Usage
This combination medication is primarily prescribed for the symptomatic relief of the common cold and allergies. It addresses symptoms such as nasal congestion, runny nose, sneezing, watery eyes, fever, headache, and body aches.
Pharmacological Classification:
This drug is a combination of three pharmacological classes:
- Analgesic and Antipyretic: Paracetamol
- Decongestant: Pseudoephedrine
- Antihistamine: Chlorpheniramine Maleate
Mechanism of Action:
- Paracetamol: Reduces fever by inhibiting prostaglandin synthesis in the hypothalamus and provides analgesia through a yet unclear central mechanism involving descending serotonergic pathways.
- Pseudoephedrine: Acts as a nasal decongestant by stimulating alpha-adrenergic receptors in the respiratory tract, causing vasoconstriction, reducing nasal mucosa swelling, and relieving congestion.
- Chlorpheniramine: An antihistamine that blocks the action of histamine at H1 receptors, relieving allergy symptoms like sneezing, runny nose, and watery eyes.
Alternate Names
This combination doesn’t have a universally recognized international non-proprietary name (INN). It’s generally referred to by its component drugs.
Brand Names:
Brand names vary regionally and may include Coldril, Snip, A-ferin Plus, Chemists’ Own Day + Night Cold & Flu Relief, and Pharmacy Health Day + Night Cold & Flu Relief, among others.
How It Works
Pharmacodynamics:
- Paracetamol: Exerts its analgesic and antipyretic effects through central mechanisms.
- Pseudoephedrine: Causes vasoconstriction in the nasal mucosa via alpha-adrenergic receptor agonism.
- Chlorpheniramine: Antagonizes H1 receptors, reducing histamine-mediated allergic responses.
Pharmacokinetics:
- Paracetamol: Well-absorbed orally, metabolized in the liver, and excreted renally.
- Pseudoephedrine: Orally absorbed, metabolized in the liver to a small extent, and excreted renally.
- Chlorpheniramine: Absorbed from the GI tract, undergoes first-pass metabolism in the liver, and is excreted renally.
Mode of Action:
- Paracetamol: Inhibits prostaglandin synthesis.
- Pseudoephedrine: Alpha-adrenergic receptor agonist.
- Chlorpheniramine: H1 receptor antagonist.
Elimination Pathways: Primarily renal excretion for all three components.
Dosage
Standard Dosage
Adults:
The usual adult dose is one or two tablets/capsules every 4-6 hours, not exceeding eight doses in 24 hours. The specific formulation strength (e.g., 325mg paracetamol/15mg pseudoephedrine/1mg chlorpheniramine) may dictate dosage.
Children:
Use with caution and under medical supervision. Dosage should be adjusted based on the child’s age and weight. This combination is generally not recommended for children under 4 years old. Some formulations are contraindicated in children under 12.
Special Cases:
- Elderly Patients: Start with lower doses due to potential age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Dose adjustments may be necessary.
- Patients with Hepatic Dysfunction: Use with caution and consider dose reductions due to the risk of paracetamol toxicity.
- Patients with Comorbid Conditions: Exercise caution in patients with cardiovascular diseases, hypertension, hyperthyroidism, diabetes, glaucoma, and prostatic hypertrophy.
Clinical Use Cases
This combination is not typically indicated for use in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary indication is the symptomatic relief of common cold and allergy symptoms.
Dosage Adjustments
Dose modifications are necessary for patients with renal or hepatic impairment, and for those with specific comorbid conditions.
Side Effects
Common Side Effects
Drowsiness, dizziness, dry mouth, blurred vision, constipation, mild headache, insomnia, nervousness, nausea, and restlessness.
Rare but Serious Side Effects
Allergic reactions (rash, itching, swelling), hallucinations, palpitations, seizures, liver damage (with paracetamol overdose), and cardiac arrhythmias.
Long-Term Effects
Chronic use of high doses of paracetamol can lead to liver damage. Prolonged use of pseudoephedrine can cause tolerance and rebound congestion.
