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Logo ACU-DICLOFENAC INJECTION

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ACU-DICLOFENAC INJECTION

COMPOSITION:
Each 3 mL contains: Diclofenac sodium 75 mg
Preservative: Benzyl alcohol 4% m/v
Anti-oxidant: Sodium metabisulfite 0,35% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Acu-diclofenac is a non-steroidal compound with antirheumatic, anti-inflammatory, analgesic and antipyretic properties. In vitro its active substance strongly inhibits prostaglandins synthetase and also has an inhibitory effect on platelet aggregation.

Pharmacokinetics:
Absorption:
Peak plasma concentrations are attained 10 - 22 minutes after a dose of diclofenac sodium i.m.
Protein binding: 99,7%
The mean terminal elimination half-life of the unchanged medicine is 1 to 2 hours.
Excretion:
Approximately 65% of the dose administered is excreted via the kidneys in the form of metabolites, and less than 1% in unchanged form. About 35% of the dose is excreted in metabolised form in the faeces.

INDICATIONS:
Acu-diclofenac injection is suitable as initial therapy for inflammatory and degenerative rheumatic diseases as well as for the treatment of painful conditions due to inflammation of non-rheumatic origin.

CONTRA-INDICATIONS:
Sensitivity to the active substance. Acu-diclofenac injection is also contra-indicated in asthmatic patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or by other medicines with prostaglandins synthetase inhibiting activity. Strict accuracy of diagnosis and close medical surveillance are imperative in patients with pre-existing dyshaemopoiesis or disorders of blood coagulation. Acu-diclofenac injection should not be used in patients with porphyria. Pregnancy, lactation and children under the age of 14 years.

WARNINGS:
Administer with caution to patients with hepatic or renal failure. Serious interactions have been reported after the concomitant use of methotrexate and diclofenac.

DOSAGE AND DIRECTIONS FOR USE:
Not intended for intravenous route administration. For adults the dosage is generally one Acu-diclofenac injection daily, injected deep intragluteally into the upper outer quadrant.
By way of exception, in severe cases two injections, separated by an interval of a few hours, can be given per day (one into each buttock).
Acu-diclofenac injection should not be given for more than a few days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Patients may complain of nausea and diarrhoea, headache, tinnitus or dizziness. Peripheral oedema and skin reactions, such as drug rash and eczema, have also been encountered. Central nervous system side-effects, such as tiredness, insomnia, nervousness, depression or irritability, have occurred. Blurred vision and other ocular reactions.
Sensitivity reactions (e.g. bronchospasm, anaphylactic/anaphylactoid systemic reactions), elevated transaminase levels, jaundice, hepatitis, renal failure and nephrotic syndrome, may occur. Dyshaemopoiesis (leucopenia, thrombocytopenia, aplastic anaemia) and erythema multiforme have been observed. Agranulocytosis and haemolytic anaemia have been observed. Abscesses and local necrosis have also occurred, particularly in elderly diabetics.

Precautions:
Patients suffering from impairment of hepatic, cardiac, or renal function should be carefully monitored.
Dosage may have to be reduces in the elderly.
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
During prolonged treatment with Acu-diclofenac injection blood counts and monitoring of hepatic and renal function are indicated as precautionary measures.
Interactions:
When given together with preparations containing lithium or digoxin, Acu-diclofenac injection may raise their plasma concentrations.
Concurrent treatment with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects. The bioavailability of Acu-diclofenac injection is reduced by acetylsalicylic acid, and that of acetylsalicylic acid is reduced by Acu-diclofenac injection, when administered together.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless liquid free from visible particles.

PRESENTATION:
50 x 3 mL and 5 x 3 mL amber glass ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/3.1/0300

NAME AND BUSINESS ADDRESS OF APPLICANT:
Acupharm (Pty) Limited Trading as APOTEX S.A.
C/o Watt- & Fleming Street
Meadowdale
ISANDO
1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 March.1993
                PA00041/10-97

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