INTRODUCTION
SITADAC M is a combination of Metformin and Sitagliptin which belongs to the group of medicines called Antidiabetic agents. It is used as an adjunct to diet and exercise to reduce blood glucose level among patients with type II diabetes mellitus when treatment with single agents is not appropriate. Type II diabetes mellitus is a chronic medical condition in which the body cannot properly utilize the circulating sugars (glucose) from the blood to make energy. As a result, the patient experiences sudden unintentional weight loss, extreme tiredness, increased urination, thirst or hunger and slow healing ulcers. If left untreated, it can cause permanent damage to the nerves in the body and may to lead to other life-threatening complications.
Sitagliptin is a DPP-4 inhibitor. It helps pancreas to secrete more insulin (a hormone that digests glucose/sugar) by inhibiting an enzyme called Dipeptidyl peptidase 4. Metformin is a biguanide which acts by blocking the production of glucose by the liver. Collectively, SITADAC M decrease blood glucose levels and makes the body respond better to insulin. While taking SITADAC M, patients must continue to take carbohydrate-regularized diet as instructed by their doctor to obtain better results.
Before taking SITADAC M inform your doctor if you have type 1 diabetes mellitus, severe liver or kidney diseases, or heart problems. SITADAC M is not recommended for use in pregnant and breastfeeding women. The common side effects of SITADAC M are nausea, vomiting, diarrhea, stomach pain and changes in taste. Consult your doctor if any of the symptoms bother you.
USES OF SITADAC M
- used to treat type II diabetes mellitus along with diet and exercise
HOW SITADAC M WORKS
SITADAC M effectively reduces elevated blood glucose levels, where sitagliptin acts by increasing the release of insulin (a hormone secreted by pancreas that helps in digestion) by inhibiting the activity of an enzyme called Dipeptidyl peptidase 4 and metformin acts by blocking the production of glucose by the liver. They collectively decrease the elevated blood glucose levels and makes the body respond better to insulin.
DIRECTIONS FOR USE
Take SITADAC M as instructed by your doctor. Swallow it as a whole and do not crush or chew it.
SIDE EFFECTS OF SITADAC M
COMMON
- low blood sugar levels
- nausea, vomiting
- flatulence, diarrhea, constipation, stomach pain
- swelling of the hands or legs
- headache
- upper respiratory infection
- stuffy or runny nose and sore throat
- joint pain or leg pain
- loss of appetite
- metallic taste in mouth
UNCOMMON
- dizziness, drowsiness
- dryness of mouth
- skin itching
RARE
- reduced number of platelet count which may cause increased tendency to bleed, or infections
Stop taking SITADAC M and consult your doctor immediately, if you experience:
- signs of lactic acidosis (such as generalized weakness and tiredness, vomiting, stomach pain, muscle pain, difficulty in breathing, reduced body temperature and decreased heartbeat)
- signs of dehydration (such as severe vomiting, diarrhea, fever, exposure to heat)
- signs of inflammation in pancreas (such as severe and persistent stomach pain which might radiate to your back with or without nausea and vomiting)
- signs of serious allergic reaction (such as skin rash, itching, blisters and peeling of skin, swelling of the face, lips, tongue, and throat which may cause difficulty in breathing or swallowing)
HOW TO MANAGE SIDE EFFECTS
Low blood sugar:
During signs of low blood sugar levels, immediately consume a meal or a snack which are fast acting, like fruit juices. Follow the carbohydrate-regularized diet as instructed by your doctor to obtain better results. Consult your doctor if the signs of low blood sugar levels do not improve.
Nausea and vomiting:
Try to take SITADAC M with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich or spicy foods.
Diarrhea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom does not improve.
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
SITADAC M is not recommended for use in pregnant women. However, consult your doctor before taking.
BREASTFEEDING
SITADAC M is not recommended for use in breastfeeding women. However, consult your doctor before taking.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if your ability is affected by SITADAC M.
ALCOHOL
Avoid alcohol consumption while taking SITADAC M as it can increase blood sugar levels further and may lead to unwanted side effects.
KIDNEY
SITADAC M is not recommended in patients with severe kidney problems. Consult your doctor before taking.
LIVER
SITADAC M is not recommended in patients with liver problems. Consult your doctor before taking.
ALLERGY
Do not take SITADAC M if you are allergic to Metformin or Sitagliptin.
HEART DISEASE
SITADAC M is not recommended for use in patients who have or recently had heart problems (like heart attack or circulatory failure). Consult your doctor before taking.
OTHERS
SITADAC M is not recommended for use if you:
- have uncontrolled diabetes (very high blood glucose levels that remains unresponsive to therapy)
- have metabolic acidosis (buildup of acids or ketone bodies in the body which can cause sever weakness, dizziness, nausea, stomach pain, muscle pain which could be fatal)
- have severe dehydration, severe infection
- are going to have a radiograph with contrast
Before taking SITADAC M, inform your doctor if you:
- have or even had pancreatitis (inflammation of pancreas causing nausea, vomiting, upper stomach pain that radiates towards your back, fever)
- have or ever had stones in gall bladder
- are alcoholic
- have very high levels of fats in blood
- have type I diabetes (insulin-dependent diabetes)
- are scheduled for a surgery
Use in Pediatrics:
- SITADAC M is generally not recommended for use in children and adolescents under 18 years of age. Consult your doctor before taking.
