G ALFENAC P TABLET

Indications

• Pain relief
• Inflammatory conditions
• Osteoarthritis
• Rheumatic disorders
• Post-operative pain
• Musculoskeletal pain

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Aceclofenac exerts its anti-inflammatory and analgesic effects by inhibiting the enzyme cyclooxygenase (COX), leading to a decrease in the synthesis of prostaglandins, which are mediators of inflammation and pain. Paracetamol predominantly acts in the central nervous system, where it inhibits a specific form of COX, leading to reduced prostaglandin synthesis in the brain, thus providing analgesic and antipyretic effects.

Pharmacodynamics

The combination of aceclofenac and paracetamol enhances pain relief and reduces inflammation through their synergistic action. Aceclofenac is effective in reducing both acute and chronic pain, while paracetamol alleviates pain and fever without significant anti-inflammatory effects. This dual action can provide comprehensive management of pain and discomfort associated with various conditions.

Pharmacokinetics

Aceclofenac is rapidly absorbed following oral administration, with peak plasma concentrations occurring within 1 to 3 hours. It undergoes extensive hepatic metabolism and is primarily excreted in urine as metabolites. Paracetamol is also well absorbed, with peak plasma levels reached within 30 minutes to 2 hours after ingestion. It is metabolized mainly in the liver and excreted in urine, predominantly as conjugated forms. Both drugs have a bioavailability that can be influenced by food intake, and dosing adjustments may be needed in patients with hepatic impairment.

Contra-indications

• Hypersensitivity to aceclofenac, paracetamol, or any other excipients
• Active peptic ulceration or gastrointestinal bleeding
• Severe hepatic impairment
• Severe renal impairment
• History of asthma, urticaria, or allergic reactions associated with NSAIDs
• Pregnancy (third trimester)

Adverse effects

• Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
• Dizziness or headache
• Rash or other skin reactions
• Hepatic dysfunction or elevated liver enzymes
• Renal impairment
• Increased risk of cardiovascular events with long-term use of NSAIDs

Interactions

• Increased risk of gastrointestinal bleeding with other NSAIDs or anticoagulants
• Potential for increased hepatotoxicity when used with other medications that affect the liver
• May enhance the effects of warfarin or other anticoagulants
• Concurrent use with corticosteroids may increase the risk of gastrointestinal side effects
• Caution with diuretics, as NSAIDs may reduce their effectiveness

Precautions

• Use with caution in patients with pre-existing liver or kidney disease
• Monitor renal function in long-term use or in patients with dehydration
• Use with caution in patients with cardiovascular disease or hypertension
• Consideration in individuals with a history of gastrointestinal disorders
• Avoid in patients with a history of allergic reactions to NSAIDs

Pregnancy

Aceclofenac should be avoided during pregnancy, especially in the third trimester, due to potential risks to the fetus.

Breast-feeding

Paracetamol is generally considered safe during breastfeeding, but caution is warranted with aceclofenac, and it is recommended to consult a healthcare provider.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

• Tablets containing a combination of aceclofenac and paracetamol
• Oral suspension for pediatric use