Product Name: Parlofenac-P Tablet

Composition:Aceclofenac 100 mg + Paracetamol 325 mg

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) analog of Diclofenac. It is used for the relief of pain and inflammation in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Paracetamol (acetaminophen) is a pain reliever and a fever reducer. Paracetamol is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Indications :

• Acute arthritis flare
• Rheumatoid arthritis
• Low back pain
• Gynecological pain
• Dental pain
• Painful & inflammation condition of ear, nose & threat.

Pharmacokinetics:

It is a phenyl acetic acid derivative that inhibits synthesis of the inflammatory cytokines interleukin-1b and tumour necrosis factor, and inhibits prostaglandin E2 production. It increases glycosaminoglycans (GAG) synthesis, the principal macromolecule of the extracellular matrix, which aids in repair and regeneration of articular cartilage. Thus, aceclofenac has +ve effects on cartilage anabolism combined with modulating effect of matrix catabolism. Paracetamol has analgesic and antipyretic action with weak anti-inflammatory activity.

Absorption Aceclofenac: Rapidly absorbed; almost 100% bioavailability; peak plasma levels reached about 1.25-3 hours after oral admin.

Distribution Aceclofenac: >99.7% bound to plasma proteins; distributes into synovial fluid. Paracetamol: Distributes throughout most fluids of the body.

Metabolism Aceclofenac: Probably metabolised by CYP2C9; average plasma elimination half-life: 4-4.3 hours. Paracetamol: Mainly metabolised hepatically; plasma elimination half-life: 1-4 hours.

Excretion Aceclofenac: About two-thirds of the administered dose is removed in the urine, mainly as conjugated hydroxymetabolites. Paracetamol: Most metabolites are removed in the urine within 24 hours.

Adverse effects:

• Nausea
• Allergic reaction
• Skin rashes

Contraindications:

• Hypersensitivity to Paracetamol.

Precautions:

• Care is advised in the administration of Paracetamol to patients with serve.
• Do not exceed the state dose.
• Do not take with any other Paracetamol containing products.
• If symptoms persist for more than 3 days or get worse consult your doctor.
• Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Drug interactions:

• Cholestyramine
• Metoclopramide & Domperidone
• Warfarin
• Chloramphernicol.

Storage:

Store it at room temperature (25˚C).