Valera M 5 Mg/1000 Mg Tablet (15 Tab)

Here is a detailed product description for VALERA M 5 MG/1000 MG TABLET (15 TAB) by ALKEM LABORATORIES LTD.:

VALERA M 5 MG/1000 MG TABLET

• Name:

  • Brand Name: Valera M.
  • Common Name: Evogliptin and Metformin Hydrochloride Tablets.

• Composition:

  • Each tablet contains Evogliptin 5 mg and Metformin Hydrochloride 1000 mg.

• Uses:

  • Valera M is prescribed for the management of type 2 diabetes mellitus to control high blood sugar levels.
  • It is used as an adjunct to diet and exercise, particularly when blood sugar levels are not adequately controlled by either evogliptin or metformin alone.
  • It also contributes to improving insulin sensitivity, reducing the risk of heart disease, and aiding in weight management in some patients.

• Dosage and Administration:

  • Typically, one tablet is taken once daily.
  • It should be administered with food to minimize gastrointestinal side effects.
  • Swallow the tablet whole without crushing, chewing, or breaking it.
  • Dosage should be determined and adjusted by a healthcare professional based on individual patient needs and response.

• Side Effects:

  • Common: Nausea, vomiting, diarrhea, abdominal pain/upset stomach, headache, flatulence, burning in chest, loss of appetite, irritation in the nose, throat, and skin, and respiratory infection.
  • Serious: Lactic acidosis (symptoms include weakness, muscle aches, drowsiness, abdominal pain, rapid breathing), and hypoglycemia (low blood sugar). Acute pancreatitis (persistent, severe abdominal pain) has also been reported.

• Precautions:

  • Contraindications: Avoid use if allergic to any ingredients, or in cases of diabetic ketoacidosis, severe infections, kidney or liver complications, and certain heart conditions that reduce blood oxygen levels.
  • Warnings: There is a risk of lactic acidosis, especially with kidney/liver disease, excessive alcohol consumption, or prolonged fasting. Hypoglycemia may occur, particularly when taken with other diabetes medications like insulin. Acute pancreatitis has been reported.
  • Pregnancy and Breastfeeding: Limited data is available; consult a doctor before use.
  • Drug Interactions: Alcohol, nifedipine, cationic medicines (e.g., cimetidine, digoxin), thiazides, certain diuretics, oral contraceptives, phenytoin, estrogens, steroids, thyroid products, and nicotinic acid may interact with Valera M.

• Storage:

  • Store in a cool and dry place away from direct sunlight, at a temperature below 30°C (or 10ºC to 25ºC).
  • Keep out of the sight and reach of children.

VALERA M 5 MG/1000 MG TABLET is a combination medication containing Evogliptin (5 mg) and Metformin Hydrochloride (1000 mg) in a sustained-release formulation. It is primarily used to help manage type 2 diabetes mellitus.

What is VALERA M 5 MG/1000 MG TABLET used for?

VALERA M 5 MG/1000 MG TABLET is prescribed as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. It is particularly used when blood sugar levels are not adequately controlled with metformin monotherapy or as an alternative to taking evogliptin and metformin separately.

How does VALERA M 5 MG/1000 MG TABLET work?

This medicine combines two active ingredients: Evogliptin and Metformin. Evogliptin works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels, thus reducing both fasting and post-meal sugar levels. Metformin, a biguanide, lowers glucose production in the liver, delays the absorption of sugar from the intestines, and enhances the body's sensitivity to insulin.

What is the usual dosage for VALERA M 5 MG/1000 MG TABLET?

VALERA M 5 MG/1000 MG TABLET (5 mg evogliptin and 1000 mg metformin hydrochloride extended release) is typically taken as a single tablet once daily. It should be administered with food to minimize gastrointestinal side effects associated with metformin. The tablet must be swallowed whole and not split, crushed, or chewed. The dosage may be gradually increased by your physician based on your blood sugar readings.

What are the possible side effects of VALERA M 5 MG/1000 MG TABLET?

Common side effects can include low blood sugar (hypoglycemia), especially when taken with other antidiabetic agents, nausea, vomiting, diarrhea, upset stomach, headache, flatulence, burning in the chest, loss of appetite, and irritation in the nose, throat, and skin. A serious but rare side effect is lactic acidosis, symptoms of which include unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, and a sensation of feeling cold. Acute pancreatitis and severe and disabling joint pain have also been reported with DPP-4 inhibitors like evogliptin.

Is VALERA M 5 MG/1000 MG TABLET safe during pregnancy or breastfeeding?

VALERA M 5 MG/1000 MG TABLET is generally not recommended during pregnancy. While metformin is classified as pregnancy category B, insulin is often preferred for glycemic control during pregnancy. For breastfeeding women, caution is advised as metformin can be detected in breast milk, and animal studies show evogliptin presence in milk. Always consult your doctor before using this medicine if you are pregnant or breastfeeding.

Can VALERA M 5 MG/1000 MG TABLET be taken with other medications?

This medicine can interact with several other medications. Taking it with insulin or sulfonylureas can increase the risk of hypoglycemia, potentially requiring a lower dose of the insulin secretagogue or insulin. Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide) can increase the risk of lactic acidosis. Certain medicines like ranolazine, vandetanib, dolutegravir, and cimetidine can interfere with metformin's renal excretion. Thiazides, certain diuretics, oral contraceptives, phenytoin, estrogens, steroids, thyroid products, and nicotinic acid may increase blood sugar levels. Always inform your doctor about all medications, including over-the-counter drugs and herbal supplements, you are currently taking.

What precautions should be taken with VALERA M 5 MG/1000 MG TABLET?

Patients should be aware of the risk of lactic acidosis, especially if they have kidney or liver impairment, heart conditions, or engage in excessive alcohol intake. It is contraindicated in patients with severe kidney impairment, type 1 diabetes, diabetic ketoacidosis, or severe infections. Patients should be informed about the symptoms of acute pancreatitis and discontinue the medication if severe abdominal pain occurs. Regular monitoring of kidney function, liver function, and blood sugar levels is important.

What happens if a dose of VALERA M 5 MG/1000 MG TABLET 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 double the dose to compensate for a missed one.

How should VALERA M 5 MG/1000 MG TABLET be stored?

VALERA M 5 MG/1000 MG TABLET should be stored at a temperature not exceeding 30°C (ideally around 25°C), protected from light and moisture. Keep it in its original packaging and out of the sight and reach of children.