Kefen 100 mg/2 ml (IM Injection)

Indications

• Rheumatoid arthritis
• Degenerative joint diseases
• Musculoskeletal and joint disorders
• Pain relief for dental pain
• Pain relief for headaches
• Pain relief for dysmenorrhea

Pharmacology

• Non-steroidal anti-inflammatory drug (NSAID)
• Analgesic and antipyretic actions
• Inhibition of prostaglandin synthesis
• Stabilization of lysosomal membranes
• Inhibition of leukotriene synthesis
• Antibradykinin activity
• Central and peripheral analgesia
• Rapid and complete absorption from GI tract
• Extensive metabolism in the liver
• Excretion in urine and feces
• Peak concentration after IM injection
• Elimination half-life

Dosage

• Anti-inflammatory dosage
• Management of pain and primary dysmenorrhea
• Recommended starting dose
• Recommended maximum daily dose
• Usual recommended dose
• Frequency of administration
• Administration with fluids and food

Administration

• Oral administration
• Administration with fluids
• Preferably with food

Interaction

• Not recommended drug associations
• Increased risk of gastrointestinal ulceration and bleeding
• Increased risk of bleeding with anticoagulants
• Coadministration precautions
• Risk of elevation of lithium plasma levels
• Increased risk of haematologic toxicity with methotrexate
• Risk of hyperkalemia with certain medicinal products
• Increased risk of gastrointestinal ulceration or bleeding with corticosteroids
• Risk of developing renal failure with diuretics
• Potential nephrotoxicity with cyclosporin and tacrolimus
• Monitoring requirements with methotrexate and pentoxifylline
• Increased risk of renal failure with tenofovir

Contraindications

• History of hypersensitivity reactions
• Severe heart failure
• Active or history of peptic ulcer/hemorrhage
• History of gastrointestinal bleeding or perforation
• Severe hepatic insufficiency
• Severe renal insufficiency
• Third trimester of pregnancy
• Rectitis or history of proctorrhagia

Side Effects

• Haemorrhagic anaemia
• Immune system reactions
• Nervous system disorders
• Vision blurred
• Tinnitus
• Exacerbation of heart failure
• Hypertension
• Asthma
• Gastrointestinal disorders
• Hepatitis
• Rash and pruritis
• Renal failure
• Oedema
• Hyponatremia and hyperkalemia
• Weight changes

Pregnancy & Lactation

• Safety in pregnant women not evaluated
• Avoidance during first and second trimester
• Contraindicated in last trimester
• Not recommended in nursing mothers

Precautions & Warnings

• Use with care in patients with gastrointestinal disease
• Monitoring of renal function in specific patient groups
• Caution in patients with history of hypertension and congestive heart failure
• Increased risk of atrial fibrillation
• Potential for hyperkalemia
• Masking of signs of infection progression
• Monitoring of liver function tests
• Discontinuation upon visual disturbances
• Impairment of female fertility
• Reduced dosage for special populations

Use in Special Populations

• Dosage adjustment for elderly
• Monitoring and minimal effective dosage for hepatic impairment
• Dosage adjustment for renal impairment

Overdose Effects

• Reported cases and symptoms
• Lethargy, drowsiness, nausea, vomiting, epigastric pain
• No specific antidotes
• Recommendations for suspected massive overdosages
• Supportive treatment and monitoring

Therapeutic Class

• Drugs for Osteoarthritis
• Drugs for Rheumatoid Arthritis
• Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

• Protection from light
• Temperature storage
• Expiry date
• Dispensing regulations

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