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 PLUS
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
STORAGE CONDITIONS:
Store at temperatures not exceeding 30°C
Formulation and Dosage
FORMULATION:
Each film-coated tablet contains:
Sitagliptin (as phosphate monohydrate)………………………….50mg
Metformin Hydrochloride ……………………………………………..1g
DOSAGE AND ADMINISTRATION:
- Take SITAGLIPTIN and METFORMIN HCI orally twice daily with meals.
- Individualize the dosage of SITAGLIPTIN and METFORMIN HCI on the basis of 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) and the dose if metformin already being taken. For patients taking metformin HCI 850 mg twice daily, the recommended starting dose of SITAGLIPTIN AND METFORMIN HCI 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 And Metformin HCI is not recommended in patients with eGFR between 30 and less than 45 ml / min / 1.73 m2.
- SITAGLIPTIN AND METFORMIN HCI FILM COATED TABLETS may need to be discontinued at time of, or prior to, iondinated contrast imaging procedures.
Indication
INDICATIONS:
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.
Sitagliptin and metformin HCI film coated tablets is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARy agonist.
Zitamet is also indicated as add-on to insulin (i.e triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
CONTRAINDICATIONS:
- Severe renal impairment: (eGFR, below 30 ml/min/1.7m)
- Metabolic acidosis, including diabetic ketoacidosis.
- History of a serious hypersensitivity reaction to sitagliptin, or metformin, such as anaphylaxis or angioedema.
Distribution
FDA Registration Number: DRP-11847-03
Manufacturer: FREDUN PHARMACEUTICALS LIMITED
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