Samsca: Effective Hyponatremia Correction with Tolvaptan Therapy
| Product dosage: 15 mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 20 | $13.82 | $319.60 $276.38 (14%) | 🛒 Add to cart |
| 30 | $15.98 | $479.40 (0%) | 🛒 Add to cart |
| 60 | $11.06
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Synonyms | |||
Samsca (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. It is specifically designed to increase free water excretion, thereby raising serum sodium concentrations in patients with conditions such as syndrome of inappropriate antidiuretic hormone secretion (SIADH), heart failure, or cirrhosis. By targeting the underlying cause of dilutional hyponatremia, Samsca offers a mechanism-driven approach to electrolyte management, supporting both short-term correction and longer-term stabilization under appropriate medical supervision. Its use requires careful patient selection, monitoring, and adherence to dosing protocols to ensure efficacy and minimize risks.
Features
- Contains tolvaptan, a selective vasopressin V2-receptor antagonist
- Available in 15 mg and 30 mg oral tablets
- Promotes aquaresis—excretion of electrolyte-free water
- Onset of action typically within 2–4 hours post-administration
- Requires hospital initiation for appropriate serum sodium monitoring
- Not indicated for hypovolemic hyponatremia
Benefits
- Effectively increases serum sodium levels in indicated hyponatremic patients
- Reduces symptoms associated with hyponatremia, such as confusion, headache, and nausea
- Provides a targeted mechanism of action with predictable aquaresis
- Supports clinical management in both euvolemic and hypervolemic states
- May help avoid overcorrection when used with appropriate monitoring
- Oral administration facilitates use in both inpatient and carefully supervised outpatient settings
Common use
Samsca is commonly used in adult patients with clinically significant hypervolemic or euvolemic hyponatremia. This includes individuals with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone (SIADH), congestive heart failure, or liver cirrhosis with ascites. It is not intended for emergency correction of severe symptomatic hyponatremia, nor is it indicated for use in patients requiring immediate intervention to prevent serious neurological symptoms. Treatment should always be initiated in a hospital setting where serum sodium can be closely monitored.
Dosage and direction
The recommended starting dose of Samsca is 15 mg administered orally once daily. Dose may be increased to 30 mg once daily, after at least 24 hours, to achieve the desired level of serum sodium. The maximum daily dose is 60 mg. Tablets should be taken with or without food. Fluid restriction during the first 24 hours of therapy is not recommended. Serum sodium, volume, and neurological status must be monitored frequently during initiation and titration. Duration of use should be limited to 30 days, due to potential risk of liver injury.
Precautions
Patients must be under close medical supervision, preferably in a hospital, during initiation and titration of Samsca due to the need for frequent monitoring of serum sodium and volume status. Rapid correction of hyponatremia can cause osmotic demyelination, resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, or death. Patients with malnutrition, alcoholism, or advanced liver disease are at particular risk. Samsca may cause liver injury; discontinue promptly if signs or symptoms of liver injury appear. Dehydration and hypovolemia may occur; patients should have access to water and be advised to drink if thirsty.
Contraindications
Samsca is contraindicated in patients with hypovolemic hyponatremia. Concomitant use with strong CYP 3A inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) is contraindicated. It should not be used in patients unable to sense or respond to thirst, or in those with anuria. Samsca is also contraindicated in patients with a history of hypersensitivity to tolvaptan or any component of the product.
Possible side effects
Common adverse reactions include thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia. Serious side effects may include overly rapid correction of sodium, leading to osmotic demyelination; liver injury; GI bleeding in cirrhotic patients; and dehydration. Less frequently, patients may experience fever, nausea, dizziness, or orthostatic hypotension. Any signs of acute liver injury (e.g., fatigue, anorexia, right upper quadrant discomfort, dark urine, jaundice) should prompt immediate discontinuation and evaluation.
Drug interaction
Samsca is primarily metabolized by CYP 3A. Concomitant use with strong CYP 3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) is contraindicated. Moderate inhibitors (e.g., erythromycin, fluconazole, aprepitant) and P-gp inhibitors may increase tolvaptan exposure. Inducers of CYP 3A (e.g., rifampin, barbiturates, St. John’s wort) may decrease tolvaptan levels. Use with hypertonic saline is not recommended. Concomitant use with other medications affecting serum sodium or volume status (e.g., diuretics, NSAIDs) requires careful monitoring.
Missed dose
If a dose is missed, it should be taken as soon as possible on the same day. Patients should not take two doses on the same day to make up for a missed dose. The next dose should be taken at the usual time the following day. Doubling the dose is not recommended due to increased risk of adverse effects, including rapid sodium correction.
Overdose
Overdose is expected to produce effects attributable to excessive pharmacologic activity—including dehydration, hypovolemia, and hypernatremia—as well as signs or symptoms of liver injury. There is no specific antidote. Treatment should consist of general supportive measures, including discontinuation of Samsca, restoration of water and electrolyte balance, and frequent monitoring of vital signs, renal function, fluid balance, and serum electrolytes. Hemodialysis is unlikely to be effective due to high protein binding.
Storage
Store Samsca tablets at room temperature, 20°–25°C (68°–77°F); excursions permitted between 15°–30°C (59°–86°F). Keep in the original container with the dessicant provided to protect from moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging.
Disclaimer
This information is intended for educational and informational purposes only and does not constitute medical advice. Samsca is a prescription medication and should be used only under the supervision of a qualified healthcare provider. Patients must follow their prescriber’s instructions and read the accompanying medication guide. Individual response to therapy may vary. Serious risks, including liver injury and osmotic demyelination, require careful patient selection and monitoring.
Reviews
Clinical trials and post-marketing experience have demonstrated that Samsca is effective in raising serum sodium levels in appropriate patient populations when used according to labeled instructions. In studies, a significant proportion of patients achieved normal or near-normal sodium levels within several days of treatment. Healthcare providers note the importance of inpatient initiation and close monitoring to mitigate risks. Patient-reported outcomes often include improvement in symptoms related to hyponatremia, though thirst and frequent urination are commonly mentioned. Long-term safety data are limited; use beyond 30 days is not recommended.
