Dexibuprofen + Paracetamol

Usage

Dexibuprofen + Paracetamol is prescribed for the relief of mild to moderate pain and fever. It is indicated for conditions such as headaches, toothaches, menstrual cramps, muscular aches, and symptoms of the common cold/flu. Its pharmacological classifications are analgesic (pain reliever) and antipyretic (fever reducer). The combination works by inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin production, which are mediators of pain, inflammation, and fever.

Alternate Names

While “Dexibuprofen + Paracetamol” is the standard generic name, regional variations may exist. Brand names for this combination include Nuromol and Maxigesic.

How It Works

Pharmacodynamics: Dexibuprofen, an NSAID, and Paracetamol exert analgesic and antipyretic effects. Dexibuprofen acts peripherally by inhibiting COX-1 and COX-2 enzymes, reducing prostaglandin synthesis. Paracetamol is thought to primarily inhibit COX enzymes in the central nervous system.

Pharmacokinetics: Both drugs are absorbed well orally. Dexibuprofen is metabolized primarily in the liver by CYP enzymes, particularly CYP2C9, and eliminated by the kidneys. Paracetamol is also metabolized in the liver, primarily by glucuronidation and sulfation, with a small fraction undergoing CYP-mediated metabolism to a reactive metabolite that is detoxified by glutathione. Elimination is primarily renal.

Mode of Action: Both drugs inhibit COX enzymes, which are responsible for the production of prostaglandins, thereby reducing pain, inflammation, and fever.

Elimination Pathways: Dexibuprofen is primarily eliminated renally after hepatic metabolism via CYP enzymes. Paracetamol is eliminated primarily renally after hepatic metabolism via glucuronidation, sulfation and CYP enzymes.

Dosage

Standard Dosage

Adults: The usual dosage is one or two tablets containing a combination of Dexibuprofen (e.g. 150mg or 200mg) and Paracetamol (e.g. 500mg) every 6 to 8 hours as needed. Maximum daily doses vary according to specific product formulations and should not exceed the limits for individual constituents, as per local guidelines (generally, no more than 2400mg of ibuprofen and 4000mg of paracetamol within a 24-hour period).

Children: Use in children under 12 years is generally not recommended without medical supervision. For adolescents (12 years and older), the dosage may be the same as for adults, though some product-specific guidelines recommend avoiding use for children under 18 years. Pediatric dosing should be carefully reviewed against product information and local prescribing guidelines.

Special Cases:

• Elderly Patients: Initiate therapy at the lower end of the dosing range and titrate as needed. Closely monitor for adverse effects.
• Patients with Renal Impairment: Dose adjustments are required for patients with renal impairment. Consult specific product information and local guidelines for recommendations based on creatinine clearance.
• Patients with Hepatic Dysfunction: Exercise caution and consider dose reduction in patients with hepatic impairment.
• Patients with Comorbid Conditions: Careful assessment and dose adjustment may be necessary for patients with conditions such as heart disease, hypertension, asthma, or gastrointestinal disorders.

Clinical Use Cases

Specific dosing guidelines for intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not established for this combination product. Pain management in these settings should be guided by patient-specific factors and clinical judgment.

Dosage Adjustments

Dose adjustments are based on patient factors such as renal and hepatic function, age, and comorbidities. Genetic polymorphisms affecting CYP2C9 activity may influence Dexibuprofen metabolism and should be considered. Consult local prescribing information and specialist advice where appropriate.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, headache, dizziness.

Rare but Serious Side Effects

Gastrointestinal bleeding or ulceration, hepatotoxicity, acute renal failure, severe allergic reactions (anaphylaxis, angioedema, skin rash, Stevens-Johnson Syndrome), blood dyscrasias.

Long-Term Effects

Chronic use of NSAIDs like Dexibuprofen may increase the risk of cardiovascular events and renal complications. Prolonged high doses of Paracetamol may lead to hepatotoxicity.

Adverse Drug Reactions (ADR)

Clinically significant ADRs requiring immediate intervention include severe allergic reactions, gastrointestinal bleeding, signs of hepatotoxicity (e.g. jaundice, abdominal pain), or acute renal failure.

