INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BSP DICLOFENAC SODIUM 75 mg Ampoules.

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

BSP DICLOFENAC SODIUM 75 mg Ampoules.

COMPOSITION:
Each ampoule contains
Diclofenac Sodium 75 mg/3 mL
Benzyl Alcohol 4% m/v as preservative, contains sodium metabisulphite.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Anti-Rheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal compound with analgesic, anti-inflammatory, antirheumatic and antipyretic properties. Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20-30% of the dose and that in bile of 10 to 20%. The mean terminal elimination half-life is 1,2 to 1,8 hours.

INDICATIONS:
For use 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.

CONTRA-INDICATIONS:
Diclofenac sodium is contra-indicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration, or severe hepatic or renal impairment. It is further contra-indicated in aspirin-sensitive patients, and in patients hypersensitive to any of the ingredients. Safety in pregnancy has not been established.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.

DOSAGE AND DIRECTIONS FOR USE:
Not to be given by intravenous injection; 75 mg by deep intragluteal injection once daily, or two times per day in severe or hospitalized cases. Each injection must be given at a different site. Each injection should be separated by an interval of a few hours. Parenteral administration should not be given more than a few days, if necessary the treatment can be continued with oral therapy.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritus, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions. Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. It is advisable to perform blood counts in patients undergoing prolonged treatment, Diclofenac should be given with care to patients with cardiovascular disease, bleeding disorders, in those who are receiving coumarin anti-coagulants, and in patients with impaired hepatic or renal function. In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.

Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin. When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations. Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side-effects. Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.

Should be used with caution in patients with asthma or bronchoconstriction. Use carefully in elderly patients. Decreased platelet aggregation with increased bleeding time may occur. The half-life of probenecid may be increased. Use with care together with other protein-bound medicines eg. tolbutamide and coumarin.

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

IDENTIFICATION:
BSP Diclofenac sodium 75 Ampoule: 3 mL amber labeled ampoule.

PRESENTATION:
BSP Diclofenac sodium 75 Ampoule in blister form in 5's in cartons containing 5, 50 and 200.

STORAGE DIRECTIONS:
Protect ampoules from heat and light. Store between 15°C and 25°C. Do not refrigerate ampoules.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
Y/3.1/122

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BROVAR S & P (PTY) LTD
24 DOGAR STREET
DELVILLE EXT 1
GERMISTON
1401

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 August 1991 Code: DA75PI/00
  Britepak

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