Avandamet 4mg/500mg
Qtern
Dapagliflozin Propanediol Monohydrate, Saxagliptin Hydrochloride
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­QTERN

(Dapagliflozin and Saxagliptin)

WHAT IS QTERN?

QTERN is a combination tablet. It contains dapagliflozin and saxagliptin. Both these drugs are used for the management of type 2 diabetes mellitus. They are taken orally and help to reduce blood glucose levels when used together with exercise and diet.

HOW DOES QTERN WORK?

QTERN contains dapagliflozin. Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It reduces the amount of glucose that is reabsorbed from the kidneys and so lowers glucose concentrations in the blood.

QTERN contains saxagliptin. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that prevents the breakdown of incretin hormones. Incretin hormones increase the secretion of insulin and decrease the concentration of glucagon. Inhibition of incretin breakdown reduces blood glucose levels in the blood

WHAT ARE THE INDICATIONS FOR QTERN?

QTERN is indicated for the treatment of patients with type 2 diabetes mellitus. It is used together with diet control and exercise to improve blood glucose levels in adults.

It should not be used in patients with type 1 diabetes mellitus or in those with diabetic ketoacidosis. Only patients who can tolerate a dose of 10 mg dapagliflozin should start QTERN.

WHAT IS THE DOSE OF QTERN?

QTERN is manufactured as a combination of 10 mg dapagliflozin and 5 mg saxagliptin. QTERN is manufactured as a light brown biconvex tablet that is round and coated with film. The number “1122” is printed on one side in blue.

The recommended dose of QTERN is one 10 mg dapagliflozin / 5 mg saxagliptin tablet taken once in the morning. This can be taken with or without food. The tablet should not be crushed, chewed, or cut.

Renal function should be tested before starting QTERN. It should not be started if the eGFR is below 60 mL/min/1.73m2. QTERN should be stopped if the eGFR is consistently found to be below 60 mL/min/1.73m2.

WARNINGS AND PRECAUTIONS

Hypotension

QTERN has been reported to cause a reduction in blood volume, leading to low blood pressure. It occurs more commonly in patients with renal impairment, older patients, and patients with preexisting low blood pressure. Therefore, ensure that any underlying volume deficit is replaced in the patients before starting QTERN. Monitor patients taking diuretics closely.

Ketoacidosis

Ketoacidosis is a condition of increased ketones in the blood or urine. This may happen in patients taking QTERN who have type 2 diabetes. This condition is life-threatening and may need to be managed in a hospital. Ketoacidosis can happen even if you have normal blood sugar. QTERN should be stopped if ketoacidosis develops

Hypoglycemia

QTERN, when used together with insulin or drugs that stimulate the secretion of insulin, can cause low blood sugar (hypoglycemia). Therefore, a lower dose of insulin or insulin secretion stimulators should be used in combination with QTERN.

Heart failure

QTERN may carry an increased risk of developing heart failure. Consider the risk and benefits for each individual patient before starting QTERN. Patients should be monitored for the development of signs and symptoms of heart failure.

Pancreatitis

QTERN has been reported to cause acute pancreatitis. This seems to be caused by saxagliptin. Patients should be carefully monitored for this complication. If pancreatitis is diagnosed, QTERN should be stopped immediately.

Impaired renal function

QTERN causes an increase in serum creatinine. This is mediated by dapagliflozin. It occurs more commonly in elderly patients and those with preexisting renal dysfunction. Before starting QTERN, assess possible risk factors that may increase the chance of developing acute kidney failure. These include hypovolemia, cardiac failure, chronic renal failure, and the use of other medications such as NSAIDs, ACE inhibitors, ARBs, or loop diuretics.

Urinary tract and genital fungal infections

QTERN increases the risk of developing urinary tract infections, infections on the kidneys, and fungal infections on the genitals.

Bladder cancer risk

QTERN may increase the risk of bladder cancer. Do not start QTERN on patients with active bladder cancer. Use QTERN with care in patients who have a history of bladder cancer.

Arthralgia

Patients taking QTERN have reported severe and disabling arthritic pain. This is thought to be related to dapagliflozin use. QTERN should be considered as a possible cause in those patients presenting with new-onset severe joint pain. QTERN should be discontinued if deemed appropriate.

SPECIAL POPULATIONS

Renal Failure or Impairment

Dapagliflozin elimination is not affected by renal dysfunction. However, Dapagliflozin can cause a reduction in vascular blood volume. This may lead to symptomatic hypotension, which can be more severe in patients with renal dysfunction, in the elderly patient, or in those taking diuretics such as furosemide.

