Cekofen P 50mg Tablet

Cekofen P 50mg Tablet

Generic Name Diclofenac Potassium Dosage Form & Strength Tablet — 50 mg Pharmacological Class Non-steroidal Anti-inflammatory Drug (NSAID)

Contents

1. Indications

2. MECHANISM OF ACTION

3. Dosage and Administration

4. Contraindications

5. Warnings and Precautions

6. Adverse Drug Reactions (ADR) / Side Effects

7. Side Effects Handling Rules

8. Mandatory Disclaimers

Indications

Diclofenac Potassium is indicated for the relief of:

  • Mild to moderate pain, sprain , strain or other injury and inflammatory conditions
  • Gout
  • Musculoskeletal disorders
  • Dysmenorrhea
  • Dental and post-operative pain
  • It can also be taken for symtoms to relieve the symptoms of migraine attacking adults.
  • Other painful condition affecting joint and muscles like Backache , rheumatoid arthritis, osteoarthritis, alkylosing spondeolysis, pyrophosphate srthropathy.

MECHANISM OF ACTION

Key Mechanisms:

  • Cyclooxygenase (COX) Inhibition:Diclofenac potently inhibits COX enzymes (COX-1 and COX-2), preventing the conversion of arachidonic acid into prostaglandins, which are key mediators of inflammation, pain, and fever.
  • Peripheral Analgesia:It reduces sensitivity of peripheral pain receptors by affecting the nitric oxide-cGMP pathway and activating potassium channels, decreasing pain signals.
  • Leukotriene Inhibition:It also inhibits lipoxygenase, affecting the synthesis of leukotrienes, another group of pro-inflammatory substances.
  • Other Actions:It may affect thromboxane receptors and influence arachidonic acid release, contributing to its broad anti-inflammatory effects.

Dosage and Administration

Adults:

  • Recommended dose: 50 mg two to three times daily
  • Maximum daily dose: 150 mg
  • Prefer shortest duration at the lowest effective dose

Special Populations:

  • Elderly: Initiate treatment at the lowest effective dose
  • Renal or hepatic impairment: Dose adjustment or avoidance may be required

Administration should be with food to minimize gastrointestinal irritation. Treatment duration should be limited to the shortest period necessary to control symptoms.

Contraindications

Diclofenac Potassium is contraindicated in patients with:

  • Known hypersensitivity to diclofenac or other NSAIDs
  • History of NSAID-induced bronchospasm, asthma, urticaria, or allergic reactions
  • Active gastrointestinal ulceration or GI bleeding
  • Severe hepatic or renal impairment
  • Severe heart failure
  • Post-coronary artery bypass graft (CABG) surgery

Pregnancy and Lactation

  • Contraindicated during the third trimester of pregnancy
  • Use during earlier stages of pregnancy or lactation only if clearly indicated and under medical supervision

Warnings and Precautions

    • Use with caution in patients with a history of gastrointestinal disease, peptic ulcer/ GI bleeding, crohn’s disease or Liver porphyria.
    • Avoid use in patients with uncontrolled hypertension, ischemic heart disease and heart failure or Cerebrovascular disease.
    • Increased risk of cardiovascular thrombotic events with prolonged use or high doses.
    • Renal function monitoring is recommended in patients with renal impairment, dehydration, SLE, mixed connective tissue disease or elderly patients (over 65).
    • Concomitant use with anticoagulants (warfarin), corticosteroids, SSRIs (increase GI Bleeding risk), or other NSAIDs may increase bleeding risk.
    • Diclofenac may mask the signs symptoms of other infections while using these tablets your doctor may want you to check up time to time.
    • Take Medical practitioner’s advise while taking with Diuretics, anticoagulant, medicines related to diabetes, potassium sparing diabetes, lithium, Potassium sparing Diuretics, Quinilones, ciclosporins, cytotoxic drugs, NSAIDs , steroidal tablets, Cardiac glycosides , BP control medicines, Mifepriston, Phenytoin, tacrolimus, Zoduvidine, Trimethoprim, SSRI’s, potent CYP2C9, Colestipol and cholestyramine.
    • Avoid use in patients with uncontrolled hypertension, ischemic heart disease and heart failure.
    • Take precautions if you are allergic to Diclofenac potassium or any other ingredients in it or you are intolerance to sugar(celiac disease) because it contain lactose, Previuosly allergic by salicylates, or if you smoke.

    Cardiovascular risk:
    Long-term or high-dose use ↑ risk of MI and stroke

Adverse Drug Reactions (ADR) / Side Effects

Common

Epigastric pain, Dyspepsia, Nausea and vomiting, Headache and dizziness.

Less Common

Gastritis, Diarrhea or constipation, Edema, skin Rash.

Serious (Rare but important)

GI ulceration or bleeding, Acute renal injury  or kidney failure., Hepatotoxicity (↑ LFTs), Cardiovascular thrombotic events, Toxic epidermal necrolysis/ Severe cutaneous adverse reactions (including Stevens–Johnson syndrome)

Side Effects Handling Rules

Management

  • Mild GI symptoms → Take with food or add gastroprotective agents PPI
  • Persistent abdominal pain / black stools → STOP drug & seek medical care
  • ↑ LFTs or creatinine → Discontinue and monitor
  • Allergic reaction (rash, wheeze, swelling) → Immediate discontinuation
  • Avoid multiple NSAIDs simultaneously
  • Monitor liver and renal function during prolonged therapy and Discontinue therapy immediately in case of gastrointestinal bleeding, severe allergic reactions, or significant hepatic or renal dysfunction

Mandatory Disclaimers

  • Should be used only under medical supervision
  • Is not a substitute for professional medical advice
  • Should not be self-medicated for long-term use
  • Requires risk–benefit assessment, especially in elderly and cardiac patients
  • Store below 30°C.
  • Protect from moisture and light.
  • Keep out of reach of children.
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