Onglisa tablets 5 mg, 30 pcs. (Saksahlyptyn)

release form

Tablets

Indications

Type 2 diabetes mellitus in addition to diet and exercise to improve glycemic control as:

monotherapy

starting combination therapy with metformin

monotherapy addition to metformin, thiazolidinediones, sulfonic sulfonylate-free control, adequate therapy.

Contraindications

type 1 diabetes mellitus (not studied)

combined with insulin (not studied)

diabetic ketoacidosis

congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption

- pregnancy

- lactation

- age under 18 years (safety and efficacy not studied)

- increased individual sensitivity to any component of the drug.

Use during pregnancy and lactation

Due to the fact that the use of saxagliptin during pregnancy has not been studied, the drug should not be prescribed during this period.

It is not known whether saxagliptin passes into breast milk.

Due to that the possibility of the penetration of saxagliptin into breast milk is not ruled out, breast-feeding should be stopped for the period of treatment with saxagliptin or therapy should be discontinued, taking into account the risk ratio for the baby and the benefit for the mother.

Composition

active substance:

saxagliptin 5 mg.

excipients:

lactose monohydrate, microcrystalline cellulose,

croscarmellose sodium,

magnesium stearate,

hydrochloric acid 1 M or sodium hydroxide solution 1 M,

Opadry II white (polyvinyl polyvinyl alcohol, polyhydroxyvinyl, 50 g) ,

Opadray II yellow (polyvinyl alcohol, titanium dioxide, macrogol (PEG 3350), talc, iron oxide dye yellow (E172)),

ink Opacode blue (shellac in ethyl alcohol, FD&C Blue # 2 / indigo carmine aluminum pigment (E132) , n-butyl alcohol, propylene glycol, sleep t isopropyl, 28% ammonium hydroxide).

Drug Interactions

Analysis of clinical trial data suggests that the risk of clinically significant interactions of saxagliptin with other drugs when used together is low.

Saxagliptin metabolism is predominantly mediated by the cytochrome P450 3A4 / 5 isoenzyme system (CYP3A4 / 5). In vitro studies have shown that saxagliptin and its main metabolite do not inhibit CYP 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and 3A4 isoenzymes and do not induce CYP 1A2, 2B6, 2C9, and 3A4 isoenzymes. In studies involving healthy volunteers, the pharmacokinetic parameters of saxagliptin and its main metabolite did not significantly change under the influence of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem, ketoconazole, omeprazole, a combination of aluminum hydroxide, magnesium hydroxide, and simethicone, Saxagliptin does not significantly change the pharmacokinetic parameters of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem or ketoconazole.

The effect of inducers of CYP 3A4 / 5 isoenzymes on the pharmacokinetics of saxagliptin has not been studied. However, the combined use of saxagliptin and inducers of CYP 3A4 / 5 isoenzymes, such as carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin, can lead to a decrease in the concentration of saxagliptin in the plasma and an increase in the concentration of its main metabolite. Studies of the effects of smoking, diet, herbal supplements, and alcohol use on saxagliptin therapy have not been conducted.

overdose

The symptoms of intoxication have not been described with prolonged administration of the drug at doses up to 80 times the recommended dose.

Treatment:

In case of overdose, symptomatic therapy should be used. Saxagliptin and its major metabolite are excreted by hemodialysis (excretion rate: 23% of dose over 4 h).

Storage conditions

At a temperature not exceeding 30 ° C

Shelf life

3 years

Terms of sale from

pharmacies Prescription

dosage form

tablets

Possible product names

ONGLIZA 0.005 N30 TABLE P / FILM / SHELL

Onglisa 5 mg No. 30

Onglisa 5 mg Tab. p / pl / rev X30 (R)

Onglisa 5mg No. 30 tab 2015

ONGLIZA 5MG. No. 30 TAB. P / O

Bristol-Myers Squibb, USA



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