Usage
Diclofenac + Paracetamol is prescribed for the relief of mild to moderate pain and inflammation associated with various conditions, including:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Acute musculoskeletal pain (e.g., back pain, sprains, strains)
- Postoperative pain
- Dental pain
- Dysmenorrhea (menstrual cramps)
- Headache, earache, and other types of pain
Pharmacological Classification:
- Nonsteroidal anti-inflammatory drug (NSAID) + Analgesic and Antipyretic
Mechanism of Action:
Diclofenac inhibits cyclooxygenase (COX) enzymes, reducing the production of prostaglandins, which are mediators of pain and inflammation. Paracetamol’s mechanism is not fully understood but involves inhibition of COX enzymes in the central nervous system and modulation of the endocannabinoid system, providing analgesic and antipyretic effects. The combination provides synergistic pain relief.
Alternate Names
While “Diclofenac + Paracetamol” is the generic name, numerous brand names exist internationally and regionally. Some examples include:
- Diclogesic Plus
- Voveran Plus
- Combiflam
How It Works
Pharmacodynamics:
Diclofenac exerts anti-inflammatory, analgesic, and antipyretic effects primarily through COX enzyme inhibition, reducing prostaglandin synthesis. Paracetamol’s analgesic and antipyretic actions are thought to be centrally mediated, potentially involving COX-3 inhibition and serotonergic pathways.
Pharmacokinetics:
- Absorption: Both drugs are rapidly absorbed after oral administration.
- Metabolism: Diclofenac is primarily metabolized in the liver by CYP2C9. Paracetamol undergoes hepatic metabolism via glucuronidation, sulfation, and minor pathways involving CYP2E1.
- Elimination: Diclofenac metabolites are excreted mainly in urine and bile. Paracetamol metabolites are primarily eliminated in urine.
Mode of Action: Diclofenac competes with arachidonic acid for the COX active site, preventing prostaglandin synthesis. Paracetamol’s exact mode of action is unclear but is thought to involve central COX inhibition and interactions with cannabinoid and serotonergic receptors.
Dosage
Standard Dosage
Adults:
- One tablet (Diclofenac 50 mg + Paracetamol 500 mg) two to three times a day, preferably with or after meals.
- Maximum daily dose of Diclofenac is generally 150 mg. Adjust Paracetamol dose based on patient’s needs, not exceeding 4 grams per day.
Children:
Use is generally not recommended for children below 14 years old. Consult specialized pediatric dosing guidelines if use is deemed necessary.
Special Cases:
- Elderly Patients: Start with the lowest effective dose and monitor closely for adverse effects, especially gastrointestinal bleeding and renal function.
- Patients with Renal Impairment: Dosage adjustments are required based on the degree of impairment. Consult renal dosing guidelines.
- Patients with Hepatic Dysfunction: Reduce the dose, particularly of Paracetamol, and monitor liver function tests.
- Patients with Comorbid Conditions: Exercise caution and adjust dosage in patients with cardiovascular disease, hypertension, or other relevant conditions.
Clinical Use Cases
The combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations where separate agents with more specific actions and controlled delivery are preferred.
Dosage Adjustments:
Adjust dosage based on patient response and individual factors like renal or hepatic impairment, age, and concomitant medications. Therapeutic drug monitoring may be useful in specific cases.
Side Effects
Common Side Effects:
- Nausea, vomiting, dyspepsia, abdominal pain
- Diarrhea, constipation
- Headache, dizziness
- Skin rash, itching
Rare but Serious Side Effects:
- Gastrointestinal bleeding or ulceration
- Myocardial infarction, stroke
- Hepatotoxicity, especially with high doses of Paracetamol
- Stevens-Johnson syndrome
- Angioedema
Long-Term Effects:
Long-term use may increase the risk of cardiovascular events, renal impairment, and gastrointestinal complications.
Adverse Drug Reactions (ADR):
Any severe adverse reaction necessitates immediate discontinuation of the medication and supportive care. Report serious ADRs to the relevant authorities.
