Januvia 25mg Tablet (7 Tab)

JANUVIA 25MG TABLET

JANUVIA 25mg Tablet is an oral medication primarily used for the management of type 2 diabetes mellitus. It is manufactured by MSD Pharmaceuticals Pvt Ltd.

• Name

  • Common Name: Sitagliptin (active ingredient)
  • Brand Name: JANUVIA 25mg Tablet

• Composition

  • Active Ingredient: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg of sitagliptin. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
  • Inactive Ingredients: Microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The film coating contains polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.

• Uses JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It helps to lower high blood sugar levels and can be used alone or in combination with other anti-diabetic medications like metformin, sulfonylureas, or insulin. It is not used for type 1 diabetes or diabetic ketoacidosis.

• Dosage and Administration

  • The typical recommended dosage of JANUVIA is 100 mg once daily, but for patients with severe renal impairment or end-stage renal disease requiring dialysis, the dose is 25 mg once daily.
  • JANUVIA can be taken with or without food.
  • It should be taken regularly at the same time each day to maintain consistent blood sugar control.
  • Do not crush, chew, or break the tablets.
  • If a dose is missed by less than 12 hours, take it as soon as remembered. If more than 12 hours have passed, skip the missed dose and resume the regular schedule. Do not double the next dose.

• Side Effects

  • Common Side Effects: Upper respiratory infection (such as common cold or sinus infection), headache, upset stomach, diarrhea, nasopharyngitis, and mild hypoglycemia (especially when used with other diabetes medications).
  • Serious Side Effects:
    • Pancreatitis (inflammation of the pancreas), which can be severe and life-threatening. Symptoms include severe and persistent stomach pain that may spread to the back, with or without vomiting.
    • Heart failure or worsening of existing heart failure, characterized by increasing shortness of breath, swelling (especially in feet, ankles, or legs), unusual tiredness, or rapid weight gain.
    • Kidney problems, including acute kidney failure.
    • Severe hypoglycemia (very low blood sugar) when used with insulin or sulfonylurea drugs.
    • Serious allergic reactions (rash, hives, swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing).
    • Severe and disabling joint pain.
    • Bullous pemphigoid (a type of severe skin reaction with blisters or sores).

• Precautions

  • Inform your doctor about any history of pancreatitis, kidney problems, or heart failure before starting JANUVIA.
  • Monitor blood sugar levels regularly as advised by your doctor.
  • Discuss alcohol consumption with your doctor, as excessive alcohol can lower blood sugar and increase the risk of pancreatitis.
  • Not recommended for use during pregnancy or while breastfeeding.
  • Not recommended for children below 18 years of age.
  • Do not stop taking JANUVIA without consulting your doctor.

• Storage

  • Store JANUVIA at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets in their blister pack until it is time to take them.
  • Store in a dry area, away from moisture, excessive heat, and direct sunlight. Do not store in the refrigerator.
  • Keep out of reach of children.

What is JANUVIA 25mg Tablet used for?

JANUVIA 25mg Tablet is a prescription medication primarily used to help lower high blood sugar levels in adults with type 2 diabetes mellitus. It is used in conjunction with a balanced diet and regular exercise to improve glycemic control. It is not intended for people with type 1 diabetes or diabetic ketoacidosis.

How does JANUVIA (sitagliptin) work?

JANUVIA, which contains the active ingredient sitagliptin, belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by blocking the enzyme DPP-4, which typically breaks down certain natural hormones called incretins (like GLP-1 and GIP). By inhibiting DPP-4, JANUVIA increases the levels of these incretins in the body. This leads to increased insulin production from the pancreas when blood sugar levels are high and decreases the production of glucagon, a hormone that raises blood sugar. This mechanism helps to normalize blood glucose levels without significantly increasing the risk of low blood sugar (hypoglycemia) when used alone.

What is the usual dosage of JANUVIA 25mg Tablet?

The recommended daily dose of JANUVIA is typically 100 mg once daily. However, the 25 mg tablet is specifically used for patients with moderate to severe renal impairment (kidney problems) or those undergoing dialysis. Your doctor will assess your kidney function before and during treatment to determine the appropriate dosage. It should be taken once a day, with or without food, ideally at the same time each day.

What are the possible side effects of JANUVIA?

Common side effects of JANUVIA include upper respiratory infection, stuffy or runny nose, sore throat, and headache. Other possible side effects can include stomach upset, diarrhea, and joint pain.

Serious side effects, though less common, can occur and include:

• Pancreatitis: Severe stomach pain that may radiate to your back, with or without vomiting.
• Heart Failure: Symptoms like increasing shortness of breath, swelling in the feet, ankles, or legs, unusual tiredness, and rapid weight gain.
• Serious Allergic Reactions: Symptoms such as rash, hives, swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing.
• Kidney Problems: Including sudden kidney failure.
• Bullous Pemphigoid: A skin reaction causing itchy skin, blistering rash, or sores.
• Severe Joint Pain: That can be disabling.

Contact your doctor immediately if you experience any serious side effects.

Is JANUVIA safe during pregnancy or breastfeeding?

JANUVIA is generally not recommended during pregnancy. There is limited data on its use in pregnant women, and it is unknown if it can harm an unborn baby. Uncontrolled diabetes during pregnancy can pose risks to both the pregnant person and the fetus. Insulin is typically the preferred medication for managing diabetes during pregnancy due to its established safety profile.

It is also not known if JANUVIA passes into breast milk or affects milk production. Caution should be exercised if JANUVIA is administered to a nursing woman. Always discuss with your doctor the best way to manage your diabetes and feed your baby if you are pregnant or breastfeeding.

Can JANUVIA be taken with other medications?

Yes, JANUVIA can be taken with other diabetes medications, including metformin, sulfonylureas (e.g., glipizide, glimepiride), and insulin. However, when taken with insulin or insulin secretagogues like sulfonylureas, the risk of low blood sugar (hypoglycemia) increases. Your doctor may need to adjust the dosage of these other medications to reduce this risk.

It's important to inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, as some may interact with JANUVIA. For example, there can be a slight increase in digoxin levels if taken concurrently, so monitoring may be necessary.

What precautions should be taken while using JANUVIA?

Before taking JANUVIA, inform your doctor if you have a history of:

• Pancreatitis: It is unknown if having a history of pancreatitis increases the risk of developing it while on JANUVIA.
• Kidney Problems: Dosage adjustments may be necessary based on your kidney function. Your doctor will monitor your kidney health.
• Heart Failure: JANUVIA can cause or worsen heart failure. Inform your doctor if you have had heart failure.
• Allergic Reactions: Do not take JANUVIA if you are allergic to sitagliptin or any of its ingredients.

Your doctor will monitor your blood sugar levels regularly and may adjust your dose or recommend other treatments based on your condition.

What happens if a dose of JANUVIA is missed?

If you miss a dose of JANUVIA, 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 two doses at the same time to make up for a missed dose, as this can increase the risk of side effects.

How should JANUVIA be stored?

JANUVIA tablets should be stored at room temperature, ideally between 68°F to 77°F (20°C to 25°C). Keep the medication in its original blister pack until it's time to take it, and store it in a cool, dry place away from moisture, heat, and direct sunlight. Always keep JANUVIA and all other medicines out of the reach of children.