Defnil – K tablets (diclofenac)
DEFNIL-K NAFDAC NO: A4 – 5499
(DICLOFENAC POTASSIUM TABLETS USP 50mg)
Each uncoated tablets:
Diclofenac Potassium USP….50mg
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It has analgesic,antipyretic ,antirheumatic and anti-inflammatory properties.
MECHANISM OF ACTION: Diclofenac is a potent inhibitor of prostaglandin bio-synthesis and modulator of arachidonic acid release and uptake. DICLOFENAC Potassium Rapid tablets have a rapid onset of action and are therefore suitable for the treatment of acute episodes of pain and inflammation.
Low back pain
Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder),tendinitis, tenosynovitis,
bursitis, sprains, strains and dislocation; relief of pain in fractures.
Control of pain and inflammation in orthopaedic, dental and other minor surgery.
DOSAGE & ADMINISTRATION: For oral administration
ADULTS: The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100mg daily in two or three divided doses is usually sufficient.
In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where relief 2hours after the first dose is not surfficient, a further dose of 50mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6hours, not exceeding a total dose of 200mg per day.
CHILDERN: For children over 14years of age, the recommended daily dose is 75-100mg in two or three divided doses.Diclofenac potassium rapid tablets are not recommended for children under 14years of age.
SYMPTOMS: Symptom’s include headache,nausea,vomiting,epigestric pain, gastrointestinal bleeding,diarrhea,disorientation,excitation,coma,drowsiness,tinnitus,fainting,occasionally convulsions. In rare case of significant poisoning acute renal failure and liver damage are possible.
THERAPEUTIC MEASURES: Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered.
Alternatively, in adults gastric lavage should be considered within one hour of ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.
The most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are: Gastrointestinal experiences including abdominal pain, constipation, diarrhea,dyspepsia,flatulence,gross bleeding /perforation,heartburn,nausea, GI ulcers (gastric/duodenal)and vomiting. Abnormal renal function, anemia, dizziness, edema elevated liver enzymes, headaches, increased bleeding time, puritis, rashes and tinnitus.
As with other NSAIDS,diclofenac k may interfere with the action of antihypertensive and diuretic agents,increase the risk of bleeding with wafarin and the risk of of bone marrow suppression with methotrexate.
-Hypersensitivity to the active substance or any of the excipients.
-Patients with active, or a history of, gastrointestinal ulcers, bleeding or perforation (two or more distinct episodes of proven ulceration or bleeding).
-Patients who has previously shown hyper-sensitivity reactions (e.g. asthma, angioedema, urticaria or acute rhinitis) to ibuprofen, aspirin or other nonsteroidal anti-inflammatory drugs.
-Severe hepatic, renal and heart failure.
-During the last trimester of pregnancy.
-History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy.
SPECIAL WARNINGS AND PRECAUTIONS.
-In all patients: Undesirable effect may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. The use of Diclofenac potassium with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided
-ELDERLY: The elderly have increases frequency of adverse reactions to NSAIDs especially gastro intestinal bleeding and perforation which may be fatal. As with all NSAIDs, patient with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).
-Administer whole, do not crush tablets, and give with food to minimize GI distress.
-Advice patients to report any sign of blood in the stool.
STORAGE: Keep in a cool, dry, dark place away from reach of children.
PRESENTATION: Blister of 10tablets