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Examiné médicalement par Fedorchenko Olga Valeryevna, Pharmacie Dernière mise à jour le 29.04.2022
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Linagliptin/Metformin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin/Metformin is appropriate, in patients inadequately controlled on metformin alone or those already being treated and well controlled with the free combination of Linagliptin/Metformin.
Linagliptin/Metformin is 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 sulphonylurea.
Linagliptin/Metformin is indicated as add-on to insulin (ie, triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.
Limitation of Use: Linagliptin/Metformin must not be used in patients with type 1 diabetes or ketoacidosis due to no clinical effects.
Clinical experience of the use of Linagliptin/Metformin in patients with pancreatitis history is limited. There is no information if patients-risk from pancretitis will be increased by the drug. Therefore, Linagliptin/Metformin should be used in these patients only when necessary and pancreatitis monitoring is required.
Linagliptin/Metformin combination is used to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.
Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of Linagliptin/Metformin combination you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.
Linagliptin/Metformin combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections.
Linagliptin/Metformin is available only with your doctor's prescription.
Recommended Dosing
The dosage of Linagliptin/Metformin should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin/Metformin 5 mg and metformin hydrochloride 2000 mg. Linagliptin/Metformin should be given once daily with a meal. For available dosage forms and strengths see [Dosage Forms and Strengths (3)].
Recommended starting dose:
- In patients currently not treated with metformin, initiate Linagliptin/Metformin treatment with 5 mg Linagliptin/Metformin/1000 mg metformin hydrochloride extended-release once daily with a meal.
- In patients already treated with metformin, start Linagliptin/Metformin with 5 mg of Linagliptin/Metformin total daily dose and a similar total daily dose of metformin once daily with a meal.
- In patients already treated with Linagliptin/Metformin or Linagliptin/Metformin, switch to Linagliptin/Metformin containing 5 mg of Linagliptin/Metformin total daily dose and a similar total daily dose of metformin once daily with a meal.
Linagliptin/Metformin should be swallowed whole. The tablets must not be split, crushed, dissolved, or chewed before swallowing. There have been reports of incompletely dissolved tablets being eliminated in the feces for other tablets containing metformin extended-release. If a patient reports seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
Linagliptin/Metformin 5 mg Linagliptin/Metformin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin/Metformin/1000 mg metformin extended-release tablets should take two tablets together once daily.
No studies have been performed specifically examining the safety and efficacy of Linagliptin/Metformin in patients previously treated with other oral antihyperglycemic agents and switched to Linagliptin/Metformin. Any change in therapy of type 2 diabetes mellitus should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Recommended Dosing in Renal Impairment
Assess renal function prior to initiation of Linagliptin/Metformin and periodically thereafter.
Linagliptin/Metformin is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.
Initiation of Linagliptin/Metformin in patients with an eGFR between 30-45 mL/min/1.73 m2 is not recommended.
In patients taking Linagliptin/Metformin whose eGFR later falls below 45 mL/min/1.73 m2, assess benefit risk of continuing therapy.
Discontinue Linagliptin/Metformin if the patient’s eGFR later falls below 30 mL/min/1.73 m2.
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue Linagliptin/Metformin at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Linagliptin/Metformin if renal function is stable.
Voir aussi:
Quelles sont les informations les plus importantes que je devrais connaître sur la linagliptine / metformine?
La linagliptine / metformine est contre-indiquée chez les patients atteints de:
- Insuffisance rénale (par ex., créatinine sérique ≥1,5 mg / dL pour les hommes, ≥1,4 mg / dL pour les femmes ou clairance anormale de la créatinine), qui peut également résulter de conditions telles que l'effondrement cardiovasculaire (choc), l'infarctus aigu du myocarde et la septicémie
- Acidose métabolique aiguë ou chronique, y compris l'acidocétose diabétique. L'acidocétose diabétique doit être traitée avec de l'insuline
- Antécédents de réaction d'hypersensibilité à la linagliptine / metformine, tels que anaphylaxie, œdème de Quincke, affections cutanées exfoliatives, urticaire ou hyperréactivité bronchique
- Hypersensibilité à la metformine
Utilisez de la linagliptine / metformine selon les directives de votre médecin. Vérifiez l'étiquette sur le médicament pour obtenir des instructions de dosage exactes.
