Glempa M 12.5/1000mg Tab

GLEMPA M 12.5/1000MG TAB by GLENMARK PHARMACEUTICALS

Name

Brand Name: GLEMPA M 12.5/1000MG TAB Common Name: Glempa M

Composition

GLEMPA M 12.5/1000MG TAB contains two active ingredients:

• Empagliflozin: 12.5 mg
• Metformin Hydrochloride (HCI): 1000 mg

Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, which helps the body remove excess sugar through urine. Metformin is a biguanide that lowers glucose production in the liver, delays glucose absorption from the intestines, and increases the body's sensitivity to insulin.

Uses

GLEMPA M 12.5/1000MG TAB is prescribed for adults with Type 2 Diabetes Mellitus. It is used as an adjunct to diet and exercise to improve blood sugar control. It is indicated for patients whose diabetes is not adequately controlled with metformin alone or with metformin in combination with other antidiabetic medicines.

Beyond glycemic control, this medicine offers additional benefits:

• Cardiovascular Benefits: Reduces the risk of heart attacks, strokes, and cardiovascular death in diabetic patients with established heart disease.
• Renal Protection: May help in protecting kidney function and slowing the progression of diabetic kidney disease.
• Weight Management: Can aid in weight loss by increasing the excretion of glucose through urine.
• Blood Pressure Lowering: May also help in lowering blood pressure levels.

Dosage and Administration

The recommended dose of Glempa-M is typically one tablet twice daily. The dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability. It is advised to take the tablet with meals to help reduce gastrointestinal side effects associated with Metformin. The tablet should be swallowed whole with a glass of water and not crushed, broken, or chewed. The maximum recommended daily dose is 25mg of Empagliflozin and 2000mg of Metformin HCl.

Side Effects

Common Side Effects:

• Nausea, vomiting, diarrhea, abdominal discomfort
• Increased urination frequency
• Mild skin rash or itchy skin
• Vaginal yeast infections in women
• Genital fungal infections in men
• Metallic taste in the mouth
• Loss of appetite
• Joint pain
• Urinary tract infection (UTI)
• Nasopharyngitis (inflammation of the throat and nasal passages)
• Hypoglycemia (low blood sugar) when used with other antidiabetic medicines or if meals are delayed/missed.

Serious Side Effects:

• Lactic Acidosis: A rare but serious condition, particularly with Metformin accumulation. Symptoms include malaise, muscle pain, respiratory distress, increasing sleepiness, and non-specific abdominal distress. If suspected, discontinue treatment and seek immediate medical attention.
• Diabetic ketoacidosis
• Acute kidney injury and impairment in renal function
• Urosepsis and pyelonephritis
• Risk for volume depletion
• Vitamin B12 deficiency with long-term Metformin use.

Precautions

• Contraindications: Do not use if allergic to Empagliflozin, Metformin, or any components of the tablet. It is contraindicated in moderate to severe renal impairment (creatinine clearance <60ml/min), end-stage renal disease, dialysis, acute or chronic metabolic acidosis (including lactic acidosis and diabetic ketoacidosis), diabetic pre-coma, and acute conditions that may alter renal function (e.g., dehydration, severe infection, shock).
• Renal Function: Renal function should be assessed before initiating treatment and at least annually thereafter.
• Pregnancy and Lactation: Generally not recommended during pregnancy or breastfeeding; insulin is advised for blood glucose control during pregnancy.
• Alcohol: Avoid excessive alcohol intake, as it increases the risk of lactic acidosis and hypoglycemia.
• Hepatic Impairment: Must not be used in patients with hepatic impairment.
• Elderly Patients: Use with caution, especially in patients 75 years and older due to an increased risk for volume depletion.
• Dehydration: Drink plenty of fluids to prevent dehydration, as the medication can increase urine volume and frequency.
• Hypoglycemia: Be aware of hypoglycemia symptoms (cold sweats, pale skin, tremor, anxious feeling) and carry sugary food or juice if combining with other antidiabetics or insulin.
• Drug Interactions: Inform your doctor about all medications, supplements, or herbal products being taken, especially diuretics, insulin, sulfonylureas, NSAIDs, cimetidine, anticoagulants, nifedipine, and glucocorticoids, as interactions can occur.
• Discontinuation: Do not stop taking the medicine abruptly without consulting a doctor, as this can lead to an increase in blood sugar levels and associated complications.
• Driving/Operating Machinery: May cause dizziness or low blood sugar; use caution when driving or operating machinery.

