Janumet tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sitagliptin (sitagliptin phosphate monohydrate), metformin (metformin hydrochloride)

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A10BD07

INN (International Name):

sitagliptin (sitagliptin phosphate monohydrate), metformin (metformin hydrochloride)

Dosage:

50mg+ 1000mg

Pharmaceutical form:

tablets film-coated

Units in package:

(56/4x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-02-01

Summary of Product characteristics

40
1.
NAME OF THE MEDICINAL PRODUCT
Janumet 50 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin phosphate monohydrate equivalent to
50 mg of sitagliptin and
1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Capsule-shaped, red film-coated tablet with “577” debossed on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Janumet is indicated as an adjunct to diet and exercise to improve
glycaemic control in patients
inadequately controlled on their maximal tolerated dose of metformin
alone or those already being
treated with the combination of sitagliptin and metformin.
Janumet is indicated in combination with a sulphonylurea (i.e., triple
combination therapy) as an
adjunct to diet and exercise in patients inadequately controlled on
their maximal tolerated dose of
metformin and a sulphonylurea.
Janumet is indicated as triple combination therapy with a peroxisome
proliferator-activated receptor
gamma (PPAR
γ
) agonist (i.e., a thiazolidinedione) as an adjunct to diet and
exercise in patients
inadequately controlled on their maximal tolerated dose of metformin
and a PPAR
γ
agonist.
Janumet is also indicated as add-on to insulin (i.e., triple
combination therapy) as an adjunct to diet
and exercise to improve glycaemic control in patients when stable dose
of insulin and metformin
alone do not provide adequate glycaemic control.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperglycaemic therapy with Janumet should be
individualised on the basis of the
patient’s current regimen, effectiveness, and tolerability while not
exceeding the maximum
recommended daily dose of 100 mg sitagliptin.
_ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥ 90 ML/MIN) _
_ _
For patients inadequately controlled on maximal tolerated dose of
metformin monotherapy
For patients not adequately controlled on metformin a