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JANUMET (METFORMIN, SITAGLIPTIN): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Janumet

There are no adequate and well-controlled studies in pregnant women with Sitagliptin with Metformin (Janumet) or its individual components; therefore, the safety of this drug in pregnant women is not known. Janumet should be used during pregnancy only if clearly needed.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., maintains a registry to monitor the pregnancy outcomes of women exposed to Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) while pregnant. Health care providers are encouraged to report any prenatal exposure to this medicine by calling the Pregnancy Registry.

No animal studies have been conducted with the combined products in Sitagliptin Phosphate with Metformin HCl (Janumet) to evaluate effects on reproduction. The following data are based on findings in studies performed with sitagliptin or metformin individually.

Sitagliptin

Reproduction studies have been performed in rats and rabbits. Doses of sitagliptin up to 125 mg / kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies with sitagliptin in pregnant women.

Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) was not teratogenic at oral doses up to 250 mg / kg (rats) and 125 mg / kg (rabbits), or approximately 30 and 20 times human exposure at the maximum recommended human dose (MRHD) of 100 mg per day based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1000 mg / kg, or approximately 100 times human exposure at the MRHD.

Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1000 mg / kg. No functional or behavioral toxicity was observed in offspring of rats.

Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours.

Metformin Hydrochloride

Metformin was not teratogenic in rats and rabbits at doses up to 600 mg / kg per day. This represents an exposure of about 2 and 6 times the maximum recommended human daily dose of 2 g based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.

Nursing Mothers

No studies in lactating animals have been conducted with the combined components of Janumet (Sitagliptin Phosphate, Metformin HCl). In studies performed with the individual components, both sitagliptin and metformin are secreted in the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Janumet (Sitagliptin, Metformin) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Sitagliptin with Metformin (Janumet) in pediatric patients under 18 years have not been established.

Geriatric Use

Janumet

Because sitagliptin and metformin are substantially excreted by the kidney, and because aging can be associated with reduced renal function, Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.

Sitagliptin

Of the total number of subjects (N=3884) in Phase II and III clinical studies of sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Metformin Hydrochloride

Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and young patients. Metformin should only be used in patients with normal renal function. The initial and maintenance dosing of metformin should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dose adjustment should be based on a careful assessment of renal function.


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Gliclazide Ratiopharm - Gliclazide
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  • Ratiopharm


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