Empavic 10 mg Tablet
Empavic 10 mg Tablet Uses, Dosage, Side Effects, Food Interaction and all others data.
Empavic 10 mg Tablet is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.
Empavic 10 mg Tablet lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine. It has a relatively long duration of action requiring only once-daily dosing. Patients should be monitored closely for signs and symptoms of ketoacidosis regardless of blood glucose level as empagliflozin may precipitate diabetic ketoacidosis in the absence of hyperglycemia. As its mechanism of action is contingent on the renal excretion of glucose, empagliflozin may be held in cases of acute kidney injury and/or discontinued in patients who develop chronic renal disease.
The overexcretion of glucose creates a sugar-rich urogenital environment which increases the risk of urogenital infections - including urosepsis, pyelonephritis, mycotic infections, and even Fournier's gangrene - in both male and female patients - monitor closely for signs and symptoms of developing infection.
| Trade Name | Empavic 10 mg Tablet |
| Availability | Prescription only |
| Generic | Empagliflozin |
| Empagliflozin Other Names | Empagliflozin, Empagliflozina, Empagliflozine, Empagliflozinum |
| Related Drugs | Farxiga, Praluent, Repatha, metformin, Xarelto, simvastatin, Brilinta, Ozempic, Trulicity, Jardiance |
| Weight | 10 mg |
| Type | Tablet |
| Formula | C23H27ClO7 |
| Weight | Average: 450.91 Monoisotopic: 450.1445309 |
| Protein binding | Empagliflozin is approximately 86.2% protein-bound in plasma. |
| Groups | Approved |
| Therapeutic Class | Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors |
| Manufacturer | Biopharma Laboratories Ltd. |
| Available Country | Bangladesh |
| Last Updated: | September 24, 2024 at 5:38 am |
Uses
Empavic 10 mg Tablet is used for:
- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and
- To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease
Empavic 10 mg Tablet is also used to associated treatment for these conditions: Cardiovascular Mortality, Type 2 Diabetes Mellitus
How Empavic 10 mg Tablet works
The vast majority of glucose filtered through the glomerulus is reabsorbed within the proximal tubule, primarily via SGLT2 (sodium-glucose linked co-transporter-2) which is responsible for ~90% of the total glucose reabsorption within the kidneys. Na+/K+-ATPase on the basolateral membrane of proximal tubular cells utilize ATP to actively pump Na+ ions into the interstitium surrounding the tubule, establishing a Na+ gradient within the tubular cell. SGLT2 on the apical membrane of these cells then utilize this gradient to facilitate secondary active co-transport of both Na+ and glucose out of the filtrate, thereby reabsorbing glucose back into the blood – inhibiting this co-transport, then, allows for a marked increase in glucosuria and decrease in blood glucose levels. Empavic 10 mg Tablet is a potent inhibitor of renal SGLT2 transporters located in the proximal tubules of the kidneys and works to lower blood glucose levels via an increase in glucosuria.
Empavic 10 mg Tablet also appears to exert cardiovascular benefits - specifically in the prevention of heart failure - independent of its blood glucose-lowering effects, though the exact mechanism of this benefit is not precisely understood. Several theories have been posited, including the potential inhibition of Na+
Dosage
Empavic 10 mg Tablet dosage
The recommended dose of Empavic 10 mg Tablet is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empavic 10 mg Tablet, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empavic 10 mg Tablet is recommended.
Side Effects
The most common adverse reactions associated with Empavic 10 mg Tablet are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.
Toxicity
Experience with empagliflozin overdose is limited - employ standard symptomatic and supportive measures, as well as gastric decontamination when appropriate. The use of hemodialysis in empagliflozin overdose has not been studied but is unlikely to be of benefit given the drug's relatively high protein-binding.
Precaution
Assessment of renal function is recommended prior to initiation of Empavic 10 mg Tablet and periodically thereafter. Empavic 10 mg Tablet should not initiated in patients with an eGFR less than 45 ml/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m2.
Interaction
Diuretics: Co-administration of Empavic 10 mg Tablet with diuretics resulted in increased urine volume.