Use in Geriatrics:
- SITADAC M should be used with caution in elderly patients. Consult your doctor before taking.
INTERACTIONS
A. Drug - Drug interactions:
Before taking SITADAC M, inform your doctor if you are taking any of the following medicines:
- corticosteroids (used to treat pain and inflammatory conditions like asthma or arthritis) Ex. dexamethasone, hydrocortisone
- diuretics (used to increase urine production) Ex. furosemide, hydrochlorothiazide
- non-steroidal anti-inflammatory medicines (used to treat pain and inflammation) such as ibuprofen and celecoxib
- medicines used to treat high blood pressure such as ACE inhibitors (Ex. captopril, enalapril) and angiotensin II receptor antagonists (Ex. losartan, telmisartan)
- beta-sympathomimetics (used to treat bronchial asthma) Ex. formoterol, salmeterol
- iodinated contrast agents (used prior to X-rays)
- alcohol-containing medicines (Ex. cough medications)
- cimetidine (used to treat stomach ulcer)
- ranolazine (used to treat chest pain)
- dolutegravir (used to treat HIV infection)
- vandetanib (used to treat thyroid cancer)
- digoxin (used to treat abnormal heartbeat)
Overdosage:
If you or anyone else accidentally take too much of SITADAC M, consult your doctor immediately. Overdose may cause signs of lactic acidosis (such as generalized weakness and tiredness, vomiting, stomach pain, muscle pain, rapid breathing, reduced body temperature, feeling cold or uncomfortable and decreased heartbeat).
SYNOPSIS
| Drug | : | Sitagliptin, Metformin |
| Pharmacological Category | : | DPP-4 inhibitor, Biguanide |
| Therapeutic Indication | : | Type II diabetes mellitus |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep SITADAC M out of reach of children
- Store SITADAC M at room temperature
FAQs ABOUT SITADAC M
Can I stop taking SITADAC M when my symptoms are relieved?
No, do not stop taking SITADAC M once your symptoms subside, because it may make your blood glucose levels high once again. Continue to take SITADAC M as instructed by your doctor to obtain better results.
Can I consume alcohol while taking SITADAC M?
No. Do not consume alcohol while taking SITADAC M as it can increase your blood sugar levels further.
What are the precautions do I need to follow while taking SITADAC M?
Before taking SITADAC M inform your doctor if you are pregnant or breastfeeding or if you have type I diabetes or any other conditions affecting your liver, kidney, or heart function. Inform your doctor if you have any signs of infections. Make sure to drink plenty of fluids to avoid dehydration and urinary infections. While taking SITADAC M, always carry a sugary snack or meal with you, so that it can help you to cope up sudden episodes of dizziness or fainting caused due to low blood sugar levels. Regularly monitor your blood glucose levels and kidney functions as instructed by your doctor without fail.
What are the possible side effects of SITADAC M?
SITADAC M can cause nausea, vomiting, diarrhea, stomach pain and changes in taste sensation. However, these side effects are usually temporary and gets resolved within two weeks of time. If they persist for longer period, contact your doctor
Can SITADAC M be taken along with antidiabetic medicines?
SITADAC M should be used with other antidiabetic medicine only under close monitoring. Avoid concomitant use of any other antidiabetic medicine with SITADAC M on your own without consulting your doctor as it can cause a very low blood sugar level in you.
REFERENCES
1. KD Tripathi MD. Insulin, Oral Hypoglycaemic Drugs and Glucagon. Hormones and related drugs. Essentials of Medical Pharmacology 7th ed. New Delhi, May 2013. Page – 274-276.
2. Erin L. St. Onge, Shannon Miller and Elizabeth Clements. Sitagliptin/Metformin (Janumet) as Combination Therapy In the Treatment of Type-2 Diabetes Mellitus. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 2018. [Accessed 1st November 2021]. December 2012. [Accessed on 26th March 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3541863
3. Chitrabhanu Ballav and Stephen C.L. Gough. Safety and Efficacy of Sitagliptin-Metformin in Fixed Combination for the Treatment of Type 2 Diabetes Mellitus. 2013. [Accessed on 26th March 2022] https://journals.sagepub.com/doi/pdf/10.4137/CMED.S7314
4. Merck Sharp & Dohme (UK) Limited. Electronic Medicines Compendium (EMC) [Revised on November 2021] [Accessed on 26th March 2022] https://www.medicines.org.uk/emc/files/pil.564.pdf
5. Merck Sharp & Dohme Corp. U.S. Food & Drug Administration. [Revised in February 2013] [Accessed on 26th March 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
PRODUCT DETAILS
ALTERNATE BRANDS
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