Diclofenac injection

(i) ROUTE OF ADMINISTRATION

Intra Muscular

DOSAGE AND ADMINISTRATION

Adults: For adults the dosage is generally one ampoule daily, injected deep intragluteally into the upper outer quadrant By way of exception, in severe cases two injections, separated by an interval of few hours, can be given per day ( one into each buttock)
Alternatively, it is possible to combine one ampoule with oral Diclofenac tablets up to a maximum daily dosage of 150 mg. Diclofenac ampoules should not be given for more than 2 days; if necessary, the treatment can be continued with Diclofenac tablets. Diclofenac ampoules are not suitable for children.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Diclofenac injection is indicated in acute severe pain and inflammation associated with arthritis disorders; painful syndromes of the vertebral column; non-articular rheumatism; acute attacks of gout and post-operative and post –traumatic pain and swelling.

(iii) DESCRIPTION OF DOSAGE FORM

Diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory properties.

(iv) CONTRAINDICATIONS

Diciofenac is contraindicated in patients with peptic ulcer, hypersensitivity to other NSAIDs, and a history of asthma, urticaria, rhinitis.

WARNINGS AND PRECAUTIONS

Caution is required in patients with a history of peptic ulcer, Crohn’s disease as well as in patients suffering from hepatic dysfunction.

All patients who are receiving long-term treatment with non-steroidal anti-inflammatory agents should also be monitored as a precautionary measure e.g. renal, hepatic function (elevation of liver enzymes may occur) and blood counts.

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (eosinophilia, rash), HEALTH 2000 Diclofenac sodium injection should be discontinued.
Use of HEALTH 2000 Diclofenac sodium injection in patients with hepatic prophyria may trigger an attack.

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of HEALTH 2000 Diclofenac sodium injection.

Patients who experience dizziness or other central nervous system disturbances while taking NSAIDs should refrain from driving or operating machinery.

Contains 0.3 % Sodium Metabisulphite as stabilising agent. Should not be used in asthma patient

PREGNANCY AND LACTATION :
The safety of diclofenac injections in pregnant and lactating women has not been established. Hence it should be administered to this group of patients only after weighing the risk benefit ratio.

DRUG INTERACTIONS: Diclofenac elevates plasma concentrations of lithium and digoxin; but no clinical signs of overdosage have been encountered. Concomitant treatment with potassism-sparing diuretics may be associated with increased serum potassium levels thus making it necessary to monitor the latter.

(v) SIDE EFFECTS
Gastro-intestinal tract:
Occasional: epigastric pain, other gastro - Intestinal disorders (e.g. nausea, vomiting, diarrhoea).
Rare: gastro-intestinal bleeding, peptic ulcer, In isolated cases: peptic ulcer with perforation, lower gut disorders (e.g. non-specific haemorrhagic colitis and exacerbations of ulcerative colitis).

Central nervous system:
Occasional: headache, dizziness, or vertigo
Rare: drowsiness.
In Isolated Cases: disturbances of sensation or Vision (blurred vision, diplopia), tinnitus, insomnia, irritability, convulsions.

Skin:
Occasional: rashes or skin eruptions.
Rare: Urticaria
Kidney:
In isolated cases: acute renal insufficiency, urinary abnormalities (e.g. haematuria), intestinal nephritic syndrome.

Liver:
Rare liver function disorders including hepatitis with or without jaundice, in isolated cases fulminant.

Blood:
In isolated cases: thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia.
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Other organ system:
Rare: Oedema, hypersensitivity reactions (e.g. bronchospasm, anaphylactic/ anaphylactoid systemic reactions including hypotension). Injection site disorders- (e.g. local pain and induration, in isolated cases abscesses and local necrosis).

(vi) TOXIC EFFECTS

Mutagenicity, Carcinogenicity and Teratogenicity
Studies of use of diclofenac in rats did not show any effect on the fertility of adult rats nor in the pre-, peri- and postnatal development of their offspring. No teratogenic effects were detected in mice, rats or rabbits. No mutagenic effects were observed in in vitro or in vivo experiments. No carcinogenic potential was detected in long term studies in rats and mice.

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