Auroempa M 12.5/1000mg Tab

AUROEMPA M 12.5/1000MG TAB

Name

• Common Name: Auroempa M 12.5/1000MG Tablet
• Brand Names (for empagliflozin/metformin combination): Synjardy, Jardiamet
• Manufacturer: PURE & CURE HEALTH PVT.LTD. (also associated with Aurobindo Pharma Ltd.)

Composition

Each tablet contains:

• Active Ingredients: Empagliflozin 12.5 mg and Metformin Hydrochloride 1000 mg.

Uses

Auroempa M 12.5/1000MG Tablet is primarily used to treat adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control.

It is also indicated for:

• Reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
• Lowering the risk of hospitalization for heart failure, and slowing the progression of kidney disease (including reducing the risk of end-stage kidney disease, cardiovascular death, and hospitalization) in patients with chronic kidney disease.
• Managing type 2 diabetes in adults whose condition is not adequately controlled by metformin alone or metformin combined with other diabetes medicines.

Dosage and Administration

• Typical Guidance: The dosage is determined by a healthcare professional based on individual patient needs and response to treatment.
• Administration: Usually taken orally once or twice daily. It is recommended to take the tablet with meals to help reduce the chance of stomach upset.
• Important: Swallow the tablet whole with water; do not cut, break, or chew it. Do not discontinue the medicine without consulting your doctor.

Side Effects

Common Side Effects:

• Frequent urination
• Mild skin rash or itchy skin
• Nausea, vomiting, diarrhea, stomach pain, loss of appetite
• Headache
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Genital fungal infections (vaginal yeast infections in women, yeast infections of the penis in men)
• Urinary tract infection (UTI)
• Hypoglycemia (low blood sugar), especially when taken with other diabetes medicines like insulin or sulfonylureas
• Joint pain

Serious Side Effects (Seek immediate medical attention if experienced):

• Lactic acidosis: Symptoms include stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, unusual muscle pain or cramping, and unusual sleepiness, tiredness, or weakness.
• Diabetic ketoacidosis: Symptoms include rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, and a sweet smell to breath.
• Dehydration: Symptoms include increased thirst, dry mouth, feeling faint or lightheaded, headache, and dark yellow or brown urine.
• Acute kidney injury
• Severe allergic reactions: Symptoms include rash, hives, itching, swelling of the face, lips, tongue, or throat, or difficulty breathing.
• Low blood pressure.
• Increased risk of lower leg, foot, or toe amputation (though rare).

Precautions

• Contraindications: Do not take if you have type 1 diabetes mellitus, severe kidney or liver disease, metabolic acidosis (e.g., lactic acidosis, diabetic ketoacidosis), or a history of severe allergic reaction to empagliflozin or metformin.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding; consult a doctor for advice.
• Alcohol Consumption: Limit or avoid alcohol as it can increase the risk of lactic acidosis.
• Dehydration: Empagliflozin can cause increased urination, leading to dehydration. Drink plenty of fluids.
• Surgery and Medical Procedures: You may need to stop this medication temporarily before surgery or diagnostic tests involving iodinated contrast agents.
• Elderly Patients: Use with caution as elderly patients may be more sensitive to side effects and more prone to kidney problems.
• Monitoring: Regular monitoring of blood sugar levels, kidney function, and vitamin B12 levels is recommended.

Storage

Store in a cool, dry place, away from direct sunlight and moisture, preferably at room temperature (below 30°C or 10-25°C). Keep the medicine in its original packaging and out of reach of children and pets. Do not store in bathrooms.

AUROEMPA M 12.5/1000MG TAB is a combination medication containing Empagliflozin (12.5mg) and Metformin (1000mg). It is primarily used in the management of Type 2 Diabetes Mellitus.

What is AUROEMPA M 12.5/1000MG TAB used for?

AUROEMPA M 12.5/1000MG TAB is used to treat Type 2 Diabetes Mellitus in adults, alongside diet and exercise, to help control high blood sugar levels. It is prescribed for adults whose diabetes is not adequately controlled by Metformin alone or Metformin with other diabetes medications, or for those already taking both Empagliflozin and Metformin as separate medicines. Additionally, this medicine helps prevent serious complications of diabetes, such as kidney damage, eye damage, nerve problems, and may reduce the risk of heart attacks, strokes, and other cardiovascular events in patients with type 2 diabetes and heart disease.

How does it work?

AUROEMPA M 12.5/1000MG TAB works through the combined action of its two active ingredients: Empagliflozin and Metformin.

• Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It works by blocking the SGLT2 enzyme in the kidneys, which helps remove excess glucose from the body through urine, thereby lowering blood sugar levels.
• Metformin belongs to the biguanide class of medications. It lowers blood sugar levels by reducing glucose production in the liver, delaying glucose absorption from the intestines, and increasing the body's sensitivity to insulin.

Together, these components improve how the body handles insulin and more effectively lower blood glucose.

What is the usual dosage?

The dosage of AUROEMPA M 12.5/1000MG TAB depends on your medical condition and your response to treatment, as well as any other diabetes medicines you may be taking. It is typically taken orally, usually once daily in the morning or twice daily with meals, as directed by your doctor. It's crucial to take this medicine exactly as prescribed by your doctor and at the same time each day for optimal benefits. Do not alter the dose or discontinue the medicine without consulting your doctor.

What are the possible side effects?

Common side effects of AUROEMPA M 12.5/1000MG TAB can include frequent urination, mild skin rash or itchy skin, nausea, vomiting, diarrhea, stomach ache, and loss of appetite. Other reported side effects include urinary tract infections, genital fungal infections, nasopharyngitis (inflammation of the throat and nasal passages), headache, and joint pain. Hypoglycemia (low blood sugar) may occur, especially when taken with other antidiabetic medicines, alcohol, or if meals are delayed or missed. More serious, though rare, side effects can include lactic acidosis (especially with Metformin), dehydration, and kidney problems.

Is it safe during pregnancy or breastfeeding?

AUROEMPA M 12.5/1000MG TAB is generally not recommended during pregnancy. Limited information exists on its effect during pregnancy, and animal studies have shown harmful effects on the developing baby. It should only be used if prescribed by your doctor, who will weigh the benefits against potential risks. For breastfeeding, this medicine may be unsafe. It is not known whether Empagliflozin passes into human breast milk, but Metformin does pass into breast milk in small amounts. Therefore, this medicine should generally not be used while breastfeeding.

Can it be taken with other medications?

It is important to inform your doctor about all medications, supplements, or herbal products you are currently taking or plan to take to avoid potential interactions.

• Caution is advised with diuretics (water pills) as concurrent use may increase the risk of dehydration and lower blood pressure. Your doctor may adjust the dose or temporarily stop this medicine.
• When taken with other antidiabetic medicines (like insulin or sulfonylureas), there's an increased risk of hypoglycemia, and your doctor may need to lower the doses of these other medications.
• Alcohol should be avoided as it can increase the risk of lactic acidosis.
• Certain medicines can affect the amount of Metformin in your blood, including verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, and olaparib.
• NSAIDs (like ibuprofen) and COX-2 inhibitors (like celecoxib) may reduce the blood pressure-lowering effect of Empagliflozin.
• Auroempa M Tablet may lower the levels of lithium in the blood.

What precautions should be taken?

• Do not take this medicine if you are allergic to Empagliflozin, Metformin, or any other ingredients.
• Inform your doctor if you have kidney or liver disease, heart disease, severe infection, or a history of metabolic acidosis (e.g., lactic acidosis or diabetic ketoacidosis).
• Avoid consuming alcohol while taking this medication.
• Stay well-hydrated by drinking plenty of fluids, as this medicine can cause dehydration and increased urination.
• Monitor your blood sugar levels regularly.
• Be aware of symptoms of hypoglycemia (cold sweats, shaking, fast heartbeat) and carry sugary food or fruit juice.
• Practice good genital hygiene to prevent yeast or urinary tract infections.
• Inform your doctor or dentist before any surgery or X-ray/scanning procedure involving iodinated contrast, as you may need to temporarily stop this medication.
• This medicine is generally not recommended for individuals with Type 1 diabetes, severe kidney or liver disease, or those aged 85 years or older.
• Do not stop taking the medicine abruptly without consulting your doctor, as this can lead to increased sugar levels and a higher risk of diabetic complications.

What happens if a dose is missed?

If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one. Missing doses of blood sugar medicines can cause fluctuations in your blood sugar levels.

How should it be stored?

AUROEMPA M 12.5/1000MG TAB should be stored in a cool, dry place, away from direct sunlight. It should be kept at room temperature, ideally between 10ºC to 25ºC or below 30ºC. Keep the medication out of reach of children and pets. The original packaging should be tightly sealed to maintain its integrity and prevent contamination. Do not store it in bathrooms or near heat sources, as temperature fluctuations can impact its effectiveness. Dispose of any unused or expired tablets responsibly.