SAMSCA- tolvaptan tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

TOLVAPTAN (UNII: 21G72T1950) (TOLVAPTAN - UNII:21G72T1950)

Dostupno od:

Otsuka America Pharmaceutical, Inc.

INN (International ime):

tolvaptan

Sastav:

tolvaptan 15 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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). 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 that raising serum sodium with SAMSCA provides a symptomatic benefit to patients. 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

Proizvod sažetak:

How Supplied SAMSCA® (tolvaptan) tablets are available in the following strengths and packages. 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 Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP controlled Room Temperature]. Keep out of reach of children.

Status autorizacije:

New Drug Application

Uputa o lijeku

Otsuka America Pharmaceutical, Inc.
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MEDICATION GUIDE
SAMSCA® (sam-sca)
tolvaptan
Tablets
Read the Medication Guide that comes with SAMSCA before you take it
and each time you get a new
prescription. There may be new information. This Medication Guide does
not take the place of talking to
your healthcare provider about your medical condition or your
treatment. Share this important information
with members of your household.
What is the most important information I should know about SAMSCA?
1) SAMSCA may make the salt (sodium) level in your blood rise too
fast. This can increase your risk of a
serious condition called osmotic demyelination syndrome (ODS). ODS can
lead to coma or death. ODS can
also cause new symptoms such as:
•
trouble speaking
•
swallowing trouble or feeling like food or liquid gets stuck while
swallowing
•
drowsiness
•
confusion
•
mood changes
•
trouble controlling body movement (involuntary movement) and weakness
in muscles of the arms and
legs
•
seizures
You or a family member should tell your healthcare provider right away
if you have any of these symptoms
even if they begin later in treatment. Also tell your healthcare
provider about any other new symptoms while
taking SAMSCA.
You may be more at risk for ODS if you have:
•
liver disease
•
not eaten enough for a long period of time (malnourished)
•
very low sodium level in your blood
•
been drinking large amounts of alcohol for a long period of time
(chronic alcoholism)
To lessen your risk of ODS while taking SAMSCA:
•
Treatment with SAMSCA should be started and re-started only in a
hospital, where the sodium levels
in your blood can be checked closely.
•
Do not take SAMSCA if you cannot tell if you are thirsty.
•
To prevent losing too much body water (dehydration), have water
available to drink at all times while
taking SAMSCA. Unless your healthcare provider tells you otherwise,
drink when you are thirsty.
•
If your healthcare provider tells you to keep taking SAMSCA after you
leave a hospital, it is

Svojstava lijeka

SAMSCA- TOLVAPTAN TABLET
OTSUKA AMERICA PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAMSCA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAMSCA.
SAMSCA (TOLVAPTAN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM
SODIUM
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
(ADPKD)
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
(A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM
SAMSCA SHOULD BE INITIATED AND RE-INITIATED IN PATIENTS ONLY IN A
HOSPITAL WHERE
SERUM SODIUM CAN BE MONITORED CLOSELY.
TOO RAPID CORRECTION OF HYPONATREMIA (E.G., >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.
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
(ADPKD)
BECAUSE OF THE RISK OF HEPATOTOXICITY, TOLVAPTAN SHOULD NOT BE USED
FOR ADPKD
OUTSIDE OF THE FDA-APPROVED REMS (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5, 5.7)
04/2021
INDICATIONS AND USAGE
SAMSCA is a selective vasopressin V -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)
DOSAGE AND ADMINISTRATION
SAMSCA should be