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INTRODUCTION
DAPAVEL S 10/100 TABLET is a combination of Dapagliflozin and Sitagliptin which belongs to the group of medicines called Antidiabetic agents. It is used in adults to manage type II diabetes mellitus which is inadequately controlled on metformin monotherapy.
Type 2 diabetes is a condition in which your body does not 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 high blood sugar levels.
DAPAVEL S 10/100 TABLET is not recommended for use in patients having severe kidney problems or those on dialysis. Before taking DAPAVEL S 10/100 TABLET, inform your doctor if you have inflammation of the pancreas, gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat) in the blood or any heart, kidney or liver problems.
DAPAVEL S 10/100 TABLET should be used in pregnant women only if considered clearly necessary. DAPAVEL S 10/100 TABLET should be used with caution in breastfeeding women. Safety and effectiveness of DAPAVEL S 10/100 TABLET in children and adolescents (under 18 years of age) have not been established.
It is important to stay on the diet and exercise recommended by your doctor while taking DAPAVEL S 10/100 TABLET as it can help your body use its blood sugar better. The most common side effects of taking DAPAVEL S 10/100 TABLET are nausea, headache, flatulence and constipation. Consult your doctor if any of the side effects worsen or persist for a long period of time.
USES OF DAPAVEL S 10/100 TABLET
- To manage type II diabetes mellitus (which is inadequately controlled on metformin monotherapy)
HOW DAPAVEL S 10/100 TABLET WORKS
DAPAVEL S 10/100 TABLET effectively controls blood sugar levels where dapagliflozin inhibits SGLT2, increasing urinary glucose excretion and reducing blood levels of glucose and sitagliptin inhibits DPP-4, increases glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), resulting in increased insulin synthesis and decreased glucagon release.
DIRECTIONS FOR USE
Take DAPAVEL S 10/100 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DAPAVEL S 10/100 TABLET can be taken with or without food. Your doctor will decide the correct dose and duration of DAPAVEL S 10/100 TABLET therapy depending on your age, body weight and disease condition.
SIDE EFFECTS OF DAPAVEL S 10/100 TABLET
COMMON
- nausea, vomiting
- flatulence, constipation
- swelling of hands or legs
- headache, dizziness
- stuffy or runny nose, sore throat
- osteoarthritis
- back, arm or leg pain
- infection (thrush) of the penis or vagina (irritation, itching, unusual discharge or odor)
- passing urine more often
- rash
UNCOMMON
- stomach pain, diarrhea
- drowsiness
- dry mouth
- itching
- waking up at night to urinate
- dehydration (dry or sticky mouth, passing little or no urine or fast heartbeat)
- thirst
- weight decreased
RARE
- angioedema (swollen face, tongue or throat, trouble swallowing and breathing, hives)
Stop taking DAPAVEL S 10/100 TABLET and contact your physician immediately if you experience any of the following side effects:
- inflamed pancreas (severe and persistent stomach pain that might reach through the back with or without nausea and vomiting)
- serious allergic reaction (rash, hives, blisters on the skin or peeling skin and swelling of the lips, tongue, face and throat that may cause difficulty in breathing or swallowing)
- necrotising fasciitis of the perineum or Fournier’s gangrene (serious soft tissue infection of the genitals or the area between the genitals and the anus causing pain, tenderness, redness or swelling)
- diabetic ketoacidosis (increased levels of ketone bodies in urine or blood, nausea or vomiting, stomach ache, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to breathe, a sweet or metallic taste in the mouth or a different odor in urine or sweat, rapid weight loss)
- urinary tract infection (fever, chills, burning sensation when passing urine, pain in the back or side, blood in urine)
- low blood sugar levels (shaking, sweating, feeling very anxious, fast heartbeat, feeling hungry, headache, change in vision, and a change in mood or feeling confused)
HOW TO MANAGE SIDE EFFECTS
Constipation
Eat plenty of fiber-rich foods such as fresh fruits, vegetables, cereals and drink plenty of water. Exercise more regularly. If symptom persists, consult your doctor.
Dry Mouth
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
Headache
Rest and relax. Keep yourself hydrated by drinking more fluids like water. Applying a pain-relieving balm on the forehead can be beneficial. Avoid consumption of alcohol, as it could aggravate your headache. If symptom persists, consult your doctor.
Nausea And Vomiting
Take DAPAVEL S 10/100 TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy food. If symptom persists, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
SafeDAPAVEL S 10/100 TABLET can be used in pregnant women only if considered clearly necessary. Consult your before taking it.
BREASTFEEDING
Use with CautionDAPAVEL S 10/100 TABLET can be used with caution in breastfeeding women. Consult your before taking it.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any machines if you feel dizzy or sleepy after taking DAPAVEL S 10/100 TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking DAPAVEL S 10/100 TABLET as it may increase the chance of diabetic ketoacidosis. Consult your doctor for advice.
KIDNEY
Use with CautionDAPAVEL S 10/100 TABLET can be used with caution in patients who had or have any kidney problems. Consult your doctor before taking DAPAVEL S 10/100 TABLET.
LIVER
Use with CautionDAPAVEL S 10/100 TABLET can be used with caution in patients with severe liver impairment. Consult your doctor before taking DAPAVEL S 10/100 TABLET.
ALLERGY
Use with CautionDo not take DAPAVEL S 10/100 TABLET if you are allergic to Dapagliflozin, Sitagliptin or any other ingredients of this medicine.
HEART DISEASE
Use with CautionDAPAVEL S 10/100 TABLET can be used with caution in patients who ever had heart failure. Consult your doctor before taking DAPAVEL S 10/100 TABLET.
