MONTECET
Montelukast Sodium is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Levocetirizine HCL, is an orally active H1-receptor antagonist.
ZITAMET
Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.
Label
Formulation and Dosage
Indication
Distribution
Label
50 mg / 500 mg Film-Coated Tablet
Combination of Oral Blood Glucose Lowering Drugs
Formulation and Dosage
FORMULATION:
Each film-coated tablet contains:
Sitagliptin (as phosphate monohydrate) …………………………………. 50mg
Metformin Hydrochloride …………………………………………………….. 500mg
DOSAGE AND ADMINISTRATION:
- Take Sitagliptin & Metformin HCI Film Coated Tablets orally twice daily with meals.
- Individualize the dosage if Sitagliptin & Metformin HCI Film Coated Tablets on the basis of the patient’s current regimen, effectiveness, and tolerability.
- The Maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin HCI.
- The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCI twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
- The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) abd the dose of metformin already being taken. For patients taking metformin HCI 850 mg twice daily, the recommended starting dose of SITAGLIPTIN AND METFORMIN HCL FILM COATED TABLETS is 50 mg Sitagliptin and 1 g metformin HCI twice daily.
- Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.2)
- Do not use in patients with eGFR below 30 ml/min/1.73 m2.
- Sitagliptin & Metformin HCI is not recommended in patients with eGFR between 30 and less than 45ml/min/1.733 m2.
- Sitagliptin and Metformin HCI may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.
Indication
For adult patients with type 2 diabetes mellitus:
Sitagliptin and Metformin HCI film coated tablets is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Distribution
FDA Registration Number: DRP-11848-03
Manufacturer: FREDUN PHARMACEUTICALS LIMITED
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