Description
Latin name
JANUMET
Release form
Yanumet is available in the form of tablets coated with a film shell of a reddish-brown color, on one side there is an engraving “577” core – from almost white to white.
packaging 28 pcs
Indications
The use of Yanumet is indicated as an adjunct to the diet and exercise regimen in the form of monotherapy and combined treatment of type 2 diabetes in the following cases:
prescribing initial therapy if dieting and exercise regimen do not allow adequate control of glycemia
lack of adequate glycemic control during monotherapy with metformin or sitagliptin, or with combined treatment with these two
drugs ovannoy therapy consisting of sitagliptin, metformin, and sulfonylureas, in the absence of adequate glycemic control from combined treatment using only two of the listed
agents, the clinical need for prescribing combination therapy including three drugs: sitagliptin, metformin and thiazolidinediones (PPAR gamma receptor agonists activated by peroxisome proliferator), in the absence of adequate glycemic control from combined treatment using only two of the listed
agents, the need for use in combination with insulin if monothera pium with insulin does not provide adequate glycemic control.
Contraindications
Type 1 diabetes mellitus
Diseases or impaired renal function with CC less than 60 ml / min or serum creatinine concentration in men 1.5 mg / dl and higher, in women 1.4 mg / dl and higher, including disorders resulting from acute myocardial infarction, shock (cardiovascular collapse), septicemia
Severe infectious diseases
Dehydration (diarrhea, vomiting)
Fever
Hypoxia conditions: renal infections, shock, sepsis chronic bronchitis, dose, including diabetic ketoacidosis
heart failure, acute myocardial infarction, respiratory distress, other acute and chronic diseases with clinically pronounced manifestations that may contribute to the development of tissue hypoxia
Severe injuries, extensive surgery, impaired liver function, liver failure
Lactic acidosis (including history)
Taking tablets within 48 hours before and 48 hours after radiological and radioisotope studies with the introduction of iodine-containing contrast medium
Compliance with a hypocaloric diet with an energy value of less than 1000 kcal per 24 hours sa
Acute alcohol poisoning, chronic alcoholism
Pregnancy period
Breastfeeding
Under 18 years of age, established hypersensitivity to the components of the drug.
According to the instructions Janumet should be used with caution in elderly patients.
Use during pregnancy and lactation
The use of Janumet during gestation and during breast-feeding is contraindicated.
Composition of
1 tablet contains:
Active ingredients:
Metformin hydrochloride – 1000 mg
Sitagliptin phosphate monohydrate – 64.25 mg (equivalent to 50 mg sitagliptin).
Auxiliary components:
Sodium stearyl fumarate
Microcrystalline cellulose
Sodium lauryl sulfate
Povidone.
Shell composition:
Opadry II Red, 85 F 15464
Polyvinyl alcohol
Macrogol-3350
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide black (E172)
Talc.
Side effects of
from the gastrointestinal tract: metallic taste in the mouth at the beginning of use – nausea, vomiting, diarrhea, flatulence, anorexia, abdominal pain
from the blood and cardiovascular system: in rare cases – megaloblastic anemia metabolic disorders of folic acid and vitamin B12
absorption: hypoglycemia in rare cases – lactic acidosis (respiratory disorders, hypothermia, weakness, drowsiness, abdominal pain, resistant bradyarrhythmia, hypotension, myalgia )
dermatological reactions: rash, dermatitis.
Additional side effects established during post-registration observations that may occur during the use of Janumet:
from the immune system: hypersensitivity reactions, including anaphylaxis, angioedema
edema dermatological reactions: pruritus, urticaria, Stevens-Johnson syndrome and other exfoliative skin diseases, skin vasculitis
from the digestive system: constipation, acute pancreatitis (including necrotic and hemorrhagic forms, including with lethal outcome from srdl) urinary system: impaired renal function, severe acute renal failure
from the respiratory system: nasopharyngitis, upper respiratory tract infection
from the nervous system We headache
the part of the musculoskeletal system: pain in the extremities, arthralgia, myalgia, back pain.
Drug Interaction
Concomitant administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1000 mg twice daily) does not cause clinically relevant changes in the pharmacokinetic parameters of drugs in type 2 diabetes mellitus.
Studies on the interaction of Janumet with other drugs have not been conducted. Therefore, the appointment of concomitant therapy should be guided by the results of similar studies conducted separately on sitagliptin and metformin.
With sitagliptin concomitant use:
rosiglitazone, glibenclamide, simvastatin, warfarin, oral contraceptives: no clinically relevant alteration of their pharmacokinetics occurs, sitagliptin does not inhibit cytochrome P450 CY4 CYP cytoplasms, CY4, CY4, CY4 not podavlyaet yzoferment CYP1A2, CYP2D6, CYP2V6, CYP2S19 not induces CYP3A4
fibrates, statyn , Ñzetymyb (hypoholesterynemycheskye sredstva), clopidogrel, hypotensive sredstva, vkljuchaja antagonists receptors of angiotensin II, ynhybytor angiotensin-converting enzyme, beta-blockers, hydrohlorotyazyd, blockers medlenn h kaltsyev h channels , non-steroidal anti-inflammatory drugs (diclofenac, naproxen, celecoxib), analgesics, antidepressants (fluoxetine, sertraline, bupropion), proton pump inhibitors (omeprazole, lansoprazole), antihistamines (cetirizine), sildenafil: do not affect the pharmacokinetics of sitagliptin
digoxin, cyclosporine: increase their AUC and Cmax values clinically.
With concomitant use of metformin:
glyburide: clinically meaningful interaction does not cause
furosemide: changes its pharmacokinetic parameters, promotes an increase of Cmax of metformin by 22%, AUC in whole blood – by 15%, renal clearance of drugs does not significantly change
nifedipine: leads to an increase in concentration, leads to an increase in concentration amounts of kidney metformin
cationic agents – morphine, amiloride, digoxin, procainamide, quinine, quinidine, trimethoprim, vancomycin, ranitidine, triamterene: can compete for the use of Noah tubular transportnoy system
fenotyazyn , diuretics, steroids, Preparations schytovydnoy glands, oral contraceptives, estrogens, nykotynovaya acid fenytoyn, sympathomimetic, isoniazid, blockers medlenn h kaltsyev h channels: obladaya hyperhlykemycheskym BUILDING, can violate glycemic control should be carefully monitored for the parameters of glycemic control
drugs that actively bind to plasma proteins, such as salicylates, sulfonamides, chloramphenicol, probenecid: do not interact with metformin.
Overdose
Overdose symptoms have not been established.
Treatment: in case of accidental administration of a high dose of Janumet, it is necessary to immediately wash the stomach or cause artificial vomiting to remove the drug that has not yet been absorbed. It is necessary to provide the patient with control of vital functions of an organism, carrying out electrocardiography, appointment of symptomatic therapy, in case of clinical need – carrying out prolonged hemodialysis. The effectiveness of peritoneal dialysis has not been established.
Storage conditions
Store at temperatures up to 25 ° C.
Expiration
3 years.
Active ingredient
Metformin, Sitagliptin
Pharmacy
pharmacy terms
Dosage
form Dosage form
tablets
