Januvia 100mg Tablet

JANUVIA 100MG TABLET

JANUVIA 100MG TABLET is an oral medication manufactured by MSD Pharmaceuticals Pvt Ltd, primarily used in the management of type 2 diabetes mellitus.

Composition

• Active Ingredient: Each tablet contains 100mg of Sitagliptin (as sitagliptin phosphate monohydrate).
• Class: Sitagliptin belongs to a class of medicines known as Dipeptidyl peptidase-4 (DPP-4) inhibitors.

Uses

JANUVIA 100MG TABLET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It works by increasing insulin release and decreasing sugar production in the liver, thereby helping to control blood sugar levels and prevent serious complications like kidney damage and blindness. This medicine can be prescribed alone or in combination with other antidiabetic medicines such as metformin, sulfonylureas, or insulin.

Dosage and Administration

The recommended dose of JANUVIA is 100 mg once daily. It can be taken with or without food. For optimal benefit, it should be taken regularly at the same time each day.

Dosage adjustments are necessary for patients with renal impairment:

• Moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73 m2): 50 mg once daily.
• Severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis: 25 mg once daily.

If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule resumed. Double doses should not be taken. The tablets should be swallowed whole and not split, crushed, or chewed.

Side Effects

Common Side Effects:

• Upper respiratory tract infection
• Stuffy or runny nose and sore throat (nasopharyngitis)
• Headache
• Stomach upset and diarrhea (especially when used with metformin and rosiglitazone)
• Swelling of the hands or legs

Serious Side Effects (seek immediate medical attention):

• Pancreatitis: Severe and persistent pain in the stomach area (abdomen) that may radiate to the back, with or without nausea and vomiting.
• Hypoglycemia (low blood sugar): More likely when used with insulin or sulfonylureas. Symptoms include headache, dizziness, drowsiness, confusion, sweating, feeling jittery, weakness, and fast heartbeat.
• Heart Failure: Symptoms like shortness of breath (even when lying down), swelling in legs or feet, and rapid weight gain.
• Allergic reactions: Hives, difficulty breathing, swelling of the face or throat, severe skin reactions (e.g., fever, sore throat, burning eyes, skin pain, red or purple rash that spreads and causes blistering and peeling).
• Severe joint pain.
• Kidney problems, including acute renal failure, sometimes requiring dialysis.
• Bullous pemphigoid: A type of blistering skin condition.

Precautions

• JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
• Patients should inform their doctor if they have a history of pancreatitis, high blood triglyceride levels, gallstones, kidney problems, or alcoholism, as these conditions can increase the risk of pancreatitis.
• Renal function should be assessed prior to initiating JANUVIA and periodically thereafter.
• When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin, a lower dose of these co-administered medications may be required to reduce the risk of hypoglycemia.
• Patients experiencing severe and disabling joint pain should contact their doctor.
• If a serious hypersensitivity reaction or bullous pemphigoid is suspected, JANUVIA should be discontinued.
• Limit alcohol intake, as it can increase the risk of low blood sugar and may harm the pancreas.
• Caution is advised while driving or operating machinery due to potential dizziness or drowsiness, and the increased risk of hypoglycemia when combined with certain medications.
• Consult a doctor if pregnant or breastfeeding; JANUVIA is generally not recommended during these periods.
• JANUVIA is not recommended for use in children below 18 years of age.

Storage

JANUVIA 100MG TABLETS should be stored below 30°C (86°F) or between 68 and 77 degrees Fahrenheit (20-25°C). Store in a dry place, away from direct heat and light. Do not store medications in a damp or humid environment, such as a bathroom medicine cabinet, and do not refrigerate. Keep the medication in its original packaging, tightly capped, and out of the sight and reach of children. Do not use expired medication, as its effectiveness and safety cannot be guaranteed past the expiration date.

Here are frequently asked questions about JANUVIA 100MG TABLET:

What is JANUVIA 100MG TABLET used for?