Insulin or Insulin Secretagogues: Co-administration of Empavic 10 mg Tablet with insulin or insulin secretagogues increases the risk for hypoglycemia.
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.
Food Interaction
- Take with or without food. Co-administration with food slightly alters pharmacokinetics, but not to a clinically significant extent.
[Moderate] GENERALLY AVOID: Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes.
Hypoglycemia most frequently occurs during acute consumption of alcohol.
Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise.
The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia.
Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion.
By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia.
Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes.
A disulfiram-like reaction (e.g., flushing, headache, and nausea) to alcohol has been reported frequently with the use of chlorpropamide and very rarely with other sulfonylureas.
MANAGEMENT: Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis.
Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan.
Alcohol should not be consumed on an empty stomach or following exercise.
Empavic 10 mg Tablet Drug Interaction
Moderate: insulin glargine, insulin glargine, metoprolol, metoprolol, insulin aspart, insulin aspart, sildenafilUnknown: aspirin, aspirin, apixaban, omega-3 polyunsaturated fatty acids, sitagliptin, pregabalin, semaglutide, acetaminophen, dulaglutide, liraglutide, cyanocobalamin, ascorbic acid, cholecalciferol
Empavic 10 mg Tablet Disease Interaction
Volume of Distribution
The estimated apparent steady-state volume of distribution is 73.8 L.
Elimination Route
Following oral administration, peak plasma concentrations are reached in approximately 1.5 hours (Tmax). At steady-state, plasma AUC and Cmax were 1870 nmol·h/L and 259 nmol/L, respectively, following therapy with empagliflozin 10mg daily and 4740 nmol·h/L and 687 nmol/L, respectively, following therapy with empagliflozin 25mg daily. Administration with food does not significantly affect the absorption of empagliflozin.
Half Life
The apparent terminal elimination half-life was found to be 12.4 h based on population pharmacokinetic analysis.
Clearance
Apparent oral clearance was found to be 10.6 L/h based on a population pharmacokinetic analysis.
Elimination Route
After oral administration of radiolabeled empagliflozin approximately 41.2% of the administered dose was found eliminated in feces and 54.4% eliminated in urine. The majority of radioactivity in the feces was due to unchanged parent drug while approximately half of the radioactivity in urine was due to unchanged parent drug.
Pregnancy & Breastfeeding use
There are no adequate and well-controlled studies of Empavic 10 mg Tablet in pregnant women. Empavic 10 mg Tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empavic 10 mg Tablet is excreted in human milk. It is not recommended when breastfeeding.
Contraindication
Empavic 10 mg Tablet is contraindicated in patients with history of serious hypersensitivity reaction to Empavic 10 mg Tablet or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.
Storage Condition
Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.
Innovators Monograph
You find simplified version here Empavic 10 mg Tablet
Empavic 10 mg Tablet contains Empagliflozin see full prescribing information from innovator Empavic 10 mg Tablet Monograph, Empavic 10 mg Tablet MSDS, Empavic 10 mg Tablet FDA label
FAQ
What are the side effects of Empavic 10 mg Tablet?
Common side effects of Empavic 10 mg Tablet include:
- dehydration,
- dizziness,
- lightheadedness,
- weakness,
- yeast infection,
- low blood sugar,
- nausea,
- upper respiratory tract infection,
- high cholesterol,
- joint pain,
- increased urination,
- urinary tract infection,
- thirst, and
- low blood pressure (hypotension).
What is the Dosage for Empavic 10 mg Tablet?
The recommended dosage of Empavic 10 mg Tablet is 10 mg once daily in the morning, taken with or without food.
What Drugs, Substances, or Supplements Interact with Empavic 10 mg Tablet?
Empavic 10 mg Tablet may interact with diuretics, insulin or insulin secretagogues. Tell your doctor all medications and supplements you use.
Can Empavic 10 mg Tablet safe during Pregnancy?
During pregnancy, Empavic 10 mg Tablet should be taken only if prescribed.
Can Empavic 10 mg Tablet safe during Breastfeeding?
It is unknown if Empavic 10 mg Tablet passes into breast milk. Consult your doctor before breastfeeding.
What is the drug Empavic 10 mg Tablet used for?
