Information

  • AROVIA- 25 mg / 50 mg
  • Dosage Form: Tablet
  • Pack Type: ALU-ALU
  • Pack Size: 2X15 Tablets
  • Division: Unitus

AROVIA- 25/50

Sitagliptin Tablets IP

AROVIA-25: Each Film Coated tablet contains Sitagliptin Phosphate Monohydrate 25 mg.

AROVIA-50: Each Film Coated tablet contains Sitagliptin Phosphate Monohydrate 50 mg.

Clinical Pharmacology:

AROVIA contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.

Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

How to take Sitagliptin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

  • Take this medication by mouth with or without food, as directed by your doctor, usually once daily.
  • The dosage is based on your medical condition, kidney function, and response to treatment. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
  • Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
  • Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Sitagliptin.

If you take more Sitagliptin than you should

If you take more than the prescribed dosage of this medicine, contact your doctor immediately.

If you forget to take Sitagliptin

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin

Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Sitagliptin.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Sitagliptin and contact a doctor immediately if you notice any of the following serious side effects:

  • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).

If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients have experienced the following side effects while taking sitagliptin alone :

Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose, and sore throat, osteoarthritis, arm or leg pain

Uncommon: dizziness, constipation, itching

Rare: reduced number of platelets

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Warning and Precautions:

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Sitagliptin.

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Sitagliptin.

Tell your doctor if you have or have had:

  • a disease of the pancreas (such as pancreatitis)
  • gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis 
  • type 1 diabetes
  • diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
  • any past or present kidney problems
  • an allergic reaction to Sitagliptin

This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Children and adolescents

Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycemia, which may affect your ability to drive and use machines or work without a safe foothold.