- La linagliptine / metformine est livrée avec une fiche d'information supplémentaire pour le patient appelée guide de médication. Lisez-le attentivement. Relisez-le à chaque fois que vous faites recharger Linagliptin / Metformin.
- Prenez de la linagliptine / metformine par voie orale avec les repas selon les directives de votre médecin.
- Prenez de la linagliptine / metformine selon un calendrier régulier pour en tirer le meilleur parti.
- Continuez à prendre Linagliptin / Metformin même si vous vous sentez bien. Ne manquez aucune dose.
- Si vous manquez une dose de linagliptine / metformine, prenez-la dès que possible. S'il est presque temps pour votre prochaine dose, sautez la dose oubliée et revenez à votre schéma posologique habituel. Ne prenez pas 2 doses à la fois.
Posez à votre fournisseur de soins de santé toutes vos questions sur la façon d'utiliser la linagliptine / metformine.
Il existe des utilisations spécifiques et générales d'un médicament ou d'un médicament. Un médicament peut être utilisé pour prévenir une maladie, traiter une maladie sur une période ou guérir une maladie. Il peut également être utilisé pour traiter le symptôme particulier de la maladie. La consommation de drogues dépend de la forme que prend le patient. Il peut être plus utile sous forme d'injection ou parfois sous forme de comprimés. Le médicament peut être utilisé pour un seul symptôme troublant ou une affection mortelle. Bien que certains médicaments puissent être arrêtés après quelques jours, certains médicaments doivent être poursuivis pendant une période prolongée pour en bénéficier.Utilisation: Indications étiquetées
Diabète sucré de type 2 : En complément du régime alimentaire et de l'exercice pour améliorer le contrôle glycémique chez les adultes atteints de diabète sucré de type 2 lorsque le traitement par la linagliptine / metformine est approprié.
See also:
What other drugs will affect Linagliptin/Metformin?
Drug Interactions With Metformin
Carbonic Anhydrase Inhibitors
Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with Linagliptin/Metformin, may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients.
Drugs That Reduce Metformin Clearance
Drugs that are eliminated by renal tubular secretion (e.g., cationic drugs such as cimetidine) have the potential for interaction with metformin by competing for common renal tubular transport systems, and may increase the accumulation of metformin and the risk for lactic acidosis. Consider more frequent monitoring of these patients.
Alcohol
Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving Linagliptin/Metformin.
Drug Interactions With Linagliptin/Metformin
Inducers Of P-glycoprotein And CYP3A4 Enzymes
Rifampin decreased Linagliptin/Metformin exposure, suggesting that the efficacy of Linagliptin/Metformin may be reduced when administered in combination with a strong P-gp inducer or CYP 3A4 inducer. As Linagliptin/Metformin is a fixed-dose combination of Linagliptin/Metformin, use of alternative treatments (not containing Linagliptin/Metformin) is strongly recommended when concomitant treatment with a strong P-gp or CYP 3A4 inducer is necessary.
Insulin Secretagogues Or Insulin
Coadministration of Linagliptin/Metformin with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Drugs Affecting Glycemic Control
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Linagliptin/Metformin, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Linagliptin/Metformin, the patient should be observed closely for hypoglycemia.
See also:
What are the possible side effects of Linagliptin/Metformin?
Summary of the Safety Profile: Fixed Dose Combination: The most frequently reported adverse reaction for Linagliptin/Metformin plus metformin was diarrhoea (0.9%) with a comparable rate on metformin plus placebo (1.2%).
Hypoglycaemia may occur when Linagliptin/Metformin is administered together with sulphonylurea (≥1 case per 10 patients).
The safety of Linagliptin/Metformin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 3500 patients with type 2 diabetes mellitus. In placebo-controlled studies, more than 1300 patients were treated with the therapeutic dose of either 2.5 mg Linagliptin/Metformin twice daily (or its bioequivalent of 5 mg Linagliptin/Metformin once daily) in combination with metformin for ≥12/24 weeks.
