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In 1 tablet of a linagliptin of 5 mg.
Mannitolum, starch corn, magnesium stearate, kopovidon — as excipients.
Tablets in a film cover of 5 mg 30 pieces.
Pharmacodynamics and pharmacokinetics
The glucose-lowering drug intended for intake. Is inhibitor of the DPP-4 enzyme inactivating hormones of an inkretina of GPP-1 and GIP which participate in regulation of carbohydrate metabolism: increase insulin secretion, reduce glycemia level, suppress products of a glucagon. Effect of these hormones short as they are split by enzyme. Linagliptin reversibly contacts DPP-4 that attracts long preservation of activity of inkretin and increase of their levels. Its use at a diabetes mellitus of the II type leads to decrease in glikozilirovanny hemoglobin, glucose level in blood on an empty stomach and after food loading in 2 hours.
At its reception with Metforminum improvement of glycemic parameters is observed, at the same time body weight does not change. The combination to derivatives of a sulfonilmochevina leads to reliable decrease in level of glikozilirovanny hemoglobin.
Treatment linagliptiny does not increase cardiovascular risk (a myocardial infarction, cardiovascular death).
At intake it is quickly soaked up and Cmax is defined by 1,5 h. Concentration dvukhfazno decreases. Meal does not affect pharmacokinetics. Bioavailability makes 30%. Only the insignificant part of drug is metabolized. About 5% are excreted with urine, other part (about 85%) — through intestines. At any degree of a renal failure there is no need for dosing change. Also change of a dose at a liver failure of any degree is not required. Researches of pharmacokinetics at children it was not studied.
Indications to use
- as monotherapy at intolerance of Metforminum or in the presence of contraindications to its use (renal failure);
- as two-component treatment with sulfonilmochevina derivatives, Metforminum or Thiazlolidinedithis, monotherapies by these drugs it is not effective;
- as ternary therapy with Metforminum and derivatives of a sulfonilmochevina;
- as two-component therapy with Insulin;
- as multicomponent therapy with Insulin + Pioglitazon or Metforminum or derivatives of a sulfonilmochevina.
- diabetes mellitus of the I type;
- age till 18 flyings;
- feeding by a breast;
If drug is used in the form of monotherapy, it seldom causes:
In case of a combination therapy the hypoglycemia is often noted. Seldom — a lock, pancreatitis, cough. Very seldom — a Quincke's disease, a nasopharyngitis, the small tortoiseshell, increase in body weight, a gipertriglitseridemiya, a lipidemia.
Trazhenta, application instruction (Way and dosage)
About 5 mg of 1 times a day are applied inside. Drug can be accepted at any time.
As it was told earlier, dose adjustment is not carried out at an abnormal liver function, kidneys and at elderly people.
It is forbidden to accept a double dose in case of the admission of one reception.
Cases of overdose are not described. Even administration of drug in a dose of 600 mg during conduct of clinical trials was transferred well and did not cause by-effects.
In case of possible overdose it is necessary to take usual measures: removal of not absorbed drug (a gastric lavage, intestines, reception of sorbents), purpose of symptomatic therapy.
Simultaneous use of Metforminum, even in a dose above therapeutic, did not lead to significant changes of pharmacokinetics of both drugs.
Combined use with Pioglitazon does not exert significant impact on pharmacokinetic indicators of both drugs.
The pharmacokinetics of this drug does not change at use with Glibenclamidum, but clinically insignificant decrease in Cmax of Glibenclamidum by 14% was noted. Also clinically significant interactions with other derivatives of a sulfonilmochevina are not expected.
Co-administration of Ritonavir increases Cmax values of a linagliptin by 3 times that is not significant and does not demand change of a dose.
Combined use of Rifampicin leads to decrease in Cmax of a linagliptin therefore its clinical performance remains, but is shown not fully.
Simultaneous use of Digoxin does not exert impact on its pharmacokinetics.
Linagliptin, does not change Warfarin pharmacokinetics.
This drug exerts insignificant impact on Simvastatin's pharmacokinetics, however in change of a dose it there is no need.
Linagliptin does not change pharmacokinetics of peroral contraceptive drugs.
Terms of sale
It is released according to the recipe.
Temperature of storage is up to 25 °C.
Period of validity
The drug having the same active ingredient — Linagliptin.
Drugs from the same group Saksagliptin, Alogliptin, Sitagliptin, Vildagliptin have similar effect.
DPP-4 inhibitors to which Trazhent's drug belongs possess not only the expressed sakharosnizhayushchy action, but also high level of safety as do not cause hypoglycemic conditions and increase in weight. Now this group of drugs are considered the most perspective at treatment of SD II of type.
High performance in various schemes of treatment is confirmed with many international researches. It is more preferable to appoint them in an initiation of treatment of SD II of type or in a combination with other drugs. Them often appoint instead of sulfonilmochevina derivatives at patients, inclined to hypoglycemic states.
Is that drug in the form of monotherapy was appointed at an insulinorezistentnost and the increased weight. After a 3-month course considerable weight reduction was noted. The majority of responses from patients who received this drug as a part of complex therapy. In this connection, it is difficult to estimate efficiency and safety of sakharosnizhayushchy therapy as influence of other drugs is possible. All note positive influence on weight — decrease is noted it that is very important at a diabetes mellitus.
Drug was appointed to patients of different age including elderly, and in the presence of pathology of a liver, kidneys and diseases of cordial vascular system. The most frequent undesirable effect of drug — a nasopharyngitis. Consumers note the high price of drug that limits its reception, especially pensioners.
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