JANUMET . 50 mg. 850 mg. 28 tablets

JANUMET . 50 mg.  850 mg. 28 tablets
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In patients with type 2 diabetes mellitus:
Janumet is indicated as an adjunct to diet and exercise to improve glycemic 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 . 50 mg. / 850 mg. 28 tablets
 

TRADE NAMES OF THE MEDICINAL PRODUCT


Janumet (MSD) - Film tablet containing sitagliptin and metformin hydrochloride 50 mg/850mg

Formulations
Tablets - coated

Witness

 
In patients with type 2 diabetes mellitus:
Janumet is indicated as an adjunct to diet and exercise to improve glycemic 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 also indicated in combination with a sulphonylurea (ie, triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.
 

Dosage and method of administration

 
The dosage of anti-diabetic treatment with Janumet should be individualized as not to exceed the maximum recommended daily dose of 100 mg sitagliptin.
 
For patients who are not satisfactorily controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
 
For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated with a dose of sitagliptin and metformin already being taken.
 
For patients who are not satisfactorily controlled on dual combination therapy with metformin and a sulphonylurea, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combination with a sulphonylurea may be necessary to use a lower dose of sulfonylurea to reduce the risk of hypoglycemia.
 
Janumet should be taken twice daily with meals to reduce side effects from the gastrointestinal tract associated with metformin.
 
Patients with renal insufficiency
Janumet should not be used in patients with moderate or severe renal impairment (creatinine clearance <60 ml / min).
 
Patients with hepatic impairment
Janumet should not be used in patients with hepatic impairment.
 
Elderly
Because sitagliptin and metformin are substantially excreted by the kidney, Janumet should be used with caution as age increases. It is necessary to monitor renal function to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. There are limited data in patients> 75 years of age and should be approached with caution.
 
Paediatric population
Janumet is not recommended for use in children below 18 years due to lack of data on safety and efficacy in this population.
 
Contraindications
 
Janumet is contraindicated in patients with:
 Hypersensitivity to the active substance or to any of the excipients
 Diabetic ketoacidosis, diabetic pre-coma;
Moderate and severe renal impairment (creatinine clearance <60 ml / min)
Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, intravascular administration of iodinated contrast agents.
 Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock.
 Liver damage
 Acute alcohol intoxication, alcoholism
 Breastfeeding.
 
Special precautions for use
 
Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Lactic acidosis is a rare but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly
controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and other conditions associated with hypoxia.
 

 Interactions

 
Simultaneous multiple doses of sitagliptin (50 mg twice daily) and metformin (1000 mg twice daily) did not alter the pharmacokinetics of sitagliptin and metformin in patients with type 2 diabetes.
There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the active substance of Janumet metformin consumption of alcohol and medicinal products containing alcohol should be avoided.
Cationic agents that are eliminated by renal tubular secretion (eg cimetidine) may interact with metformin by competing for common transport systems in the renal tubules.
The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity. Patients should be informed and more frequent blood glucose monitoring, especially at the beginning of treatment with these medications.
ACE-inhibitors may decrease blood sugar levels. If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
 

Use during pregnancy and lactation

 
There are no adequate data from the use of sitagliptin in pregnant women.
Janumet should not be used during pregnancy. If a patient wishes to become pregnant or if pregnancy occurs, Janumet should be discontinued and switched to insulin treatment as soon as possible.
Metformin is excreted into breast milk in small amounts. It is not known whether sitagliptin is excreted in human milk. Therefore, Janumet should not be used in women who are breastfeeding.
 

Effects on ability to drive and use machines

 
Janumet No studies on the effects on ability to drive and use machines. In addition, patients should be warned of the risk of hypoglycaemia when Janumet is used in combination with other sulfonylurea agents.
 
Adverse reactions
 
You should not use this medication if you are allergic to metformin (Glucophage) or pioglitazone (Actos), or kidney problems, heart failure or severe metabolic acidosis.
You may file a lactic acidosis from metformin. Early symptoms may get worse over time fatal. Emergency medical care is needed even in mild symptoms such as: muscle pain or weakness, numb or cold feeling in hands and feet, difficulty breathing, stomach pain, nausea with vomiting, slow or uneven heartbeat, dizziness, or feeling tired.
 

 Pharmacological

 

 Pharmacokinetic properties:

 
A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin / metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
 

 Pharmacodynamic properties:

 
 Pharmacotherapeutic group: Combinations of oral medications to reduce blood sugar.
Janumet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the class of biguanides.
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