Clofenac DT

Indications

1. Rheumatology: Addressing inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, and peri-articular rheumatic disorders.
2. Surgery and Traumatology: Treating sprains, bruises, dislocations, fractures, soft tissue injuries, and aiding in surgical interventions.
3. Obstetrics and Gynecology: Managing primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.
4. Otorhinolaryngology: Providing pre-operative medication to prevent pain, inflammation, and swelling.
5. Dentistry: Assisting in post-operative and post-traumatic pain, inflammation, and swelling management.
6. Other indications: Alleviating pain, inflammation, and swelling in patients undergoing urogenital tract surgeries, renal and biliary colic procedures.

Pharmacology

Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug (NSAID), exhibits significant anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. Additionally, it demonstrates some uricosuric effects. Diclofenac functions by inhibiting prostaglandin biosynthesis, a key factor in inflammation, pain, and fever. The drug is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations approximately two hours post-ingestion. It binds extensively to plasma proteins at therapeutic concentrations and undergoes hepatic metabolism and first-pass metabolism.

Dosage & Administration

1. Diclofenac FC Tablet: For adults, the recommended daily dosage ranges from 75-150 mg, administered in 2 to 3 divided doses after meals. Long-term use may necessitate dose reduction.
2. Diclofenac SR Tablet: Adults typically take one tablet daily, whole with liquid, preferably during meals. Dosage may be increased to 150 mg daily if needed. For children, the dose ranges from 1-3 mg/kg body weight daily, divided.
3. Diclofenac Dispersible Tablet: Adults are advised to take 2-3 tablets daily, not exceeding a maximum daily dose of 150 mg. In milder cases, 2 tablets per day suffice. It’s recommended to take before meals. For children with juvenile rheumatoid arthritis, the dose is 1-3 mg/kg body weight. The tablet should be dissolved in half a glass of water before ingestion.
4. Diclofenac TR Capsule: One capsule daily, preferably taken after meals.
5. Diclofenac Suppository: For adults, 50 mg suppository 2-3 times daily, with a maximum daily dose of 150 mg.
6. Diclofenac Injection: Typically, adults receive one ampoule daily, with a possible increase to 2 ampoules daily in serious cases.
7. Diclofenac Gel: For external use only. Apply 2-4 g to the affected area 3-4 times daily, rubbing lightly into the skin.

Interaction

Diclofenac may interact with various drugs including lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, and steroids. Caution is advised when combining these medications to avoid potential adverse effects.

Contraindications

Diclofenac is contraindicated in patients hypersensitive to any ingredient, those with peptic ulcers, hypersensitivity to NSAIDs, and asthmatic patients prone to attacks triggered by acetylsalicylic acid or prostaglandin synthetase inhibitors. Avoid use under occlusive dressings.

Side Effects

Side effects of diclofenac are generally mild, rare, and transient. These may include epigastric pain, eructation, nausea, diarrhea, dizziness, headache, peripheral edema, skin reactions, rash, eczema, local skin irritation, and reddening.

Pregnancy & Lactation

Use during pregnancy should be limited to compelling reasons and the lowest effective dose. Avoid use during the first trimester. Diclofenac may be excreted in breast milk but typically does not cause adverse effects in infants.

Precautions & Warnings

Monitor patients for peptic ulceration or gastrointestinal bleeding, especially in elderly patients. Avoid contact with eyes or mucous membranes with diclofenac gel. Properly wash hands after application. Do not ingest.

Therapeutic Class

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

Storage Conditions

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