Onglyza 5 Mg Tablet (14 Tab)

ONGLYZA 5 MG TABLET is a medication manufactured by ASTRAZENECA PHARMA INDIA LIMITED, primarily used in the management of type 2 diabetes mellitus.

Name

• Common Name: Onglyza
• Brand Name: ONGLYZA 5 MG TABLET
• Generic Name: Saxagliptin

Composition

Each film-coated tablet contains 5 mg of saxagliptin (as hydrochloride), which is the active ingredient. Other inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, macrogol 3350, titanium dioxide, talc, and iron oxide red. The printing ink contains shellac and indigo carmine aluminium lake.

Uses

ONGLYZA is indicated for adult patients (18 years and older) with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control. It can be used as monotherapy when metformin is inappropriate due to intolerance or contraindications, or in combination with other anti-diabetic medications, including metformin, sulfonylureas, or insulin, when these do not provide adequate glycemic control. This helps prevent serious complications of diabetes such as kidney damage, blindness, and nerve damage. ONGLYZA is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Dosage and Administration

The recommended dose of ONGLYZA is 5 mg once daily. The tablets should be swallowed whole with water and must not be split or cut. It can be taken with or without food, preferably at the same time each day to aid adherence.

Dosage adjustments for renal impairment:

• No dose adjustment is recommended for mild renal impairment (creatinine clearance > 50 mL/min).
• For patients with moderate or severe renal impairment (creatinine clearance ≤ 50 mL/min), or end-stage renal disease (ESRD) requiring hemodialysis, the recommended dose is 2.5 mg once daily. ONGLYZA should be administered following hemodialysis.
• Assessment of renal function is recommended prior to initiation of treatment and periodically thereafter.

Side Effects

Common side effects:

• Upper respiratory tract infection (such as the common cold)
• Urinary tract infection (UTI)
• Headache
• Peripheral edema (swelling of hands, ankles, or feet)
• Hypoglycemia (low blood sugar) when used in combination with insulin or sulfonylurea

Serious side effects:

• Pancreatitis (inflammation of the pancreas), characterized by severe and persistent abdominal pain, nausea, and vomiting.
• Heart failure, especially in patients with risk factors such as a history of heart failure or moderate to severe renal impairment. Symptoms may include shortness of breath, fatigue, and swelling in legs, ankles, or feet.
• Severe allergic reactions (e.g., rash, hives, swelling of the face, lips, tongue, and throat causing difficulty breathing or swallowing).
• Severe joint pain.
• Bullous pemphigoid (a serious skin condition causing blistering).

Precautions

• Pancreatitis: Use with extreme caution in patients with a history of pancreatitis, as it may increase the risk of recurrent pancreatitis.
• Heart Failure: Use with caution in patients with known risk factors for heart failure. Patients should be advised to report symptoms of heart failure immediately.
• Renal Impairment: Dose adjustment is necessary for moderate to severe renal impairment or ESRD requiring hemodialysis.
• Hepatic Impairment: Saxagliptin should be used with caution in patients with moderate hepatic impairment and is not recommended for use in patients with severe hepatic impairment.
• Hypoglycemia: When ONGLYZA is used in combination with insulin or a sulfonylurea, a lower dose of these medications may be required to reduce the risk of hypoglycemia.
• Allergic Reactions: Contraindicated in patients with a history of serious hypersensitivity reactions to saxagliptin or any other DPP-4 inhibitors.
• Drug Interactions: The dose should be reduced to 2.5 mg once daily when co-administered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
• Alcohol: Consumption of alcohol with ONGLYZA 5mg Tablet is unsafe.
• Driving: Patients should be cautious while driving or operating machinery if they experience dizziness or symptoms of hypoglycemia.
• Pregnancy and Breastfeeding: Generally considered safe if prescribed during pregnancy. Consult a doctor regarding use during breastfeeding as it is probably unsafe.
• Lactose Intolerance: The tablets contain lactose monohydrate; patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Storage

Store ONGLYZA 5 MG TABLET below 30°C. Keep the tablets in the original blister pack to protect them from excessive heat, moisture, and direct sunlight. Keep out of reach and sight of children and pets.

