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Empagliflozin(Empagliflozin)

Empagliflozin(Empagliflozin)

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Tablet 10-25 mg

 

Empagliflozin is an inhibitor of SGLT2. Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.




INDICATIONS

Empagliflozin is indicated:

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

• To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

• Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients

• Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2

DOSAGE AND ADMINISTRATION

• Assess renal function before initiating empagliflozin and as clinically indicated.

• The recommended dose of empagliflozin is 10 mg once daily, taken in the morning, with or without food.

•Dose may be increased to 25 mg once daily.

WARNINGS AND PRECAUTIONS

Empagliflozin may cause serious side effects including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with empagliflozin. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with empagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with empagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking empagliflozin and call your doctor 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 empagliflozin, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

• Dehydration. empagliflozin can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking empagliflozin. You may be at higher risk of dehydration if you:

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

o are on low sodium (salt) diet

o have kidney problems

o are 65 years of age or older

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

• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking empagliflozin. Tell your doctor 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). If you take empagliflozin 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 empagliflozin. Signs and symptoms of low blood sugar may include:

O headache

O irritability

O confusion

O dizziness

O drowsiness

O  hunger

O shaking or feeling jittery

o sweating

o weakness

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 who take empagliflozin. 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 a 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 your anus and genitals:

O pain or tenderness

O swelling

O redness of skin (erythema)

• Vaginal yeast infection. 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). Swelling of an uncircumcised penis may develop 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 penis

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

• Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking empagliflozin. Symptoms may include:

o swelling of your face, lips, throat and other areas of your skin

o difficulty with swallowing or breathing.

o raised, red areas on your skin (hives)

If you have any of these symptoms, stop taking empagliflozin and call your doctor right away or go to the nearest hospital emergency room.

Call your healthcare provider right away if you have aforementioned symptoms.

The most common side effects

• urinary tract infections

• yeast infections in females

DRUG INTERACTIONS

• Diuretics

Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Before initiating empagliflozin, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating empagliflozin. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.

•Insulin or Insulin Secretagogues

The risk of hypoglycemia is increased when empagliflozin is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Coadministration of empagliflozin with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

•Positive Urine Glucose Test

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

•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. Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.