(and dosage form)
Each 3 mL contains diclofenac sodium 75 mg and benzyl alcohol 4,0% m/v as a preservative.
Also contains sodium sulphite.
A. 3.1 Antirheumatics (Anti-inflammatory Agents)
Diclofenac sodium is a non-steroidal compound, a phenylacetic acid derivative, with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of prostaglandins which are known to be implicated in the pathogenesis of inflammation, pain and fever. Peak plasma levels are obtained ten to twenty two minutes after an intramuscular injection of 75 mg diclofenac sodium. There is at least 99% binding to plasma-proteins with ADCO-DICLOFENAC 75 Injection and excretion of metabolites is mainly in the urine.
Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis, painful post-operative and post-traumatic inflammation and swelling, and dysmenorrhoea.
Diclofenac sodium is contra-indicated in patients with a known hypersensitivity to diclofenac and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.
Serious interactions have been reported after the use of high dose 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. Only for deep intragluteal injection into the upper outer quadrant. After inserting the needle the plunger should be pulled back to avoid inadvertent intra-arterial injection.
One 75 mg/3 mL ampoule daily, intramuscularly into the upper, outer quadrant of the buttocks. (Parenteral administration should be supplemented by oral therapy). In severe or acute conditions this may be increased to two ampoules daily, the injections given one in each buttock, separated by an interval of a few hours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastric or intestinal ulceration with associated bleeding has been reported. Therapy with ADCO-DICLOFENAC 75 Injection should be discontinued immediately in such cases. Skin rashes and gastro-intestinal disturbances may occur. Headache, nervousness, pruritus, tinnitus, insomnia, blurred vision and other ocular reactions, dizziness, oedema, peripheral oedema, malaise, jaundice, elevated transaminase levels, drowsiness and hypersensitivity reactions (eg. bronchospasm) have occurred. Blood counts and monitoring of hepatic and renal function are advised during prolonged therapy with ADCO-DICLOFENAC 75 Injection as blood dyscrasias have been reported. The safe use ofADCO-DICLOFENAC 75 Injection in pregnancy has not been demonstrated. Blood concentrations of lithium are increased when ADCO-DICLOFENAC 75 Injection is administered concommitantly. ADCO-DICLOFENAC 75 Injection should be given with care to patients with bleeding disorders, cardiovascular disease, and in those who are receiving coumarin anticoagulants.
Patients who are sensitive to aspirin generally should not be given ADCO-DICLOFENAC 75 injection. Injections of ADCO-DICLOFENAC 75 may cause local pain and irritation; abscesses and local necrosis have been reported, especially in elderly diabetics.
ADCO-DICLOFENAC 75 may mask the signs and symptoms of infection due to its pharmacodynamic properties.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.
Clear, colourless liquid in clear glass ampoules.
Clear, colourless liquid in plastic ampoules.
3 mL Ampoules in packs of 5 and 50's.
3 mL fill in 5 mL plastic ampoules in sets of 10 in laminated foil overpouches.
Store below 25°C. Protect from heat and light. Keep out of reach of children.
REGISTRATION NUMBER :
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 October 1987
New addition to this site: April 2004
Source: Pharmaceutical Industry
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