Ambroxol + Chlorpheniramine Maleate + Dextromethorphan Hydrobromide + Phenylephrine

Usage

• This combination medication is prescribed for the relief of symptoms associated with the common cold, allergies, and other upper respiratory tract infections. These symptoms may include cough (both dry and productive), nasal and chest congestion, runny nose, sneezing, itchy or watery eyes, and throat irritation.
• Pharmacological Classification: This is a combination drug containing a mucolytic (ambroxol), an antihistamine (chlorpheniramine maleate), a cough suppressant (dextromethorphan hydrobromide), and a decongestant (phenylephrine).
• Mechanism of Action: Briefly, ambroxol thins and loosens mucus; chlorpheniramine blocks histamine, reducing allergic symptoms; dextromethorphan suppresses the cough reflex; and phenylephrine constricts blood vessels, reducing nasal congestion.

Alternate Names

• No widely recognized alternate names exist for this specific four-component combination. However, each individual component has other names (e.g., ambroxol hydrochloride).
• Brand Names: This combination is available under various brand names, which may vary regionally. Some examples include Cofvex AD, Ellkuf-AD and IFCOF-NOW DX.

How It Works

• Pharmacodynamics: Ambroxol breaks down mucopolysaccharides, reducing mucus viscosity. Chlorpheniramine antagonizes H1 histamine receptors, relieving allergic symptoms. Dextromethorphan acts centrally in the medulla to suppress the cough reflex. Phenylephrine is an alpha-1 adrenergic agonist, causing vasoconstriction in the nasal mucosa, which reduces congestion.
• Pharmacokinetics: Absorption, metabolism, and elimination for each component vary. Ambroxol is well-absorbed orally. Chlorpheniramine undergoes hepatic metabolism. Dextromethorphan is also metabolized in the liver. Phenylephrine is metabolized by monoamine oxidase. Elimination pathways are primarily renal and hepatic.
• Mode of Action: At the cellular level, ambroxol alters the structure and function of serous and mucous cells in the respiratory tract. Chlorpheniramine competitively inhibits histamine binding to H1 receptors. Dextromethorphan acts on sigma opioid receptors and NMDA receptors in the CNS. Phenylephrine activates alpha-1 adrenergic receptors on vascular smooth muscle.
• Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Chlorpheniramine exhibits receptor binding (H1 receptor antagonism). Dextromethorphan modulates neurotransmitter activity. Phenylephrine binds to alpha-1 adrenergic receptors.

Dosage

Standard Dosage

Adults: Syrup formulations commonly contain specific concentrations of each component per 5 mL. Typical adult dosage is 5-10 mL every 4-6 hours, not exceeding a maximum daily dose for each component (check specific product labeling). Tablet formulations are also available.

Children: Dosages are usually based on age or weight and require careful calculation to avoid exceeding maximum daily limits for each component. Pediatric doses are lower than adult doses and depend on the specific formulation and age group. Please see dosage information for children in sources 3, 11 and 24.

Special Cases:

• Elderly Patients: Begin with lower doses and titrate upwards as needed, monitoring carefully for adverse effects.
• Patients with Renal Impairment: Dose adjustments are usually needed based on the degree of impairment.
• Patients with Hepatic Dysfunction: Dose reductions might be necessary.
• Patients with Comorbid Conditions: Careful assessment is crucial, especially in cardiovascular disease, hypertension, glaucoma, or thyroid issues.

Clinical Use Cases

• Intubation: No specific recommendations for the combination therapy for intubation and other clinical cases can be provided based on the provided information.

Dosage Adjustments: Refer to the specific product label and follow renal/hepatic impairment guidelines for each individual component.

Side Effects

Common Side Effects:

Drowsiness, dizziness, dry mouth, nausea, constipation, upset stomach, nervousness, restlessness, headache, blurred vision.

Rare but Serious Side Effects:

Allergic reactions (rash, itching, swelling), hallucinations, seizures, confusion, increased blood pressure, difficulty breathing, rapid heartbeat, difficulty urinating.

Long-Term Effects:

Chronic use of this combination can lead to tolerance to the cough suppressant effect and rebound congestion with phenylephrine.

Adverse Drug Reactions (ADR):

Severe allergic reactions (anaphylaxis), significant changes in blood pressure or heart rate, respiratory depression, neurological effects.

Contraindications

• Hypersensitivity to any of the components.
• Severe hypertension or heart disease.
• Severe liver or kidney disease.
• Concurrent use of monoamine oxidase inhibitors (MAOIs).
• Narrow-angle glaucoma.

Drug Interactions

• MAOIs (severe hypertension risk)
• Alcohol (increased sedation)
• Other CNS depressants (additive effects)
• Antihistamines, antidepressants, muscle relaxants, antibiotics (refer to sources for specific interactions).
• OTC drugs and some supplements may interact.

Pregnancy and Breastfeeding

• This medication is typically not recommended during pregnancy and breastfeeding unless the benefits significantly outweigh the potential risks. Consult specialized guidelines.

Drug Profile Summary

• Mechanism of Action: See above.
• Side Effects: See above.
• Contraindications: See above.
• Drug Interactions: See above.
• Pregnancy & Breastfeeding: Not generally recommended.
• Dosage: See above.
• Monitoring Parameters: Blood pressure, heart rate, respiratory rate, especially in patients with pre-existing conditions.

Popular Combinations

• While this specific combination is itself a common formulation, individual components are often combined with other drugs, like analgesics or antipyretics.

Precautions

• General Precautions: Assess patient history for allergies, metabolic disorders, and organ dysfunction.
• Specific Populations: See “Special Cases” under Dosage and “Pregnancy and Breastfeeding.”
• Lifestyle Considerations: Advise patients to avoid alcohol and operating machinery due to potential drowsiness.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Ambroxol + Chlorpheniramine Maleate + Dextromethorphan Hydrobromide + Phenylephrine?

A: See the “Dosage” section above. Always consult the specific product labeling for precise dosing information.

Q2: Can this combination be used in children under 2 years old?

A: Generally not recommended. Consult a pediatrician for safe alternatives.

Q3: What are the common side effects?

A: Drowsiness, dizziness, dry mouth, nausea, and constipation are common.

Q4: Are there any serious drug interactions I should be aware of?

A: Yes, MAOIs, alcohol, and other CNS depressants. Refer to the “Drug Interactions” section for details.

Q5: Can pregnant or breastfeeding women take this medication?

A: Generally not recommended unless benefits clearly outweigh risks. Consult specialized guidelines.

Q6: What should I do if a patient experiences an allergic reaction?

A: Discontinue the medication and provide appropriate medical care, which might include antihistamines, corticosteroids, or epinephrine depending on the severity.

Q7: Can this medication be taken with other cough and cold medications?

A: Generally, avoid concurrent use with other cough and cold medications, especially those containing similar ingredients, as it could lead to overdose of certain components.

Q8: How long should a patient take this medication?

A: This medication is intended for short-term use to relieve acute symptoms. If symptoms persist beyond a week or worsen, re-evaluate the patient’s condition.

Q9: Are there any dietary restrictions while taking this medication?

A: While no specific dietary restrictions apply to the entire combination, patients should stay well-hydrated. Alcohol should be avoided due to increased sedative effects.