Clofenac

Indications

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

Surgery and Traumatology: Effective for sprains, bruises, dislocations, fractures, soft tissue injuries, and post-surgical interventions.

Obstetrics and Gynecology: Alleviating primary dysmenorrhoea, episiotomy discomfort, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: Used as pre-operative medication to prevent pain, inflammation, and swelling.

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

Other Uses: Providing pain relief and reducing inflammation and swelling for patients undergoing urogenital tract surgery, as well as those experiencing renal and biliary colic.

Pharmacological Information

Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug (NSAID), offers significant anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. It also exhibits some uricosuric properties. By inhibiting prostaglandin biosynthesis, diclofenac addresses inflammation, pain, and fever. The medication is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations reached within approximately 2 hours post-ingestion. Diclofenac is highly bound to plasma proteins at therapeutic concentrations and undergoes hepatic metabolism with first-pass metabolism.

Dosage and Administration

• Diclofenac FC Tablet: Adults typically take 75-150 mg daily in 2 to 3 divided doses after meals, with long-term use requiring dosage adjustment.
• Diclofenac SR Tablet: Adults usually take one tablet daily, preferably with meals, with the option to increase the dose to 150 mg daily if necessary. Children’s dosage is based on body weight.
• Diclofenac Dispersible Tablet: Adults typically take 2-3 tablets daily, with a maximum daily dose of 150 mg. Children’s dosage varies based on condition.
• Diclofenac TR Capsule: One capsule daily, preferably after meals.
• Diclofenac Suppository: Adults may use 50 mg suppositories 2-3 times daily, not exceeding 150 mg daily.
• Diclofenac Injection: The usual adult dose is one ampoule daily, potentially increased to two ampoules in serious cases.
• Diclofenac Gel: Applied externally 3-4 times daily as needed, rubbing lightly onto the affected area.

Interactions

Diclofenac may interact with various medications, potentially affecting plasma concentrations and clinical effects. Caution is advised when using diclofenac alongside lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, and steroids.

Contraindications

The medication is contraindicated in individuals hypersensitive to any component, with peptic ulcers, and in asthmatic patients experiencing reactions to acetylsalicylic acid or prostaglandin synthetase inhibitors. The gel form should not be used under occlusive dressings.

Side Effects

Adverse effects are typically mild, transient, and infrequent. They may include gastrointestinal discomfort, dizziness, headache, peripheral edema, skin reactions, and local irritation from the gel.

Pregnancy and Lactation

Use during pregnancy should be limited to compelling reasons, with the lowest effective dose employed. Avoid use during the first trimester. While a minimal amount may pass into breast milk, adverse effects on the infant are not expected.

Precautions and Warnings

Monitor patients for peptic ulceration or gastrointestinal bleeding, especially in elderly individuals. Avoid contact with eyes or mucous membranes when using the gel. Wash hands thoroughly after application and ensure the gel is not ingested.

Therapeutic Class

Diclofenac belongs to the therapeutic classes of drugs for osteoarthritis, drugs used for rheumatoid arthritis, and non-steroidal anti-inflammatory drugs (NSAIDs).

Storage Conditions

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