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ECONAC is a brand name for Diclofenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For Intramuscular use Diclofenac ampoules are indicated in - acute forms of pain, including renal colic - exacerbations of osteo- and rheumatoid arthritis - acute back pain - acute gout - acute trauma and fractures - post-operative pain For Intravenous use- For the treatment or prevention of post-operative pain in the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
Ampoules for Intramuscular use: 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 alternate buttock be used for the second injection. Econac injection 75 mg/3 ml should not be given for more than 2 days; if necessary, treatment can be continued with tablets or suppositories.
Econac injection 75 mg / 3 ml should not be administered by intravenous injection. Combinations with other dosage forms of Diclofenac (tablets or suppositories) can be used up to the maximum daily dosage of 150mg.
Renal colic:
One 75 mg ampoule intramuscularly. A further ampoule may be administered after 30 minutes if necessary. The recommended maximum daily dose of 150 mg in any combination of the three formulations of Econac should not be exceeded. 9%) or glucose solution (5%).
2%). For the treatment of moderate to severe post-operative pain, 75mg should be infused over a period of 30 minutes to 2 hours. This can be repeated after 4-6 hours, without exceeding 150mg within any 24-hour period. For the prevention of post-operative pain, a loading dose of 25mg-50mg should be infused after surgery over 15 minutes to an hour, followed by a continuous infusion of around 5mg per hour up to a maximum of 150mg daily.
Elderly Although the pharmacokinetics of Diclofenac are not impaired to any clinically relevant extent in older patients, non-steroidal anti-inflammatory drugs should be used with particular caution in such patients as older patients are at increased risk of the serious consequences of adverse reactions.
4) Paediatric population Econac 75 mg / 3 ml Solution for Injection is not suitable for children.
Method of administration:
For IM (intramuscular) and IV (intravenous) infusion use only. 6
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common: (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.
The following undesirable effects include those reported with either short-term or long-term use. System Organ Class Frequency Adverse reactions Infections and infestations Not known Injection site necrosis Blood and lymphatic system disorders Very rare Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders Rare Very rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Angioedema, face oedema). Psychiatric disorders Very rare Not known Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder, anxiety, Confusion, hallucination Nervous system disorders Common Rare Very rare Not known Headache, dizziness.
Somnolence. Paraesthesia, memory impairment, convulsion, tremor, meningitis aseptic*, dysgeusia, cerebrovascular accident. disturbances of sensation Eye disorders Very rare Not known Visual impairment, vision blurred, diplopia. Optic neuritis Ear and labyrinth disorders Common Very rare Vertigo.
Tinnitus, hearing impaired. Cardiac disorders Very rare Palpitations, chest pain, cardiac failure, myocardial infarction. Not Known Kounis syndrome Vascular disorders Very rare Hypertension, vasculitis, hypotension Respiratory, thoracic and mediastinal disorders Rare Very rare Asthma (including dyspnoea).
Pneumonitis. Gastrointestinal disorders Common Rare Very rare Not known Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer** Colitis***, constipation, stomatitis, glossitis, Crohn’s disease, mouth ulceration, oesophageal disorder, large intestinal stricture, pancreatitis.
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 and injection site necrosis. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (GI and cardiovascular risks below).
The concomitant use of Econac 75mg / 3ml Solution for Injection with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.
Caution is indicated in older patients on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail older patients or those with a low body weight. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with Diclofenac without earlier exposure to the drug.
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, Econac 75mg / 3ml Solution for Injection may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Gastro-intestinal effect:
Gastrointestinal bleeding 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 gastrointestinal events.
They generally have more serious consequences in older patients. If gastrointestinal bleeding or ulceration occurs in patients receiving Econac 75mg / 3ml Solution for Injection the medicinal product should be withdrawn. 8). NSAIDs, including diclofenac, may be associated with increased risk of gastro- intestinal anastomotic leak.
1. • Active gastric or intestinal ulcer, bleeding or perforation. • History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy. 6). 4). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), Diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs. Specifically for IV use.
• Concomitant NSAID or anticoagulant use (including low dose heparin). • History of haemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding. • Operations associated with a high risk of haemorrhage. • A history of asthma.
• Moderate or severe renal impairment (serum creatinine>160μmol/l). • Hypovolaemia or dehydration from any cause.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ischaemic colitis Hepatobiliary disorders Common Rare Very rare Transaminases increased. Hepatitis, jaundice, liver disorder. hepatitis fulminant, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders Common Rare Very rare Rash.
Urticaria. Dermatitis bullous, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis**** dermatitis exfoliative, alopecia, photosensitivity reaction, purpura, Henoch- Schonlein purpura, pruritus.
Renal and urinary disorders Very rare Renal failure acute, haematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis. Reproductive system and breast disorders Not known Erectile dysfunction.
General disorders and administration site conditions Common Very Rare Not known Injection site reaction, injection site pain, injection site induration, Generalised oedema Injection site abscess. Malaise. *Meningitis aseptic (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation ** Gastrointestinal ulcer could be with or without bleeding or perforation sometime fatal in older people *** Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis), ****Toxic epidermal necrolysis includes Lyell’s syndrome Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of Diclofenac, particularly at high dose (150mg daily) and in long term treatment.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery. The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.
Older patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in older patients, the treatment should be initiated and maintained at the lowest effective dose.
Combination therapy with protective agents (e 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 other medicinal products likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly older patients, should report any unusual abdominal symptoms (especially GI bleeding). 5). 8).
Hepatic impairment:
Close medical surveillance required when prescribing Diclofenac to patients with impaired 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. g. eosinophilia, rash), Diclofenac should be discontinued. Hepatitis may occur with use of Diclofenac without prodromal symptoms.
Caution is called for when using Diclofenac in patients with hepatic porphyria, since it may trigger an attack. g. 3). Monitoring of renal function is recommended as a precautionary measure when using Diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.
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 Econac 75 mg/3 ml Solution for Injection.
Skin effects:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section […]