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INTRODUCTION
JUSTOZA M 10/500 TABLET is a combination of Dapagliflozin and Metformin which belongs to the group of medicines called Antidiabetics. It is used to treat 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.
Prior to the treatment, your doctor may want you to take several blood tests to understand your existing kidney condition. Avoid consumption of alcohol while taking JUSTOZA M 10/500 TABLET as it may increases the risk of lactic acidosis.
JUSTOZA M 10/500 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, cardiovascular collapse (shock), septicaemia or severe infection, diabetic ketoacidosis, hypoxemia, diabetic coma or uncontrolled diabetes. Contact your doctor before taking the medicine.
JUSTOZA M 10/500 TABLET is generally not recommended for use in second and third trimester of pregnancy unless considered clearly necessary. Contact your doctor before taking. JUSTOZA M 10/500 TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Contact your doctor before taking.
JUSTOZA M 10/500 TABLET is not recommended for use in children and adolescents under 18 years of age. Contact your doctor before taking. JUSTOZA M 10/500 TABLET should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before taking the medicine. The most common side effects of this medicine are nausea, vomiting, diarrhoea, stomach pain and loss of appetite. Contact your physician if any of the symptoms worsen.
USES OF JUSTOZA M 10/500 TABLET
- Used to treat type-2 diabetes mellitus
HOW JUSTOZA M 10/500 TABLET WORKS
JUSTOZA M 10/500 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.
DIRECTIONS FOR USE
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 JUSTOZA M 10/500 TABLET
COMMON
- nausea, vomiting
- diarrhoea
- stomach pain
- loss of appetite
- genital infection (irritation, itching, unusual discharge, or odour)
- runny nose, sore throat
- back pain
- discomfort when passing urine
- increased urination
- changes in cholesterol or fat levels in blood
- increased red blood cells
- decrease in creatinine clearance
- changes in taste
- dizziness
- rash
UNCOMMON
- thirst
- constipation
- dry mouth
- decreased weight
- elevated creatinine or urea levels
RARE
Stop taking JUSTOZA M 10/500 TABLET and contact your physician immediately if you experience any of the following side effects:
- nausea, vomiting, stomach pain, muscle cramp, feeling of not being well with severe tiredness, body pains, 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)
- symptoms of necrotising fasciitis of the perineum or Fournier’s gangrene such as pain, tenderness, redness, or swelling of the genitals and the anus with fever or feeling generally unwell
- signs of dehydration such as very dry or sticky mouth, feeling very thirsty, sleepy or tiredness, passing little or no urine, fast heartrate, dizziness, faintness, light-headedness, or weakness when standing up
- 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)
- skin rash, raised red patches on skin, swelling of the face, lips, tongue, and throat causing difficulty in breathing or swallowing (symptoms of serious allergic reactions)
HOW TO MANAGE SIDE EFFECTS
Constipation
Eat plenty of fibre rich foods such as fresh fruits, vegetables, and cereals and drink water. Exercise regularly. Contact your doctor if constipation did not improve.
Diarrhea
Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own for treating diarrhoea. Contact your doctor if diarrhoea did not improve.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not consume alcohol, as it increase dizziness. Contact your doctor if dizziness did not improve.
Nausea And Vomiting
Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if nausea and vomiting did not improve.
Stomach Pain
Try to rest and relax. Eat small meals but take frequently. Keep a heat pad on your stomach. Contact your doctor if stomach pain worsens.
Headache
Rest and relax. Drink plenty of fluids such as water and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if headache worsens.
WARNING & PRECAUTIONS
PREGNANCY
Monitoring requiredJUSTOZA M 10/500 TABLET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Contact your doctor before taking.
BREASTFEEDING
Consult your doctorIt is not known whether JUSTOZA M 10/500 TABLET pass through the breast milk, contact your doctor before taking the medicine.
DRIVING AND USING MACHINES
Use with CautionDo 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 JUSTOZA M 10/500 TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking JUSTOZA M 10/500 TABLET as it increases the risk of lactic acidosis.
KIDNEY
Consult your doctorJUSTOZA M 10/500 TABLET is not recommended for use in patients with moderate to severe kidney disease and should be used with caution in patients with acute kidney injury. Contact your doctor before taking this medicine.
LIVER
Use with CautionJUSTOZA M 10/500 TABLET should be used with caution in patients with liver disease. Contact your doctor before taking JUSTOZA M 10/500 TABLET.
