Caution should be used to ensure that the correct dose of JANUVIA is prescribed.

In this population, the dose-adjusted AUC of sitagliptin in plasma was approximately 18 % lower compared to adult patients with type 2 diabetes for a 100 mg dose. In patients taking pre-mixed insulin, the mean daily dose was 70.9 U/day. Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels. However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported.In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with a sulphonylurea or with insulin.Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9). healthy diet, and getting regular exercise. Baseline HbAA study comparing sitagliptin at 25 or 50 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in patients with moderate to severe renal impairment. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Many other drugs can also affect blood sugar control. Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.The pharmacokinetics of sitagliptin (single dose of 50 mg, 100 mg or 200 mg) were investigated in paediatric patients (10 to 17 years of age) with type 2 diabetes. Eating a lot of foods and drinking beverages with simple carbohydrates However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.No dose adjustment is required based on age. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).Follow your doctor's instructions about any restrictions on food, beverages, or activity.Stop taking Januvia and call your doctor right away if you have This is not a complete list of side effects and others may occur. In this population, the dose-adjusted AUC of sitagliptin in plasma was approximately 18 % lower compared to adult patients with type 2 diabetes for a 100 mg dose. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Continue typing to refine. dependent, which means a person with this type of diabetes requires treatment with insulin. See how to avoid carbs and control your blood sugar with healthier...Searching for low-sugar drink ideas? This is not considered to be a clinically meaningful difference compared to adult patients based on the flat PK/PD relationship between the dose of 50 mg and 100 mg. No studies with sitagliptin have been performed in paediatric patients with age <10 years.No dose adjustment is necessary based on gender, race, or body mass index (BMI). These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. With higher insulin levels, tissue glucose uptake is enhanced. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted. You can take : JANUVIA: with or without food.