JANUVIA 100MG TABLET is an oral medication primarily used to treat type 2 diabetes mellitus in adults. It helps lower high blood sugar levels when used in conjunction with a healthy diet and regular exercise. It can be prescribed alone or in combination with other diabetes medications, such as metformin or insulin, to improve overall blood sugar control and help prevent serious diabetes complications like kidney damage and blindness.

How does JANUVIA work?

JANUVIA contains the active substance sitagliptin, which is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by blocking the action of the DPP-4 enzyme, which helps to increase the levels of natural hormones (incretins) in the body. These incretin hormones increase insulin production after a meal and decrease the amount of sugar produced by the body, thereby lowering blood glucose levels. JANUVIA works more when blood sugar is high and less when it is low.

What is the usual dosage of JANUVIA 100MG TABLET?

The recommended dosage of JANUVIA for treating type 2 diabetes is typically 100 mg once daily. It can be taken with or without food. Your doctor may prescribe a lower dose (such as 25 mg or 50 mg) if you have kidney problems. It is crucial to take this medicine regularly at the same time each day for maximum benefit and not to stop taking it without consulting your doctor.

What are the possible side effects of JANUVIA?

Common side effects of JANUVIA can include upper respiratory tract infection, stuffy or runny nose, sore throat, and headache.

More serious, though less common, side effects can occur:

• Pancreatitis: Severe and persistent pain in the stomach area that may spread to your back, with or without nausea and vomiting. If you experience these symptoms, stop taking JANUVIA and contact your doctor immediately.
• Heart Failure: Symptoms may include increasing shortness of breath, trouble breathing (especially when lying down), swelling in the feet, ankles, or legs, and unusual tiredness or rapid weight gain.
• Kidney Problems: Worsening renal function, sometimes requiring dialysis, has been reported.
• Allergic Reactions: Severe allergic reactions (e.g., rash, hives, swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) have been reported. Stop taking the medicine and seek immediate medical attention if these occur.
• Severe Joint Pain: Some patients have reported severe and disabling joint pain.
• Skin Reactions: Blistering or peeling skin, known as bullous pemphigoid, has been observed.

Is JANUVIA safe during pregnancy or breastfeeding?

You should not take JANUVIA during pregnancy as there are no adequate human data, and potential risks to humans are unknown. It is also not known if JANUVIA passes into breast milk, so it should not be used if you are breastfeeding or plan to breastfeed. Always consult your doctor for advice if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding.

Can JANUVIA be taken with other medications?

JANUVIA can be taken with certain other medicines that lower blood sugar, such as insulin, metformin, or sulfonylureas. However, when used in combination with sulfonylureas or insulin, there is an increased risk of low blood sugar (hypoglycemia), and your doctor may need to adjust the dose of these other medications. Additionally, if you are taking digoxin (a medicine for heart problems), its blood levels may need to be checked, as JANUVIA may slightly increase its concentration. Always inform your doctor or pharmacist about all other medicines you are taking, including over-the-counter drugs, vitamins, and herbal supplements.

What precautions should be taken?

Before taking JANUVIA, inform your doctor if you have or have had:

• A history of pancreatitis (inflammation of the pancreas), as it's unknown if you have a higher chance of getting it while taking JANUVIA.
• Kidney problems, as your dosage may need to be adjusted.
• Gallstones, high blood triglyceride levels, or alcohol dependence, as these can increase the risk of pancreatitis.
• Heart failure or other heart problems.
• Type 1 diabetes or diabetic ketoacidosis, as JANUVIA is not for these conditions.
• Any past or present allergic reactions to JANUVIA or its ingredients.
• Be cautious while driving or operating machinery until you know how JANUVIA affects you, as dizziness and drowsiness have been reported.

What happens if a dose 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 a double dose to make up for a forgotten one.

How should JANUVIA 100MG TABLET be stored?

JANUVIA tablets should be stored at room temperature, ideally between 68 and 77 degrees Fahrenheit (20-25 degrees Celsius). Keep them in their original packaging, away from direct heat, moisture, and sunlight. Do not store medications in a damp place like a bathroom medicine cabinet or in the refrigerator. Keep all medications out of the sight and reach of children.