Contraindications
- Hypersensitivity to Diclofenac, Paracetamol, or other NSAIDs
- Active peptic ulcer or gastrointestinal bleeding
- Severe hepatic or renal impairment
- Severe heart failure or coronary artery disease
- Third trimester of pregnancy
- Aspirin-exacerbated respiratory disease (AERD)
Drug Interactions
- Other NSAIDs (increased risk of gastrointestinal side effects)
- Anticoagulants (increased bleeding risk)
- Lithium, methotrexate, digoxin (increased serum levels)
- Antihypertensives (reduced efficacy)
- Alcohol (increased risk of liver damage)
Pregnancy and Breastfeeding
- Pregnancy: Avoid use during the third trimester. Use with caution during the first and second trimesters if the potential benefit outweighs the risk.
- Breastfeeding: Diclofenac and Paracetamol are considered compatible with breastfeeding at recommended therapeutic doses. Monitor the infant for potential side effects.
Drug Profile Summary
- Mechanism of Action: Diclofenac inhibits COX enzymes, reducing prostaglandins; Paracetamol’s mechanism involves central COX inhibition and modulation of endocannabinoid and serotonergic systems.
- Side Effects: Nausea, vomiting, gastrointestinal upset, headache, dizziness, rare but serious: gastrointestinal bleeding, cardiovascular events, hepatotoxicity.
- Contraindications: Hypersensitivity, peptic ulcer, severe hepatic/renal disease, severe heart failure, third-trimester pregnancy, AERD.
- Drug Interactions: Other NSAIDs, anticoagulants, lithium, methotrexate, digoxin, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Avoid in third-trimester pregnancy; compatible with breastfeeding at recommended doses.
- Dosage: Adults: one tablet two to three times daily; adjustments needed for special populations.
- Monitoring Parameters: Blood pressure, renal function, liver function tests, signs of gastrointestinal bleeding.
Popular Combinations
Diclofenac + Paracetamol is itself a popular combination. Occasionally, serratiopeptidase might be added for its purported anti-inflammatory properties, although clinical evidence supporting its efficacy is limited.
Precautions
- Assess for allergies, hepatic/renal dysfunction, cardiovascular disease before starting therapy.
- Monitor for gastrointestinal bleeding, especially in elderly patients.
- Caution patients about potential drug interactions.
- Advise pregnant and breastfeeding women about potential risks.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diclofenac + Paracetamol?
A: The usual adult dose is one tablet (Diclofenac 50 mg + Paracetamol 500 mg) two or three times a day. Maximum daily dose of Diclofenac should not exceed 150 mg. Adjust Paracetamol dose as needed, not exceeding 4 grams daily. Pediatric use is generally not recommended.
Q2: Can Diclofenac + Paracetamol be taken on an empty stomach?
A: While it can be taken on an empty stomach, it is generally recommended to take it with or after food to minimize gastrointestinal upset.
Q3: Is it safe to take Diclofenac + Paracetamol with alcohol?
A: Alcohol should be avoided or consumed in moderation while taking this medication, as it can increase the risk of gastrointestinal bleeding and liver damage, especially with Paracetamol.
Q4: Can Diclofenac + Paracetamol be used during pregnancy?
A: It should be avoided during the third trimester. Use with caution during the first and second trimesters only if the potential benefit outweighs the risk. Discuss potential risks with the patient.
Q5: What are the signs of an allergic reaction to this medication?
A: Allergic reactions can manifest as skin rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing, and wheezing. Seek immediate medical attention if these occur.
Q6: How long can I take Diclofenac + Paracetamol?
A: For short-term pain relief, follow the prescribed duration. For chronic conditions like osteoarthritis, long-term use may be necessary under close medical supervision.
Q7: Can I take Diclofenac + Paracetamol with other painkillers?
A: Avoid concurrent use of other NSAIDs like ibuprofen, naproxen, or aspirin, as it can increase the risk of side effects. Consult a doctor before combining with other painkillers.
Q8: What should I do if I miss a dose?
A: If a dose is missed, take it as soon as remembered. If it is close to the time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose.
Q9: What are the serious side effects to watch out for?
A: Be vigilant for signs of gastrointestinal bleeding (black, tarry stools, persistent abdominal pain), signs of liver damage (jaundice, dark urine), allergic reactions, and cardiovascular symptoms like chest pain or shortness of breath.
Q10: Can Diclofenac + Paracetamol be used for children with fever?
A: Paracetamol alone is generally preferred for fever in children. Consult pediatric dosage guidelines for combined use if deemed necessary.
Please remember that this information is intended for qualified Indian doctors and should not be used for self-treatment. Always consult with a medical professional for personalized advice and treatment plans.
