JANUMET XR TABLET 50MG/1000MG

MSD International GmbH (Puerto Rico Branch) LLC (UNITED STATES)AIAC International Pharma, LLC (UNITED STATES)Laurus Labs Limited, Unit-2 (Metformin Granules) (INDIA)Patheon Inc. (CANADA)🇸🇬 Health Sciences Authority

Approval Date: Dec 22, 2014
Approval ID: 1181b0e39ab7ba35
Company: MSD International GmbH (Puerto Rico Branch) LLC (UNITED STATES)AIAC International Pharma, LLC (UNITED STATES)Laurus Labs Limited, Unit-2 (Metformin Granules) (INDIA)Patheon Inc. (CANADA)
Type: Therapeutic

Approval Details

Approval Id: 1181b0e39ab7ba35
Drug Name: JANUMET XR TABLET 50MG/1000MG
Product Name: JANUMET XR TABLET 50MG/1000MG
Approval Number: SIN14703P
Approval Date: 2014-12-22
Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
Licence Holder: MSD PHARMA (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Dosage: III. DOSAGE AND ADMINISTRATION General: The dosage of antihyperglycemic therapy with JANUMET XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. JANUMET XR should be given once daily with a meal preferably in the evening. The dose should be escalated gradually to reduce the gastrointestinal (GI) side effects due to metformin. Additionally, administration of JANUMET XR with food enhances plasma concentrations of metformin. To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing. There have been reports of incompletely dissolved JANUMET XR tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. Dosing Recommendations: The starting dose of JANUMET XR should be based on the patient’s current regimen. In patients already treated with metformin, the starting dose of JANUMET XR should include the equivalent daily dose of metformin while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. JANUMET XR should be given once daily with a meal preferably in the evening. JANUMET XR tablets are available in the following strengths: <ul class="nobull"> <li>50 mg sitagliptin/500 mg extended-release metformin hydrochloride</li> <li>50 mg sitagliptin/1000 mg extended-release metformin hydrochloride</li> <li>100 mg sitagliptin/1000 mg extended-release metformin hydrochloride</li> </ul> For patients using the 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablet or the 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet, two tablets should be taken together once daily. The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients inadequately controlled with diet and exercise alone: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with diet and exercise alone, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. Patients with inadequate glycemic control on this dose can be titrated gradually to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily metformin dose of 2000 mg. For patients inadequately controlled on metformin monotherapy: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on metformin alone, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and the previously prescribed dose of metformin. For patients inadequately controlled on sitagliptin monotherapy: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on sitagliptin alone, the recommended starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. The metformin dose can be titrated as needed to achieve glycemic control. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to JANUMET XR (see CONTRAINDICATIONS). For patients switching from coadministration of sitagliptin and metformin: For patients switching from coadministration of sitagliptin and metformin, JANUMET XR may be initiated at the previously prescribed dose of sitagliptin and metformin. For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate in this setting, the usual starting dose of JANUMET XR should provide 100 mg total daily dose of sitagliptin. In determining the starting dose of the metformin component, the patient’s level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For patients inadequately controlled on dual combination therapy with insulin and metformin: The usual starting dose of JANUMET XR should provide 100 mg total daily dose of sitagliptin. In determining the starting dose of the metformin component, the patient’s level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No studies have been performed specifically examining the safety and efficacy of JANUMET XR in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. Recommendations for use in renal impairment: Assess renal function prior to initiation of JANUMET XR and periodically thereafter. JANUMET XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. Discontinue JANUMET XR if the patient’s eGFR later falls below 30 mL/min/1.73 m2 (see CONTRAINDICATIONS and PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Initiation of JANUMET XR in patients with an eGFR ≥ 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2 is not recommended. In patients taking JANUMET XR whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once day. Discontinuation for iodinated contrast imaging procedures: Discontinue JANUMET XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR ≥ 30 to < 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 JANUMET XR if renal function is acceptable (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: II. INDICATIONS JANUMET XR is indicated as initial therapy in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise do not provide adequate glycemic control. JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. JANUMET XR is also indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents: metformin, sitagliptin, or a sulfonylurea. JANUMET XR is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when insulin and metformin alone do not provide adequate glycemic control. Important Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: V. CONTRAINDICATIONS JANUMET XR (sitagliptin phosphate/metformin HCl extended-release) are contraindicated in patients with: <ol> <li>Severe renal impairment (eGFR < 30 mL/min/1.73 m2) (see PRECAUTIONS, Metformin hydrochloride, Lactic Acidosis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Known hypersensitivity to sitagliptin phosphate, metformin hydrochloride or any other component of JANUMET XR (see PRECAUTIONS, Sitagliptin phosphate, Hypersensitivity Reactions and SIDE EFFECTS, Postmarketing Experience – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.</li> </ol> JANUMET XR should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see PRECAUTIONS; Metformin hydrochloride – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: A10BD07
Atc Item Name: metformin and sitagliptin
Pharma Manufacturer Name: MSD PHARMA (SINGAPORE) PTE. LTD.

Active Ingredients

Metformin 780mg eqv to metformin hydrochloride

1000mg

Sitagliptin Phosphate 64.25mg eqv to Sitagliptin

50 mg

METFORMIN 780 MG EQV TO METFORMIN HYDROCHLORIDE

1,000 MG

SITAGLIPTIN PHOSPHATE 64.25 MG EQV TO SITAGLIPTIN

50 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 22, 2014

Approval ID

1181b0e39ab7ba35

Type

Therapeutic

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