Clofenac SR 100 mg Tablet

Overview

Clofenac SR 100 mg Tablet is a sustained-release formulation of Diclofenac Sodium manufactured by Square Pharmaceuticals PLC, designed to provide prolonged relief from pain and inflammation with once or twice-daily dosing convenience.

Indications

Clofenac SR is indicated in:

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

Surgery and Traumatology: Sprain, bruises, dislocations, fractures, soft tissue injuries, surgical interventions.

Obstetrics and Gynecology: Primary dysmenorrhoea, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Other indications: Pain and inflammation following urogenital tract surgery, renal and biliary colic.

Pharmacology

Diclofenac Sodium is a potent NSAID with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties, also having some uricosuric effect. The sustained-release formulation gradually releases the active drug, maintaining therapeutic plasma levels over an extended period while reducing dosing frequency. It is 99.7% protein-bound and undergoes hepatic first-pass metabolism.

Dosage and Administration

Diclofenac SR Tablet: Adults: 100 mg once daily; in more severe cases, 100 mg twice daily. The tablet should be swallowed whole with liquid, preferably with or after food, and should not be chewed or crushed.

Interaction

Lithium and digoxin: May increase plasma concentrations of lithium and digoxin.

Anticoagulants: Isolated reports of increased haemorrhage risk.

Antidiabetic agents: Can be co-administered without influencing clinical effect.

Cyclosporin: Nephrotoxicity reported with concomitant use.

Methotrexate: Serious toxicity reported when given within 24 hours of NSAIDs.

Quinolone antimicrobials: Convulsions may occur due to interaction with NSAIDs.

Contraindications

Contraindicated in patients hypersensitive to any ingredient, those with peptic ulcer, and asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

Side Effects

Generally well tolerated. Mild, rare and transient effects include epigastric pain, eructation, nausea, diarrhea, dizziness or headache. Peripheral edema and skin reactions such as rash and eczema have also been reported.

Pregnancy and Lactation

Should be used during pregnancy only for compelling reasons at the lowest effective dose, and is not recommended in the first trimester. A very insignificant quantity may be detected in breast milk with no expected undesirable effect on the infant.

Precautions and Warnings

In rare instances, peptic ulceration or gastrointestinal bleeding may occur. Patients of advanced age should be kept under close observation. The SR tablet should not be split or crushed, as this may disrupt its release profile.

Storage Conditions

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Frequently Asked Questions

1. What is Clofenac SR 100 mg Tablet used for?
It is used for sustained relief of pain and inflammation in arthritis, musculoskeletal injuries and related conditions, with the advantage of once- or twice-daily dosing.

2. Can the SR tablet be crushed or split?
No, the tablet should be swallowed whole, as crushing or splitting may disrupt the sustained-release mechanism.

Disclaimer: This information is provided for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always consult a registered physician before starting, stopping, or changing any medication.