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TOLVAPTAN ZENTIVA is a brand name for Tolvaptan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tolvaptan Zentiva is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Verbatim from this product's MHRA label. Tap a section to expand.
4), treatment with Tolvaptan Zentiva has to be initiated in hospital. Posology Tolvaptan has to be initiated at a dose of 15 mg once daily. The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium.
4). 4). In case of inadequate improvement in serum sodium levels, other treatment options have to be considered, either in place of or in addition to tolvaptan. 5). For patients with an appropriate increase in serum sodium, the underlying disease and serum sodium levels must be monitored at regular intervals to evaluate further need of tolvaptan treatment.
In the setting of hyponatremia, the treatment duration is determined by the underlying disease and its treatment. Tolvaptan treatment is expected to last until the underlying disease is adequately treated or until such time that hyponatremia is no longer a clinical issue.
5). 3). Tolvaptan has not been studied in patients with severe renal failure. The efficacy and safety in this population is not well established. Based on the data available, no dose adjustment is required in those with mild to moderate renal impairment.
Hepatic impairment No information is available in patients with severe hepatic impairment (Child-Pugh class C). 4). No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). Elderly No dose adjustment is needed in elderly patients.
Paediatric population The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established. Tolvaptan Zentiva is not recommended in the paediatric age group. Method of administration Oral use.
Administration preferably in the morning, without regard to meals. Tablets must be swallowed without chewing with a glass of water.
Summary of the safety profile The adverse reaction profile of tolvaptan in SIADH is based on a clinical trials database of 3,294 tolvaptan-treated patients and is consistent with the pharmacology of the active substance. The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients.
Tabulated list of adverse reactions The frequencies of the adverse reactions from clinical trials correspond with 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) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Consequently, the frequency of these adverse reactions is qualified as "not known". 4)1 transaminases2 Surgical and medical procedures Rapid correction of hyponatremia, sometimes leading to neurological symptoms 1 observed in clinical trials investigating other indications 2 from post-authorisation safety study in hyponatremia secondary to SIADH 3 observed in post-marketing with tolvaptan in ADPKD.
Liver transplantation was necessary. Description of selected adverse reactions Rapid correction of hyponatremia In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, including a high proportion of patients with tumours (especially Small Cell Lung Cancer), patients with low baseline serum sodium as well as patients with concomitant use of diuretics and/or sodium chloride solution the incidence of rapid correction of hyponatremia was found to be higher than in clinical trials.
Urgent need to raise serum sodium acutely Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely. For such patients, alternative treatment has to be considered. 8). Therefore, patients must have access to water and be able to drink sufficient amounts of water.
If fluid restricted patients are treated with tolvaptan, extra caution has to be exercised to ensure that patients do not become overly dehydrated. Dehydration Volume status must be monitored in patients taking tolvaptan because treatment with tolvaptan may result in severe dehydration, which constitutes a risk factor for renal dysfunction.
If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake. Urinary outflow obstruction Urinary output must be secured. Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition, have an increased risk of developing acute retention.
Fluid and electrolyte balance Fluid and electrolyte status has to be monitored in all patients and particularly in those with renal and hepatic impairment. Administration of tolvaptan may cause too rapid increases in serum sodium (≥ 12 mmol/l per 24 hours, please see below); therefore, monitoring of serum sodium in all patients must start no later than 4 to 6 hours after treatment initiation.
During the first 1 to 2 days and until the tolvaptan dose is stabilised serum sodium and volume status must be monitored at least every 6 hours. Too rapid correction of serum sodium Patients with very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium.
Too rapid correction of hyponatremia (increase ≥ 12 mmol/l/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death. Therefore, after initiation of treatment, patients have to be closely monitored for serum sodium and volume status (see above).
6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
In order to minimise the risk of too rapid correction of hyponatremia the increase of serum sodium should be less than 10 mmol/l/24 hours to 12 mmol/l/24 hours and less than 18 mmol/l/48 hours. Therefore, more precautionary limits apply during the early treatment phase.
If sodium correction exceeds 6 mmol/L during the first 6 hours of administration or 8 mmol/l during the first 6 to 12 hours, respectively, the possibility that serum sodium correction may be overly rapid should be considered. These patients should be monitored more frequently regarding their serum sodium and administration of hypotonic fluid is recommended.
In case serum sodium increases ≥ 12 mmol/l within 24 hours or ≥ 18 mmol/l within 48 hours, tolvaptan treatment is to be interrupted or discontinued followed by administration of hypotonic fluid. In patients at higher risk of demyelination syndromes, for example those with hypoxia, alcoholism or malnutrition, the appropriate rate of sodium correction may be lower than that in patients without risk factors; these patients should be very carefully managed.
5) prior to initiation of treatment with Tolvaptan Zentiva must be managed very cautiously. These patients may be at higher risk for developing rapid correction of serum sodium during the first 1 to 2 days of treatment due to potential additive effects.
5). , in excess of 300 mg/dl) may present with pseudo-hyponatremia. This condition should be excluded prior and during treatment with tolvaptan. 8). Therefore, diabetic patients treated with tolvaptan should be managed cautiously. In particular this applies to patients with inadequately controlled type II diabetes.
8). 8). In these clinical trials, clinically significant increases (greater than 3 × Upper Limit of Normal [ULN]) in serum alanine aminotransferase (ALT), along with clinically significant increases (greater than 2 × ULN) in serum total bilirubin were observed in 3 patients treated with tolvaptan.
0 % (5/484)]. 8 % (4/484) patients on placebo. Most of the liver enzyme abnormalities were observed during the first 18 months of treatment. The elevations gradually improved after discontinuation of tolvaptan. These findings may suggest that tolvaptan has the potential to cause irreversible and potentially fatal liver injury.
8). Liver function tests must be promptly […]