Diclofenac Sodium 100mg tablet:

Pharmacology of Diclofenac sodium 100mg tablets – this tablets alone or in combination can be used as a analgesic (pain killers). Its available in plain or combinations as follows –

Diclofenac 50 MG

Diclofenac 100 MG

Diclofenac 75 MG INJ

Diclofenac 100 MG +Misoprostol 100MG

Diclofenac 50 MG+Paracetamol 500 MG

Diclofenac 50 MG+Dicyclomine 20 MG

Diclofenac Sodium 100mg

Diclofenac sodium 100mg

IUPAC name: 2-(2-(2,6-dichlorophenylamino)phenyl)acetic acid

  • Trade name: Cataflam, Voltaren
  • Legal status: Rx-only most preparations/countries. Limited OTC some countries.
  • Routes: oral, rectal,imiv (renal- and gallstones), topical.
  • CAS no: 15307-86-5
  • Formula: C14H11Cl2NO2
  • Mass: 296.148 g/mol

Drug category:

  • Non-steroidal Anti-inflammatory Agents(NSAIDSs)
  • Cyclo-oxygenase Inhibitors

Physical Properties:

Physical State: White crystalline powder

-Solubility in water: soluble

-Stability – Stable under ordinary conditions.

Pharmacology of Diclofenac sodium 100MG:

  • Diclofenac is an acid non steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
  • Diclofenac is used to treat pain, dysmenorrheal, ocular inflammation, osteoarthritis, rheumatoid arthritis,ankylosing spondylitis and acitinic keratosis.

Mechanism of Action:

  • It is a cyclo-oxygenase inhibitor. Its anti-inflammatory property is due to decreased prostaglandin synthesis in the tissues.

Pharmacokinetics:

  • On oral administration, completely absorbed in a fasting state.  It is subject to first-pass metabolism and only 50% is bioavailable.
  • Onset of action is 10 minutes. Duration is 8 hours.  It penetrates the synovial fluid and is detected in breast milk.
  • Excreted in the form of glucoronide and sulphate conjugates, mainly in the urine but also in the bile.

INDICATIONS:

  • Abdominal and renal colic.
  • Dental extraction.
  • Dysmenorrhoea, abdominal and renal colic.

Dosage:

  • Adults:  usually given: 50 mg 2-3 times a day.
  • For dysmenorhoea : 100 mg initially followed by 50 mg after 8 hours if required.
  • For chronic inflammatory disorders: 150-200 mg in 2,3 divided doses or 100 mg/day of SR

Preparation

Children:

Orally: 1-3 mg/kg body WEIGHT/day in divided doses.

Parenteral or IM: 75 mg once or twice daily depending on requirements.

Contraindications:

  • Active peptic ulcer.
  • Bleeding disorders and patients on anticoagulant, therapy.
  • History of hypersensitivity reactions to other NSAIDS.
  • Porphyria.

Drug Interactions

  • May decrease effects of thiazide and furosemide.

Adverse Effects:

Common effects:

  • Epigastric pain, bleeding from ulcers and perforation.  Elderly patients, smokers, alcoholic patients are especially at risk for GI side effects.

Rare effects:

  • Hepatic enzymes like SGOT, SGPT may be elevated, especially in chronic users, rarely acute fulminant hepatitis can occur.  Therefore, periodic monitoring of liver function tests to be done in chronic users.
  • Fluid retention and edema.
  • Precipitation of asthmatic attacks in susceptible individuals.
  • Haematological – anaemia due to either gastro-intestinal bleeding or fluid retention, inhibition of platelet aggregation, increase in bleeding time.
  • Rashes, pruritis, bullous dermatitis and erythema multiforme.

Drug Toxicity:

  • Drowsiness, CNS depression and acute renal failure.

Treatment of Toxicity:

  • Reduce absorption by vomiting, lavage, activated charcoal.
  • Forced diuresis.
  • Symptomatic treatment – monitor electrolyte and fluid balance.

Storage:

  • Store in a cool, dry, dark place.
  • Shelf Life  3 years.

Precautions / Practice points:

  • The chronic users are warned about symptoms of liver toxicity like nausea, fatigue, lethargy, pruritis, right hypochondrial pain, flu like symptoms.
  • Use with caution in patients with compromised renal, hepatic orcardiacfailure; renal failure can be precipitated Due to reduction of renal blood flow.
  • Monitor blood counts, hepatic and renal parameters periodically in patients on long term therapy.
  • Administration Instructions:
  • Take with food to reduce GI effects.

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