Empavic 10 mg Tablet is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in people with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).
What are the benefits of Empavic 10 mg Tablet?
By removing excessive glucose from the body through urine, Jardiance helps to improve glycemic control among patients with type 2 diabetes. This can result in improved HbA1c levels, which can reduce the risk of diabetes-related complications.
Is Empavic 10 mg Tablet safe?
The evidence for Empavic 10 mg Tablet is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD.
Is Empavic 10 mg Tablet bad for kidneys?
Empavic 10 mg Tablet is a diabetes medication that may protect the kidneys in patients with diabetes but has also been reported in rare cases to cause kidney failure. Importantly, Empavic 10 mg Tablet has diuretic effects and interacts with other nephrotoxic drugs (drugs on this list), raising the risk for toxic kidney effects.
Is Empavic 10 mg Tablet better than metformin?
Empavic 10 mg Tablet (Empagliflozin) works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better.
How long does Empavic 10 mg Tablet take to work?
The beneficial effect on your blood sugar levels may begin quickly, within the first 1 to 2 weeks. However, Empavic 10 mg Tablet is a drug used long-term. It can take up to 24 weeks for the full therapeutic results with Empavic 10 mg Tablet (empagliflozin) treatment, based on clinical studies.
Will I lose weight on Empavic 10 mg Tablet?
Empavic 10 mg Tablet can lead to moderate weight loss in patients when taken alone, or when combined with other medications, including metformin or a sulfonylureas. Overall, patients could lose 2% to 3% of their weight, although this is variable and can be affected by many factors, such as diet and exercise.
When should I stop taking Empavic 10 mg Tablet?
You may need to stop taking your Empavic 10 mg Tablet tablets if you need to stop eating before your operation. This is because there's a risk of diabetic ketoacidosis.
Does Empavic 10 mg Tablet make me pee more?
Because of the way Empavic 10 mg Tablet works to lower blood sugar, it may make you urinate more often than usual. In studies, this was a common side effect in people taking Empavic 10 mg Tablet. Increased urination could raise your risk for becoming dehydrated.
Who should not take Empavic 10 mg Tablet?
You should not use Empavic 10 mg Tablet during the second or third trimester of pregnancy. You should not breastfeed while using this medicine. Empavic 10 mg Tablet is not approved for use by anyone younger than 18 years old.
How much weight can I lose on Empavic 10 mg Tablet?
“Patients lost on average 1.5-2kg (about 4 pounds) of weight with empagliflozin, compared with placebo,” Dr. Neeland said.
Is Empavic 10 mg Tablet a diuretic?
This favorable diuretic profile may offer significant advantage in the management of volume status in patients with heart failure and may represent a mechanism contributing to the superior long-term heart failure outcomes observed with these agents.
Is Empavic 10 mg Tablet good for diabetes?
Rosebraugh of the FDA's Center for Drug Evaluation and Research said in a press statement, “Empavic 10 mg Tablet provides an additional treatment option for the care of patients with Type 2 diabetes. It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Is Empavic 10 mg Tablet used for heart failure?
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Empavic 10 mg Tablet for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure.
Does Empavic 10 mg Tablet lower A1C?
When used alone, Empavic 10 mg Tablet decreases hemoglobin A1C levels by 0.7 to 0.9 percentage points, with only a small increase in effect with the higher dose. When added to other antidiabetic agents, empagliflozin produces an additional average A1C decrease of 0.6 percentage points.
Is Empavic 10 mg Tablet being recalled?
Empavic 10 mg Tablet have been recalled. The FDA's warning required manufacturers to add warnings about Fournier's gangrene to the prescribing information of SGLT2 inhibitors, but did not go as far as recalling the drugs from the market.
What drugs should not be taken with Empavic 10 mg Tablet?
Drug interactions of Empavic 10 mg Tablet include diuretics, insulin or drugs that increase insulin secretion, and other SGLT2 inhibitors.
Who should not take Empavic 10 mg Tablet?
You should not use Empavic 10 mg Tablet during the second or third trimester of pregnancy. You should not breastfeed while using this medicine. Empavic 10 mg Tablet is not approved for use by anyone younger than 18 years old.
