Indication
Dicloban D® is indicated in the following conditions:
- Post-operative pain, inflammation, and swelling e.g. following dental or orthopedic surgery.
- Painful post-traumatic inflammatory states, e.g. due to sprains.
- Non-articular rheumatism
- Painful symptoms of the vertebral column.
- Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea, Acute attacks of gout.
- As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngitis, otitis.
* In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Composition
Each Dicloban D® dispersible tablet contains:
- diclofenac 46.5 mg (equivalent to diclofenac sodium 50 mg).
Dosage
- Dicloban D® dispersible tablets should preferably be taken before meals.
- Dicloban D® dispersible tablets are dropped into a glass of water and stirred to aid dispersion before swallowing. Since a portion of the active substance (diclofenac) may remain in the glass after swallowing, it is advisable to rinse the glass with a small amount of water and to swallow again.
Adults:
- The recommended initial dosage is 2 - 3 Dicloban D® dispersible tablets.
- In milder cases as well as for children over 14 years of age, 2 Dicloba D® dispersible tablets daily are usually sufficient.
- The daily dosage should generally be prescribed in 2 - 3 divided doses.
- In primary dysmenorrhea the daily dosage, which should be individually adapted, is generally 1 - 3 Dicloban D®.
Children:
- Because of the dosage strength, Dicloban D® dispersible tablets are not recommended for use in children below 14 years of age.
- Diclofenac is a non-steroidal anti-inflammatory compound with pronounced analgesic, anti-inflammatory and antipyretic properties. Diclofenac acts by inhibiting prostaglandin biosynthesis, by decreasing the activity of the enzyme, cyclo-oxygenase, and results in decreased formation of prostaglandin precursors, which plays a major role in causing inflammation, pain and fever.
- Dicloban D® have a rapid onset of action, which makes them particularly suitable for the treatment of acute painful and inflammatory conditions, and for those patients who have difficulty in swallowing conventional tablets.
Pharmacokinetics:
- Absorption of diclofenac from Dicloban D® dispersible tablets sets in immediately after administration. The time to achieve maximum plasma concentration is attained on average 1 hour after ingestion of one tablet Dicloban D® dose on an empty stomach.
- The bioavalability of diclofenac from Dicloban D® is 82% of the bioavailability of diclofenac enteric-Coated tablets.
- Administration of diclofenac together with or immediately after a meal does not delay the onset of absorption but reduces the amount absorbed by an average of about 16% and the maximum concentrations by about 50%.
- Diclofenac appears to be widely distributed in the body, with significant amounts in synovial fluid (present in the joints) the concentrations attained in the synovial fluid are higher than those in plasma and remain higher for up to 12 hours.
- Diclofenac is metabolized in the liver and the metabolites are excreted in the urine and the bile.
- The elimination half-life is about 1-2 hours following oral administration.
Each Dicloban D® dispersible tablet contains:
- diclofenac 46.5 mg (equivalent to diclofenac sodium 50 mg).
Dicloban D® is indicated in the following conditions:
- Post-operative pain, inflammation, and swelling e.g. following dental or orthopedic surgery.
- Painful post-traumatic inflammatory states, e.g. due to sprains.
- Non-articular rheumatism
- Painful symptoms of the vertebral column.
- Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea, Acute attacks of gout.
- As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngitis, otitis.
* In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Dicloban D® like other non-steroidal anti-inflammatory drugs, should not be given to
- patients with active peptic ulcer.
- patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis have been precipitated by aspirin or any other4 drugs with prostaglandin-synthetase inhibiting activity.
- Dicloban® D should be avoide in patients with a history of acute prophyria.
- Dicloban D® is contraindicated for the tratment of perioperative pain in the setting of coronary artery bypass graft (CABG )surgery.
- Concomitant use of anticoagulants and antiplatlets.
- Dicloban D® is contraindicated for patient with prior gastrointestinal bleeding or perforation, related to the use of anti-inflammatory analgesics.
- Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently.
- When given simultaneously with preparations contain digoxin, methotrexate,cyclosporin, sulfonylureas or lithium, diclofenac may raise their plasma concentrations.
