Each suppository contains: Diclofenac sodium 50 mg.
Pharmacology: Pharmacokinetics: Diclofenac potassium is rapidly absorbed when given as an oral solution or by rectal suppository. It is absorbed more slowly when given as enteric-coated tablets, especially when this dosage form is given with food. Although orally administered diclofenac is almost completely absorbed, it is subject to first-pass metabolism so that about 50% of the drug reaches the systemic circulation in the unchanged form. Diclofenac is also absorbed percutaneously. At therapeutic concentrations it is more than 99% bound to plasma proteins. Diclofenac penetrate synovial fluid where concentration may persist even when plasma concentrations fall; diclofenac is distributed into breast milk but the amount is considered by some authorities to be too small to be harmful to a breast fed infant. The terminal plasma half-life is about 1 to 2 hours. Diclofenac is metabolized to 4'-hydroxydiclofenac, 5-hydroxydiclofenac,3'-hydroxydiclofenac and 4',5-dihydroxydiclofenac. It is then excreted in the form of glucoronide and sulfate conjugates mainly in the urine (about 65%) but also in the bile (about 35%).
Relief of pain and inflammation in various conditions: musculoskeletal and joint disorders such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis; peri-articular disorders such as bursitis and tendinitis; soft tissue disorders such as sprains and strains; and other painful conditions such as renal colic, acute gout, dysmenorrhoea, migraine and following some surgical procedures.
Adult: Insert one (1) suppository daily deep into the anus, preferably after stool or as prescribed by the physician.
Children: 1 to 12 years of age (juvenile arthritis) - 1 to 3 mg/kg daily in divided doses.
6 to 12 years of age (post operative pain) - 1 to 2 mg/kg daily in divided doses for maximum of 4 days.
The maximum daily dose is 200 mg.
Directions for use: 1. Wash hands thoroughly before and after insertion of Diclofenac suppository.
2. Clean the area around the rectum with mild soap and warm water, and rinse thoroughly. Gently dry by patting or blotting with toilet issue or soft cloth.
3. Detach one suppository from the strip and hold the suppository in an upright position and carefully peel the wrapper evenly on both sides. Avoid excessive handling as the suppository is designed to melt at body temperature.
4. Position the patient flat on back or on one side with anal opening exposed.
5. Gently insert the suppository well into the rectum; use fingertip to complete insertion.
6. If necessary, hold the buttocks together for 30-60 seconds to keep suppository in place.
7. If suppository is soft, hold the wrapper under cold water for solidification and then use the suppository.
Gastric or intestinal ulcer. Known hypersensitivity to diclofenac and other NSAIDs.
Absolute contraindications: Not to be given to those patients who have a history of: Stroke: cerebrovascular accident, CVA; Heart attack: myocardial infarction, MI; Coronary artery bypass graft, CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II - IV.
Contraindicated in patients with history of hypersensitivity to ASA or any other NSAIDs.
NSAIDs are contraindicated in patients with previous or active peptic ulceration.
Administration of diclofenac is contraindicated in patients with moderate or severe renal impairment, hypovolemia, or dehydration; in patients with a history of hemorrhagic diasthesis, cerebrovascular bleeding (including suspected), or asthma; and in patients undergoing surgery with a high risk of haemorrhage. Use with caution in patients with cardiac, liver and renal diseases. Dose adjustment like using the lowest effective dose and monitoring of renal and liver functions should be instituted.
Use in Pregnancy: Diclofenac may inhibit labor pains and increase tendency to bleed.
Diclofenac may inhibit labor pains and increase tendency to bleed.
The side effects that occur during therapy with NSAIDs are generally gastrointestinal disturbances such as gastrointestinal discomfort, nausea and diarrhea; these are usually mild and reversible but in some patients, peptic ulceration and severe gastrointestinal bleeding may occur. CNS-related side effects include headache, vertigo dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur occasionally and include fever, angioedema, bronchospasm, and rashes. Hepatotoxicity and aseptic meningitis, which occur rarely, may also be hypersensitivity reactions. Some patients may experience visual disturbances.
Diclofenac potassium should not be administered intravenously to patients already receiving other NSAIDS or anticoagulants including low-dose heparin, and also with the use of cyclosporine, diuretics, gastrointestinal drugs, lipid regulating drugs and misoprostol.
For rectal use only. Not for oral use.
Store at temperatures not exceeding 30°C.
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.