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IZINOVA CONCENTRATE FOR is a brand name for Potassium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Izinova is indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel (e.g. bowel visualisation including endoscopy and radiology or surgical procedure). Izinova is not a treatment for constipation.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Two bottles of Izinova are needed for appropriate cleansing of the bowel. 5 litres, and must be followed by the ingestion of an additional 1 litre of water or clear liquid within 2 hours. Authorised clear liquids are: water, tea or coffee (no milk or non-dairy creamer), fizzy (carbonated) or still (non-carbonated) soft drinks, strained fruit juices without pulp (not coloured red or purple), clear soup or soup strained to remove any solids.
In total, the volume of liquid intake required for bowel cleansing is approximately 3 litres taken orally prior to the procedure. This medicine can be taken either as a split-dose (two-day; with the first bottle taken the night before the procedure, and the second to be taken the following morning), or as a one-day oral preparation as described below (see Method of administration).
The exact regimen and rate of ingestion of Izinova may be determined by the physician. If allowed by the timing of the procedure, the split-dose regimen should be favoured over the one-day regimen. The one-day dose regimen is a potentially useful alternative regimen.
5 litres). : approximately 1 litre) over the next two hours. 5 litres). : approximately 1 litre) over the next two hours. The intake of the whole diluted solution of Izinova and additional liquid (water or clear liquid) should be completed: - In the absence of anaesthesia, at least one hour prior to the start of the procedure.
- In case of anaesthesia, usually at least 2 hours prior to the start of the procedure, in accordance with the instructions of the anaesthetist. 5 litres). : approximately 1 litre) over the next two hours. 5 litres). : approximately 1 litre) over the next two hours.
The intake of the whole diluted solution of Izinova and additional liquid (water or clear liquid) should be completed: - In the absence of anaesthesia, at least one hour prior to the start of the procedure. - In case of anaesthesia, usually at least 2 hours prior to the start of the procedure, in accordance with the instructions of the anaesthetist.
After the procedure In order to replace fluid lost during the preparation for the procedure, patients should be encouraged to drink a sufficient amount of fluids afterwards to maintain adequate hydration. Dietary restrictions The day prior to the procedure, a light breakfast may be consumed.
Summary of the safety profile Diarrhoea is the expected outcome of the bowel cleansing preparation; therefore this occurs after Izinova ingestion. As with any intervention of this type, undesirable effects occur in the majority of patients.
The most commonly reported adverse drug reactions from clinical trials and post-marketing experience are discomfort, abdominal distension, abdominal pain, nausea, and vomiting. During clinical trials more patients reported vomiting when Izinova was given as a one-day preparation than when split-dose regimen was followed.
Tabulated summary of adverse reactions The frequency of adverse drug reactions to Izinova is classified as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), unknown (cannot be estimated from the available data).
The table below lists adverse drug reactions collected from clinical trial data, and includes events experienced by individual patients. Additionally, adverse events reported in post-marketing are included. *Clinical consequences of dehydration and/or electrolyte imbalance Additional information on special populations Temporary elevations in uric acid have been observed during clinical trials.
4. 1]. 4]. 4. System Organ Class Frequency Adverse Drug Reaction Immune System Disorders Unknown (post- marketing data) Hypersensitivity (including urticaria, pruritus, rash, erythema, dyspnoea, throat tightness) Unknown (post- marketing data) DehydrationMetabolism and nutrition disorders Unknown (post- marketing data) Electrolyte imbalance Psychiatric disorders Unknown (post- marketing data Confusional state* Uncommon Headache, dizziness Unknown (post- marketing data) Loss of consciousness* Nervous System Disorders Unknown (post- marketing data) Tremor* Cardiac disorders Unknown (post- marketing data) Cardiac arrhythmia* Palpitations* Very common Abdominal distension, abdominal pain, nausea, vomiting Uncommon Anorectal discomfort, dry mouth Gastrointestinal Disorders Unknown (post- marketing data) Ischemic colitis Skin and subcutaneous tissue disorders Unknown (post- marketing data) Hyperhidrosis* Musculoskeletal and connective tissue disorders Unknown (post- marketing data) Muscle spasms* Renal and Urinary Disorders Uncommon Dysuria Very common Discomfort Uncommon Chills General Disorders and Administration Site Conditions Unknown (post- marketing data) Asthenia* Investigations Uncommon Aspartate aminotransferase increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood phosphorus increased, hyperbilirubinaemia, blood chemistry disturbances including hyponatraemia, hypokalaemia, hypocalcaemia and hyperuricaemia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Electrolyte disorders and dehydration: • Given the potential risk of severe electrolyte disorders, the benefit/risk ratio of Izinova needs to be carefully considered before initiating treatment in at-risk populations. Special attention should be given when prescribing Izinova to any patients with regard to known contraindications, and special precautions for use, including the importance of adequate hydration.
• All patients should be advised to hydrate adequately before, during and after the use of Izinova. If a patient develops significant vomiting or signs of dehydration after taking the medicine, rehydration measures should be set up to avoid the potential risks of serious complications associated with fluid and electrolyte disturbances (such as seizure and cardiac arrhythmia).
In addition, performing pre-procedure laboratory tests (electrolytes, creatinine and blood urea nitrogen) should be considered. The patient should be advised to drink as much additional water or clear liquids as necessary to maintain an appropriate level of hydration.
• Dehydration could lead to functional renal failure reversible with appropriate fluids administration. At-risk patients: • In debilitated fragile patients, elderly patients, those with clinically significant renal, hepatic or cardiac impairment and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte and renal function tests.
• Patients presenting dehydration or patients with electrolyte abnormalities should have them corrected before administration of the bowel cleansing preparation. In addition, use caution in patients with conditions, or who are using medications, that increase the risk of fluid and electrolyte disturbances (including hyponatraemia and hypokalaemia) or may increase the risk of potential complications.
In this case, patients should be appropriately monitored. • There is a theoretical risk that QT interval prolongation may occur as a result of electrolyte imbalance. Use with caution in patients with: • Impaired gag reflex and patients prone to regurgitation or aspiration.
g. 73m2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Afterwards the patient should only have clear liquids for lunch, dinner and any other meals until the procedure is performed. Red and purple liquids, milk and alcoholic beverages should be avoided. 1]. 4]. Patients with renal impairment Insufficient data are available for this population.
Dose adjustment is not required in the patients with mild to moderate renal impairment however special precautions should be taken in this population as for any high-risk population. 4). Patients with hepatic impairment Insufficient data are available for this population.
4). e. patients below 18 years old) have not yet been established. 1).
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.
Such patients should be observed during administration of the bowel cleansing preparation. • Gastrointestinal hypomotility disorders or a history of medical conditions or gastrointestinal surgery that predispose to hypomotility disorders.
8]. 8). Ischaemic colitis: • Osmotic laxatives could cause aphtous ulcers of the colonic mucosa. Serious cases of ischaemic colitis requiring hospitalisation have been reported. Consequently, this diagnosis is to be considered in the event of abdominal with or without proctorrhagia after the administration of Izinova.
Additional information: • Izinova is not for direct ingestion. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration and electrolyte disturbances. Each bottle must be diluted with water and taken with additional water as recommended to ensure patient tolerance.
684 g) sodium per bottle. To be taken into consideration by patients on a controlled sodium diet. 405 g) potassium per bottle. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.