Usage
This combination medication is primarily prescribed for the symptomatic relief of the common cold, flu, and other upper respiratory tract infections. It addresses multiple symptoms simultaneously due to the combined effects of its components. It is classified as an analgesic, antipyretic, anti-inflammatory, and antihistamine drug.
Its mechanism of action involves reducing pain and inflammation, lowering fever, and relieving allergic symptoms.
Alternate Names
While “Chlorpheniramine Maleate + Diclofenac + Paracetamol” is the generic name, several brand names exist depending on the manufacturer and region. A few examples include Clodip and Dacron Plus. International and regional variations in the name may also occur.
How It Works
Pharmacodynamics
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Diclofenac: A non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), enzymes responsible for prostaglandin synthesis. This leads to a decrease in prostaglandins, which mediate pain and inflammation.
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Paracetamol: An analgesic and antipyretic that reduces fever and pain. Its precise mechanism is not fully elucidated, but it is thought to inhibit COX enzymes in the central nervous system, potentially through an endocannabinoid-mediated mechanism. It also may influence serotonergic pathways.
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Chlorpheniramine Maleate: An antihistamine that blocks the H1 histamine receptor, thereby reducing histamine’s effects. This alleviates allergic symptoms like sneezing, runny nose, itchy eyes, and watery eyes.
Pharmacokinetics
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Absorption: All three components are well-absorbed orally.
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Metabolism: Primarily hepatic metabolism, with some renal excretion. Diclofenac is metabolized by CYP2C9. Paracetamol is majorly conjugated with glucuronic acid and sulfate; however, it also forms a small amount of a hepatotoxic metabolite N-acetyl-p-benzoquinone imine (NAPQI), typically detoxified by glutathione. Chlorpheniramine undergoes hepatic metabolism, likely via CYP enzymes.
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Elimination: Mainly renal excretion for all components, either as the parent drug or metabolites.
Dosage
Standard Dosage
Adults:
A typical dosage is Diclofenac 50mg + Paracetamol 500mg + Chlorpheniramine Maleate 4mg. The standard frequency is up to three times a day.
Children:
Use in children under 12 years of age is generally not recommended unless under direct medical supervision. Dosages must be carefully calculated based on weight or age.
Special Cases:
- Elderly Patients: Start with the lowest effective dose and monitor closely due to age-related physiological changes.
- Patients with Renal Impairment: Dose adjustment needed according to renal function.
- Patients with Hepatic Dysfunction: Exercise caution and consider dose reductions due to potential impaired drug metabolism.
- Patients with Comorbid Conditions: Carefully assess potential drug interactions and adjust accordingly.
Clinical Use Cases
The combination is not typically indicated for use in specialized clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. Other medications are more suitable for these scenarios.
Dosage Adjustments
Dosages must be individualized considering patient-specific factors, including renal or hepatic impairment, other medical conditions, and concomitant medications.
Side Effects
Common Side Effects
Nausea, vomiting, indigestion, dizziness, drowsiness, dry mouth, and constipation are common adverse effects.
Rare but Serious Side Effects
Allergic reactions (rash, itching, swelling, difficulty breathing), liver damage (with high doses of paracetamol), stomach ulcers or bleeding (with diclofenac), and irregular heartbeat.
Long-Term Effects
Long-term use of diclofenac can increase the risk of cardiovascular events. Chronic high doses of paracetamol can lead to nephrotoxicity. Long-term antihistamine use may result in tolerance.
Adverse Drug Reactions (ADR)
Any serious or unexpected adverse reactions should be reported to relevant pharmacovigilance authorities.
Contraindications
Hypersensitivity to any component, active peptic ulcer, severe hepatic impairment, severe renal impairment, severe heart failure, aspirin-exacerbated respiratory disease, and last trimester of pregnancy. Patients recovering from heart bypass surgery should not use this medicine.
Drug Interactions
This combination can interact with other NSAIDs, anticoagulants, antihypertensives, alcohol, and some OTC medications and supplements. Specific CYP450 enzyme interactions (especially involving CYP2C9) should be considered.
Pregnancy and Breastfeeding
Contraindicated in the third trimester of pregnancy. Use in the first and second trimesters only if the potential benefit outweighs the risk. Consult with a specialist before use during breastfeeding as diclofenac and paracetamol are excreted in breast milk. Chlorpheniramine is also not advised during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Analgesic, antipyretic, anti-inflammatory, antihistamine.
- Side Effects: Nausea, dizziness, drowsiness, stomach upset, constipation. Serious side effects include allergic reactions, liver damage, GI bleeding, and cardiovascular events.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal/heart failure, last trimester of pregnancy.
- Drug Interactions: NSAIDs, anticoagulants, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Use with caution. Contraindicated in the third trimester.
- Dosage: Adult: Diclofenac 50mg + Paracetamol 500mg + Chlorpheniramine Maleate 4mg up to three times daily. Adjust according to patient-specific conditions.
- Monitoring Parameters: Liver function tests, renal function tests, blood pressure.
Popular Combinations
This combination itself is a popular combination. Adding a decongestant like phenylephrine is sometimes done.
Precautions
Standard precautions include assessing allergy history, renal and hepatic function, and cardiac status before initiating therapy. Caution is advised in special populations like the elderly, pregnant women, and breastfeeding mothers. Avoid alcohol. May cause drowsiness, impacting activities requiring alertness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorpheniramine Maleate + Diclofenac + Paracetamol?
A: A common dosage is Diclofenac 50mg + Paracetamol 500mg + Chlorpheniramine Maleate 4mg up to three times a day. Adjust for patient-specific conditions.
Q2: Can this combination be used in children?
A: Not generally recommended for children under 12 years without careful medical supervision.
Q3: What are the common side effects?
A: Nausea, dizziness, drowsiness, dry mouth, constipation.
Q4: Is it safe during pregnancy?
A: Contraindicated in the third trimester. Use with caution in the first and second trimesters only if the benefits clearly outweigh the risks.
Q5: What are the serious side effects to watch for?
A: Allergic reactions, liver damage, gastrointestinal bleeding, cardiovascular issues.
Q6: Can patients with kidney problems take this medication?
A: Dosage adjustment may be necessary depending on the severity of renal impairment. Consult with a nephrologist.
Q7: Does it interact with other drugs?
A: Yes, it can interact with NSAIDs, anticoagulants, antihypertensives, and others. Carefully review the patient’s medication history.
Q8: Should this combination be taken with food?
A: Yes, preferably with or after meals to reduce the risk of gastrointestinal upset.
Q9: Can it be used for long periods?
A: Long-term use should be under medical supervision due to potential risks like cardiovascular and renal issues.
Q10: What if a dose is missed?
A: Take the missed dose as soon as remembered, unless it is almost time for the next dose. Do not double the dose.
