| Initial U.S. Approval: 05/2009
Tolvaptan is (±)-4′-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94.
SAMSCA tablets for oral use contain 15 mg or 30 mg of tolvaptan. Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and FD&C Blue No. 2 Aluminum Lake as colorant.
| CLINICAL PHARMACOLOGY
Mechanism of Action
Plasma concentrations of native AVP may increase (avg. 2-9 pg/mL) with tolvaptan administration
| 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, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
It has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients.
Do not administer to patients requiring urgent intervention to raise serum sodium acutely.
Do not use in patients who are unable to sense or to respond appropriately to thirst.
Do not use in patients with hypovolemic hyponatremia.
Do not use with strong CYP 3A inhibitors.
Do not administer to patients who are anuric as no benefit is expected.
| WARNINGS AND PRECAUTIONS
| Most common adverse reactions (5% placebo) are thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia.
To report SUSPECTED ADVERSE REACTIONS, contact Otsuka at 1-877-726-7220 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
| DOSAGE AND ADMINISTRATION
Usual Dosage in Adults
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. 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 advised that they can continue ingestion of fluid in response to thirst [see Warnings and Precautions].
Co-Administration with CYP 3A Inhibitors, CYP 3A Inducers and P-gp Inhibitors——–
CYP 3A Inhibitors
CYP 3A Inducers
| DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg and 30 mg
HOW SUPPLIED/STORAGE AND HANDLING
SAMSCA 15 mg tablets are non-scored, blue, triangular, shallow-convex, debossed with “OTSUKA” and “15” on one side.
SAMSCA 30 mg tablets are non-scored, blue, round, shallow-convex, debossed with “OTSUKA” and “30” on one side.
Storage and Handling
Keep out of reach of children
| Package Insert data:
SAMSCA is a trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
0708L-0023C Rev. 05, 2009
This Medication Guide has been approved by the U.S. Food and Drug Administration.
PRINCIPAL DISPLAY PANEL – 15 mg Tablet Carton
Carton contains 1 strip with 10 tablets.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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