INTRODUCTION
DAXIGA V TABLET is a combination of Dapagliflozin and Vildagliptin which belongs to the group of medicines called Antidiabetic agents. It is used in adults to treat type II diabetes mellitus which is poorly controlled on metformin monotherapy.
Type 2 diabetes is a condition in which your body fails to make enough insulin and the insulin that is produced does not work as well as it should. This results in sugar (glucose) build-up in the blood and thus increased blood sugar levels. You should follow the recommendations for skin and foot care that you are given by your doctor.
Before taking DAXIGA V TABLET, inform your doctor if you have any liver, kidney, pancreatic or heart disease or if you are undergoing dialysis. DAXIGA V TABLET is not recommended for use in pregnant women, breastfeeding woman, children and adolescents (below 18 years of age) so, consult your doctor for advice.
Your doctor might ask you to take certain blood tests to check your liver function and to examine that the treatment is having the desired effect. The most common side effects of taking DAXIGA V TABLET are dizziness, genital infection (thrush) of penis or vagina, back pain, frequent or excessive urination than normal and rash. Call your doctor if the symptoms do not improve.
USES OF DAXIGA V TABLET
Treats type II diabetes mellitus in adults which is poorly controlled on metformin monotherapy
HOW DAXIGA V TABLET WORKS
DAXIGA V TABLET effectively lowers blood sugar levels where Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2) in kidneys which allows excretion of excessive glucose through urine and Vildagliptin decreases the glucose production in liver and increases the insulin sensitivity to absorb glucose.
DIRECTIONS FOR USE
Always take DAXIGA V TABLET as directed by your physician. Swallow with a glass of water. Do not chew or crush the medicine. Your doctor will advise the suitable dose and duration of treatment depending upon your age, body weight and disease condition. Do not stop taking DAXIGA V TABLET unless your doctor advises you to stop.
SIDE EFFECTS OF DAXIGA V TABLET
COMMON
Dizziness
Genital infection (thrush) of penis or vagina (itching, irritation, unusual discharge or odour)
Back pain
Frequent or excessive urination than normal
Rash
Changes in the blood cholesterol or fat level
Increased amount of red blood cells
Decrease in creatinine renal clearance in the beginning of treatment
UNCOMMON
Headache
Constipation, heartburn
Swelling of hands, feet or ankle and joint pain
Dehydration or loss of too much body fluid (very dry or sticky mouth, fast heartbeat, little or no urination)
Thirst
Waking in between sleep at night to pass urine
Weight loss
Increased urea and creatinine levels
RARE
Stop taking DAXIGA V TABLET and contact your doctor immediately if you experience any of the following side effects:
Angioedema (swollen face, throat or tongue, trouble swallowing and breathing, sudden onset of hives or rash)
Liver inflammation (yellowing of skin and eyes, nausea, loss of appetite, dark-coloured urine)
Inflammation of the pancreas (persistent and severe stomach pain which may radiate to your back, nausea, vomiting)
Diabetic ketoacidosis (nausea, vomiting, stomach pain, excessive thirst, deep and fast breathing, confusion, unusual tiredness or sleepiness, sweet breath odour, metallic or sweet taste in mouth or a different odour in your sweat, rapid weight loss)
Fournier’s gangrene or necrotising fasciitis of the perineum (soft tissue infection of genitals or between anus and genital which might be serious)
Urinary tract infection (fever, chills, burning sensation, seeing blood while urinating, back or side pain)
Low blood sugar level (sweating, shaking, anxiety, fast heartbeat, feeling hungry, headache, change in vision, mood changes or confusion)
New onset of blisters or ulcers
HOW TO MANAGE SIDE EFFECTS
Dizziness:
Lie or sit down promptly when you feel dizzy. If you’re feeling severe episode of spinning, lie in a dark and quite place and close your eyes. Try to avoid vehicle driving. If symptom persists, contact your doctor.
Diarrhoea:
To avoid dehydration of your body, drink plenty of fluids such as water, fruit juices or electrolytes. If symptom persists, contact your doctor.
Nausea or vomiting:
Take DAXIGA V TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.
Headache:
Apply hot or cold-water bag on your head. Try to rest in a quiet and dark room. Massage the scalp or head gently. Avoid the consumption of excessive alcohol, as it could make your headache worse. If symptom persists, contact your doctor.
Low blood sugar:
Drink a fruit juice or consume glucose tablets or gel, soft drinks, honey or sugary candy. Check your sugar level after 10 minutes. If it’s still not improved, take another sugary snack or drink and check the blood sugar again. If symptom persists, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
DAXIGA V TABLET is not recommended for use if you are pregnant or planning to have a baby. Consult your doctor before taking it.
BREASTFEEDING
DAXIGA V TABLET is not recommended for use in breastfeeding woman as it is not known if this medicine passes into breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy after taking DAXIGA V TABLET.
ALCOHOL
DAXIGA V TABLET should be used with caution in patients with a history of alcohol abuse. Consult your doctor for advice.
