Dexifen

• Approved Indications:
• Management of mild to moderate pain such as musculoskeletal pain, dental pain, and dysmenorrhea.
• Symptomatic treatment of inflammatory conditions including osteoarthritis and rheumatoid arthritis.
• Treatment of fever (antipyretic use).
• Important Off-Label/Clinically Accepted Uses:
• Acute gout attacks.
• Postoperative pain management.
• Ankylosing spondylitis and other inflammatory joint diseases.

• Adults:
• Typical oral dose: 200–400 mg every 6 to 8 hours as needed.
• Maximum daily dose: 1200 mg.
• For chronic inflammatory conditions, maintenance dose ranges between 300–600 mg daily in divided doses.
• Elderly:
• Start at the lowest effective dose due to increased risk of adverse effects.
• Careful monitoring for gastrointestinal and renal adverse effects is recommended.
• Pediatrics:
• Safety and efficacy in children below 12 years not well established; dosing must be individualized.
• Special Populations:
• No dosage adjustment is usually required for mild to moderate renal or hepatic impairment; use with caution in severe impairment.
• Avoid or closely monitor in severe hepatic or renal dysfunction.
• Administration:
• Oral administration with food or milk to reduce gastrointestinal irritation.

Dexibuprofen is the pharmacologically active S-(+)-enantiomer of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). It exerts its therapeutic effects primarily by reversibly inhibiting the cyclooxygenase (COX) enzymes COX-1 and COX-2. This inhibition reduces the synthesis of prostaglandins—lipid compounds that mediate inflammation, pain, and fever. By decreasing prostaglandin formation, dexibuprofen alleviates pain, reduces inflammation, and lowers elevated body temperature.

• Absorption:
• Rapidly and completely absorbed after oral administration.
• Peak plasma concentrations reached within 1–2 hours.
• Bioavailability:
• High oral bioavailability, typically >80%.
• Distribution:
• Widely distributed; approximately 99% bound to plasma proteins, mainly albumin.
• Metabolism:
• Hepatic metabolism predominantly via cytochrome P450 enzymes (CYP2C9).
• Undergoes oxidation to inactive metabolites.
• Elimination:
• Excreted mainly in urine as metabolites and conjugates.
• Plasma elimination half-life: approximately 1.8 to 3.5 hours.

• Pregnancy:
• Generally classified as FDA Pregnancy Category C in the first and second trimesters. Use only if clearly needed.
• Avoid use in the third trimester due to risk of premature closure of the fetal ductus arteriosus and other adverse fetal effects.
• Lactation:
• Excreted in small amounts in breast milk.
• Caution advised; breastfeeding mothers should avoid or use with caution.

• Nonsteroidal Anti-Inflammatory Drug (NSAID)
• Propionic acid derivative
• Analgesic, anti-inflammatory, and antipyretic agent

• Known hypersensitivity to dexibuprofen, ibuprofen, aspirin, or other NSAIDs
• History of asthma, urticaria, or allergic-type reactions following NSAID administration
• Active or history of recurrent peptic ulcer or gastrointestinal bleeding
• Severe heart failure, renal failure, or hepatic impairment
• Third trimester of pregnancy

• Increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke; caution in patients with cardiovascular disease or risk factors.
• Gastrointestinal risks including bleeding, ulceration, and perforation which may be fatal; monitor closely especially in elderly or those with prior GI events.
• May cause renal toxicity, including acute renal failure, especially in volume-depleted patients.
• Use with caution in patients with hypertension or fluid retention.
• Potential for hypersensitivity reactions including anaphylaxis.
• Avoid concurrent use with other NSAIDs.

• Common:
• Gastrointestinal discomfort (nausea, dyspepsia, abdominal pain)
• Headache, dizziness
• Mild elevation of liver enzymes
• Serious but Rare:
• Gastrointestinal bleeding, ulceration, and perforation
• Serious allergic reactions (rash, anaphylaxis)
• Cardiovascular events (myocardial infarction, stroke)
• Renal impairment and fluid retention

• May reduce the antihypertensive effect of ACE inhibitors, beta-blockers, and diuretics.
• Increased risk of bleeding with anticoagulants (warfarin), antiplatelet agents, and selective serotonin reuptake inhibitors (SSRIs).
• Concurrent use with other NSAIDs or corticosteroids increases risk of gastrointestinal toxicity.
• Metabolized by CYP2C9; inhibitors or inducers may alter plasma levels.

• Current guidelines emphasize using the lowest effective dose for the shortest duration to minimize cardiovascular and gastrointestinal risks.
• Recent warnings reinforce avoiding use in patients with established cardiovascular disease unless benefits outweigh risks.
• Updated recommendations promote careful screening for GI and renal risk factors prior to initiation.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and light
• Keep tightly closed in original container
• Keep out of reach of children