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Introduction About XIGDUO XR 10/1000MG TABLET

XIGDUO XR 10/1000MG TABLET is used to manage type-2 diabetes mellitus along with diet and exercise when diabetes cannot be controlled with other medicines. It is also used in combination with insulin or GLP-1 receptor agonist like liraglutide. It is a combination of Dapagliflozin and Metformin which belongs to the group of medicines called Antidiabetics. XIGDUO XR 10/1000MG TABLET helps to lowers blood glucose levels, where Dapagliflozin works by removing excess sugar from the body in the form of urine and Metformin works by inhibiting glucose production in the liver.

Prior to the management, your doctor may want you to take several blood tests to understand your existing kidney condition. Avoid consumption of alcohol while taking XIGDUO XR 10/1000MG TABLET as it may increase the risk of lactic acidosis. XIGDUO XR 10/1000MG TABLET is not recommended for use in patients with liver disease, moderate to severe kidney disease, recent heart attack or acute myocardial infarction, heart failure, septicemia or severe infection, diabetic ketoacidosis, hypoxemia or uncontrolled diabetes. Contact your doctor before taking the medicine.

XIGDUO XR 10/1000MG TABLET is not recommended for use in second and third trimester of pregnancy unless considered clearly necessary. XIGDUO XR 10/1000MG TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. XIGDUO XR 10/1000MG TABLET is not recommended for use in children and adolescents under 18 years of age. XIGDUO XR 10/1000MG TABLET should be used with caution in elderly patients (aged 65 years or above). The most common side effects of this medicine are diarrhea, stomach pain and loss of appetite. Contact your physician if any of the above side effects worsen or persists for a longer duration.

Uses Of XIGDUO XR 10/1000MG TABLET

Used in the management of type-2 diabetes mellitus

How XIGDUO XR 10/1000MG TABLET Works

XIGDUO XR 10/1000MG TABLET helps to lowers blood glucose levels, where Dapagliflozin works by removing excess sugar from the body in the form of urine and Metformin works by inhibiting glucose production in the liver.

How to use XIGDUO XR 10/1000MG TABLET

Take this medicine as advised by your physician
Swallow this medicine as whole with a glass of water and do not crush or chew the medicine
Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition

Side Effects Of XIGDUO XR 10/1000MG TABLET

Common side effects of XIGDUO XR 10/1000MG TABLET:

diarrhoea
stomach pain
loss of appetite
genital infection (irritation, itching, unusual discharge, or odour)
back pain
increased urination
decrease in creatinine clearance
changes in taste
constipation

Stop taking XIGDUO XR 10/1000MG TABLET and contact your physician immediately if you experience any of the following side effects:

nausea, vomiting, stomach pain, muscle cramps, feeling of not being well with severe tiredness, body pain, increasing somnolence, difficulty in breathing, dizziness, light headedness, reduced body temperature, heartbeat, and low blood pressure (symptoms of lactic acidosis)
dehydration, nausea, vomiting, abdominal pain, excessive thirst, generalised weakness, rapid weight loss, fast and deep breathing, confusion, unusual sleepiness or tiredness, fruity smell breath, a sweet or metallic taste in mouth, different odour to your urine or sweat (signs and symptoms of diabetic ketoacidosis)
fever, chills, burning sensation while passing urine, back pain, or blood in urine (signs of urinary tract infection)
weakness, shaking, sweating, drowsiness, dizziness, feeling very anxious, fast heartbeat, hunger, headache, change in vision, change in mood or confusion, and irritability (signs of low blood sugar)

Warning & Precautions

Pregnancy

Risky

XIGDUO XR 10/1000MG TABLET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding

Consult your doctor

It is not known whether XIGDUO XR 10/1000MG TABLET pass through the breast milk, contact your doctor before taking the medicine.

Driving and Using Machines

Use with Caution

Do not drive or operate any machines if you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heartbeat, change in vision, difficulty in concentration, weakness, sleepiness, light-headedness after taking XIGDUO XR 10/1000MG TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking XIGDUO XR 10/1000MG TABLET as it increases the risk of lactic acidosis.

