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Faxibet(Dapagliflozin)

Faxibet(Dapagliflozin)

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Tablet 5- 10 mg

 

Dapagliflozin is a Sodium-glucose cotransporter 2 (SGLT2) inhibitor. Dapagliflozin reduces reabsorption of filtered glucose and increases urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.




INDICATIONS

Dapagliflozin is prescribed in adults with :

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.

• to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV).

• to reduce 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.

• dapagliflozin is not recommended for use to improve glycemic control in adults with

type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. 

•  dapagliflozin 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. dapagliflozin is not expected to be effective in these populations.

DOSAGE AND ADMINISTRATION

Recommended Dosing  The recommended starting dose of Dapagliflozin is 5 mg once daily, taken in the morning, with or without food. In patients tolerating Dapagliflozin5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Dapagliflozin is recommended.

Patients with Renal Impairment Assessment of renal function is recommended prior to initiation of Faxibet therapy and periodically thereafter. Faxibet should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2 . No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater). Faxibet should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2.

WARNINGS AND PRECAUTIONS

• Dehydration. Dapagliflozin can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking dapagliflozin. You may be at a higher risk of dehydration if you:

o  take medicines to lower your blood pressure, including water pills (diuretics)

o  are 65 years of age or older

o  are on a low salt diet

o  have kidney problems

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.

•  Vaginal yeast infection. Women who take dapagliflozin may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:

o vaginal odor

o white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)

o vaginal itching

• Yeast infection of the penis (balanitis). Men who take dapagliflozin may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

o redness, itching, or swelling of the penis

o rash of the penis

o foul smelling discharge from the penis

o pain in the skin around the penis

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

• Ketoacidosis in people with diabetes mellitus (increased ketones in your blood or urine).  Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with dapagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death.

Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking dapagliflozin and call your healthcare provider right away if you get any of the following symptoms:

o nausea

o tiredness

o vomiting

o trouble breathing

o stomach area (abdominal) pain

If you get any of these symptoms during treatment with dapagliflozin, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

• Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take dapagliflozin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take dapagliflozin. Signs and symptoms of low blood sugar may include:

o headache

o weakness

o confusion

o shaking or feeling jittery

o drowsiness

o dizziness

o irritability

o sweating

o hunger

o fast heartbeat

•  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). Necrotizing fasciitis of the perineum has happened in women and men with diabetes mellitus who take dapagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:

o pain or tenderness

o swelling

o redness of skin (erythema)

DRUG INTERACTIONS

•Positive Urine Glucose Test

Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

• Interference with 1,5-anhydroglucitol (1,5-AG) Assay

Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.