Introduction About DAPALEX S 10/100 TABLET

DAPALEX S 10/100 TABLET is used to manage type II diabetes mellitus which is inadequately controlled on metformin monotherapy. It is a combination of Dapagliflozin and Sitagliptin which belongs to the group of medicines called Antidiabetic agents. It 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.

DAPALEX S 10/100 TABLET is not recommended for use in patients having severe kidney problems or those on dialysis. Before taking the medicine, inform your doctor if you have inflammation of the pancreas, gallstones, alcohol dependence, or very high levels of triglycerides in the blood or any heart, kidney or liver problems. It should be used in pregnant women only if considered clearly necessary. It should be used with caution in breastfeeding women. Safety and effectiveness of DAPALEX 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 DAPALEX S 10/100 TABLET as it can help the body use its blood sugar better. The most common side effects are headache, flatulence and constipation. Consult your doctor if any of the side effects worsen or persist for a longer period of time.

Uses Of DAPALEX S 10/100 TABLET

• Used to manage type II diabetes mellitus (which is inadequately controlled on metformin monotherapy)

How DAPALEX S 10/100 TABLET Works

DAPALEX 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.

How to use DAPALEX S 10/100 TABLET

• Take DAPALEX S 10/100 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 food
• Your doctor will decide the correct dose and duration of DAPALEX S 10/100 TABLET therapy depending on your age, body weight and disease condition.

Side Effects Of DAPALEX S 10/100 TABLET

Common Side Effects of DAPALEX S 10/100 TABLET:

• flatulence, constipation, stomach pain, diarrhea
• swelling of hands or legs
• headache, dizziness
• stuffy or runny nose, sore throat
• passing urine more often
• dry mouth

Stop taking DAPALEX 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)
• 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)

Warning & Precautions

Pregnancy

Consult your doctor

If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breastfeeding

Consult your doctor

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and Using Machines

Use with Caution

Do not drive or operate any machines if you feel dizzy or sleepy after taking DAPALEX S 10/100 TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking DAPALEX S 10/100 TABLET as it may increase the chance of diabetic ketoacidosis.  

Kidney

Use with Caution

DAPALEX S 10/100 TABLET can be used with caution in patients who had or have any kidney problems.

Liver

Use with Caution

DAPALEX S 10/100 TABLET can be used with caution in patients with severe liver impairment.

Allergy

Contraindicated

Do not take DAPALEX S 10/100 TABLET if you are allergic to Dapagliflozin, Sitagliptin or any other ingredients of this medicine.

Heart Disease

Use with Caution

DAPALEX S 10/100 TABLET can be used with caution in patients who have heart failure.

Use In Pediatrics

Consult your doctor

Safety and effectiveness of DAPALEX S 10/100 TABLET in children and adolescents (under 18 years of age) have not been established.  

Use In Geriatrics

Consult your doctor

No dose adjustment is required for elderly patients.

Interactions

A. Drug-Drug interactions:

Before taking DAPALEX S 10/100 TABLET, inform your doctor if you are taking any of the following medicines:

• Anti-fungal (Ex. ketoconazole, itraconazole)
• Anti-viral agents (Ex. Ritonavir)
• Antibiotics (Ex. Clarithromycin)
• Immunosuppressants (Ex. Ciclosporin)
• Cardiac glycosides (Ex. Digoxin)
• Diuretics (Ex. hydrochlorothiazide, furosemide)
• Anti-diabetics (Ex. metformin, insulin, glimepiride)

Overdosage:

If you or anyone else accidentally takes too much of DAPALEX S 10/100 TABLET, consult your doctor or visit a nearby hospital immediately.

Synopsis

FAQs About DAPALEX 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]  click here

3. Annaswamy Raji, Zhi Jin Xu, Raymond L. H. Lam, Edward A.O’Neill, Keith D. Kaufman, Samuel S. Engel. Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in People ≥65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency. SpringerLink. August 2020. [Accessed on 27th November 2023]  click here

4. Torrent Pharmaceuticals Ltd. Sitaxa D/ Sitalix D/Glucreta S (Dapagliflozin + Sitagliptin). [Revised in July 2022] [Accessed on 27th November 2023] click here

5. Cipla Ltd. Exemed Pharmaceuticals. Darasach S (Dapagliflozin + Sitagliptin). Ciplamed. [Revised in September 2022] [Accessed on 27th November 2023]  click here

User Feedback

Useful Diagnostic Tests

• HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
• Random Blood Sugar (RBS)
• Post Prandial Blood Sugar (PPBS)
• Fasting Blood Sugar (FBS)
• Sugar Risk Package

Author Details

Written By Srilekha. R - B.Pharm

Reviewed By Dr. Sankara Babu Gorle - MBBS, MD(Pharmacology) View profile

Last updated on 20 Nov 2024 | 09:28 AM(IST)