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SAMSCA is a brand name for Tolvaptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. , >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death.
In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. Close monitoring of serum sodium during tolvaptan treatment is required, especially in patients with very low sodium (< 120 mEq/L) at baseline, or in those at high risk of demyelination syndromes, as described just above.
Very careful management of these patients is required. , > 12 mEq/L over 24 hours, or > 18 mEq/L over 48 hours. Co-administration of tolvaptan with other treatments for hyponatremia, such as hypertonic saline or other therapies that may increase serum sodium levels is not recommended, particularly during initiation or in patients with fluctuating serum sodium, due to risk of developing hypernatremia.
, > 6 mEq/L over the first 6 hours, may be at risk for serious neurologic sequelae. In controlled clinical trials, this rapid rate of sodium correction has been observed in approximately 3% of patients treated with tolvaptan (N = 223) and 0% of placebo-treated patients (N = 220), in titrated doses of SAMSCA between 15 mg/day and 60 mg/day.
Patients treated with tolvaptan should be monitored to assess serum sodium concentrations and neurologic status, especially during initiation and after titration, as serious neurologic sequelae can result from over rapid correction of sodium.
Patients with syndrome of inappropriate anti-diuretic hormone (SIADH) or very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium. Fluid restriction during the first 24 hours of therapy with SAMSCA may increase the likelihood of overly-rapid correction of serum sodium and should generally be avoided.
, > 12 mEq/L/24 hours). Osmotic demyelination may result in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death. None of the patients in the controlled clinical trials with tolvaptan exhibited evidence of osmotic demyelination syndrome or related neurological sequelae, but such complications have been reported following too rapid correction of serum sodium.
g. mirtazapine), or to any ingredient in the formulation. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. , ketoconazole, itraconazole, clarithromycin, telithromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone (see DRUG INTERACTIONS, Drug-Drug Interactions) • Pregnancy (See WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women) • Nursing women (See WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women) • Use in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) outside of Health Canada Risk Management Plan (RMP) • Patients with one of the following rare hereditary diseases: Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption as lactose is a non-medicinal ingredient in SAMSCA SAMSCA® Product Monograph Page 5 of 35 WARNINGS AND PRECAUTIONS SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely.
, >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.
Close monitoring of serum sodium during tolvaptan treatment is required, especially in patients with very low sodium (< 120 mEq/L) at baseline, or in those at high risk of demyelination syndromes, as described just above. Very careful management of these patients is required.
, > 12 mEq/L over 24 hours, or > 18 mEq/L over 48 hours. Co-administration of tolvaptan with other treatments for hyponatremia, such as hypertonic saline or other therapies that may increase serum sodium levels is not recommended, particularly during initiation or in patients with fluctuating serum sodium, due to risk of developing hypernatremia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tolvaptan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
SAMSCA® Product Monograph Page 6 of 35 There is no experience with concomitant use of SAMSCA and hypertonic saline. Concomitant use with hypertonic saline is not recommended. Carcinogenesis and Mutagenesis See TOXICOLOGY 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. 5% for placebo-treated patients. In patients receiving SAMSCA who develop medically significant signs or symptoms of hypovolemia, interrupt or discontinue SAMSCA therapy immediately and provide supportive care with careful management of vital signs, fluid balance and electrolytes.
Fluid restriction during therapy with SAMSCA may increase the risk of dehydration and hypovolemia. SAMSCA should not be prescribed to patients who cannot perceive or respond to thirst (see CONTRAINDICATIONS). Patients receiving SAMSCA should be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration and improve tolerability of tolvaptan (see DOSAGE AND ADMINISTRATION).
Hepatotoxicity Drug induced liver injury has been observed in clinical trials investigating the autosomal dominant polycystic kidney disease (ADPKD) with long-term use of tolvaptan at higher doses than for SAMSCA approved indication.
In a large double-blind, three-year, placebo-controlled trial (TEMPO 3:4) conducted in about 1,400 ADPKD patients, and its open-label extension trial, three patients treated with tolvaptan developed clinically significant (> 3x ULN) increases in serum alanine aminotransferase (ALT), along with clinically significant (> 2x ULN) increases in serum total bilirubin.
Following discontinuation of tolvaptan treatment, all three patients improved. These findings indicate, however, that tolvaptan has the potential to cause irreversible and potentially fatal liver injury. 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. SAMSCA® Product Monograph Page 7 of 35 In the ADPKD trials, the maximum daily dose of tolvaptan administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for use in the treatment of hyponatremia.
In other clinical trials of SAMSCA, including the trials supporting the approved indication of clinically significant […]
, > 6 mEq/L over the first 6 hours, may be at risk for serious neurologic sequelae. In controlled clinical trials, this rapid rate of sodium correction has been observed in approximately 3% of patients treated with tolvaptan (N = 223) and 0% of placebo-treated patients (N = 220), in titrated doses of SAMSCA between 15 mg/day and 60 mg/day.
Patients treated with tolvaptan should be monitored to assess serum sodium concentrations and neurologic status, especially during initiation and after titration, as serious neurologic sequelae can result from over rapid correction of sodium.
Patients with syndrome of inappropriate anti-diuretic hormone (SIADH) or very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium. Fluid restriction during the first 24 hours of therapy with SAMSCA may increase the likelihood of overly-rapid correction of serum sodium and should generally be avoided.
, > 12 mEq/L/24 hours). Osmotic demyelination may result in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death. None of the patients in the controlled clinical trials with tolvaptan exhibited evidence of osmotic demyelination syndrome or related neurological sequelae, but such complications have been reported following too rapid correction of serum sodium.
SAMSCA® Product Monograph Page 6 of 35 There is no experience with concomitant use of SAMSCA and hypertonic saline. Concomitant use with hypertonic saline is not recommended. Carcinogenesis and Mutagenesis See TOXICOLOGY 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. 5% for placebo-treated patients. In patients receiving SAMSCA who develop medically significant signs or symptoms of hypovolemia, interrupt or discontinue SAMSCA therapy immediately and provide supportive care with careful management of vital signs, fluid balance and electrolytes.
Fluid restriction during therapy with SAMSCA may increase the risk of dehydration and hypovolemia. SAMSCA should not be prescribed to patients who cannot perceive or respond to thirst (see CONTRAINDICATIONS). Patients receiving SAMSCA should be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration and improve tolerability of tolvaptan (see DOSAGE AND ADMINISTRATION).
Hepatotoxicity Drug induced liver injury has been observed in clinical trials investigating the autosomal dominant polycystic kidney disease (ADPKD) with long-term use of tolvaptan at higher doses than for SAMSCA approved indication.
In a large double-blind, three-year, placebo-controlled trial (TEMPO 3:4) conducted in about 1,400 ADPKD patients, and its open-label extension trial, three patients treated with tolvaptan developed clinically significant (> 3x […]