Contraindications

Hypersensitivity to Dexibuprofen or Paracetamol, history of hypersensitivity reactions to other NSAIDs or aspirin, active peptic ulcer disease, severe hepatic impairment, severe renal impairment, active bleeding disorders, third trimester of pregnancy.

Drug Interactions

Dexibuprofen + Paracetamol can interact with other NSAIDs, anticoagulants (e.g. warfarin), antiplatelet drugs (e.g. aspirin), SSRIs, SNRIs, ACE inhibitors, ARBs, beta-blockers, diuretics, digoxin, lithium, methotrexate, corticosteroids, certain antibiotics (e.g. quinolones), and other medications metabolized by CYP enzymes, especially CYP2C9. Alcohol consumption should be avoided as it increases the risk of gastrointestinal bleeding.

Pregnancy and Breastfeeding

Dexibuprofen is contraindicated during the third trimester of pregnancy due to potential premature closure of the ductus arteriosus. Its use in earlier trimesters is generally avoided unless specifically indicated by a physician, and then only at the lowest effective dose for the shortest possible duration. Paracetamol is generally considered safe during pregnancy and breastfeeding at recommended doses. However, all medication use during these periods should be under the guidance of a healthcare professional.

Drug Profile Summary

• Mechanism of Action: COX enzyme inhibition, reducing prostaglandin synthesis.
• Side Effects: Nausea, vomiting, gastrointestinal issues; rarely, serious hepatic, renal, or allergic reactions.
• Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal impairment, bleeding disorders, third-trimester pregnancy.
• Drug Interactions: Other NSAIDs, anticoagulants, antiplatelets, certain antibiotics, other drugs metabolized by CYP2C9.
• Pregnancy & Breastfeeding: Dexibuprofen contraindicated in the third trimester. Paracetamol generally safe at recommended doses.
• Dosage: Varies by product; consult product information.
• Monitoring Parameters: Liver function tests, renal function tests, signs of gastrointestinal bleeding, blood pressure.

Popular Combinations

Dexibuprofen + Paracetamol may be used in combination with other analgesics like opioids for more severe pain, though careful monitoring for adverse effects is crucial.

Precautions

Pre-existing medical conditions should be carefully assessed, including renal/hepatic function. Alcohol and concomitant NSAID use should be avoided. Dosage adjustments are crucial in special populations (elderly, pregnant/breastfeeding women, children).

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Dexibuprofen + Paracetamol?

A: The recommended dose varies based on product formulation and patient-specific factors. Consult product information and local guidelines. Generally, one or two tablets every 6 to 8 hours, not exceeding maximum daily limits for individual constituents.

Q2: What are the common side effects?

A: Common side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, and headache.

Q3: Is this combination safe during pregnancy?

A: Dexibuprofen is contraindicated in the third trimester. Use during earlier trimesters should be limited and under medical supervision. Paracetamol is generally considered safe.

Q4: What are the contraindications?

A: Contraindications include hypersensitivity to either drug, active peptic ulcer disease, severe hepatic or renal impairment, bleeding disorders, and third-trimester pregnancy.

Q5: How does this combination interact with other drugs?

A: It can interact with other NSAIDs, anticoagulants, antiplatelets, certain antibiotics, and other medications metabolized by CYP2C9.

Q6: Can patients with renal impairment take this medication?

A: Dose adjustment is needed for patients with renal impairment. Consult product information and local guidelines.

Q7: Are there any long-term effects of taking this combination?

A: Chronic use of NSAIDs like Dexibuprofen is associated with increased risk of cardiovascular and renal complications. Long-term, high-dose Paracetamol use can lead to hepatotoxicity.

Q8: What should I monitor in patients taking Dexibuprofen + Paracetamol?

A: Monitor for liver and renal function, signs of gastrointestinal bleeding, and blood pressure changes.

Q9: What is the mechanism of action of this drug combination?

A: Both components inhibit COX enzymes, thereby reducing prostaglandin production.