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INTRODUCTION
4 DAPA 10 TABLET contains Dapagliflozin which belongs to the group of medicines called Antidiabetic agents. It is used to manage type II diabetes mellitus in adults and in children (aged 10 years or older) when diet and exercise does not result in adequate control on blood glucose levels. It is also used in the management of heart failure and chronic kidney disease (reduced kidney function) in adults.
Type II diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused due to inadequate production of a hormone called insulin (produced by pancreas to metabolize glucose) in the body or due to inadequate sensitivity of body cells to the actions of insulin.
During therapy with 4 DAPA 10 TABLET, your doctor might regularly monitor your blood sugar levels and kidney functions to avoid the risk of unwanted side effects. He/she might also ask you to make certain lifestyle changes such as following a healthy diet, regular physical exercise and quitting alcohol consumption to achieve better results. You must also check your feet regularly and follow the foot care advice given by your doctor as a precaution.
Before taking 4 DAPA 10 TABLET inform your doctor if you have any liver or kidney problems. You must also inform your doctor if you have type I diabetes, severe low blood pressure, severe dehydration or conditions which can cause dehydration (such as nausea, vomiting, fever, serious illness any surgery etc.).
4 DAPA 10 TABLET is not recommended for use in pregnant or breastfeeding women. Therefore, consult your doctor for advice. The most common side effects of taking 4 DAPA 10 TABLET are genital infections, back pain, passing more urine, constipation, dizziness and rash. Consult your physician if any of these side effect worsens.
USES OF 4 DAPA 10 TABLET
It is used in adults to manage:
- Type II diabetes mellitus (including children aged 10 years and older)
- Heart failure
- Chronic kidney disease
HOW 4 DAPA 10 TABLET WORKS
4 DAPA 10 TABLET is a SGLT-2 inhibitor. It works by blocking the action of a protein called SGLT-2 in the kidneys. This action prevents the reabsorption of glucose and sodium ions in the kidneys. As a result, it excretes excess glucose and from the body in the form urine leading to decrease in blood sugar levels. It also protects kidney function and prevents it from further damage. Additionally, it reduces the strain on the heart and helps it to pump blood more efficiently with less pressure.
DIRECTIONS FOR USE
Take 4 DAPA 10 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. It can be taken with or without meals.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking 4 DAPA 10 TABLET unless your doctor advice you to stop.
SIDE EFFECTS OF 4 DAPA 10 TABLET
SERIOUS
Stop taking 4 DAPA 10 TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- signs of allergic reaction (such as skin rash, itching, swelling of the face, tongue or throat, causing difficulty in breathing and swallowing)
- signs of diabetic ketoacidosis (such as nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to breath, a sweet or metallic taste in the mouth or a different odor to urine or sweat, and rapid weight loss)
- pain, swelling, redness or tenderness of the genitals or the areas between the genitals and the anus accompanied with high fever or a feeling generally unwell (sign of necrotising fasciitis of the perineum)
- signs of urinary tract infection (such as fever and/or chills, burning sensation while passing urine, pain in the back or side)
- bloody urine
- signs of low blood sugar levels (such as shaking, sweating, anxiety, hunger, fast heartbeat, headache, change in vision, mood swings, confusion)
COMMON
- fungal infections of genital (thrush) causing itching, irritation, unusual discharge, odor
- back pain
- passing more urine, increased urine frequency
- dizziness
- skin rash
- changes in blood cholesterol levels
- changes in RBC in blood
UNCOMMON
- dehydration
- thirst
- constipation
- dry mouth
- weight loss
HOW TO MANAGE SIDE EFFECTS
Constipation
Taking 4 DAPA 10 TABLET with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
WARNING & PRECAUTIONS
PREGNANCY
Contraindicated4 DAPA 10 TABLET is not recommended for use in pregnant women especially during the second and third trimesters. Therefore, inform your doctor before taking 4 DAPA 10 TABLET if you are pregnant, think you may be pregnant or planning to have a baby.
BREASTFEEDING
Consult your doctorIt is not known whether 4 DAPA 10 TABLET can pass through breast milk or not. Therefore, it should be used in breastfeeding women only if considered necessary by the physician.