Kidney

Consult your doctor

XIGDUO XR 10/1000MG TABLET is not recommended for use in patients with moderate to severe kidney disease. It should be used with caution in patients with acute kidney injury.

Liver

Use with Caution

XIGDUO XR 10/1000MG TABLET should be used with caution in patients with liver disease.

Allergy

Contraindicated

Do not take XIGDUO XR 10/1000MG TABLET if you are allergic to Dapagliflozin, Metformin or to any other ingredients of this medicine.

Heart Disease

Consult your doctor

XIGDUO XR 10/1000MG TABLET is not recommended for use in patients with recent heart attack or acute myocardial infarction, heart failure, cardiovascular shock. It should be used with caution in patients with hypotension.

Use In Pediatrics

Consult your doctor

It is not known whether XIGDUO XR 10/1000MG TABLET is safe and effective in children and adolescents below 18 years of age.

Use In Geriatrics

Use with Caution

XIGDUO XR 10/1000MG TABLET should be used with caution in elderly patients (aged above 65 years).

Others

XIGDUO XR 10/1000MG TABLET is not recommended for use if you have or had:

septicemia or severe infection
diabetic ketoacidosis or type 1 diabetes
dehydration from diarrhoea, vomiting and excessive heat exposure
uncontrolled diabetes
lactic acidosis

Before taking XIGDUO XR 10/1000MG TABLET, inform your doctor if you:

have to undergo intravascular radiocontrast study with iodinated materials for X-ray procedure
had any surgical procedure
have acute febrile illness
are taking reduced intake of food
had prolonged fasting due to acute illness or post-surgery
have pancreatic diseases
have urinary tract infections
have low blood sugar
are debilitated, or malnourished
have adrenal or pituitary insufficiency
have vitamin B12 deficiency
have genital mycotic infections
have or had bladder cancer
have serious illness
are on low salt diet
had stroke

Interactions

A. Drug-Drug interactions:

Before taking XIGDUO XR 10/1000MG TABLET inform your doctor if you are taking any of the following medicine:

Antidiabetics (Ex. glyburide, metformin, pioglitazone, sitagliptin, glimepiride, voglibose and insulin)
Diuretics (Ex. furosemide, nifedipine, propranolol, enalapril, hydrochlorothiazide, bumetanide, valsartan, digoxin, ranolazine)
Anticoagulants (Ex. warfarin)
Antilipidemic agents (Ex. simvastatin)
Anti-TB agents (Ex. isoniazid, rifampin)
NSAID’s (Ex. ibuprofen, mefenamic acid)
H2 blockers (Ex. cimetidine)
Anticonvulsants (Ex. phenytoin or phenobarbital)
Anti-viral agents (Ex. ritonavir, dolutegravir)
Short-acting beta-2 adrenergic agonist (Ex. salbutamol)
kinase inhibitors (Ex. vandetanib)
carbonic anhydrase inhibitors (Ex. acetazolamide, zonisamide, or dichlorphenamide)
Corticosteroids (Ex. betamethasone, dexamethasone)
Ant-psychotics (Ex. fluphenazine)
Hormones (Ex. levothyroxine)
Oral contraceptives (Ex. levonorgestrel)
Vitamin supplements (Ex. nicotinic acid)

Overdosage:

If you or anyone else accidentally took too much of this medicine, consult your doctor immediately. Symptoms of overdose are hypoglycaemia and lactic acidosis.

Synopsis

Drug	:	Dapagliflozin, Metformin
Pharmacological Category	:	Antidiabetics
Therapeutic Indication	:	Type II diabetes mellitus
Dosage Forms	:	Tablet

FAQs About XIGDUO XR 10/1000MG TABLET

Q: What XIGDUO XR 10/1000MG TABLET used for?

A: XIGDUO XR 10/1000MG TABLET is used to manage type-2 diabetes mellitus along with diet and exercise when diabetes cannot be controlled with other medicines. It is also used in combination with insulin or GLP-1 receptor agonist like liraglutide.

Q: Who should not take XIGDUO XR 10/1000MG TABLET?

