JANUMET XR

Land: Indonesien

Språk: indonesiska

Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiva substanser:

SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE

Tillgänglig från:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International namn):

SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE

Dos:

64.25 MG /500.0 MG

Läkemedelsform:

TABLET PELEPASAN LAMBAT

Enheter i paketet:

BOTOL @ 28 TABLET PELEPASAN LAMBAT

Tillverkad av:

MSD INTERNATIONAL GMBH (PUERTO RICO BRANCH) L.L.C - Puerto Rico

Tillstånd datum:

2021-09-11

Produktens egenskaper

JANUMET™ XR
(Sitagliptin phosphate – Metformin HCl extended-release 50/500,
50/1000, 100/1000 mg)
INDICATIONS AND USAGE
-
JANUMET XR is indicated as an adjunct to diet and exercise to improve
glycemic control in patients
with type 2 diabetes mellitus inadequately controlled on metformin or
sitagliptin alone or in patients
already being treated with the combination of sitagliptin and
metformin.
-
JANUMET XR is also indicated in combination with a sulfonylurea (i.e.
triple combination therapy) as
an adjunct to diet and exercise in patients with type 2 DM
inadequately controlled with any two of the
three agents: metformin, sitagliptin, or a sulfonylurea.
-
JANUMET XR is also indicated as add-on to insulin (i.e., triple
combination therapy) as an adjunct to
diet and exercise to improve glycemic control in patients when stable
dose of insulin and metformin
alone do not provide adequate glycemic control.
When Janumet XR is used in combination with sulfonylurea or with
insulin, a lower dose of sulfonylurea or
insulin may be required to reduce the risk of hypoglycemia.
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSING
The dosage of antihyperglycemic therapy with JANUMET XR should be
individualized on the basis of the
patient’s current regimen, effectiveness, and tolerability while not
exceeding the maximum recommended
daily dose of 100 mg sitagliptin and 2000 mg metformin.
When Janumet XR is used in combination with sulfonylurea or with
insulin, a lower dose of sulfonylurea
or insulin may be required to reduce the risk of hypoglycemia.
WARNING: LACTIC ACIDOSIS
Lactic acidosis is a rare, but serious complication that can occur due
to metformin accumulation.
The risk increases with conditions such as sepsis, dehydration, excess
alcohol intake, hepatic
impairment, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific such as
malaise, myalgias, respiratory
distress, increasing somnolence, and nonspecific abdominal distress.
If acidosis is suspected, JANUMET XR shoul