Storage

Store below 30°C. Protect from heat, light, and moisture. Keep out of reach of children. Store in a cool and dry place away from direct sunlight.

GLEMPA M 12.5/1000MG TAB is a medication prescribed for adults with type 2 diabetes mellitus. It combines two active ingredients, empagliflozin and metformin, to help manage blood sugar levels.

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

GLEMPA M 12.5/1000MG TAB is used to treat adults with type 2 diabetes mellitus, alongside diet and exercise. It is prescribed when blood sugar levels are not adequately controlled by metformin alone or by metformin with other diabetes medications. It can also be used for patients already taking empagliflozin and metformin as separate tablets. Additionally, it helps reduce the risk of cardiovascular death in adults with established cardiovascular disease and may lower the risk of hospitalization for heart failure in certain patient groups.

How does GLEMPA M 12.5/1000MG TAB work?

This medicine contains two active components: Empagliflozin and Metformin Hydrochloride. Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor that works by causing the kidneys to remove excess sugar from the body through urine. Metformin is a biguanide that reduces glucose production in the liver, improves the body's sensitivity to insulin (helping muscle cells absorb more glucose), and delays glucose absorption from the intestines. Together, these actions more effectively lower blood glucose.

What is the usual dosage for GLEMPA M 12.5/1000MG TAB?

The recommended dose is one tablet twice daily, taken with meals to help reduce gastrointestinal side effects. The dosage should be individualized by your doctor based on your current treatment, effectiveness, and how well you tolerate the medication. It is important to swallow the tablet whole with water and not to crush, break, or chew it.

What are the possible side effects of GLEMPA M 12.5/1000MG TAB?

Common side effects include frequent urination, mild skin rash or itchy skin, nausea, vomiting, diarrhea, abdominal discomfort, taste changes, joint pain, urinary tract infections, and genital yeast or fungal infections. More serious, but less common, side effects can include dehydration, lactic acidosis (symptoms like vomiting, stomach pain, muscle cramps, general malaise), and hypoglycemia (low blood sugar), especially when taken with other diabetes medicines or alcohol.

Is GLEMPA M 12.5/1000MG TAB safe during pregnancy or breastfeeding?

GLEMPA M 12.5/1000MG TAB is generally not recommended during pregnancy, and insulin is often preferred to manage blood glucose levels in pregnant individuals with diabetes. For breastfeeding, it is probably unsafe. Metformin is known to pass into breast milk, and it is unknown if empagliflozin does as well; limited human data suggests it may harm the baby. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can GLEMPA M 12.5/1000MG TAB be taken with other medications?

Yes, but caution is advised. Diuretics can increase the risk of dehydration and volume depletion. When taken with insulin or insulin secretagogues (like sulfonylureas), there is an increased risk of low blood sugar, and the dose of these other medications may need to be adjusted. Nonsteroidal anti-inflammatory drugs (NSAIDs) may affect kidney function, which can increase the risk of metformin-related side effects. It is crucial to inform your doctor about all prescription, over-the-counter, and herbal medications you are taking.

What precautions should be taken while taking GLEMPA M 12.5/1000MG TAB?

Avoid consuming alcohol, as it significantly increases the risk of serious side effects like lactic acidosis and can also lead to hypoglycemia. The medication is contraindicated in individuals with moderate to severe kidney impairment, end-stage renal disease, dialysis, or liver problems. Drink plenty of fluids to prevent dehydration. Also, maintain good hygiene to prevent genital fungal and urinary tract infections. Regular monitoring of blood sugar levels is important.

What happens if a dose of GLEMPA M 12.5/1000MG TAB is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this can lead to fluctuations in your blood sugar levels.

How should GLEMPA M 12.5/1000MG TAB be stored?

Store GLEMPA M 12.5/1000MG TAB below 30°C. Keep it protected from heat, light, and moisture, and always out of the reach of children.