Avonac

Diclofenac sodium.

Each film-coated tablet contains: Diclofenac sodium 100mg.

Pharmacology: Pharmacodynamics: Diclofenac sodium is a non-steroidal anti-inflammatory agent which has analgesic and antipyretic properties. It is a prostaglandin synthetase (cyclo-oxygenase) inhibitor.
Pharmacokinetics: Following ingestion, diclofenac sodium is completely absorbed from the intestinal tract but undergoes first pass metabolism and peak plasma concentrations occur in about 2 to 4 hours; at therapeutic concentrations it is more than 99% bound to plasma proteins. Diclofenac is almost entirely metabolized in the liver and the terminal plasma half-life is about 1-2 hours, with metabolic excretion mainly via the kidneys and also in the bile.

For rheumatoid arthritis & ankylosing spondylitis; osteoarthrosis & spondylarthritis; non-articular rheumatism; painful, post-operative & post-traumatic inflammation & swelling; painful inflammatory conditions in gynecology.

For oral administration.
This is slow release tablet. It should be swallowed whole with liquid, and must not be divided or chewed. The recommended initial daily dosage is 100mg. As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see PRECAUTIONS).
Established cardiovascular disease or significant cardiovascular risk factors: Treatment with diclofenac is generally with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes melilitus and smoking) should be treated with diclofenac only after careful consideration and only at doses ≥ 100 mg daily if treated for more than 4 weeks (see PRECAUTIONS).

Treatment should be symptomatic and supportive. Gastric lavage and treatment with active charcoal, as soon as possible, to prevent absorption together with symptomatic measures to treat gastro-intestinal irritation and other complications such as hypotension, convulsions, respiratory disorders and renal failure are indicated. Correction of severe electrolyte abnormalities may need to be considered.
The extensive metabolism and high rate of protein binding of NSAIDs obviate the use of specific therapies such as forced diuresis, haemoperfusion or dialysis.

Avonac SR is contraindicated for: The blood abnormality sufferers of advanced case.
The liver obstacle sufferers of advanced case.
The kidney obstacle sufferers of advanced case.
Hypersensitivity to aspirin.
Hypersensitivity to diclofenac.
Sufferers of peptic ulcer.
Severe Cardiac failure (see Warning).

RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID.
Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.

Severe cutaneous reactions, including Stevens- Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported with diclofenac sodium. Patients treated with diclofenac sodium should be closely monitored for signs of hypersensitivity reactions.
Discontinue diclofenac sodium immediately if rash occurs.
Adverse effects: Dermatological: Occasional - rashes or skin eruptions.
Cases of hair loss, bullous eruptions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and photosensitivity reactions have been reported.
For the treatment of chronic disease: All patients who are receiving long-term treatment with NSAIDs should be monitored as a precautionary measure, e.g. renal, hepatic function (elevation of liver enzymes may occur) and blood counts.
Non-drug treatment should be considered.
For the treatment of acute disease: Treatment according to the pain and the level of fever.
Avoid using the same kind of drugs for a long time.
Notice the status of the patients if side effects are happened during the treatment.
Using carefully for: Severe hepatic or renal damage. Peptic ulceration of gastrointestinal bleeding. Asthma. Bronchospasm. Cardiovascular disease. Elderly.
Cardiovascular effects: Treatment with NSAIDs including diclofenac, particularly at high dose and in long term, may be associated with an increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes melilitus and smoking) should be treated with diclofenac only after careful consideration and only at doses ≥ 100 mg daily when treatment continues for more than 4 weeks.
As the cardiovascular risk 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 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.
Effects on ability to drive and use machines: It is advisable not to drive or operate machinery if visual disturbances, headaches, dizziness or drowsiness occur while taking Diclofenac sodium.

Safety and efficacy in pregnant women have not been established. Diclofenac sodium should be used in pregnancy only if the benefits outweigh the risk, when the lowest effective dose should be employed. Use of prostaglandin synthetase inhibitors may result in premature closure of the foetal ductus arteriosus or uterine inertia and therefore are not recommended during the last trimester of pregnancy.
Excretion in breast milk unknown/not recommended.

Epigastric pain, eructation. Slight dizziness or headache. Isolated anaphylactoid reactions, mild skin rash, peripheral oedema. Depression. Drowsiness. Insomnia & blurred vision. Impairment of liver & kidney function. Agranulocytosis & thrombocytopenia.
Cardiac disorders: Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
*The frequency reflects data from long-term treatment with a high dose (150 mg/day).
Description of selected adverse drug reactions: Arteriothrombotic events: Meta-analysis and pharmacoepidemiological data point towards an 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 (see Precautions).

Increase plasma concentration of lithium, methotrexate & warfarin.
Reduce effects of diuretics & beta-blockers.
Alters plasma concentration of sulfonylureas, captopril, triamterene.

Store below 30°C and protect from moisture.
Shelf-Life: 3 years.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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