A: XIGDUO XR 10/1000MG TABLET is not recommended for use in patients with allergic history to dapagliflozin, metformin, liver disease, moderate to severe kidney disease, recent heart attack or acute myocardial infarction, heart failure, cardiovascular collapse (shock), septicaemia or severe infection, diabetic ketoacidosis dehydration, hypoxemia, diabetic coma, uncontrolled diabetes, and lactic acidosis.

Q: Can I take alcohol while taking XIGDUO XR 10/1000MG TABLET?

A: No. Avoid consumption of alcohol while taking XIGDUO XR 10/1000MG TABLET as it may increase the risk of lactic acidosis.

Q: How does XIGDUO XR 10/1000MG TABLET work?

A: XIGDUO XR 10/1000MG TABLET contains two antidiabetic medicines Metformin and Dapagliflozin which lowers the blood sugar levels in type 2 diabetes mellitus by eliminating excess sugars through urine and also by increasing the activity of insulin.

Q: Can I use XIGDUO XR 10/1000MG TABLET with other diabetic medications?

A: Your doctor may advise XIGDUO XR 10/1000MG TABLET with or without other medications to control your blood sugar levels. However, it is advised to maintain a proper diet and exercise to achieve the controlled blood sugar levels while using this medicine with or without other antidiabetic medications.

Q: Does XIGDUO XR 10/1000MG TABLET cause low blood sugar?

A: Yes. XIGDUO XR 10/1000MG TABLET may cause low blood sugar. Stop taking XIGDUO XR 10/1000MG TABLET and contact your doctor if you experience any unusual symptoms like weakness, shaking, sweating, drowsiness, dizziness, feeling very anxious, fast heartbeat, hunger, headache, change in vision, change in mood or confusion, and irritability. Consult your doctor for advice.

Q: Who can take XIGDUO XR 10/1000MG TABLET?

A: XIGDUO XR 10/1000MG TABLET is prescribed for adults with type 2 diabetes when diet, exercise, and either drug alone do not provide adequate blood sugar control. It is particularly beneficial for overweight patients or those at risk of heart and kidney disease. It is not recommended for type 1 diabetes, diabetic ketoacidosis, or individuals with severe kidney impairment. Always consult a doctor to determine suitability.

Q: Can XIGDUO XR 10/1000MG TABLET cause weight loss?

A: Yes, XIGDUO XR 10/1000MG TABLET may lead to weight loss, primarily due to dapagliflozin's ability to excrete excess glucose in urine. This feature makes the combination particularly helpful for overweight patients with type 2 diabetes. However, weight loss may vary between individuals.

Q: Can XIGDUO XR 10/1000MG TABLET be taken during pregnancy or breastfeeding?

A: This medicine is not recommended during pregnancy due to insufficient safety data and the potential risk of harm to the unborn baby. If you are pregnant or planning to conceive, consult your doctor for alternative options. Similarly, it is not advised during breastfeeding, as dapagliflozin may affect the infant's kidney development.

Q: Can XIGDUO XR 10/1000MG TABLET cause hypoglycemia (low blood sugar)?

A: XIGDUO XR 10/1000MG TABLET does not typically cause hypoglycemia when used alone. However, if taken with other diabetes medications like sulfonylureas (e.g., glimepiride) or insulin, the risk of hypoglycemia increases. Be cautious and monitor blood sugar regularly if combining with other drugs.

References

1. K.D. Tripathi. Insulin, oral hypoglycaemic drugs and glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page-278, 275.

2. Clifford J Bailey, Jorge L Gross, Delphine Hennicken, Nayyar Iqbal, Traci A Mansfield, James F List. Uses of metformin and dapagliflozin. Biomed Central (BMC). February 2013. [Accessed on 27th June 2022] click here

3. AstraZeneca UK Ltd. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 27th June 2022] click here

4. AstraZeneca Pharmaceuticals. U.S. Food & Drug Administration. [Revised in July 2017] [Accessed on 27th June 2022] clcik here

5. Torrent Pharmaceuticals Ltd. Dapagliflozin and Metformin. [Revised in May 2022] [Accessed on 27th June 2022] click here

6. AstraZeneca Pharmaceuticals LP. Dapagliflozin and Metformin. [Revised in April 2022] [Accessed on 27th June 2022] click here

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Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)

Last updated on 18 Nov 2024 | 03:25 PM(IST)