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INTRODUCTION
VYLDA D 10/100 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 VYLDA D 10/100 TABLET, inform your doctor if you have any liver, kidney, pancreatic or heart disease or if you are undergoing dialysis. VYLDA D 10/100 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 VYLDA D 10/100 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 VYLDA D 10/100 TABLET
- Treats type II diabetes mellitus in adults which is poorly controlled on metformin monotherapy
HOW VYLDA D 10/100 TABLET WORKS
VYLDA D 10/100 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 VYLDA D 10/100 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 VYLDA D 10/100 TABLET unless your doctor advises you to stop.
SIDE EFFECTS OF VYLDA D 10/100 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 VYLDA D 10/100 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 VYLDA D 10/100 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
VYLDA D 10/100 TABLET is not recommended for use if you are pregnant or planning to have a baby. Consult your doctor before taking it.
BREASTFEEDING
VYLDA D 10/100 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 VYLDA D 10/100 TABLET.
ALCOHOL
VYLDA D 10/100 TABLET should be used with caution in patients with a history of alcohol abuse. Consult your doctor for advice.
KIDNEY
VYLDA D 10/100 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
VYLDA D 10/100 TABLET should be used with caution in patients with liver disease. Consult your doctor before taking it.
ALLERGY
Do not take VYLDA D 10/100 TABLET if you are allergic to Dapagliflozin, Vildagliptin or any of the other ingredients of this medicine.
HEART DISEASE
VYLDA D 10/100 TABLET should be used with caution in patients suffering from heart failure. Consult your doctor before taking it.
OTHERS
Before taking VYLDA D 10/100 TABLET, inform your doctor if you:
- have or had any pancreatic disease
Use in paediatrics:
VYLDA D 10/100 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:
VYLDA D 10/100 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 VYLDA D 10/100 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 VYLDA D 10/100 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 VYLDA D 10/100 TABLET out of reach of children
- Store VYLDA D 10/100 TABLET below 30°C
FAQs ABOUT VYLDA D 10/100 TABLET
Can VYLDA D 10/100 TABLET treatment affect my skin?
Not VYLDA D 10/100 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 VYLDA D 10/100 TABLET. Should these occur, you should immediately consult your doctor.
How long should I take VYLDA D 10/100 TABLET?
Take VYLDA D 10/100 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 VYLDA D 10/100 TABLET treatment is having the desired effect.
Does VYLDA D 10/100 TABLET cause weight loss?
Yes. VYLDA D 10/100 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 VYLDA D 10/100 TABLET cause vaginal infections?
Women taking VYLDA D 10/100 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 VYLDA D 10/100 TABLET, consult your doctor immediately.
What should I do if I forgot to take VYLDA D 10/100 TABLET?
If you forget to take a dose by chance, try to take the next dose of VYLDA D 10/100 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 VYLDA D 10/100 TABLET make me feel dehydrated?
One of the ingredients of VYLDA D 10/100 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
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