ALLERGY
ContraindicatedDo not take JUSTOZA M 10/500 TABLET if you are allergic to Dapagliflozin, Metformin or to any other ingredients of this medicine.
HEART DISEASE
Consult your doctorJUSTOZA M 10/500 TABLET is not recommended for use in patients with recent heart attack or acute myocardial infarction, heart failure, cardiovascular collapse (shock). It should be used with caution in patients with hypotension. Contact your doctor before taking the medicine.
OTHERS
JUSTOZA M 10/500 TABLET is not recommended for use if you had or have:
- septicaemia or severe infection
- diabetic ketoacidosis or type 1 diabetes
- dehydration from diarrhoea, vomiting and excessive heat exposure
- diabetic coma
- uncontrolled diabetes
- lactic acidosis
Before taking JUSTOZA M 10/500 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 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
Use in Pediatrics:
It is not known whether JUSTOZA M 10/500 TABLET is safe and effective in children and adolescents below 18 years of age. Contact your doctor before taking.
Use in Geriatrics:
JUSTOZA M 10/500 TABLET should be used with caution in elderly patients (aged above 65 years). Contact your doctor before taking.
INTERACTIONS
A. Drug-Drug interactions:
Before taking JUSTOZA M 10/500 TABLET inform your doctor if you are taking any of the following medicine:
- medicines used to treat diabetes mellitus (Ex. glyburide, metformin, pioglitazone, sitagliptin, glimepiride, voglibose and insulin)
- medicines used to treat high blood pressure and heart diseases (Ex. furosemide, nifedipine, propranolol, enalapril, hydrochlorothiazide, bumetanide, valsartan, digoxin, ranolazine)
- warfarin (medicines used to treat blood clots)
- simvastatin (medicines used to treat high cholesterol levels)
- isoniazid, rifampin (medicines used to treat or prevent tuberculosis)
- ibuprofen, mefenamic acid (medicines used to treat pain)
- cimetidine (medicines used to treat gastric ulcers)
- phenytoin or phenobarbital (medicines used to treat fits)
- ritonavir, dolutegravir (medicines used to treat HIV infections)
- salbutamol (medicines used to treat asthma, breathing problems)
- vandetanib (medicines used for thyroid cancer)
- acetazolamide, zonisamide, or dichlorphenamide (medicines used to treat glaucoma, heart failure, epilepsy)
- betamethasone, dexamethasone (medicines used to treat inflammation)
- fluphenazine (medicines used to treat schizophrenia)
- levothyroxine (medicines used to treat hypothyroidism)
- oestrogens, oral contraceptives (Ex. levonorgestrel) medicines used to prevent pregnancy
- nicotinic acid (vitamin supplements)
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-2 Diabetes mellitus |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep JUSTOZA M 10/500 TABLET out of reach of children
- Store at room temperature
FAQs ABOUT JUSTOZA M 10/500 TABLET
Q: What JUSTOZA M 10/500 TABLET used for?
A: It is used to treat 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 JUSTOZA M 10/500 TABLET?
A: JUSTOZA M 10/500 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 JUSTOZA M 10/500 TABLET?
A: No. Avoid consumption of alcohol while taking JUSTOZA M 10/500 TABLET as it may increases the risk of lactic acidosis.
Q: How does JUSTOZA M 10/500 TABLET work?
A: It contains two antidiabetic medicines metformin and dapagliflozin which lower 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 JUSTOZA M 10/500 TABLET with other diabetic medications?
A: Your doctor may advise JUSTOZA M 10/500 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 JUSTOZA M 10/500 TABLET cause low blood sugar?
A: Yes. JUSTOZA M 10/500 TABLET may cause low blood sugar. Stop taking JUSTOZA M 10/500 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.
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] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606470/
3. AstraZeneca UK Ltd. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 27th June 2022] https://www.medicines.org.uk/emc/files/pil.5293.pdf
4. AstraZeneca Pharmaceuticals. U.S. Food & Drug Administration. [Revised in July 2017] [Accessed on 27th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf
5. Torrent Pharmaceuticals Ltd. Dapagliflozin and Metformin. [Revised in May 2022] [Accessed on 27th June 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3008.pdf
6. AstraZeneca Pharmaceuticals LP. Dapagliflozin and Metformin. [Revised in April 2022] [Accessed on 27th June 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859
USEFUL DIAGNOSTIC TESTS
- Blood glucose levels
- LDL cholesterol
- HbA1c
- Kidney function test
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