Ultrafen

Ultrafen

diclofenac

Manufacturer:

Beximco Pharma

Distributor:

Pharmatech Resources
Full Prescribing Info
Contents
Diclofenac sodium.
Description
Diclofenac is a non-steroid anti-inflammatory agent with marked analgesic, anti-inflammatory and antipyretic properties.
Indications/Uses
Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculo-skeletal disorders such as frozen shoulder, tendinitis, teno-synovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis, acute gout, pain in orthopaedics, dental and other minor surgery.
Dosage/Direction for Use
Adults: 75-150 mg daily in divided doses.
Children: 1-3 mg/kg body weight in divided doses.
Special populations: Established cardiovascular disease or significant cardiovascular risk factors: The use of high dose diclofenac (150 mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for more than 4 weeks. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Overdosage
There is no known antidote to Ultrafen. Hemodialysis is unlikely to decrease plasma concentration due to high degree of protein binding.
Contraindications
Ultrafen should not be given in patients with previous hypersensitivity to Diclofenac. Ultrafen should not be given to asthmatic patients and in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.
The use of high dose diclofenac (150 mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.
Special Precautions
Ultrafen should not be prescribed to pregnant women unless there is compelling reason for doing so. Patients with a history of peptic ulcer, hematemesis, melena, bleeding diathesis or with severe hepatic or renal insufficiency should be kept under close surveillance. If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Ultrafen should be discontinued. Use of Ultrafen in patients with hepatic porphyria may trigger an attack.
Cardiovascular effect: Treatment with NSAIDs, including diclofenac, particularly at high dose and in long term, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for more than 4 weeks. Patients should be advised to remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a physician immediately in case of such an event.
Adverse Reactions
Cardiac disorders: Uncommon: Myocardial infarction, cardiac failure, palpitations, chest pain.
*The frequency reflects data from long-term treatment with high dose (150 mg/day).
Description of selected adverse drug reactions: Arteriothrombotic events: Meta-analysis and pharmacoepidemiological data point towards a small increased risk of arteriothrombotic events (for example myocardial infarction) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment.
Side Effects
Epigastric pain, nausea and diarrhea, headache and slight dizziness may be complained by some patients. These are often transient, disappearing with continuation of medication.
Occasionally skin rash, peripheral edema and abnormalities of serum transaminase have been reported.
Very rarely reported side effects include activation of peptic ulcer, hematemesis or melena, blood dyscrasia (in course of extensive usage). There have been isolated reports of anaphylactoid reactions.
Drug Interactions
Diclofenac has been reported to increase plasma concentrations of lithium by impairing its renal excretion. It has been also reported to increase plasma concentrations of digoxin, but no clinical signs of overdosage have been encountered. Various non-steroidal anti-inflammatory agents are liable to inhibit the activity of diuretic and to potentiate the effects of potassium-sparing diuretic, thus making it necessary to monitor serum potassium levels. Caution should be exercised if diclofenac and methotrexate are administered within 24 hours of each other since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity. Diclofenac has been reported to lower salicylate concentrations and vice versa.
Storage
Store in a cool dry place. Store suppositories below 30°C.
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Supp 12.5 mg x 10's.
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