USE IN PEDIATRICS
Consult your doctorSafety and effectiveness of DAPAVEL S 10/100 TABLET in children and adolescents (under 18 years of age) have not been established. Consult your child’s doctor for advice.
USE IN GERIATRICS
SafeNo dose adjustment of DAPAVEL S 10/100 TABLET is required for elderly patients, however, consult your doctor before taking it.
OTHERS
DAPAVEL S 10/100 TABLET is not recommended for use if you have:
- type I diabetes mellitus
- diabetic ketoacidosis (enhanced levels of ketone bodies in the blood)
Before taking DAPAVEL S 10/100 TABLET inform your doctor if you:
- have inflammation of the pancreas
- have gallstones
- have alcohol dependence
- have very high levels of triglycerides (a form of fat) in the blood
- are fasting
- are dehydrated
INTERACTIONS
A. Drug-Drug interactions:
Before taking DAPAVEL S 10/100 TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used to manage fungal infections (Ex. ketoconazole, itraconazole)
- ritonavir (used to manage HIV)
- clarithromycin (used to manage bacterial infections)
- ciclosporin (used to stop organ transplant rejection)
- digoxin (used to manage heart problems)
- medicines used to manage fluid retention (Ex. hydrochlorothiazide, furosemide)
- other medicines used to manage diabetes (Ex. metformin, insulin, glimepiride)
Overdosage:
If you or anyone else accidentally take too much of DAPAVEL S 10/100 TABLET, consult your doctor or visit a nearby hospital immediately.
SYNOPSIS
| Drug | : | Dapagliflozin, Sitagliptin |
| 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 DAPAVEL S 10/100 TABLET out of reach of children
- Store DAPAVEL S 10/100 TABLET below 30°C
FAQs ABOUT DAPAVEL S 10/100 TABLET
Q: What is DAPAVEL S 10/100 TABLET and why is it prescribed?
A: DAPAVEL S 10/100 TABLET is a combination of Dapagliflozin and Sitagliptin which belongs to the group of medicines called Antidiabetic agents. It is used in adults to manage type II diabetes mellitus which is inadequately controlled on metformin monotherapy.
Q: Does DAPAVEL S 10/100 TABLET cause weight loss?
A: Yes, DAPAVEL S 10/100 TABLET may cause weight loss in some individuals. To avoid weight loss, follow a healthy diet and regular physical activity as advised by your physician. However, if the weight loss bothers you, consult your doctor.
Q: Can DAPAVEL S 10/100 TABLET be taken along with insulin?
A: Taking DAPAVEL S 10/100 TABLET along with insulin might increase the chance of hypoglycemia (decreased blood sugar levels). Consult your doctor before taking any other medicine with DAPAVEL S 10/100 TABLET.
Q: How does DAPAVEL S 10/100 TABLET work?
A: DAPAVEL S 10/100 TABLET effectively controls blood sugar levels where dapagliflozin inhibits SGLT2, increasing urinary glucose excretion and reducing blood levels of glucose and sitagliptin inhibits DPP-4, increases glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), resulting in increased insulin synthesis and decreased glucagon release.
Q: Is DAPAVEL S 10/100 TABLET safe to use in patients with kidney problems?
A: DAPAVEL S 10/100 TABLET can be used with caution in patients who had or have any kidney problems. Your doctor may monitor your kidney function test before and during management with this medicine to prevent the risk of any unusual effects. Consult your doctor before taking DAPAVEL S 10/100 TABLET.
REFERENCES
1. KD. Tripathi. Insulin, Oral Antidiabetic Drugs and Glucagon. Essentials of Medical Pharmacology. Eighth edition. 2019. Page – 297 & 301.
2. Serge A. Jabbour; Elise Hardy; Jennifer Sugg; Shamik Parikh. Dapagliflozin Is Effective as Add-on Therapy to Sitagliptin With or Without Metformin: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Diabetes care. American Diabetes Association. February 2014. [Accessed on 27th November 2023] https://diabetesjournals.org/care/article/37/3/740/29499/Dapagliflozin-Is-Effective-as-Add-on-Therapy-to
3. Annaswamy Raji, Zhi Jin Xu, Raymond L. H. Lam, Edward A.O’Neill, Keith D. Kaufman, Samuel S. Engel. Ef?cacy and Safety of Sitagliptin Compared with Dapagli?ozin in People ≥65 Years Old with Type 2 Diabetes and Mild Renal Insuf?ciency. SpringerLink. August 2020. [Accessed on 27th November 2023] https://link.springer.com/article/10.1007/s13300-020-00907-w
4. Torrent Pharmaceuticals Ltd. Sitaxa D/ Sitalix D/Glucreta S (Dapagliflozin + Sitagliptin). [Revised in July 2022] [Accessed on 27th November 2023] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3096.pdf
5. Cipla Ltd. Exemed Pharmaceuticals. Darasach S (Dapagliflozin + Sitagliptin). Ciplamed. [Revised in September 2022] [Accessed on 27th November 2023] https://www.ciplamed.com/content/dapasach-s-tablets
USEFUL DIAGNOSTIC TESTS
- HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin Glycosylated Hemoglobin
- Blood Glucose Fasting (FBS)
- Random Blood Sugar (Rbs)
- Post Prandial Blood Sugar (PPBS)
- Comprehensive Diabetes Care
- Diabetes Screening
- Diabetes Care Package
- Jaanch Diabetic Profile Basic
- Diabetes Care Package - Essential
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 27 Nov 2023 | 06:05 PM(IST)
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