Faxibet plus® ER (Dapagliflozin/Metformin)

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Dapagliflozin (as propanediol monohydrate) /Metformin HCl extended-release:

2.5 mg/1000 mg, 10 mg/ 500 mg, 10 mg/1000 mg, 5 mg/500 mg, 5 mg/1000 mg

INDICATIONS

diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dapagliflozin is indicated to reduce:

the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.
the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Limitations of use:
Not for treatment of type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
Because of the metformin HCl component, the use of Faxibet Plus^®ER is limited to adults with type 2 diabetes mellitus for all indications.
Faxibet Plus^® ER is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. Faxibet Plus^® ER is not expected to be effective in these populations.

It is not known if Faxibet Plus^® ER is safe and effective in children younger than 18 years of age.

DOSAGE AND ADMINISTRATION

Individualize the starting dose based on the patient’s current treatment.
Assess renal function before initiating and periodically thereafter.
To improve glycemic control, for patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily.
For indications related to heart failure and chronic kidney disease the recommended dose of dapagliflozin is 10 mg once daily.
Do not exceed a daily dose of 10 mg dapagliflozin/2000 mg metformin HCl extended release.
Faxibet Plus^® ER may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

WARNINGS AND PRECAUTIONS

Lactic Acidosis
Dehydration.
Ketoacidosis (increased ketones in your blood or urine).
Serious urinary tract infections.
Low blood sugar (hypoglycemia).
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum).
Low vitamin B12 (vitamin B12 deficiency).
Vaginal yeast infection.
Yeast infection of the penis (balanitis or balanoposthitis).

DRUG INTERACTIONS

Carbonic Anhydrase Inhibitors: Concomitant use of these drugs (Topiramate or other carbonic anhydrase inhibitors e.g., zonisamide, acetazolamide or dichlorphenamide) with Faxibet Plus^® ER may increase the risk for lactic acidosis.
Drugs that Reduce Metformin Clearance :Concomitant use of these drugs (ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.
Alcohol: Alcohol is known to potentiate the effect of metformin on lactate metabolism.
Drugs Affecting Glycemic Control: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These medications include thiazides and other diuretics, insulin and insulin secretagogues, such as sulphonylureas, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.
Positive Urine Glucose Test: SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay :Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.

Brochure

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	Faxibet plus En.pdf	6.82 MB