Usage
This combination medication is primarily prescribed for the symptomatic relief of the common cold and flu. It targets multiple symptoms simultaneously:
- Ambroxol: A mucolytic that thins and loosens mucus in the airways, facilitating expectoration.
- Caffeine: A CNS stimulant that helps reduce fatigue and may enhance the analgesic effect of paracetamol.
- Levocetirizine: An antihistamine that relieves allergic symptoms such as runny nose, sneezing, watery eyes, and itching.
- Paracetamol: An analgesic and antipyretic that reduces fever and pain.
- Phenylephrine: A decongestant that relieves nasal congestion.
Pharmacological Classifications: This combination is a multi-faceted product encompassing mucolytic, stimulant, antihistamine, analgesic, antipyretic, and decongestant properties.
Alternate Names
This combination is marketed under various brand names (e.g. 6xDMR, Coldria, Cyflu Plus), which vary based on manufacturer and region. It lacks a universally recognized alternate generic name.
How It Works
Pharmacodynamics:
- Ambroxol: Reduces mucus viscosity and promotes ciliary activity, improving airway clearance. Also possesses anti-inflammatory and antioxidant effects.
- Caffeine: Antagonizes adenosine receptors, leading to increased alertness and reduced fatigue. May potentiate paracetamol’s analgesic effect.
- Levocetirizine: Selectively blocks peripheral H1 receptors, mitigating histamine’s effects, thereby relieving allergic symptoms.
- Paracetamol: Inhibits prostaglandin synthesis in the CNS, reducing fever and pain. Its mechanism of action peripherally is not fully understood.
- Phenylephrine: Stimulates α1-adrenergic receptors in the nasal mucosa, causing vasoconstriction and reducing nasal congestion.
Pharmacokinetics: All components are absorbed orally. Paracetamol and caffeine are extensively metabolized in the liver, while ambroxol, levocetirizine, and phenylephrine undergo varying degrees of hepatic metabolism. Elimination primarily occurs through renal excretion, with some biliary excretion for certain components. Specific CYP450 enzyme involvement varies for each drug.
Dosage
Standard Dosage
Adults: A typical adult dose could be Ambroxol 30mg, Levocetirizine 5mg, Paracetamol 500mg, and Phenylephrine 10mg, along with 25-30mg of caffeine. This combination can be taken every 6-8 hours, as needed. The maximum daily dose of paracetamol should not exceed 4000mg.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary based on renal and hepatic function. Lower initial doses are advised, titrating upwards cautiously.
- Patients with Renal Impairment: Dose reductions or increased dosing intervals may be required.
- Patients with Hepatic Dysfunction: Similar to renal impairment, dosage adjustments are required based on the severity of dysfunction.
- Patients with Comorbid Conditions: Caution should be exercised in patients with hypertension, cardiovascular disease, diabetes, hyperthyroidism, glaucoma, and prostatic hyperplasia, given phenylephrine’s and caffeine’s effects.
Clinical Use Cases
Dosage for specific clinical situations (intubation, surgical procedures, mechanical ventilation, ICU use, emergencies) should be determined on a case-by-case basis by the attending physician, factoring in patient-specific variables and clinical context. This combination is not typically used in these settings.
Dosage Adjustments
Dose modifications are necessary for patients with renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms affecting drug metabolism. The specific adjustments should be guided by clinical assessment and laboratory data.
Side Effects
Common Side Effects:
Nausea, drowsiness, dizziness, dry mouth, headache, restlessness, insomnia, nervousness.
Rare but Serious Side Effects:
Allergic reactions, liver damage (with paracetamol overdose), cardiac arrhythmias, hypertension (especially with phenylephrine in susceptible individuals).
Long-Term Effects:
Chronic complications from long-term use are not well-established but may include potential for liver damage with excessive paracetamol use.
Adverse Drug Reactions (ADR):
Severe allergic reactions, hepatotoxicity, cardiac events related to phenylephrine, serotonin syndrome (rare, but possible with drug interactions).
Contraindications
- Hypersensitivity to any of the components.
- Severe hepatic impairment.
- Severe hypertension or coronary artery disease.
- MAOI use within the past 14 days.
- Angle-closure glaucoma, benign prostatic hyperplasia, urinary retention (due to phenylephrine).
Drug Interactions
- Alcohol can increase the risk of hepatotoxicity with paracetamol and exacerbate drowsiness from levocetirizine.
- Other sedating medications can potentiate the drowsiness caused by levocetirizine.
- Tricyclic antidepressants, MAOIs, beta-blockers, and digoxin can interact with phenylephrine and potentially cause serious adverse events like a hypertensive crisis.
- Other medications containing paracetamol should be avoided to prevent exceeding the maximum daily dose.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been definitively established. Individual components have varying safety profiles, and potential risks to the fetus or neonate should be carefully weighed against potential benefits. Consult a healthcare professional before using this combination during pregnancy or breastfeeding.
Drug Profile Summary
- Mechanism of Action: See “How It Works” above.
- Side Effects: See “Side Effects” above.
- Contraindications: See “Contraindications” above.
- Drug Interactions: See “Drug Interactions” above.
- Pregnancy & Breastfeeding: Not definitively established; consult a healthcare professional.
- Dosage: See “Dosage” above.
- Monitoring Parameters: Liver function tests, blood pressure, heart rate, respiratory status.
Popular Combinations
While this is already a combination product, the constituents can be combined with other drugs for broader symptom management. Guaifenesin may be added for cough, ibuprofen for pain and inflammation, or other cold and flu medications based on the clinical scenario.
Precautions
- Pre-existing medical conditions like liver/kidney disease, cardiovascular disorders, and metabolic conditions necessitate careful consideration and potential dosage adjustment.
- Special populations (pregnant/breastfeeding women, children, elderly) require careful assessment of risks and benefits.
- Avoid driving or operating machinery if drowsiness or dizziness occurs.
- Avoid excessive caffeine intake from other sources.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Caffeine + Levocetirizine + Paracetamol + Phenylephrine?
A: See “Dosage” section.
Q2: Can this combination be used in children?
A: Yes, with dosage adjusted based on age and weight. Pediatric formulations should be used.
Q3: What are the common side effects?
A: Nausea, drowsiness, dizziness, dry mouth, and headache.
Q4: Are there any serious side effects?
A: Yes, rare but serious side effects include allergic reactions, liver damage (paracetamol overdose), and cardiovascular effects (phenylephrine).
Q5: Can I take this medication if I am pregnant or breastfeeding?
A: Consult a healthcare professional before use during pregnancy or breastfeeding, as safety is not definitively established.
Q6: What medications should I avoid while taking this combination?
A: Alcohol, MAOIs, other sedatives, tricyclic antidepressants, beta-blockers, digoxin, and other medications containing paracetamol.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as remembered, unless it’s almost time for the next dose. Do not double the dose.
Q8: What are the signs of an overdose?
A: Severe drowsiness, nausea, vomiting, liver damage, and potentially serious cardiovascular effects. Seek immediate medical attention if overdose is suspected.
Q9: Can I drive or operate machinery after taking this medication?
A: Avoid these activities if experiencing drowsiness or dizziness.
Q10: How should this medication be stored?
A: Store in a cool, dry place away from direct sunlight and out of reach of children.