Renal function should be tested before starting QTERN. It should not be started if the eGFR is below 60 mL/min/1.73m2. QTERN should be stopped if the eGFR is consistently measured to be below 60 mL/min/1.73m2. It should not be used in patients with end-stage renal disease or by those on dialysis.

Hepatic Dysfunction

QTERN can be used in patients with hepatic dysfunction. However, QTERN has not been extensively studied in this population, and so clinicians should individually assess the safety and efficacy of using QTERN in this population.

Elderly

Dapagliflozin can cause a reduction in vascular blood volume. This may lead to symptomatic hypotension, which can be more severe in patients with renal dysfunction, in the elderly patient, or in those taking diuretics such as furosemide. Care should be taken when prescribing QTERN to elderly patients.

Pediatrics

There are little long-term clinical data to determine the safety of QTERN in pediatric patients. QTERN should not be used in persons under the age of 18.

Pregnancy

QTERN may be detrimental to the fetus in the second and third trimesters. Therefore, use during pregnancy should only be considered if the potential benefit to the mother outweighs the risk to the fetus. The amount of drug expressed in breast milk is unknown. QTERN should not be taken when breastfeeding.

CONTRAINDICATIONS

QTERN is contraindicated in:

  • Patients with hypersensitivity to dapagliflozin or saxagliptin
  • Moderate or severe renal dysfunction
  • Established renal failure – eGFR < 30 ml/min/1.73m2
  • Patients on dialysis

SIDE EFFECTS

Common side effects of QTERN include:

  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Symptoms like a cold – stuffy nose, sinus pain, sneezing
  • Infections of the urinary tract
  • Genital fungal infections
  • Dehydration
  • Low blood sugar

Less common side effects include:

  • Ketoacidosis
  • Renal dysfunction
  • New or worsening heart failure
  • New or unusual pain in the joints
  • Abnormal lipid levels
  • Pain in the stomach or vomiting
  • Possible increased risk of bladder cancer

If any of these side effects are noticed, a doctor should be contacted immediately.

DRUG INTERACTIONS

Certain drugs may interact with QTERN. These include:

  • Ketoconazole
  • Atazanavir
  • Clarithromycin
  • Indinavir
  • Itraconazole
  • Nefazodone
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Telithromycin

Care should be taken when using QTERN with other medications that can cause an increase in blood glucose levels. This includes:

  • Thiazides
  • Diuretics
  • Corticosteroids
  • Phenothiazines
  • Thyroid products
  • Estrogens
  • Oral contraceptives
  • Phenytoin
  • Nicotinic acid
  • Sympathomimetics
  • Calcium channel blocking drugs
  • Isoniazid

FREQUENTLY ASKED QUESTIONS

QTERN is manufactured as a combination tablet of 10 mg dapagliflozin and 5 mg saxagliptin. QTERN is manufactured as a light brown biconvex tablet that is round and coated with film. The number “1122” is printed on one side in blue.

The recommended dose of QTERN is one 10 mg dapagliflozin / 5 mg saxagliptin tablet taken once in the morning.

The QTERN should be taken once in the morning with or without food. The tablet should not be crushed, chewed, or cut. Contact your doctor as your medication may need to be adjusted during periods of stress, such as new infections, trauma, or surgery.

Persons with renal dysfunction, renal failure, those on dialysis, or those with a hypersensitivity to dapagliflozin or saxagliptin should not take QTERN. Your kidney function should be tested before you start QTERN. QTERN should not be started if your eGFR is below 60 mL/min/1.73m2. QTERN should be stopped if your eGFR is consistently measured to be below 60 mL/min/1.73m2.

If you miss a dose of QTERN, try to take it as soon as possible, then continue with the usual medication schedule. However, if you are due to take your next dose soon, skip the dose you missed and continue with your regular medication schedule. Under no circumstances should you take a double dose of the medication to make up for the missed dose. If you are unsure about what to do, contact your doctor or local pharmacist to obtain advice.

Common side effects of QTERN include:

  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Symptoms like a cold – stuffy nose, sinus pain, sneezing
  • Infections of the urinary tract
  • Genital fungal infections
  • Dehydration
  • Low blood sugar

Less common side effects include:

  • Ketoacidosis
  • Kidney problems
  • New or worsening heart failure
  • New or unusual pain in the joints
  • Abnormal lipid levels
  • Pain in the stomach or vomiting
  • Possible increased risk of bladder cancer

If any of these side effects are noticed, a doctor should be contacted immediately.

If you experience severe side effects, immediately contact your doctor, or go to the nearest emergency health care facility.

QTERN should be stored away from children. It should be stored in a dry place at room temperature, away from heat, sunlight, and moisture. It should be stored in a closed container.