Usage
This combination medication is prescribed for the symptomatic relief of cough, cold, and allergy symptoms, including nasal and chest congestion, runny nose, sneezing, sore throat, and cough (both dry and productive). It is particularly useful in alleviating symptoms associated with upper respiratory tract infections (URTIs) and allergic rhinitis.
Pharmacological Classification:
This combination includes drugs from several classes:
- Mucolytic: Ambroxol
- Cough suppressant: Dextromethorphan Hydrobromide
- Decongestant: Phenylephrine
- Antihistamine: Chlorpheniramine Maleate
- Topical anesthetic/cooling agent: Menthol
Mechanism of Action: Ambroxol breaks down mucus, facilitating expectoration. Dextromethorphan suppresses the cough reflex. Phenylephrine constricts blood vessels in the nasal passages, reducing congestion. Chlorpheniramine blocks histamine, relieving allergy symptoms. Menthol provides a cooling and soothing effect on irritated mucosal membranes.
Alternate Names
No widely recognized alternate names exist for this specific five-drug combination. It is typically identified by its constituent drugs. Various brand names are used for marketing.
Brand Names:
Several brand names exist depending on the manufacturer. Some examples include Mituss-A, Ellkuf-AD, Cofvex AD, Nakuf Total SF and Kufquit AD.
How It Works
Pharmacodynamics: The combination targets various symptoms concurrently. Ambroxol reduces mucus viscosity and promotes clearance. Dextromethorphan acts centrally to suppress cough. Phenylephrine, an alpha-adrenergic agonist, causes vasoconstriction in the nasal mucosa, reducing congestion. Chlorpheniramine, an H1-receptor antagonist, counteracts histamine’s effects, relieving allergic symptoms. Menthol activates TRPM8 receptors, producing a cooling sensation and relieving throat irritation.
Pharmacokinetics:
- Absorption: All components are absorbed orally.
- Metabolism: Primarily hepatic metabolism via CYP450 enzymes for most components.
- Elimination: Mainly renal excretion of metabolites.
Mode of Action:
- Ambroxol: Increases serous secretions in the respiratory tract, reducing mucus viscosity.
- Dextromethorphan: NMDA receptor antagonist and sigma-1 receptor agonist in the CNS, suppressing the cough reflex.
- Phenylephrine: α1-adrenergic receptor agonist, causing vasoconstriction and reducing nasal congestion.
- Chlorpheniramine: H1-receptor antagonist, inhibiting histamine’s effects.
- Menthol: TRPM8 receptor agonist, producing a cooling sensation.
Dosage
Standard Dosage
Adults: 10 ml every 4-6 hours, not exceeding 60ml in 24 hours. Administration is typically oral.
Children:
- 6-12 years: 5 ml every 4-6 hours, not exceeding 30ml in 24 hours.
- 2-6 years: 2.5 ml 3-4 times daily.
- Below 2 years: Not recommended.
Special Cases:
- Elderly Patients: Start with lower doses due to potential for increased sensitivity. Monitor closely.
- Patients with Renal Impairment: Dose adjustments are necessary. Consult specific guidelines based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dose reduction is required. Close monitoring is essential.
- Patients with Comorbid Conditions: Exercise caution in patients with hypertension, diabetes, glaucoma, cardiovascular disease, and prostatic hyperplasia. Dose adjustment may be necessary. Consult specific guidelines.
Clinical Use Cases
The combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. Its use is primarily for outpatient symptomatic relief. In emergency situations, specific drugs are preferred over this combination.
Dosage Adjustments
Adjustments are based on age, renal function, hepatic function, and coexisting medical conditions. Closely monitor patients for adverse effects.
Side Effects
Common Side Effects:
Drowsiness, dizziness, dry mouth, nausea, constipation, headache, stomach upset, vomiting, nervousness, restlessness, blurred vision.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), cardiac arrhythmias, seizures, respiratory depression.
Long-Term Effects:
Chronic use can lead to tolerance to dextromethorphan. Phenylephrine can cause rebound congestion with prolonged use.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome, toxic epidermal necrolysis, QT prolongation, serotonin syndrome (with concurrent serotonergic drugs).
Contraindications
Hypersensitivity to any components, severe hypertension, coronary artery disease, severe liver or kidney disease, concurrent or recent use of MAOIs (within 14 days), narrow-angle glaucoma, urinary retention due to prostatic hyperplasia, asthma attack.
Drug Interactions
MAOIs (hypertensive crisis), antihistamines, antidepressants, sedatives (additive sedative effects), alcohol (increased CNS depression), CYP450 inhibitors or inducers, grapefruit juice (can increase phenylephrine levels).
Pregnancy and Breastfeeding
Pregnancy: Use only if clearly needed. Safety not established.
Breastfeeding: Not recommended. Components may be excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Mucolytic, cough suppressant, decongestant, antihistamine, topical cooling agent
- Side Effects: Drowsiness, dizziness, dry mouth, nausea, constipation
- Contraindications: Hypersensitivity, severe cardiovascular/liver/kidney disease, MAOI use
- Drug Interactions: MAOIs, antihistamines, antidepressants, sedatives, alcohol
- Pregnancy & Breastfeeding: Use with caution. Safety not established.
- Dosage: See detailed dosage section above.
- Monitoring Parameters: Blood pressure, heart rate, respiratory status, mental status
Popular Combinations
This five-drug combination is commonly used. Individual components may be combined with other medications for specific needs.
Precautions
Assess for allergies, renal/hepatic function, cardiovascular disease, glaucoma. Caution in elderly and children. Avoid alcohol and other CNS depressants. May impair driving ability.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Chlorpheniramine Maleate + Dextromethorphan Hydrobromide + Menthol + Phenylephrine?
A: Adults: 10 ml every 4-6 hours, not exceeding 60 ml daily. Children (6-12 years): 5 ml every 4-6 hours, not exceeding 30 ml daily. Children (2-6 years): 2.5 ml 3-4 times/day. Not recommended for children under 2.
Q2: Can this combination be used in patients with hypertension?
A: Use with caution in patients with mild to moderate hypertension; avoid in severe hypertension. Monitor blood pressure.
Q3: What are the common side effects?
A: Drowsiness, dizziness, dry mouth, nausea, and constipation.
Q4: Can this medication be taken with alcohol?
A: No. Alcohol can potentiate the sedative effects of this combination.
Q5: Is it safe to use during pregnancy?
A: Only if clearly needed. Safety during pregnancy is not fully established.
Q6: Can it be used in patients with glaucoma?
A: Contraindicated in patients with narrow-angle glaucoma.
Q7: What should be done in case of an overdose?
A: Seek immediate medical attention. Supportive care and symptomatic treatment may be necessary.
Q8: Can this medication be used with MAOIs?
A: Contraindicated. Concurrent use can cause a hypertensive crisis.
Q9: What are the potential drug interactions?
A: MAOIs, antihistamines, antidepressants, sedatives, and alcohol can interact with this combination.
Q10: Can this medication impair driving ability?
A: Yes, this combination can cause drowsiness and may impair driving or operating machinery. Patients should avoid such activities until they know how the medication affects them.