SAMSCA 15 mg/1
tolvaptan · TABLET · Otsuka America Pharmaceutical, Inc.
SAMSCA is a tablet containing tolvaptan at 15 mg/1, taken oral. Manufactured by Otsuka America Pharmaceutical, Inc..
Key Facts
- Brand Name
- SAMSCA
- Generic Name
- tolvaptan
- NDC Code (Product)
59148-020- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Strength
- 15 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA022275
- Drug Class
- Vasopressin V2 Receptor Antagonist [EPC]
- Marketing Start
- 05/19/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SAMSCA ® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). SAMSCA is a selective vasopressin V 2 -receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) ( 1 ) Limitations of Use: Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with SAMSCA ( 1 ) It has not been established that SAMSCA provides a symptomatic benefit to patients ( 1 ) Limitations of Use Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with SAMSCA. It has not been established t…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION SAMSCA should be initiated and re-initiated in a hospital ( 2.1 ) The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals ≥24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. ( 2.1 ) 2.1 Recommended Dosage Patients should be in a hospital for initiation and re-initiation of therapy to evaluate the therapeutic response and because too rapid correction of hyponatremia can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. The usual starting dose for SAMSCA is 15 mg administered once daily without regard to meals. Increase the dose 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. Do not administer SAMSCA for more than 30 days to minimize the risk of liver injury [see Warnings and Precautions (5.2) ]. During initiation and titration, frequently monitor for changes in serum electrolytes and volume. Avoid fluid restriction during the first 24 hours of therapy. Patients receiving SAMSCA should be advise…
Contraindications
4 CONTRAINDICATIONS SAMSCA is contraindicated in the following conditions: Patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS [see Warnings and Precautions (5.2) ] Unable to sense or respond to thirst Hypovolemic hyponatremia Taking strong CYP3A inhibitors [see Warnings and Precautions (5.5) ] Anuria Hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or any components of the product [see Adverse Reactions (6) ] Use in patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS ( 4 ) Patients who are unable to respond appropriately to thirst ( 4 ) Hypovolemic hyponatremia ( 4 ) Concomitant use of strong CYP3A inhibitors ( 4 ) Anuria ( 4 ) Hypersensitivity ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Avoid concomitant use with: Moderate CYP3A inhibitors ( 7.1 ) Strong CYP3A inducers ( 7.1 ) V 2 -receptor antagonists ( 7.3 ) Monitor serum potassium during concomitant therapy with ( 7.2 ): Angiotensin receptor blockers Angiotensin converting enzyme inhibitors Potassium sparing diuretics 7.1 CYP3A Inhibitors and Inducers Strong CYP3A Inhibitors Tolvaptan's AUC was 5.4 times as large and C max was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] . Larger doses of the strong CYP3A inhibitor would be expected to produce larger increases in tolvaptan exposure. Concomitant use of tolvaptan with strong CYP3A inhibitors is contraindicated [see Contraindications (4) ] . Moderate CYP3A Inhibitors A substantial increase in the exposure to tolvaptan would be expected when SAMSCA is co-administered with moderate CYP3A inhibitors. Avoid co-administration of SAMSCA with moderate CYP3A inhibitors [see Warnings and Precautions (5.5) ]. Patients should avoid grapefruit juice beverages while taking SAMSCA [see Clinical Pharmacology (12.3) ] . Strong CYP3A Inducers Co-administrat…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥5% placebo) are thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka at 1-877-726-7220 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. In multiple-dose, placebo-controlled trials, 607 hyponatremic patients (serum sodium <135 mEq/L) were treated with SAMSCA. The mean age of these patients was 62 years; 70% of patients were male and 82% were Caucasian. One hundred eighty-nine (189) tolvaptan-treated patients had a serum sodium <130 mEq/L, and 52 patients had a serum sodium <125 mEq/L. Hyponatremia was attributed to cirrhosis in 17% of patients, heart failure in 68% …
Frequently Asked Questions
What is SAMSCA used for?
SAMSCA contains tolvaptan. It is a tablet taken oral. Consult your doctor for specific uses.
Is SAMSCA a controlled substance?
SAMSCA is not classified as a controlled substance by the DEA.
What is the generic name for SAMSCA?
The generic name for SAMSCA is tolvaptan. There are 11 other brand versions of tolvaptan.
What is the NDC code for SAMSCA 15 mg/1?
The NDC (National Drug Code) for SAMSCA 15 mg/1 is 59148-020, listed by Otsuka America Pharmaceutical, Inc..