Zipsor

Generic name:

Diclofenac potassium

Drug class:

Nonsteroidal anti-inflammatory drug (NSAID)

Dosage form:

Soft gelatin capsules, 25 mg

Route of administration:

Oral

Dose:

Typical adult dose: 25 mg every 6 hours as needed for acute pain; maximum 150 mg/day. Doses may be adjusted based on clinical response and tolerability.

Mechanism of action:

Diclofenac potassium reversibly inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis and reducing inflammation and pain.

Drug usage cases:

• Relief of acute mild to moderate pain
• Musculoskeletal pain (e.g., strains, sprains)
• Dysmenorrhea
• Dental pain (off-label)
• Migraine and tension headaches (off-label)
• Postoperative pain (off-label, non–coronary bypass)

Drug contra indications:

• Hypersensitivity to diclofenac or other NSAIDs
• Aspirin- or NSAID-induced asthma, urticaria, or allergic-type reactions
• Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
• Active or history of peptic ulcer disease or gastrointestinal bleeding
• Severe hepatic or renal impairment
• Congestive heart failure NYHA III/IV
• History of cerebrovascular bleeding or hemorrhagic diathesis

Side effects:

• Gastrointestinal: dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation, flatulence, GI ulceration, bleeding, perforation
• Central nervous system: headache, dizziness, drowsiness
• Cardiovascular: hypertension, edema, palpitations
• Hepatic: elevated liver enzymes (ALT, AST), hepatotoxicity, jaundice
• Renal: increased blood urea nitrogen (BUN), creatinine, renal impairment
• Hematologic: anemia, prolonged bleeding time, thrombocytopenia
• Dermatologic: rash, pruritus, photosensitivity reactions
• Respiratory: bronchospasm in susceptible individuals
• Hypersensitivity: anaphylaxis, angioedema

Warnings:

• Cardiovascular risk: increased risk of myocardial infarction and stroke; avoid in patients with established cardiovascular disease unless benefits outweigh risks
• Gastrointestinal risk: risk of serious GI bleeding, ulceration, perforation; monitor for abdominal pain, melena
• Renal risk: monitor renal function; may cause fluid retention and renal impairment
• Hepatic risk: monitor liver enzymes; discontinue if clinical signs of liver dysfunction
• Serious skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis
• Hematologic effects: anemia, prolonged bleeding; monitor CBC
• Anaphylactoid reactions: may occur in patients without prior exposure
• Pregnancy: avoid in late pregnancy (see section below)

Use during pregnancy or breastfeeding:

Pregnancy: Category C until 30 weeks gestation; Category D after 30 weeks due to risk of premature closure of the ductus arteriosus, oligohydramnios, and pulmonary hypertension in the fetus. Avoid use in the third trimester.

Breastfeeding: Diclofenac is excreted in breast milk in low concentrations. Use with caution; consider discontinuation of nursing or the drug, taking into account the importance of the medication to the mother.