Qtern 5 Mg/10 Mg Tablet (14 Tab)

QTERN 5 MG/10 MG TABLET (14 TAB)

QTERN 5 MG/10 MG TABLET is a prescription medicine manufactured by AstraZeneca Pharma India Limited.

• Name

  • Brand Name: QTERN
  • Common Name: Dapagliflozin/Saxagliptin

• Composition Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride) and 10 mg dapagliflozin (as propanediol monohydrate). Inactive ingredients include anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.

• Uses QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults aged 18 years and older with type 2 diabetes mellitus. It is used when metformin and/or a sulfonylurea along with one of the components do not provide adequate control, or in patients already treated with the free combination of dapagliflozin and saxagliptin. This medication helps lower blood sugar levels and may help reduce the risk of serious diabetes complications and heart disease. QTERN is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis.

• Dosage and Administration The recommended dose of QTERN is one tablet taken orally once daily in the morning, with or without food. Tablets should be swallowed whole and not crushed, cut, or chewed. Renal function should be assessed prior to initiation of QTERN therapy and periodically thereafter.

• Side Effects

  • Common: Upper respiratory tract infection (e.g., sore throat, cough, runny nose), urinary tract infection, dyslipidemia, headache, diarrhea, back pain, genital infection, arthralgia, and hypoglycemia.
  • Serious: Diabetic ketoacidosis, pancreatitis, severe urinary tract infections (urosepsis, pyelonephritis), necrotizing fasciitis of the perineum (Fournier's gangrene), heart failure, severe joint pain, bullous pemphigoid, acute kidney injury, and serious hypersensitivity reactions (e.g., anaphylaxis, angioedema).

• Precautions Do not take QTERN if you have type 1 diabetes, diabetic ketoacidosis, or severe renal impairment (eGFR persistently <45 mL/min/1.73 m²). Use with caution in patients with a history of heart failure or risk factors. If used with insulin or insulin secretagogues, a lower dose of these medications may be necessary to reduce the risk of hypoglycemia. Correct volume depletion before starting QTERN. Avoid coadministration with strong CYP3A4/5 inhibitors. QTERN is not recommended during the second and third trimesters of pregnancy or while breastfeeding. It contains lactose.

• Storage Store QTERN tablets at temperatures not exceeding 30°C (86°F). Keep the medicine in its blister packaging in a cool, dry place, away from moisture, heat, and direct sunlight. Keep out of reach of children.

QTERN 5 MG/10 MG TABLET is a medication used to manage type 2 diabetes mellitus in adults. It contains two active ingredients: dapagliflozin and saxagliptin.

What is QTERN 5 MG/10 MG TABLET used for?

QTERN 5 MG/10 MG TABLET is used in adults (18 years and older) with type 2 diabetes mellitus to improve blood sugar control. It is prescribed when diet and exercise alone, or in combination with other diabetes medications like metformin, do not adequately control blood sugar levels. This medication helps reduce the risk of serious diabetes complications such as kidney damage, eye damage, nerve problems, and cardiovascular disease. It is not for type 1 diabetes or diabetic ketoacidosis.

How does QTERN 5 MG/10 MG TABLET work?

QTERN is a combination of two medicines, dapagliflozin and saxagliptin, which work in different ways to control blood sugar.

• Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works in the kidneys to prevent the reabsorption of sugar back into the body, causing the body to get rid of excess sugar through urine.
• Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by blocking DPP-4, an enzyme that breaks down natural hormones that tell your body to make more insulin and produce less sugar, especially after meals.

What is the usual dosage?

The recommended dose of QTERN 5 MG/10 MG TABLET is one tablet (5 mg saxagliptin/10 mg dapagliflozin) taken once daily. It can be taken at any time of the day, with or without food, but it's recommended to take it at the same time each day to help with remembering. The tablet should be swallowed whole and not crushed, cut, or chewed.

What are the possible side effects?

Common side effects include upper respiratory tract infections (like sore throat and cough), urinary tract infections (UTIs), headache, diarrhea, and genital yeast infections. More serious, though uncommon, side effects can include:

• Hypoglycemia (low blood sugar), especially when used with other diabetes medications that cause low blood sugar.
• Dehydration due to increased urination.
• Ketoacidosis, a serious condition where too much acid builds up in the blood.
• Pancreatitis (inflammation of the pancreas).
• Serious allergic reactions (rash, swelling, trouble breathing).
• Fournier's gangrene, a rare but serious genital infection.
• Heart failure.
• Severe joint pain.
• Bullous pemphigoid, a rare skin reaction with blisters.

Is it safe during pregnancy or breastfeeding?

QTERN is not recommended during pregnancy and should be discontinued if pregnancy occurs. It is also not recommended while breastfeeding, as it is unknown if the medicine passes into human breast milk. Your doctor will advise on the best way to control blood sugar during pregnancy.

Can it be taken with other medications?

QTERN can interact with certain medications. It's important to inform your doctor about all medicines and supplements you are taking.

• Insulin or sulfonylureas: Combining QTERN with these can increase the risk of low blood sugar, and a lower dose of insulin or the insulin secretagogue may be needed.
• Diuretics (water pills): These can increase the risk of dehydration when taken with QTERN.
• Strong CYP3A4/5 inhibitors/inducers: Medications like ketoconazole (a strong inhibitor) or rifampicin, carbamazepine, phenobarbital, phenytoin, and dexamethasone (inducers) can affect the levels of saxagliptin in your body. Your doctor may monitor your blood sugar more frequently.
• Lithium: Special caution is advised.
• Alcohol: Excessive alcohol intake should be avoided as it may increase the risk of diabetic ketoacidosis and can affect blood sugar levels.

What precautions should be taken?

Before taking QTERN, inform your doctor about any history of:

• Kidney disease, liver disease, heart failure, or pancreatitis.
• Type 1 diabetes or diabetic ketoacidosis.
• Serious allergic reactions to other similar diabetes medicines.
• Frequent urinary tract infections.
• Low blood pressure or if you are taking medicines to lower blood pressure.
• Risk factors for ketoacidosis (e.g., changes in diet, reduced appetite, upcoming surgery). Your kidney function should be assessed before starting QTERN and periodically thereafter. Maintain good hygiene to reduce the risk of urinary and genital infections. Stay hydrated by drinking plenty of water.

What happens if a dose is missed?

If you miss a dose and it's less than 12 hours until your next scheduled dose, take the missed dose as soon as you remember. If it's less than 12 hours until your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten one.

How should it be stored?

QTERN tablets should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). Keep the container tightly closed and protect it from light. Keep it out of reach and sight of children.