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VOLTAROL AMPOULES is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ampoules for im use: The ampoules are effective in acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures, and post-operative pain. Ampoules used in intravenous infusion: For treatment or prevention of post-operative pain in…
Verbatim from this product's MHRA label. Tap a section to expand.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section
). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac.
Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties. The instructions for intramuscular injection should be strictly followed in order to avoid adverse events at the injection site, which may result in muscle weakness, muscle paralysis, hypoaesthesia, embolia cutis medicamentosa (Nicolau syndrome) and injection site necrosis.
Gastrointestinal effects:
Gastrointestinal bleeding (haematemesis, melaena), ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn. 8 Undesirable effects). The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses including diclofenac, and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.
2 Posology and method of administration). To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.
g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal products likely to increase gastrointestinal risk.
). Adults Voltarol ampoules (given im or iv) should not be given for more than two days; if necessary, treatment can be continued with Voltarol tablets or suppositories.
Intramuscular injection:
The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve or other tissue at the injection site. One ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant.
If two injections daily are required it is advised that the alternative buttock be used for the second injection. Alternatively, one ampoule of 75mg can be combined with other dosage forms of Voltarol (tablets or suppositories) up to the maximum daily dosage of 150mg.
Renal colic:
One 75mg ampoule intramuscularly. A further ampoule may be administered after 30 minutes if necessary. The recommended maximum daily dose of Voltarol is 150mg. 9%) or glucose solution (5%). 2%). Only clear solutions should be used. Voltarol must not be given as an intravenous bolus injection.
Two alternative regimens 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 4-6 hours, not exceeding 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 approx. 5mg per hour up to a maximum daily dosage of 150mg. Special populations Elderly Although the pharmacokinetics of Voltarol are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions.
). Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 Interactions with other medicinal products and other forms of interaction). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding). 5 Interaction with other medicinal products and other forms of interaction).
8 Undesirable effects). NSAIDs, including diclofenac, may be associated with increased risk of gastro- intestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery.
Hepatic effects:
Close medical surveillance is required when prescribing Voltarol to patients with impairment of hepatic function as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase.
During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Voltarol should be discontinued.
Hepatitis may occur with diclofenac without prodromal symptoms. Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack. g. 3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases.
Discontinuation therapy is usually followed by recovery to the pre-treatment state. 8 Undesirable effects). Patients appear to be at the highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Voltarol should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. 8 Undesirable effects). g. hypertension, […]
In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy. 3 Contraindications).
Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. 4 Special warnings and precautions for use). 3 Contraindications).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. 4 Special warnings and precautions for use). 3 Contraindications). No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made.
4 Special warnings and precautions for use). Paediatric population Voltarol ampoules are not recommended for use in children. The recommended maximum daily dose of Voltarol is 150mg. 3 Contraindications • Hypersensitivity to the active substance, sodium metabisulphite or any of the excipients.
• Active, gastric or intestinal ulcer, bleeding or perforation • History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) • Last trimester of pregnancy (see section