DRIVING AND USING MACHINES
Use with Caution4 DAPA 10 TABLET does not affect your ability to drive or operate any heavy tools or machines. However, if it is combined with other antidiabetic medicines, it may cause dizziness, shakiness, or vision changes. Therefore, do not drive or handle any heavy tools if your ability is affected by 4 DAPA 10 TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking 4 DAPA 10 TABLET as it may increase the risk of unwanted side effects.
KIDNEY
Use with Caution4 DAPA 10 TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
Use with Caution4 DAPA 10 TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
ContraindicatedDo not take 4 DAPA 10 TABLET if you are allergic to dapagliflozin.
USE IN PEDIATRICS
Consult your doctor4 DAPA 10 TABLET can be used in children and adolescents (aged 10 years or older) for the management of type II diabetes. It is not recommended for use in children aged below 10 years due to lack of safety data. It is also not suitable in the management of heart failure and kidney disease in children aged below 18 years. However, consult your doctor before taking it.
USE IN GERIATRICS
Use with Caution4 DAPA 10 TABLET should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.
OTHERS
Before taking 4 DAPA 10 TABLET, inform your doctor if you:
- have type I diabetes (insulin-dependent diabetes)
- have diabetes related kidney problem
- have low blood pressure
- have uncontrollably high levels of blood glucose levels
- have fever, nausea, vomiting or if you are unable to eat or drink anything
- often get infections of the urinary tract
- are on fasting
- are dehydrated (due to recent vomiting, diarrhea or other reasons)
- have any serious illness or had a major surgery recently
INTERACTIONS
A. Drug-Drug interactions:
Before taking 4 DAPA 10 TABLET, inform your doctor if you are taking any of the following medicines such as:
- diuretics (medicine used to remove water from the body) Ex. furosemide, hydrochlorothiazide
- other medicines used to treat diabetes (such as insulin or glimepiride, gliclazide)
Overdosage:
If you or anyone else accidentally take too much of 4 DAPA 10 TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Dapagliflozin |
| Pharmacological Category | : | SGLT-2 Inhibitors |
| Therapeutic Indication | : | Type II Diabetes Mellitus, Heart Failure, Chronic Kidney Disease |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep 4 DAPA 10 TABLET out of reach of children
- Store 4 DAPA 10 TABLET at a room temperature
FAQs ABOUT 4 DAPA 10 TABLET
Q: What is 4 DAPA 10 TABLET used for?
A: 4 DAPA 10 TABLET is used to manage type II diabetes mellitus in adults and in children (aged 10 years or older) when diet and exercise does not result in adequate control on blood glucose levels. It can also be used to manage heart failure and chronic kidney disease (reduced kidney function) in adults.
Q: Is 4 DAPA 10 TABLET safe to use in children?
A: 4 DAPA 10 TABLET can be used in children and adolescents (aged 10 years or older) for the management of type II diabetes. It is not recommended for use in children aged below 10 years due to lack of safety data. It is also not suitable in the management of heart failure and kidney disease in children aged below 18 years. However, consult your doctor before taking it.
Q: Can the use of 4 DAPA 10 TABLET cause weight loss?
A: 4 DAPA 10 TABLET may cause weight loss in some individuals. It is because of excessive loss of fluid from the body in the form of urine. However, consult your doctor if this side effect troubles you.
Q: Can 4 DAPA 10 TABLET affects pregnancy?
A: 4 DAPA 10 TABLET is generally not recommended for use in pregnant women especially during the second and third trimesters. Therefore, consult your doctor for advice.
Q: Can 4 DAPA 10 TABLET cause urinary tract infection?
A: Yes, taking 4 DAPA 10 TABLET may cause urinary tract infections in few peoples. Not every individual gets the side effect, so it is always better to practice good hygiene. Contact your doctor for advice.
Q: How does 4 DAPA 10 TABLET work?