Here are frequently asked questions about ONGLYZA 5 MG TABLET:

What is ONGLYZA used for?

ONGLYZA 5 MG TABLET is an oral medication primarily used in adults to treat type 2 diabetes mellitus. It is prescribed as an adjunct to diet and exercise to improve blood sugar control. It can be used alone or in combination with other anti-diabetic medicines, such as metformin, sulfonylureas, or insulin, when these therapies alone do not adequately control blood sugar levels.

How does ONGLYZA work?

ONGLYZA contains saxagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). It works by increasing the levels of natural hormones called incretins (GLP-1 and GIP) in the body. These hormones help the pancreas release more insulin when blood sugar levels are high (especially after meals) and decrease the amount of sugar produced by the liver, thereby lowering blood glucose levels.

What is the usual dosage of ONGLYZA?

The typical recommended dosage for adults is 2.5 mg or 5 mg taken once daily, with or without food. It is important to swallow the tablets whole and not split or cut them. For patients with moderate to severe kidney impairment (creatinine clearance ≤ 50 mL/min) or those requiring hemodialysis, the recommended dose is typically 2.5 mg once daily, administered after hemodialysis.

What are the possible side effects of ONGLYZA?

Common mild side effects can include headache, upper respiratory tract infection (like the common cold), and urinary tract infection (UTI).

Serious side effects, though less common, can include:

• Pancreatitis: Symptoms may include severe stomach or abdominal pain that might spread to your back, with or without vomiting.
• Heart failure: Symptoms can include increasing shortness of breath, fatigue, swelling in your feet, ankles, or legs, and rapid weight gain.
• Severe allergic reactions: Symptoms such as rash, hives, swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing.
• Severe and disabling joint pain.
• Bullous pemphigoid: A serious skin condition causing severe blistering.
• Hypoglycemia (low blood sugar): This risk is higher when ONGLYZA is taken with other diabetes medications like sulfonylureas or insulin. Symptoms include shaking, sweating, rapid heartbeat, hunger, blurred vision, dizziness, or tingling in hands/feet.

Is ONGLYZA safe during pregnancy or breastfeeding?

Pregnancy: There is limited data on the use of ONGLYZA in pregnant women. It should only be used during pregnancy if clearly needed, considering that poorly controlled diabetes poses risks to both the mother and the fetus. Animal studies indicate the drug crosses the placenta.

Breastfeeding: It is not known if saxagliptin passes into human breast milk, though it is excreted into animal milk. Caution is advised, and your healthcare provider will help you decide whether to discontinue breastfeeding or discontinue the medication, weighing the importance of the drug to the mother.

Can ONGLYZA be taken with other medications?

Yes, ONGLYZA can be taken with other diabetes medications like metformin, sulfonylureas, or insulin. However, if taken with sulfonylureas or insulin, a lower dose of those medications may be required to reduce the risk of low blood sugar (hypoglycemia). Additionally, strong inhibitors of CYP3A4/5 enzymes (such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin) can increase saxagliptin levels, potentially requiring a dosage adjustment of ONGLYZA to 2.5 mg once daily. It is advisable to avoid grapefruit or grapefruit juice while taking ONGLYZA as it may affect how the medicine works. Always inform your healthcare provider about all medications, vitamins, and herbal supplements you are taking.

What precautions should be taken while taking ONGLYZA?

ONGLYZA is not for treating type 1 diabetes or diabetic ketoacidosis. Use with caution if you have a history of pancreatitis, heart failure, or kidney problems. Your kidney function should be assessed before starting and periodically during treatment. If you have a history of serious allergic reactions to saxagliptin or similar drugs, ONGLYZA should not be used. The tablets contain lactose, so individuals with certain hereditary disorders related to lactose intolerance should discuss this with their doctor. During periods of stress (like fever, infection, trauma, or surgery), your blood sugar control may be affected, and your doctor may need to adjust your medication.

What happens if a dose of ONGLYZA 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 take your next dose at the usual time. Do not take two doses at the same time to make up for a missed dose.

How should ONGLYZA be stored?

Store ONGLYZA at room temperature, typically between 68°F and 77°F (20°C and 25°C). Keep the medication out of reach and sight of children and pets.