Clofenac 12.5 mg Supp

Overview

Clofenac 12.5 mg Suppository is a non-steroidal anti-inflammatory drug (NSAID) manufactured by Square Pharmaceuticals PLC, containing Diclofenac Sodium as its active ingredient. This low-strength suppository form is particularly useful for pediatric patients and adults who cannot take oral medication, providing effective relief from pain, inflammation and fever.

Indications

Clofenac 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, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

Other indications: For the prevention of pain and treatment of inflammation and swelling in patients operated on the urogenital tract, renal and biliary colic.

Pharmacology

Diclofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. At therapeutic concentrations, it is 99.7% bound to plasma proteins, and is metabolized in the liver, undergoing first pass metabolism.

Dosage and Administration

Diclofenac Suppository: For adults, 50 mg suppository 2-3 times daily, up to a maximum daily dose of 150 mg. The 12.5 mg strength is commonly used in children, with dosage adjusted according to body weight and the supervising physician's advice.

Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy.

Antidiabetic agents: Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.

Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving cyclosporin and diclofenac concomitantly.

Methotrexate: Cases of perious toxicity have been reported when methotrexate and NSAIDs are given within 24 hours of each other.

Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs.

Other NSAIDs and steroids: Co-administration may increase the frequency of unwanted effects.

Contraindications

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

Side Effects

Diclofenac is generally well tolerated. Adverse effects are mild, rare and transient, including epigastric pain, eructation, nausea, diarrhea, dizziness or headache. Peripheral edema and skin reactions such as rash and eczema have also been encountered.

Pregnancy and Lactation

During pregnancy, Diclofenac should be employed only for compelling reasons, using the lowest effective dose. It is not recommended during the first trimester. A very insignificant quantity may be detected in breast milk, but no undesirable effects on the infant are expected.

Precautions and Warnings

In rare instances, peptic ulceration or gastrointestinal bleeding may occur during treatment. Patients of advanced age should be kept under close observation.

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 12.5 mg Suppository used for?
It is used to relieve pain, inflammation and fever associated with rheumatic, post-surgical, dental and gynecological conditions, and is especially suited for patients, including children, who cannot take oral medication.

2. Is Clofenac 12.5 mg Suppository safe for children?
The 12.5 mg strength is commonly used in pediatric patients under medical supervision, with the dose adjusted according to the child's body weight.

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.