A: 4 DAPA 10 TABLET is a SGLT-2 inhibitor. It works by blocking the action of a protein called SGLT-2 in the kidneys. This action prevents the reabsorption of glucose and sodium ions in the kidneys. As a result, it excretes excess glucose and from the body in the form urine leading to decrease in blood sugar levels. It also protects kidney function and prevents it from further damage. Additionally, it reduces the strain on the heart and helps it to pump blood more efficiently with less pressure.
Q: How and when to take 4 DAPA 10 TABLET?
A: Take 4 DAPA 10 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not cursh or chew the medicine. It can be taken with or without meals.
Q: How long should I take 4 DAPA 10 TABLET?
A: You need to take 4 DAPA 10 TABLET as long as your doctor prescribes you the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition
Q: What to do if I forgot to take a dose of 4 DAPA 10 TABLET?
A: If you forgot to take a dose of 4 DAPA 10 TABLET, take it as soon as you remember. However, if it is time for the next dose of 4 DAPA 10 TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of 4 DAPA 10 TABLET to compensate the missed one.
Q: What are the most common side effects of taking 4 DAPA 10 TABLET?
A: The most common side effects of taking 4 DAPA 10 TABLET are genital infections, back pain, passing more urine, constipation, dizziness and rash. Contact your physician if any of these side effect worsens.
Q: Can I stop taking 4 DAPA 10 TABLET without consulting your doctor?
A: No. You should not stop taking 4 DAPA 10 TABLET without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using 4 DAPA 10 TABLET, consult your doctor for advice.
Q: Will taking a higher dose of 4 DAPA 10 TABLET be more effective?
A: No, taking a higher dose of 4 DAPA 10 TABLET will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
Q: What precautions do I need to follow while taking 4 DAPA 10 TABLET?
A: Before taking 4 DAPA 10 TABLET inform your doctor if you have any liver or kidney problems. You must also inform your doctor if you have severe low blood pressure or are severely dehydrated due to excessive vomiting or diarrhea. Along with the therapy, follow the diet and lifestyle changes advised by your doctor to achieve better results. Consult your doctor before taking 4 DAPA 10 TABLET if you are pregnant or breastfeeding.
Q: Can I take 4 DAPA 10 TABLET with metformin?
A: Studies have shown that the combination of 4 DAPA 10 TABLET with metformin may effectively control blood sugar levels. However, the combination should be used only under careful medical supervision.
Q: Can 4 DAPA 10 TABLET be taken with insulin?
A: Co-administration of 4 DAPA 10 TABLET with insulin is considered risky as they increase the chance of hypoglycemia (decreased blood sugar levels). Therefore, consult your doctor before taking it.
Q: Can 4 DAPA 10 TABLET cause constipation?
A: Yes. Constipation is a common side effect of taking 4 DAPA 10 TABLET. Eat plenty of fiber rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly while taking this medicine. Contact your doctor if this side effect bothers you.
REFERENCES
1. KD. Tripathi. Insulin, oral hypoglycaemic drugs, and glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 278.
2. Sarah L. Anderson. Dapagliflozin efficacy and safety: a perspective review. National Institute of Health. NLM. National Centre for Biotechnology Information. PMC. Pubmed Central. December 2014 [Accessed on 31st October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232499/
3. John J.V. McMurray, Scott D. Solomon, Silvio E. Inzucchi, Lars Kober, Mikhail N. Kosiborod, Felipe A. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. The New England Journal of Medicine. November 2019 [Accessed on 31st October 2022] https://www.nejm.org/doi/full/10.1056/NEJMoa1911303
4. Feng, Miao MM, Lv, Haihong PhD, Xu, Xia MM, Wang, Jue MM, Lyu, Wenyi MA, Fu, Songbo MM, Li., Sheyu. Efficacy and safety of dapagliflozin as monotherapy in patients with type 2 diabetes mellitus. Journal of Medicines. July 2019 [Accessed on 31st October 2022] https://journals.lww.com/md-journal/fulltext/2019/07260/efficacy_and_safety_of_dapagliflozin_as.65.aspx
5. AstraZeneca UK Limited. Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 9th June 2022] https://www.medicines.org.uk/emc/files/pil.7607.pdf
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 18 Oct 2023 | 05:04 PM(IST)
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