Samsca: Effective Hyponatremia Correction with Tolvaptan Therapy
| Product dosage: 15 mg | |||
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| 60 | $11.03
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Synonyms | |||
Samsca (tolvaptan) is an oral 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 pathophysiology, Samsca offers a targeted approach to managing this complex electrolyte imbalance, helping restore sodium levels under careful medical supervision. Its use requires hospital initiation for close monitoring of serum sodium and volume status.
Features
- Active ingredient: tolvaptan
- Pharmacologic class: selective vasopressin V2-receptor antagonist
- Available as 15 mg and 30 mg tablets
- Oral administration, once daily
- Requires hospital initiation for appropriate monitoring
- Boxed warning regarding the need to monitor serum sodium and risk of overly rapid correction
Benefits
- Promotes aquaresis—excretion of free water without substantial electrolyte loss
- Effectively increases serum sodium concentrations in indicated hyponatremic patients
- May improve certain clinical symptoms associated with hyponatremia when sodium correction is achieved
- Oral dosing convenience supports treatment continuity post-discharge under guidance
- Targeted mechanism addresses vasopressin-mediated water retention
- Can be used in both euvolemic and hypervolemic hyponatremia, offering broad applicability within its indication
Common use
Samsca is commonly used in adult patients with clinically significant hypervolemic or euvolemic hyponatremia. This includes individuals with heart failure, cirrhosis, or the syndrome of inappropriate antidiuretic hormone secretion (SIADH). It is not intended for use in patients requiring urgent intervention to prevent or treat serious neurological symptoms. Treatment should be initiated and re-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 a maximum of 60 mg once daily, as needed to achieve the desired level of serum sodium. Tablets should be taken with or without food. Avoid grapefruit juice during treatment, as it may increase tolvaptan exposure. Treatment duration should be limited to 30 days due to potential risk of liver injury. Always initiate in a hospital for proper monitoring.
Precautions
Samsca should be used with caution in patients with renal impairment, as there is limited experience in those with severe impairment (CrCl <10 mL/min) or requiring dialysis. Hepatic impairment can affect drug exposure; avoid use in patients with underlying liver disease. Monitor for signs of dehydration or hypovolemia. Due to the risk of rapid correction of sodium, frequent monitoring of serum sodium and volume status is essential, especially during initiation and titration. Not recommended for use in hypovolemic hyponatremia.
Contraindications
Samsca is contraindicated in patients with hypovolemic hyponatremia. Concomitant use with strong CYP 3A inhibitors (e.g., ketoconazole, clarithromycin) is contraindicated. It must not be used in patients unable to sense or respond to thirst, or in those with anuria. Additionally, Samsca is contraindicated in patients with a history of hypersensitivity to tolvaptan or any component of the formulation.
Possible side effect
Common side effects include thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, hyperglycemia, and fever. Serious side effects may include overly rapid correction of serum sodium leading to osmotic demyelination, liver injury, dehydration, and hypovolemia. GI bleeding has been reported in cirrhotic patients. Discontinuation should be considered if significant side effects or signs of liver injury occur.
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., fluconazole, aprepitant) may increase tolvaptan exposure; reduce Samsca dose if used concomitantly. Inducers of CYP 3A (e.g., rifampin, phenytoin) may decrease tolvaptan efficacy. Use with P-gp inhibitors may also increase concentrations. Avoid grapefruit juice during treatment.
Missed dose
If a dose is missed, it should be taken as soon as possible on the same day. However, if it is near the time for the next dose, skip the missed dose and resume the usual dosing schedule. Do not double the dose to make up for a missed one. Patients should be advised to maintain a consistent daily dosing routine and inform their healthcare provider of any missed doses.
Overdose
Overdose of Samsca may lead to pronounced aquaresis with significant dehydration and hypovolemia, potentially resulting in hypotension, circulatory collapse, or cardiac arrhythmias. Signs and symptoms may include excessive thirst, dry mouth, dizziness, weakness, or oliguria. Treatment should focus on supportive care, including replacement of water and electrolytes, and monitoring of vital signs and serum sodium. There is no specific antidote; hemodialysis is not expected to enhance elimination.
Storage
Store Samsca tablets at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container 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 healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Do not disregard professional medical advice or delay in seeking it because of something you have read here. Full prescribing information, including boxed warning, should be reviewed prior to use.
Reviews
Clinical trials and post-marketing experience have demonstrated Samsca’s efficacy in raising serum sodium levels in appropriate patient populations. Many specialists value its targeted mechanism for managing chronic hyponatremia, though emphasis is placed on the necessity of inpatient initiation and vigilant monitoring to mitigate risks such as overly rapid correction or liver injury. It is generally regarded as a useful option within a comprehensive hyponatremia management strategy when used according to guidelines.