Usage
This combination medication is prescribed for the symptomatic relief of the common cold, flu, and allergies. It is particularly effective in addressing symptoms such as cough, fever, headache, body aches, nasal congestion, runny nose, sneezing, itchy or watery eyes, and sore throat.
Pharmacological Classification: This combination includes drugs from multiple classes:
- Ambroxol: Mucolytic expectorant
- Levocetirizine: Antihistamine
- Paracetamol: Analgesic and antipyretic
- Phenylephrine: Decongestant
Mechanism of Action: This combination targets various symptoms simultaneously:
- Ambroxol: Reduces the viscosity of mucus, making it easier to expectorate. It also exhibits anti-inflammatory and antioxidant properties, soothing irritated airways.
- Levocetirizine: Blocks the action of histamine, a chemical mediator responsible for allergic reactions. This alleviates symptoms like sneezing, runny nose, and itching.
- Paracetamol: Inhibits prostaglandin synthesis, which reduces fever and pain.
- Phenylephrine: Constricts blood vessels in the nasal mucosa, reducing congestion and facilitating easier breathing.
Alternate Names
There is no officially recognized alternate name for this specific combination. However, it may sometimes be referred to simply as a “cold and flu medication.” Some alternate names include “Ambroxol/Levocetirizine/Paracetamol/Phenylephrine.”
Brand Names: This combination is available under various brand names, including LCZ Plus, Cheston Cold Total, Apicold AL, and Nasycold. Availability may vary regionally. ELZIK is another brand name containing this combination. Many other brand names exist depending on the manufacturer.
How It Works
Pharmacodynamics:
- Ambroxol: Stimulates serous cells in the respiratory tract, increasing the secretion of less viscous mucus, promoting mucociliary clearance.
- Levocetirizine: Selectively antagonizes peripheral H1 receptors, mitigating the effects of histamine.
- Paracetamol: Inhibits central cyclooxygenase (COX) enzymes, reducing prostaglandin production in the central nervous system.
- Phenylephrine: Acts as an α1-adrenergic receptor agonist, leading to vasoconstriction in the nasal mucosa.
Pharmacokinetics:
- Ambroxol: Well-absorbed orally. Metabolized in the liver and excreted primarily in the urine.
- Levocetirizine: Rapidly absorbed after oral administration. Minimally metabolized and primarily eliminated renally.
- Paracetamol: Extensively absorbed from the gastrointestinal tract. Metabolized in the liver through glucuronidation and sulfation pathways. Eliminated in the urine, mainly as conjugates.
- Phenylephrine: Absorbed from the gastrointestinal tract but undergoes significant first-pass metabolism. Metabolized by monoamine oxidase in the intestine and liver. Excreted in the urine.
Mode of Action: The mode of action is described above in the pharmacodynamics section.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation:
- Levocetirizine binds to and blocks histamine H1 receptors.
- Paracetamol inhibits COX enzymes.
- Phenylephrine activates α1-adrenergic receptors.
Elimination Pathways: Each component is primarily eliminated via renal excretion, as described in the pharmacokinetics section.
Dosage
Standard Dosage
Adults:
A typical adult dose is Ambroxol 30mg, Levocetirizine 5mg, Paracetamol 500mg, and Phenylephrine 10mg. This can be administered every 6-8 hours as needed, not exceeding a maximum daily dose of 4000mg of Paracetamol.
Children:
Dosing for children depends on their age and weight and must be determined by a healthcare professional. Pediatric formulations exist and are preferred for young patients. Closely monitor children for adverse reactions. This combination is not recommended for children below 6 years of age.
Special Cases:
- Elderly Patients: Start with lower doses and adjust based on renal and hepatic function.
- Patients with Renal Impairment: Dose reduction or increased dosing intervals may be necessary.
- Patients with Hepatic Dysfunction: Similar to renal impairment, dosage adjustments are often needed. Paracetamol should be used cautiously.
- Patients with Comorbid Conditions: Additional dose adjustments may be required for patients with diabetes, cardiovascular disease, or other conditions.
Clinical Use Cases
This combination is not typically used in clinical settings such as intubation, surgical procedures, mechanical ventilation, or the ICU. Its primary role is in outpatient management of common cold and flu symptoms.
