JANUMET

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

SITAGLIPTIN PHOSPHATE, METFORMIN HYDROCHLORIDE

Dosis:

64.25 MG /500.0 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT

Diproduksi oleh:

PATHEON PUERTO RICO, INC. - United States of America

Tanggal Otorisasi:

2021-08-05

Karakteristik produk

_ _
JANUMET™
50/500, 50/1000 mg Film Coated Tablets
(Sitagliptin – Metformin 50/500, 50/1000 mg)
INDICATIONS AND USAGE
-
JANUMET 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 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 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 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 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 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 should be discontinued and