KIDNEY
DAXIGA V TABLET should be used with caution in patients having moderate or severe kidney disease and in those undergoing dialysis. Consult your doctor before taking it.
LIVER
DAXIGA V TABLET should be used with caution in patients with liver disease. Consult your doctor before taking it.
ALLERGY
Do not take DAXIGA V TABLET if you are allergic to Dapagliflozin, Vildagliptin or any of the other ingredients of this medicine.
HEART DISEASE
DAXIGA V TABLET should be used with caution in patients suffering from heart failure. Consult your doctor before taking it.
OTHERS
Before taking DAXIGA V TABLET, inform your doctor if you:
Have or had any pancreatic disease
Use in paediatrics:
DAXIGA V TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
DAXIGA V TABLET should be used with caution in elderly patients (above 65 years of age). Consult your doctor for advice.
INTERACTIONS
A. Drug – Drug interactions:
Before taking DAXIGA V TABLET, inform your doctor if you are taking any of the following medicines:
Other medicines used to lower blood sugar levels (Ex. glimepiride, glipizide)
Medicines used to remove excess body fluids from the body (Ex. methyclothiazide, trichlormethiazide, furosemide)
Medicines used to reduce inflammation (Ex. prednisolone, hydrocortisone)
Medicines used to treat underactive thyroid (Ex. levothyroxine, liothyronine)
Medicines used to treat fits (Ex. phenytoin, phenobarbital)
Overdosage:
If you or anyone else accidentally take too much of DAXIGA V TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
Drug : Dapagliflozin, Vildagliptin
Pharmacological Category : Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor, Dipeptidyl Peptidase 4 (DPP-4) inhibitor
Therapeutic Indication : Type II diabetes mellitus
Dosage Forms : Tablet
MORE INFORMATION
Keep DAXIGA V TABLET out of reach of children
Store DAXIGA V TABLET below 30°C
FAQs ABOUT DAXIGA V TABLET
Can DAXIGA V TABLET treatment affect my skin?
Not DAXIGA V TABLET, but diabetes has a complication of diabetic skin lesions. You should follow the recommendations for skin and foot care that you are given by your doctor and should pay particular attention to new onset of blisters or ulcers while taking DAXIGA V TABLET. Should these occur, you should immediately consult your doctor.
How long should I take DAXIGA V TABLET?
Take DAXIGA V TABLET every day for as long as your doctor advises you. You may have to take this medicine over a long period of time. Your doctor will regularly monitor your condition to ensure that DAXIGA V TABLET treatment is having the desired effect.
Does DAXIGA V TABLET cause weight loss?
Yes. DAXIGA V TABLET may cause weight loss in some individuals. To avoid weight loss, follow a healthy diet and regular exercise as advised by your physician. However, if the weight loss worries you, consult your doctor.
Can DAXIGA V TABLET cause vaginal infections?
Women taking DAXIGA V TABLET may get vaginal yeast infections because of one of its components (Dapagliflozin). If you experience white or yellowish vaginal discharge, vaginal odour or itching while taking DAXIGA V TABLET, consult your doctor immediately.
What should I do if I forgot to take DAXIGA V TABLET?
If you forget to take a dose by chance, try to take the next dose of DAXIGA V TABLET as soon as you notice. However, if the time for the next dose is closer, skip the missed dose and do not try to take a double dose.
Can DAXIGA V TABLET make me feel dehydrated?
One of the ingredients of DAXIGA V TABLET (Dapagliflozin) can make some people feel dehydrated (loss of body water and salt). If you feel dizzy, faint, lightheaded or weak, especially when you stand up, see your doctor immediately.
REFERENCES
1. KD. Tripathi. Insulin, Oral Anti Diabetic Drugs and Glucagon. Essentials of Medical Pharmacology. Eighth edition. 2013. Page – 298, 301.
2. PubChem Compound Summary for CID 9887712, Dapagliflozin. National Center for Biotechnology Information. PubChem. November 2022. [Accessed on 18th November 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Dapagliflozin
3. PubChem Compound Summary for CID 6918537, Vildagliptin. National Center for Biotechnology Information. PubChem. November 2022. [Accessed on 18th November 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Galvus#section=Mechanism-of-Action
4. Exemed Pharmaceuticals. TORGLIP D 5/ TORGLIP D 10 (Dapagliflozin + Vildagliptin). Torrent Pharmaceuticals Ltd. [Revised in April 2022]. [Accessed on 18th November 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3084.pdf
5. AstraZeneca UK Limited. Electronic Medicines Compendium (EMC). [Revised in October 2021]. [Accessed on 18th November 2022] https://www.medicines.org.uk/emc/files/pil.7607.pdf
6. Pharmadox Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2021]. [Accessed on 18th November 2022] https://www.medicines.org.uk/emc/files/pil.14086.pdf
USEFUL DIAGNOSTIC TESTS
Glucose – Fasting Blood
Glucose – Postprandial Blood
Glycosylated Hemoglobin
PRODUCT DETAILS
Country Of Origin
India
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