its use.
Standard Dosage
Due to the safety concerns related to phenylpropanolamine, providing a standard dosage can be misleading. It is crucial to consult up-to-date local guidelines and regulations. Phenylpropanolamine is often unavailable or restricted in many regions. If it is available, the usual individual component doses for adults would be: Bromhexine (8-16mg three times daily), Dextromethorphan (10-20mg every four hours, with maximum of 120 mg/day). Always consult specific product information for guidance.
Children:
Use with caution in children, particularly under 4 years of age. Consult a pediatrician or pediatric dosing charts for appropriate guidance. Phenylpropanolamine is generally avoided in children.
Special Cases:
Dose adjustments are usually needed for patients with renal or hepatic impairment, the elderly, and patients with other comorbid conditions. Individualized dosing based on clinical evaluation is essential.
Clinical Use Cases
The combination is not typically recommended for use in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Adjustments are needed for patients with hepatic or renal impairment and based on the patient’s overall clinical status.
Side Effects
Common Side Effects:
Nausea, dizziness, drowsiness, rash, itching, headache, dry mouth, insomnia, restlessness, stomach upset, vomiting.
Rare but Serious Side Effects:
Allergic reactions (difficulty breathing, swelling of face, hives), cardiac effects (palpitations, tachycardia).
Long-Term Effects:
Chronic complications from prolonged use are not typically reported for this specific combination. However, prolonged use of phenylpropanolamine can carry cardiovascular risks.
Adverse Drug Reactions (ADR):
Serious allergic reactions, significant cardiovascular effects.
Contraindications
Hypersensitivity to any of the components, concurrent or recent use of MAO inhibitors, severe cardiovascular or thyroid disease, angle-closure glaucoma. Phenylpropanolamine is generally contraindicated in pregnancy and breastfeeding.
Drug Interactions
MAO inhibitors, alcohol, other CNS depressants, antidepressants (TCAs, SSRIs), antihistamines, sedatives, opioids, antihypertensives, other cough and cold medications, caffeine.
Pregnancy and Breastfeeding
This combination should generally be avoided during pregnancy and breastfeeding due to the risks associated with phenylpropanolamine. Consult a doctor for safer alternatives.
Drug Profile Summary
- Mechanism of Action: Bromhexine thins mucus, dextromethorphan suppresses cough, phenylpropanolamine decongests.
- Side Effects: Nausea, dizziness, drowsiness, rash, itching. Rarely, serious allergic reactions or cardiac effects.
- Contraindications: Hypersensitivity, MAOI use, severe cardiovascular or thyroid disease, angle-closure glaucoma.
- Drug Interactions: MAOIs, alcohol, other CNS depressants.
- Pregnancy & Breastfeeding: Consult a doctor; phenylpropanolamine is generally avoided.
- Dosage: See detailed section above. Phenylpropanolamine’s use is restricted.
- Monitoring Parameters: Respiratory status, blood pressure, heart rate.
Popular Combinations
While bromhexine and dextromethorphan are frequently combined, phenylpropanolamine is often replaced with other decongestants. Combinations with guaifenesin may also be found.
Precautions
Use with caution in patients with hepatic or renal impairment, prostatic hyperplasia, asthma. Avoid alcohol during treatment. Caution when operating machinery or driving.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine + Dextromethorphan Hydrobromide + Phenylpropanolamine?
A: Phenylpropanolamine is often unavailable or its use is restricted. If available, typical individual doses for adults are: Bromhexine (8-16 mg three times daily), Dextromethorphan (10-20 mg every four hours, max 120 mg/day). Always consult specific product information and local guidelines, as availability and recommendations vary. Pediatric dosages should be determined by a healthcare professional.
Q2: Can this combination be used in children?
A: Use with caution in children, especially under 4 years old. Consult pediatric dosing charts or a healthcare professional. Phenylpropanolamine is generally avoided in children.
Q3: What are the contraindications for this combination?
A: Hypersensitivity, MAOI use, severe cardiovascular or thyroid disease, angle-closure glaucoma, pregnancy (for phenylpropanolamine).
Q4: What are the major drug interactions?
A: MAOIs, alcohol, CNS depressants, some antidepressants, antihistamines, sedatives, opioids.
Q5: Is this combination safe during pregnancy and breastfeeding?
A: Phenylpropanolamine is generally avoided during pregnancy and breastfeeding. Consult a doctor regarding safety and alternatives.
Q6: What are the common side effects?
A: Nausea, dizziness, drowsiness, rash, itching.
Q7: What are the serious side effects?
A: Allergic reactions (difficulty breathing, facial swelling), cardiac effects (tachycardia).
Q8: What should patients be monitored for?
A: Respiratory status, blood pressure, and heart rate. For prolonged use, liver function tests may be considered.
Q9: Are there any specific lifestyle considerations while taking this medication?
A: Avoid alcohol and activities requiring alertness (like driving) as the medication can cause drowsiness.
Q10: Why is phenylpropanolamine restricted or unavailable in many regions?
A: Due to the increased risk of hemorrhagic stroke associated with its use.
