Galvus Met 50/850 Tablet

GALVUS MET 50/850 TABLET

GALVUS MET 50/850 Tablet is an oral antidiabetic medication manufactured by Cipla Health Ltd., used in the management of Type 2 Diabetes Mellitus.

• Composition Each film-coated tablet contains 50 mg of Vildagliptin and 850 mg of Metformin Hydrochloride.

• Uses GALVUS MET 50/850 Tablet is prescribed as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus. It is indicated when diabetes is not adequately controlled by metformin or vildagliptin alone, or when patients are already on a combination of these two agents. It can also be used in combination with other anti-diabetic medications, including insulin or sulfonylureas.

• Dosage and Administration The typical dosage guidance is twice daily, with one tablet taken in the morning and the other in the evening. It should be taken with meals to minimize gastrointestinal side effects associated with metformin hydrochloride. The maximum recommended daily dose of vildagliptin is 100 mg. If a dose is missed, it should be taken as soon as remembered, but a double dose should not be taken on the same day. Dosage may be adjusted based on the patient's current regimen and response to therapy.

• Side Effects

  • Common: Headache, nausea, vomiting, diarrhea, stomach pain, dizziness, fatigue, tremors, and nasopharyngitis (sore throat, nasal congestion). Hypoglycemia (low blood sugar) may occur, especially when used in combination with insulin or a sulfonylurea.
  • Serious (rare): Lactic acidosis (symptoms include deep/rapid breathing, persistent nausea, vomiting, stomach pain, muscle pain or weakness, tiredness, feeling cold in arms and legs), hepatic dysfunction (liver problems, hepatitis), pancreatitis, severe joint pain, and skin lesions.

• Precautions GALVUS MET is contraindicated in patients with Type 1 diabetes, diabetic ketoacidosis, severe kidney impairment (e.g., GFR < 30 ml/min), liver impairment, congestive heart failure requiring pharmacological treatment, or metabolic acidosis. Excessive alcohol intake should be avoided due to an increased risk of lactic acidosis. Caution is advised in patients with kidney disease, and renal function should be monitored regularly. It is not recommended for children under 18 years of age. Pregnant or breastfeeding women should consult their doctor. Monitoring for skin disorders is recommended.

• Storage Store GALVUS MET 50/850 Tablet in its original packaging (blister) to protect it from moisture. Do not store above 30°C. Keep it out of reach of children and away from direct sunlight and excessive heat.

GALVUS MET 50/850 TABLET is a medication used to manage Type 2 diabetes mellitus in adults. It combines two active ingredients, vildagliptin and metformin hydrochloride, to help control blood sugar levels when diet and exercise alone are insufficient.

Here are some frequently asked questions about GALVUS MET 50/850 TABLET:

What is GALVUS MET 50/850 TABLET used for?

GALVUS MET 50/850 TABLET is prescribed for adults with Type 2 diabetes mellitus to improve glycemic control. It is used as an adjunct to diet and exercise, particularly when blood sugar is not adequately controlled with metformin or vildagliptin alone, or as part of a combination therapy with other antidiabetic medications, including insulin or sulfonylureas. It is not for treating Type 1 diabetes or diabetic ketoacidosis.

How does GALVUS MET 50/850 TABLET work?

GALVUS MET 50/850 TABLET contains two active components: vildagliptin and metformin. Vildagliptin is a DPP-4 inhibitor that works by increasing the levels of natural hormones (incretins) in the body, which helps the pancreas produce more insulin and less glucagon when blood sugar levels are high. Metformin, a biguanide, reduces the amount of glucose produced by the liver, decreases glucose absorption from the intestines, and enhances the body's sensitivity to insulin, allowing cells to utilize glucose more effectively.

What is the usual dosage for GALVUS MET 50/850 TABLET?

The dosage of GALVUS MET 50/850 TABLET is individualized by your doctor based on your current treatment regimen, effectiveness, and tolerability, without exceeding a maximum daily dose of 100 mg of vildagliptin. Typically, it is initiated at strengths like 50 mg/500 mg, 50 mg/850 mg, or 50 mg/1000 mg, taken twice daily, once in the morning and once in the evening. It should always be taken with meals to help minimize gastrointestinal side effects associated with metformin.

What are the possible side effects of GALVUS MET 50/850 TABLET?

Common side effects may include headache, dizziness, nausea, vomiting, diarrhea, stomach pain, changes in taste, and upper respiratory symptoms. Hypoglycemia (low blood sugar) is also possible, especially when taken with other diabetes medications like sulfonylureas or insulin.

More serious but rare side effects include lactic acidosis (symptoms like severe abdominal pain, rapid breathing, muscle cramps, weakness, and hypothermia), liver problems (yellow skin/eyes, dark urine, loss of appetite), pancreatitis (severe upper stomach pain with nausea/vomiting), and skin reactions. If you experience any severe or persistent side effects, contact your doctor immediately.

Is GALVUS MET 50/850 TABLET safe during pregnancy or breastfeeding?

GALVUS MET 50/850 TABLET is generally not recommended during pregnancy due to insufficient experience and potential risks. Similarly, it is not advised for breastfeeding mothers because its components can pass into breast milk, posing a potential risk of hypoglycemia to the infant. Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can GALVUS MET 50/850 TABLET be taken with other medications?

Vildagliptin has a low potential for drug interactions. However, metformin can interact with certain medications. For instance, drugs that affect kidney function (such as some antihypertensives, diuretics, and NSAIDs) can increase the risk of lactic acidosis. Other medications like corticosteroids, thiazide diuretics, and estrogens may affect blood sugar control and might require dosage adjustments. Always inform your doctor about all medicines, supplements, or herbal products you are taking to avoid potential interactions. If taken with a sulfonylurea, your doctor may consider a lower dose of the sulfonylurea to reduce the risk of low blood sugar.

What precautions should be taken with GALVUS MET 50/850 TABLET?

Avoid taking GALVUS MET 50/850 TABLET if you have a known allergy to its ingredients, severe kidney impairment, liver impairment, metabolic acidosis (including diabetic ketoacidosis or lactic acidosis), or congestive heart failure. Regular monitoring of kidney and liver function is important during treatment. Excessive alcohol consumption should be avoided due to an increased risk of lactic acidosis. Inform your doctor if you have a history of pancreatitis, vitamin B12 deficiency, or are scheduled for surgery, as the medication may need to be temporarily discontinued. Do not stop taking the medicine abruptly without consulting your doctor.

What happens if a dose of GALVUS MET 50/850 TABLET is missed?

If you miss a dose of GALVUS MET 50/850 TABLET, 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 compensate for the missed one.

How should GALVUS MET 50/850 TABLET be stored?

Store GALVUS MET 50/850 TABLET in a cool, dry place, protected from direct sunlight, moisture, and heat, typically not above 30°C. Keep the tablets in their original packaging (blister pack) to protect them from moisture and out of the reach and sight of children.