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    / Tradis Gat


    Active Ingredient *

    Status in Israel
    RX

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    Presentation Basket Yarpa Pharmasoft

    Sachets

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    Dosage

    The treatment can be administered in one of the following ways:
    • Usually, one sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure.
    • Alternatively, both sachets on the afternoon and evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning.
    The time elapsed between the two sachets should be at least 5 hours.


    Indications

    For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.
    Indicated in adults (including the elderly) aged 18 years and over.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients, congestive cardiac failure, severe dehydration, hypermagnesaemia, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation.
    Do not use in patients with rhabdomyolysis as laxatives may induce rhabdomyolysis and may therefore exacerbate the condition.
    Do not use in patients with active inflammatory bowel disease e.g. Crohn’s disease, ulcerative colitis.
    In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.


    Special Precautions

    Should not be used as a routine laxative.
    Could rarely lead to severe and potentially fatal cases of electrolyte disorders or impaired renal function in frail or debilitated patients. Therefore, the benefit/risk ratio of this drug needs to be carefully considered before initiating treatment in this at-risk population.
    Special attention should be taken when prescribing to any patient with regard to known contra-indications and special attention made to the importance of adequate hydration and, in at-risk populations (as defined below), to the importance of also obtaining baseline and post-treatment electrolyte levels.
    Elderly and debilitated patients, and patients at risk of hypokalaemia or hyponatraemia, may need particular attention.
    Should be used with caution in patients with known disorders of water and/or electrolyte balance or on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium.
    Care should also be taken in patients who have recently undergone gastrointestinal surgery or who have renal impairment, mild to moderate dehydration, hypotension or heart disease.
    The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
    Due to the evacuating effect of this drug, diarrhoea may occur with the result of fluid and electrolyte losses, hypovolemia and hypotension. Additionally, vasovagal reflex may be the consequence of abdominal stimuli, like pain, which in turn, might trigger loss of consciousness or faint in the patient. That is why an adequate intake of clear liquids is required.
    This drug may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy.
    This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
    This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially “sodium-free”.


    Side Effects

    The most common adverse events reported in clinical trials using the combination of sodium picosulfate and magnesium citrate were related to direct effects on the bowel (abdominal pain and nausea) and the consequences of diarrhoea and dehydration (sleep disturbance, dry mouth, thirst, headache and fatigue).
    Common: abdominal distension, anal discomfort, proctalgia.


    Drug interactions

    As a purgative, this drug increases the gastrointestinal transit rate. Absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period.Tetracycline and fluoroquinolone antibiotics, and pencillamine, should be taken at least 2 hours before and not less than 6 hours after administration to avoid chelation with magnesium.
    The efficacy of this drug is lowered by bulk-forming laxatives.
    Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.


    Pregnancy and Lactation

    Pregnancy
    Neither clinical data on exposed pregnancy nor reproductive toxicity are available. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of this drug during pregnancy.
    Breast-feeding
    There is no experience with use in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment may be considered for females who are breastfeeding.


    Overdose

    No cases of overdose of sodium picosulfate and magnesium citrate, have been reported. However, because of its modes of action, an overdose would be expected to cause profuse diarrhoea with dehydration and electrolyte loss.
    Dehydration could also lead to orthostatic hypotension and dizziness. Dehydration and electrolyte imbalances should be corrected with fluid and electrolytes as necessary.

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