Примери за използване на Alogliptin and pioglitazone на Английски и техните преводи на Български
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It is unknown whether alogliptin and pioglitazone are excreted in human milk.
What Incresync contains- The active substances are alogliptin and pioglitazone.
If you are already taking both alogliptin and pioglitazone as single tablets, Incresync can replace them in one tablet.
What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet.
Concomitant treatment with alogliptin and pioglitazone did not produce new toxicities, nor did it exacerbate any pioglitazone-related findings.
Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
The active substances in Incresync, alogliptin and pioglitazone, work in different ways to help correct this.
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
For patients switching from separate tablets of alogliptin and pioglitazone, both alogliptin and pioglitazone should be dosed at the daily dose already being taken.
The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus,including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies.
The co-administration of alogliptin and pioglitazone has been studied as dual therapy in patients initially treated with pioglitazone alone(with or without metformin or a sulphonylurea) and as add-on therapy to metformin.
The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients.
Combination treatment with alogliptin and pioglitazone to pregnant rats slightly augmented pioglitazone-related foetal effects of growth retardation and visceral variations, but did not induce embryo-foetal mortality or teratogenicity.
In studies performed with the individual active substances, both alogliptin and pioglitazone were excreted in the milk of lactating rats.
The safety profile of co-administered alogliptin and pioglitazone was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for pioglitazone. .
Incresync can also be used as a replacement tablet(supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.
The efficacy and safety of the recommended doses of alogliptin and pioglitazone in a subgroup of patients with type 2 diabetes mellitus and≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients< 65 years old.
In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 yearsand older with type 2 diabetes mellitus already being treated with this combination.
Studies in animal models of diabetes showed that concomitant treatment with alogliptin and pioglitazone produced both additiveand synergistic improvements in glycaemic control, increased pancreatic insulin content and normalised pancreatic beta-cell distribution.
A total of 3,504 patients with type 2 diabetes mellitus,including 1,908 patients treated with alogliptin and pioglitazone, participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and pioglitazone on glycaemic controland their safety.
These studies evaluated the effects of co-administered alogliptin and pioglitazone on glycaemic controland their safety as initial combination therapy, as dual therapy in patients initially treated with pioglitazone alone(with or without metformin or a sulphonylurea), and as add-on therapy to metformin.
The maximum recommended daily dose of 25 mg alogliptin and 45 mg pioglitazone should not be exceeded.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. .
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. .
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone. .
Incresync is available as tablets(12.5 or25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription.
If patients were previously taking pioglitazone and alogliptin separately, Incresync should be used in a strength that continues to provide the same doses.
The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
No information is available on pioglitazone and alogliptin use in dialysed patientsand, therefore, co-administered alogliptin plus pioglitazone should not be used in such patients(see sections 4.2 and 5.2).
In the other study the effects of adding alogliptin to existing treatment with pioglitazone and metformin was compared with increasing the doses of pioglitazone. .