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  • Abitren 75 mg / 3 ml Solution for Injection
    / Teva


    Active Ingredient
    Diclofenac Sodium 75 mg / 3 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 3 ml X 75 mg

    not in the basket chart 8303 1858

    Ampoule

    10 X 3 ml X 75 mg

    not in the basket chart 6945

    Related information


    Dosage

    The dose is generally one 75 mg ampoule daily, given by deep intragluteal injection into the upper outer quadrant. 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 Abitren (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.


    Indications

    Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, non-articular rheumatism.
    Treatment of painful conditions due to inflammation of non rheumatic origin.
    Renal colic and  biliary colic.
    Post-traumatic and post-operative pain, inflammation and swelling


    Contra-Indications

    Known hypersensitivity to the active substance, sodium metabisulfite or any of the other 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.
    Severe hepatic and renal and cardiac failure (see Special warnings and special precautions for use).
    Established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
    Like other non-steroidal anti-inflammatory drugs (NSAIDs), Abitren is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria, or acute rhinitis are precipitated by ibuprofen , acetylsalicylic acid or other NSAIDs.


    Special Precautions

    Although the pharmacokinetics of this drug 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. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight and the patient should be monitored for GI bleeding during NSAID therapy.
    Renal impairment: Diclofenac is contraindicated in patients with severe renal impairment. 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 mild to moderate renal impairment.
    Hepatic impairment: Diclofenac is contraindicated in patients with severe hepatic impairment. 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.
    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.
    Arterial thrombotic events: 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 (150 mg daily) and in long-term treatment. Patients with cardiovascular disease or with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) may also be at greater risk and should only be treated with diclofenac after careful consideration. To minimise the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
    Hypertension: NSAIDs may lead to the onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
    Heart failure: Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.
    Hematological effects: During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood count is recommended. Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of hemostasis, bleeding diasthesis or hematological abnormalities should be carefully monitored.
    Systemic lupus erythematosus and mixed connective tissue disease: In patients with systemic lupus erythematosus and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
    Severe skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported very rarely in association with the use of NSAIDs, including diclofenac. These serious adverse events are idiosyncratic and are independent of dose or duration of use.
    Patients appear to be at 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. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity, and this drug  should be discontinued.


    Side Effects

    Headache, dizziness, transaminases increased, rash, injection site react.
    See prescribing information for full details.


    Drug interactions

    Potent CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.
    Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects Avoid concomitant use of 2 or more NSAIDs (see Special warnings and special precautions for use).
    Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently.
    Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.
    Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. This might be mediated through renal antiprostagladin effects of both NSAID and calcineurin inhibitor.
    Colestipol and cholestyramine: These agents can induce a delay or decrease in absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4 to 6 hours after administration of colestipol/ cholestyramine.
    Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone


    Pregnancy and Lactation

    Pregnancy: The use of diclofenac in pregnant women has not been studied. Therefore, Abitren should not be used during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the risk to the fetus. As with other NSAIDs, use during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus .Animal studies have not shown any directly or indirectly harmful effects on pregnancy, embryonal/fetal development, parturition or postnatal development.
    Fertility: As with other NSAIDs, the use of this drug may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.
    Lactation: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, this drug should not be administered during breast feeding in order to avoid undesirable effect in the infant.


    Overdose

    Symptoms: There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
    Therapeutic measures: Management of acute poisoning with NSAIDs 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 due to the high protein binding and extensive metabolism.


    Important notes

    Incompatibilities: As a rule, this drug solution for injection should not be mixed with other injection solutions.
    Storage: Protect from light.
    Pediatric Use: Because of their dosage strength, Abitren solution for injection is not suitable for children and adolescents.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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