Dosage Adjustments
Adjustments should be individualized based on renal and hepatic function, metabolic disorders, or potential genetic polymorphisms impacting drug metabolism.
Side Effects
Common Side Effects:
Drowsiness, headache, dry mouth, nausea, vomiting, dizziness, tiredness, stomach upset, insomnia, loss of appetite.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling, difficulty breathing), severe liver damage (manifested as jaundice, dark urine, or abdominal pain), irregular heartbeat, seizures.
Long-Term Effects:
Chronic complications from prolonged use are rare, but prolonged high doses of Paracetamol can lead to liver damage.
Adverse Drug Reactions (ADR):
Any signs of allergic reaction or severe liver toxicity require immediate medical attention.
Contraindications
- Hypersensitivity to any component of the combination.
- Severe liver or kidney impairment.
- Recent use of monoamine oxidase inhibitors (MAOIs).
- Patients with gastric ulcers.
Drug Interactions
- MAOIs (e.g., phenelzine, selegiline): May cause severe interactions, including hypertensive crisis.
- Blood thinners (e.g., warfarin, heparin): Paracetamol may enhance the anticoagulant effect.
- Beta-blockers (e.g., atenolol, metoprolol): Phenylephrine may interact, potentially causing increased blood pressure.
- Other decongestants, antihistamines, or cough and cold medications: May potentiate side effects.
- Alcohol: May increase drowsiness and dizziness.
- Tricyclic antidepressants, digoxin: Avoid concomitant use.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding is not fully established. Consult a physician before use during these periods. Animal studies have shown potential harm to the developing fetus. It is generally advised to avoid using this combination unless the potential benefits outweigh the risks.
Drug Profile Summary
- Mechanism of Action: Multifaceted, targeting cough, fever, pain, congestion, and allergic symptoms.
- Side Effects: Drowsiness, headache, dry mouth, nausea, dizziness, among others. Rarely, severe allergic reactions or liver damage.
- Contraindications: Hypersensitivity, severe liver/kidney disease, recent MAOI use.
- Drug Interactions: MAOIs, blood thinners, beta-blockers, alcohol, other cold and flu medications.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: Varies by age and condition; see detailed section above.
- Monitoring Parameters: Liver function tests, kidney function tests, blood pressure, heart rate, allergic reactions.
Popular Combinations
This combination itself is a popular combination. Sometimes it is used with other cold or flu medications containing different ingredients to improve overall relief of cold/flu symptoms.
Precautions
Pre-screening for allergies, metabolic disorders, organ dysfunction is crucial.
- Pregnant Women: Avoid use unless clearly necessary.
- Breastfeeding Mothers: Consult a doctor before use.
- Children & Elderly: Age-specific precautions are necessary; see Dosage section.
- Lifestyle Considerations: Avoid alcohol while taking this medication. Avoid driving or operating machinery if drowsiness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Levocetirizine + Paracetamol + Phenylephrine?
A: The standard adult dose is Ambroxol 30mg, Levocetirizine 5mg, Paracetamol 500mg, and Phenylephrine 10mg every 6-8 hours. Children’s dosages must be determined by a physician based on age and weight. Elderly patients may require dose adjustments.
Q2: Can this combination be used during pregnancy or breastfeeding?
A: The safety profile isn’t fully established. Consult a physician before use.
Q3: What are the common side effects?
A: Drowsiness, headache, dry mouth, nausea, and dizziness are common side effects.
Q4: Are there any serious side effects?
A: Rarely, allergic reactions or severe liver damage can occur. Seek immediate medical attention if these occur.
Q5: What are the major drug interactions?
A: Avoid concurrent use with MAOIs, blood thinners, and beta-blockers. Alcohol may worsen side effects.
Q6: Can this medicine cause drowsiness?
A: Yes, drowsiness is a common side effect. Avoid driving or operating machinery if drowsiness occurs.
Q7: Does this combination relieve nasal congestion?
A: Yes, the phenylephrine component acts as a decongestant.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember unless it is close to the next scheduled dose. Do not double the dose.
Q9: Can I take this combination with other cold and flu medications?
A: Consult a physician before combining this medication with other products, as it may potentiate side effects or lead to interactions.
Q10: Does this combination interact with alcohol?
A: Alcohol may increase the risk of side effects like drowsiness and dizziness. It is advised to avoid alcohol while taking this medication.
