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INTRODUCTION
OXRA 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 treat 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.
OXRA S 10/100 TABLET is not recommended for use in patients having severe kidney problems or those on dialysis. Before taking OXRA 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.
OXRA S 10/100 TABLET should be used in pregnant women only if considered clearly necessary. OXRA S 10/100 TABLET should be used with caution in breastfeeding women. Safety and effectiveness of OXRA 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 OXRA S 10/100 TABLET as it can help your body use its blood sugar better. The most common side effects of taking OXRA S 10/100 TABLET are nasopharyngitis (cold), headache and low blood sugar levels. Consult your doctor if any of the symptoms worsen or persist.
USES OF OXRA S 10/100 TABLET
- Treats type II diabetes mellitus in adults which is inadequately controlled on metformin monotherapy
HOW OXRA S 10/100 TABLET WORKS
OXRA 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 OXRA S 10/100 TABLET as advised by your physician. Swallow the medicine with water. Do not crush or chew it. OXRA S 10/100 TABLET can be taken with or without food. Your doctor will decide the correct dose and duration of OXRA S 10/100 TABLET treatment depending on your age, body weight and disease condition.
SIDE EFFECTS OF OXRA S 10/100 TABLET
COMMON
- low blood sugar
- nausea, vomiting
- flatulence, constipation
- swelling of hands or legs
- headache, dizziness
- upper respiratory infection
- 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
- elevated amount of cholesterol, fats and blood cells
- change in the creatinine level
- 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
- increased urea level
RARE
- reduced number of platelets
- angioedema (swollen face, tongue or throat, trouble swallowing and breathing, hives)
Stop taking OXRA 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
Nausea and vomiting:
Take OXRA S 10/100 TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. If symptom persists, contact your doctor.
Headache:
Rest and relax. Keep yourself hydrated by drinking more fluids like water or electrolytes. Applying a pain-relieving balm or cream on the forehead can be beneficial. Avoid the consumption of excessive alcohol, as it could aggravate your headache. If symptom persists, contact your doctor.
Constipation:
Eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. If symptom persists, contact your doctor.
Low blood sugar:
Drink a fruit juice or have glucose tablets or gel, soft drinks, honey or sugary candy. Check your blood sugar after 10 minutes. If it's still low, take another sugary snack or drink and check the blood sugar again. If symptom persists, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
OXRA S 10/100 TABLET should be used in pregnant women only if considered clearly necessary Consult your doctor for advice.
BREASTFEEDING
OXRA S 10/100 TABLET should be used with caution in breastfeeding women. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or drowsy after taking OXRA S 10/100 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking OXRA S 10/100 TABLET as it may increase the chances of diabetic ketoacidosis. Consult your doctor for advice.
KIDNEY
OXRA S 10/100 TABLET should be used with caution in patients who had or have any kidney problems. Consult your doctor for advice.
LIVER
OXRA S 10/100 TABLET should be used with caution in patients with severe liver impairment. Consult your doctor for advice.
ALLERGY
Do not take OXRA S 10/100 TABLET if you are allergic to Dapagliflozin, Sitagliptin or any of the other ingredients of this medicine.
HEART DISEASE
OXRA S 10/100 TABLET should be used with caution in patients who ever had heart failure. Consult your doctor for advice.
OTHERS
OXRA 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 OXRA 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
Use in pediatrics:
Safety and effectiveness of OXRA 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:
No dose adjustment of OXRA S 10/100 TABLET is required for elderly patients, however, consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking OXRA S 10/100 TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used to treat fungal infections (Ex. ketoconazole, itraconazole)
- ritonavir (used to treat HIV)
- clarithromycin (used to treat bacterial infections)
- ciclosporin (used to stop organ transplant rejection)
- digoxin (used to treat heart problems)
- medicines used to treat fluid retention (Ex. hydrochlorothiazide, furosemide)
- other medicines used to treat diabetes (Ex. metformin, insulin, glimepiride)
Overdosage:
If you or anyone else accidentally took more OXRA S 10/100 TABLET, contact your doctor immediately or go to a hospital straight away.
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 OXRA S 10/100 TABLET out of reach of children
- Store OXRA S 10/100 TABLET below 30°C
FAQs ABOUT OXRA S 10/100 TABLET
Does OXRA S 10/100 TABLET cause weight loss?
Yes. OXRA 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.
Can OXRA S 10/100 TABLET be taken with insulin?
Taking OXRA S 10/100 TABLET along with insulin might increase the chances of hypoglycemia (decreased blood sugar levels). Consult your doctor before taking any other medicine with OXRA S 10/100 TABLET.
How much OXRA S 10/100 TABLET should I take?
OXRA S 10/100 TABLET should be used only under medical supervision. Your doctor will decide the correct dose and duration of OXRA S 10/100 TABLET for you depending upon your age, body condition and severity of the disease condition.
Can OXRA S 10/100 TABLET cause vaginal infections?
Women taking OXRA S 10/100 TABLET may get vaginal yeast infections because of one of its ingredients (Dapagliflozin). If you experience vaginal odour, white or yellowish vaginal discharge or vaginal itching, call your doctor immediately.
Can OXRA S 10/100 TABLET make me feel dehydrated?
One of the ingredients of OXRA S 10/100 TABLET (Dapagliflozin) can cause some people to feel dehydrated (the loss of body water and salt). If you feel dizzy, faint, lightheaded or weak, especially when you stand up, call your doctor immediately.
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 18th November 2022] 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 18th November 2022] 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 18th November 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3096.pdf
5. Exemed Pharmaceuticals. Darasach S (Dapagliflozin + Sitagliptin). Ciplamed. [Revised in September 2022] [Accessed on 18th November 2022] https://www.ciplamed.com/content/dapasach-s-tablets
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
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