Adverse Drug Reactions (ADR)
Severe allergic reactions, hepatotoxicity (paracetamol), cardiac events (pseudoephedrine), and seizures (high doses).
Contraindications
Hypersensitivity to any component, concurrent or recent use of MAO inhibitors, severe coronary artery disease, severe hypertension, uncontrolled hyperthyroidism, closed-angle glaucoma, severe liver or kidney disease, and urinary retention due to prostatic hypertrophy.
Drug Interactions
MAO inhibitors, alcohol, other sedatives, antidepressants (especially tricyclic antidepressants), antihypertensives, anticoagulants, and other medications containing sympathomimetics (like decongestants or stimulants).
Pregnancy and Breastfeeding
This combination should generally be avoided during pregnancy, especially the first trimester, due to potential risks to the fetus. Its use during breastfeeding should be cautiously considered as the components can be excreted in breast milk. Consult with a physician to assess the risks and benefits.
Drug Profile Summary
- Mechanism of Action: Paracetamol: Analgesic/antipyretic; Pseudoephedrine: Decongestant; Chlorpheniramine: Antihistamine.
- Side Effects: Drowsiness, dizziness, dry mouth, blurred vision, constipation.
- Contraindications: Hypersensitivity, MAOI use, severe cardiovascular disease, hepatic/renal impairment.
- Drug Interactions: MAOIs, alcohol, sedatives, antidepressants, antihypertensives.
- Pregnancy & Breastfeeding: Generally avoided.
- Dosage: Varies by age and condition; typically 1-2 tablets/capsules every 4-6 hours, not exceeding 8 doses/24h.
- Monitoring Parameters: Liver function tests (with prolonged use), blood pressure.
Popular Combinations
This combination itself represents a frequently used combination for cold and allergy symptoms. Combining it with other drugs requires careful consideration of potential interactions and overlapping side effects.
Precautions
Screen for allergies, pre-existing medical conditions (especially cardiovascular, hepatic, and renal), and concomitant medications. Caution in elderly patients and pregnant or breastfeeding women. Avoid alcohol. May impair driving ability.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Paracetamol + Pseudoephedrine?
A: The standard adult dosage is typically 1-2 tablets/capsules every 4-6 hours, not exceeding 8 doses in 24 hours. Pediatric doses are determined by weight and age under medical supervision. Special dose adjustments are needed for elderly patients and those with renal or hepatic impairment.
Q2: Can this combination be used during pregnancy?
A: It’s generally best to avoid this medication during pregnancy, especially in the first trimester, due to potential fetal risks. Consult with a physician for individual risk assessment.
Q3: Is it safe to breastfeed while taking this medicine?
A: The components of this drug can be excreted in breast milk and may pose a risk to the infant. Discuss the benefits and risks with a physician before use while breastfeeding.
Q4: What are the common side effects?
A: Common side effects include drowsiness, dizziness, dry mouth, blurred vision, and constipation.
Q5: Can I drink alcohol while taking this medicine?
A: No, avoid alcohol as it can potentiate the sedative effects of chlorpheniramine and increase the risk of liver damage with paracetamol.
Q6: What are the serious side effects to watch out for?
A: Serious side effects can include allergic reactions, liver damage (paracetamol overdose), hallucinations, and cardiac events.
Q7: Does this combination interact with other medications?
A: Yes, it can interact with MAO inhibitors, other sedatives, some antidepressants, antihypertensives, and anticoagulants.
Q8: What are the contraindications to its use?
A: Contraindications include hypersensitivity to the components, current or recent MAOI use, severe cardiovascular disease, glaucoma, severe hepatic/renal dysfunction, and urinary retention due to prostatic hypertrophy.
Q9: How does this combination relieve nasal congestion?
A: Pseudoephedrine, a component of the drug, acts as a decongestant by constricting blood vessels in the nasal passages.
Q10: Can I operate machinery after taking this medication?
A: The antihistamine component, chlorpheniramine, can cause drowsiness and impair alertness. Avoid operating machinery or driving until you know how this medication affects you.