In the pooled analysis of the four placebo-controlled trials, the overall incidence of adverse reactions in patients treated with placebo and metformin was comparable to that seen with Linagliptin/Metformin 2.5 mg and metformin (50.6 and 47.8%). Discontinuation of therapy due to adverse reactions was comparable in patients who received placebo and metformin to patients treated with Linagliptin/Metformin (2.6% and 2.3%).
Adverse Reactions Reported When Linagliptin/Metformin were Combined with Sulphonylurea: In one study Linagliptin/Metformin was given as add-on to metformin plus sulphonylurea. When Linagliptin/Metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse reaction (Linagliptin/Metformin plus metformin plus sulphonylurea 22.9% versus 14.8% in placebo plus metformin plus sulphonylurea).
Adverse Reactions Reported When Linagliptin/Metformin were Combined with Insulin: When Linagliptin/Metformin were administrated in combination with insulin, hypoglycaemia was the most frequently reported adverse reactions, but occurred at comparable rate when placebo and metformin were combined with insulin (Linagliptin/Metformin plus metformin plus insulin 29.5% versus 30.9% in the placebo plus metformin plus insulin group) with a low rate of severe episodes (1.5% versus 0.9%).
Tabulated List of Adverse Reactions: Adverse Reactions Reported with the Fixed Dose Combination: Adverse reactions reported in all clinical trials with Linagliptin/Metformin are shown as follows according to system organ class. Adverse reactions known to occur with each active substance given singly, but which have not been seen in clinical trials with Linagliptin/Metformin, may occur during treatment with this medicinal product.
The adverse reactions are listed by system organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000) and not known (cannot be estimated from the available data)..
Adverse Reactions Reported When Linagliptin/Metformin were Combined with Sulphonylurea: When Linagliptin/Metformin were administered in combination with a sulphonylurea, hypoglycaemia was identified as an additional adverse reaction under these conditions..
None of the hypoglycaemias was classified as severe.
Adverse Reactions Reported When Linagliptin/Metformin were Combined with Insulin: When Linagliptin/Metformin were administered in combination with insulin, constipation was identified as an additional adverse reaction under these conditions. The combination of Linagliptin/Metformin when administered in combination with insulin may be associated with an increased risk of hepatic events..
Additional Information on Individual Components: Adverse reactions previously reported with one of the individual active substances may be potential adverse reactions with Linagliptin/Metformin, even if not observed in clinical trials with this medicinal product.
Linagliptin/Metformin: All identified adverse reactions of Linagliptin/Metformin monotherapy are also described for Linagliptin/Metformin in Table 2.Metformin: Known adverse reactions for metformin, that were not reported in patients who received Linagliptin/Metformin are listed in Table 5..
Description of Selected Adverse Reactions: Gastrointestinal disorders such as, nausea, vomiting, diarrhoea and decreased appetite (Table 2) and abdominal pain (Table 5) occur most frequently during initiation of therapy with Linagliptin/Metformin or metformin hydrochloride and resolve spontaneously in most cases. For prevention, it is recommended that Linagliptin/Metformin be taken in 2 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption (Table 5) which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Chaque comprimé contient 2,5 mg de linagliptine / metformine et 500 mg, 850 mg ou 1000 mg de chlorhydrate de metformine.
Excipients / Ingrédients inactifs: Noyau de la tablette: Arginine, copovidone, stéarate de magnésium, amidon de maïs, silice, colloïdale anhydre.
Revêtement de film: Hypromellose, dioxyde de titane (E171), talc, propylène glycol.
Linagliptine / Métformine 2,5 mg / 500 mg: oxyde de fer, jaune (E172).
Linagliptine / Métformine 2,5 mg / 850 mg: oxyde de fer, jaune (E172), oxyde de fer, rouge (E172).
Linagliptine / Métformine 2,5 mg / 1000 mg: oxyde de fer, rouge (E172).