MICRO DICLOFENAC INJECTION
(and dosage form):
MICRO DICLOFENAC INJECTION
Each 3 mL contains 75 mg Diclofenac sodium with 4% v/v benzyl alcohol as preservative
A 3.1 Antirheumatics (anti-inflammatory agents)
Diclofenac sodium has analgesic, anti-inflammatory, anti-rheumatic and antipyretic activities. It is non-steroidal. It is an inhibitor of cyclo-oxygenase. Diclofenac is metabolised in the liver to 4-hydroxydiclofenac and other hydroxylated forms. Afgter glucoronidallon and sulphation the metabolites are excreted in the urine (65%) and bile (35%).
To be used as initial therapy for inflammatory and degenerative rheumatic diseases, as well as for painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout.
Patients with known hypersensitivity to diclofenac, or other non-steroidal anti-inflammatory medicines. Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylicacid, or other medicines with prostaglandin synthetase inhibiting activity. Diclofenac sodium is contra-indicated in patients with a history of active gastro-intestinal bleeing or peptic ulceration, or severe hepatic or renal impairment. It should be administered with care to patients with asthma or bronchospasm. Patients with porphyria. Safety during pregnancyand lactation has not been established.
Regular use of NSAID's during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased. Serious interactions have been reported after the use of methotrexate with diclofenac.
DOSAGE AND DIRECTIONS FOR USE:
The directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site. After inserting the needle the plunger should be pulled back to avoid inadvertent intra-arterial injection. Not intended for intravenous injection. Only for deep intragluteal injection into the upper quadrant. 75 mg by intramuscular injection once daily, or twice daily in sever cases; each injection should be given at a different site. Diclofenac ampoules should not be given for more than two (2) days. If necessary treatment can be continued with oral therapy.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer. Central nervous system related side-effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia. Hypersensitivity reactions may occur and include fever and rashes. Hepatotoxicity and aseptic meningitis may also be hypersensitivity reactions. It can provoke bronchospasm in patients with asthma. It may cause cystitis and haematuria. It may also cause acute renal failure, interstitial nephritis, and nephritic syndrome. Other adverse effects include anaemias, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, abnormalities in liver function tests, blurred vision, changes in visual colour perception, and toxic amblyopia. Injections of MICO DICLOFENAC may cause local pain and irritation, abscesses and local necrosis have been reported. It should not be given to patients with active peptic ulceration. It should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, a history of peptic ulceration, and in liver or renal failure. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis. Care is required to those who are also receiving coumarin anticoagulants. Patients who are sensitive to aspirin or other NSAID's should generally not be given diclofenac. Diclofenac should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis. In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients. MICRO DICLOFENAC may mask the signs and symptoms of infection due to its pharmacodynamic properties. When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their blood concentrations. Patients receiving long-term treatment with diclofenac should have periodic blood counts,. Studies have demonstrated a pharmacokinetic interaction between diclofenac and salcyclates when both are co-administered in anti-inflammatory doses.
KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".
Treatment is symptomatic and supportive.
Clear, colourless, to a pale yellow solution.
Clear, colourless or amber, type 1 , glass ampoules in packs of 5 and 50.
Protect from heat and light.
Store below 25°C.
Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MICRO HEALTHCARE (Pty) Ltd.
10 Lindley Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: September 2005
Source: Pharmaceutical Industry
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