Janumet Long, 1000 mg+100 mg 28 pcs
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A remedy to improve the metabolism and energy supply of tissues. ATP is a natural component of body tissues – it participates in many metabolic processes.
Indications
- As starter therapy in patients with type 2 diabetes to improve glycemic control when diet and exercise regimen does not achieve adequate glycemic control;
- As an adjunct to diet and exercise regimen to improve glycemic control in patients with type 2 diabetes who have not achieved adequate glycemic control on monotherapy.As adjunct to diet and exercise regimen to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control with metformin or sitagliptin monotherapy, or in patients already taking a combination of sitagliptin and metformin monotherapy;
- In combination with sulfonylurea derivatives (triple combination therapy: metformin + sitagliptin + sulfonylurea derivative) as an adjunct to diet and exercise regimen in patients with type 2 diabetes who have not achieved adequate glycemic control on therapy with any two of the above three drugs – metformin, sitagliptin, or sulfonylurea derivative;
- CombinationIn combination with PPAR-γ agonists (thiazolidinedione) as an adjunct to diet and exercise regimen in patients with type 2 diabetes who have not achieved adequate glycemic control on therapy with any two of the indicated three drugs – metformin, sitagliptin or PPAR-γ agonist;
- In combination with insulin as an adjunct to diet and exercise regimen in patients with type 2 diabetes to improve glycemic control.
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Active ingredient
Metformin, Sitagliptin
Composition
1 tablet contains:
Sitagliptin phosphate 128.50 mg, which corresponds to a sitagliptin content of 100 mg;
Metformin 1000 mg.
Directions for use
Orally, once daily with a meal, preferably in the evening.
The dosing regimen of Janumet® Long should be adjusted individually based on current therapy, efficacy and tolerability, but without exceeding the maximum recommended daily dose of metformin 2000 mg and sitagliptin 100 mg.
The dose of the drug should be increased gradually to reduce adverse gastrointestinal reactions due to metformin. In addition, taking the drug Janumet® Long with food contributes to the increase in plasma concentration of metformin. To ensure prolonged release of metformin, the tablet should not be divided, broken, crushed or chewed before swallowing. There have been reports of finding incompletely dissolved tablets in feces. It is not known whether the material contained active ingredients. The patient should be warned to inform the treating physician if the tablets are repeatedly found in the stool. If such reports are received, the attending physician should evaluate the adequacy of the patient’s glycemic control.
Special Instructions
Influence on the ability to drive vehicles and complex mechanisms
Contraindications
- Knowledgeable hypersensitivity to sitagliptin, metformin, or any of the components of Janumet® Long
- Knowledgeable hypersensitivity to sitagliptin, metformin, or any of the components of Janumet® Long
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma);
- Clinically manifest acute and chronic diseases that may lead to the development of tissue hypoxia, such as cardiac or respiratory failure; acute myocardial infarction;
- Hepatic failure, liver dysfunction;
- Chronic alcoholism, acute alcohol poisoning;
- Diabetes mellitus type 1;
- Pregnancy;
- Breastfeeding period;
- Age under 18 years of age (due to insufficient data on efficacy and safety).
.Renal disease or decreased renal function (with serum creatinine concentrations ≥1.5 mg/dL (in men) and ≥1.4 mg/dL (in women) or decreased Cl creatinine (< 60 ml/min), incl.ч. acute conditions with risk of renal dysfunction, such as dehydration (vomiting, diarrhea), fever, severe infectious diseases; hypoxic conditions (shock, sepsis, renal infections, bronchopulmonary disease); use less than 48 hours before and within 48 hours after radiological studies with intravascular administration of iodine-containing contrast agents;
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Overdose
Csymptoms: caused by metformin – hypoglycemia (approximately 10% of all cases), lactate acidosis (approximately 32% of all cases). A single dose of sitagliptin up to 800 mg in healthy subjects was generally well tolerated. There may be a minimal increase in the QTc interval, which is not considered clinically significant.
Weight | 0.101 kg |
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Conditions of storage | In a dry place out of the reach of children, at a temperature no higher than +25 ° C. |
Manufacturer | MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico |
Medication form | sustained release tablets |
Brand | MSD International GmbH (Puerto Rico Branch) LLC |
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