Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: P.T.Hadjigeorgiou Co Ltd, P.O.Box 53158-3301, Limassol, Cyprus, Tel: 25372425, Fax: 25376400, e-mail: info.pth@cytanet.com.cy
Treatment of:
Treatment or prevention of post-operative pain in a hospital setting.
As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose given for the shortest duration necessary to control symptoms (see section 4.4). .
Diclofenac solution for injection should not be given for more than two days; if necessary, treatment can be continued with Diclofenac tablets or suppositories (see section 4.2).
Because of their dosage strength, the ampoules of diclofenac solution for injection are not suitable for children and adolescents.
No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight (see section 4.4).
Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration and only at doses ≤ 100 mg daily if treated for more than 4 weeks (see section 4.4).
Diclofenac is contraindicated in patients with renal failure (GFR <15 mL/min/1.73 m²) (see section 4.3).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with renal impairment (see section 4.4).
Diclofenac is contraindicated in patients with hepatic failure (see section 4.3).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section 4.4).
The following directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site (which may result in muscle weakness, muscle paralysis and hypoaesthesia).
The dose is generally one 75 mg ampoule daily, given by deep intragluteal injection into the upper outer quadrant using aseptic technique. In severe cases (e.g. colic), the daily dose can exceptionally be increased to two injections of 75 mg, separated by an interval of a few hours (one into each buttock). Alternatively, one ampoule of 75 mg can be combined with other pharmaceutical forms of diclofenac (e.g. tablets, suppositories) up to a total maximum daily dose of 150 mg.
In migraine attacks, clinical experience is limited to initial use of one ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dose should not exceed 175 mg on the first day.
Diclofenac solution for injection must not be given as an intravenous bolus injection.
Immediately before starting an intravenous infusion, diclofenac solution for injection must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate according to the instructions given in section 6.6.
Two alternative dosage regimens of diclofenac solution for injection are recommended.
For the treatment of moderate to severe post-operative pain, 75mg should be infused continuously over a period of 30 minutes to 2 hours. If necessary, treatment may be repeated after few hours, but the dose should not exceed 150mg within any period of 24 hours.
For the prevention of post-operative pain, a loading dose of 25mg-50mg should be infused after surgery over 15 minutes to 1 hour, followed by a continuous infusion of about 5mg per hour up to a maximum daily dosage of 150mg.
There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms, such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications, such as hypotension, renal failure, convulsions, gastrointestinal disorder and respiratory depression.
Special measures, such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.
36 months.
The medication should not be used any more after the expiry date printed on the package.
Do not store at temperatures above 25°C.
Store in the original package in order to protect from light.
Diclofenac – parenteral must be kept out of the reach and sight of children.
5, 10 or 20 ampoules with 3 ml injectable solution.
The following directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.
To be injected either intramuscularly by deep intragluteal injection into the upper outer quadrant using aseptic technique, or intravenously by slow infusion after dilution in accordance with the following instructions. Each ampoule is for single use only. The solution should be used immediately after opening. Any unused contents should be discarded.
Appropriate injection technique and length of the needle (considering the thickness of the patient’s gluteal fat) should be used to avoid inadvertent subcutaneous administration of diclofenac injection.
Depending on the intended duration of infusion (see section 4.2), mix 100 to 500 mL of isotonic saline (sodium chloride 0.9% solution) or glucose 5% solution with the contents of one diclofenac ampoule. Both solutions should be buffered with sodium bicarbonate injectable solution (0.5 mL of 8.4% or 1 mL of 4.2% or a corresponding volume of a different concentration) taken from a freshly opened container. Only clear solutions should be used. If crystals or precipitates are observed, the infusion solution should not be used.
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