- Like other NSAIDs concomitant administration with beta-blockers may antagonize the hypotensive effect of the beta-blockers.
- Concomitant administration of other systemic NSAIDs or corticosteroids may increase the occurrence of side effects.
- Patients taking diclofenac and oral anticoagulants should undergo routine blood tests.
- Colestipol and Cholestyramine causes decrease in absorpion of diclofenac.
- Dicloban D® should not be used during pregnancy particularly the last three months owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.
- Dicloban D® is excreted in breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.
*is generally well tolerated.
*The reported adverse effects include :-
- gastro-intestinal disturbances such as epigastric pain, heartburn, nausea, vomiting, diarrhea, and indigestion.
- Rarely gastrointestinal bleeding
- gastric or intestinal ulcer with or without bleeding or perforation may occur.
- fluid retention
- liver function disorders
- rash and pruritis have been reported.
Overdosage:
* Management of acute poisoning with NSAIDs consists essentially of supportive and symptomatic measures. There is no typical clinical picture associated with overdosage of diclofenac.
* The following therapeutic measures should be taken in cases of overdosage:
- Absorption should be prevented as soon as possible after the overdosage by means of gastric lavage and treatment with activated charcoal.
- Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression.
- Specific therapy such as forced diuresis, dialysis or haemoperfusion is unlikely to be helpful in accelerating the elimination of NSAIDs because of their high protein binding rate and extensive metabolism.
- Dicloban D® dispersible tablets should preferably be taken before meals.
- Dicloban D® dispersible tablets are dropped into a glass of water and stirred to aid dispersion before swallowing. Since a portion of the active substance (diclofenac) may remain in the glass after swallowing, it is advisable to rinse the glass with a small amount of water and to swallow again.
Adults:
- The recommended initial dosage is 2 - 3 Dicloban D® dispersible tablets.
- In milder cases as well as for children over 14 years of age, 2 Dicloba D® dispersible tablets daily are usually sufficient.
- The daily dosage should generally be prescribed in 2 - 3 divided doses.
- In primary dysmenorrhea the daily dosage, which should be individually adapted, is generally 1 - 3 Dicloban D®.
Children:
- Because of the dosage strength, Dicloban D® dispersible tablets are not recommended for use in children below 14 years of age.
- Use of Dicloban D® particulary higher doses of 150 mg/ day and in prolong treatment may be associated with a slightly increased risk of arterial thromobotic events.
- Patients with uncontrolled hyprtension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/ or cerebrovascular disease should only be treated with Dicloban D® after careful consideration.
- similar consideration should also be made before initiating longer term treatment of patients with risk factors for cardiovascular events.
- As with all types of analgesics, long term use for relief of headache can develop or worsen. Headache caused by over usage of analgesic should not be treated with increased dose of analgesic. In such cases the treatment should be withdrawn.
- Dicloban D® should be used cautiously with the elderly patients. In patients with congestive heart failure, hyprtension, decreased renal or hepatic function, history of gastrointestinal disease or those receiving anticoagulants.
- Dicloban D® is recommended for short-term treatment only.
Warning:
- Dicloban D® may cause elevation of one or more liver enzyme;close medical surveillance is required when prescribing Dicloban D® to patients with impaired hepatic function.
- If abnormal liver function tests persist or worsen, if signs or symptoms consistent with liver disease develop, Diclofenac should be discontinued.
- Physicians should measure transaminases periodically in patients receiving long-term therapy with Dicloban D®. Transaminases should be monitored during 4 to 8 weeks after initiating treatment with Dicloban D®.
Cardiovascular risk:
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infraction and stroke, which can be fatal.This risk may increase with duration of use.
- Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk:
- NSAIDs may cause an increased risk of serious gastrointestinal adverse events including { bleeding ulceration and perforation of the stomach or intestines, which can be fatal } . These events can occur at any time during use and without warming symptoms. ( Elderly patients are at greater risk for serious gastrointestinal events) .
- Dicloban D® dispersible tablets: pack of 2 blisters, blister of 10 tablets.
- Store below 25°C in a dry place, away from light.