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INTRODUCTION
SITAZIT M 500 TABLET is a combination of Metformin and Sitagliptin which belongs to the group of medicines called Antidiabetic agents. It is used to control blood sugar levels in patients with type II diabetes mellitus along with proper diet and exercise.
Type II diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused due to inadequate production of a hormone called insulin (produced by pancreas to metabolize glucose) in the body or due to inadequate sensitivity of body cells to the actions of insulin.
Before taking SITAZIT M 500 TABLET inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have high blood cholesterol levels, severe systemic infections or are severely dehydrated due to excessive vomiting or diarrhea recently.
During therapy with SITAZIT M 500 TABLET, your doctor might regularly monitor your blood sugar levels and kidney functions to avoid the risk of unwanted side effects. He might also ask you to make certain lifestyle changes such as following a healthy diet, regular physical exercise and quitting alcohol consumption to achieve better results.
SITAZIT M 500 TABLET is not recommended for use in patients with severe uncontrollable diabetes. It is also not suitable for use in patients with alcoholism, shock or problems in breathing or blood circulation.
Consult your doctor before taking SITAZIT M 500 TABLET if you are pregnant or breastfeeding. The most common side effects of taking SITAZIT M 500 TABLET are low blood sugar levels, stomach upset, constipation, flatulence, metallic taste in mouth, sore throat, stuffy nose and joint pain. Consult your doctor if they bother you.
USES OF SITAZIT M 500 TABLET
- Manage type II diabetes mellitus
HOW SITAZIT M 500 TABLET WORKS
SITAZIT M 500 TABLET is an antidiabetic medicine. It contains two medicines namely metformin and sitagliptin. Metformin makes the body more sensitive to insulin (a hormone involved in glucose metabolism). This helps our body cells to utilize more amount of the circulating blood glucose. Additionally, it can stop glucose production by the liver and reduces its absoprtion in the body.
Teneligliptin controls blood sugar levels by blocking the actions of an enzyme called dipeptidyl peptidase (DPP)-4 that reduces insulin secretion in the body. Collectively, SITAZIT M 500 TABLET controls blood sugar levels and improve glycemic control in patients with type II diabetes.
DIRECTIONS FOR USE
Take SITAZIT M 500 TABLET preferably after meals or as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking SITAZIT M 500 TABLET unless your doctor advice you to stop.
SIDE EFFECTS OF SITAZIT M 500 TABLET
SERIOUS
Stop taking SITAZIT M 500 TABLET and consult your doctor immediately if you experience any of the following side effects:
- serious allergic reaction (such as hives, swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing)
- severe blistering of the skin (signs of an allergic skin reaction called bullous pemphigoid)
- signs of pancreatitis (severe and persistent pain in the stomach areas which might reach through to your back with or without nausea and vomiting)
- signs of lactic acidosis (cold hands or feet, dizziness or light-headedness, slow or irregular heartbeat, weakness or tiredness, unusual muscle pain, trouble breathing, sleepiness or drowsiness, stomach pains, nausea or vomiting)
COMMON
- hypoglycemia (low blood sugar)
- nausea, vomiting
- flatulence, diarrhea, constipation, stomach pain, loss of appetite
- swelling of hands and legs (edema)
- upper respiratory infections
- stuffy nose, sore throat
- joint pain, pain in arms or legs
- metallic taste
UNCOMMON
- drowsiness, dizziness
- dry mouth
- headache
- skin itching
HOW TO MANAGE SIDE EFFECTS
Constipation
Taking SITAZIT M 500 TABLET with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Headache
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Hypoglycemia
Have foods rich in sugars such as fruit juices, glucose drinks, candies, honey or biscuits. Check your blood sugar after 10 minutes. If not gained optimum level, take another sugary snack or a drink and check your blood sugar levels once again. Contact your doctor if there is no improvement in your condition.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedSITAZIT M 500 TABLET is not recommended for use in pregnant women. Therefore, inform your doctor before taking SITAZIT M 500 TABLET if you are pregnant, think you may be pregnant or planning to have a baby.
BREASTFEEDING
ContraindicatedSITAZIT M 500 TABLET is not recommended for use in breastfeeding women. However, consult your doctor before taking it.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any machines if you feel dizzy after taking SITAZIT M 500 TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking SITAZIT M 500 TABLET as it may increase the risk of unwanted side effects.
KIDNEY
ContraindicatedSITAZIT M 500 TABLET is not recommended for use in patients with severely reduced kidney functions. Therefore, consult your doctor before taking it.
LIVER
Consult your doctorSITAZIT M 500 TABLET is not recommended for use in patients with severe liver problems. It should be used with caution in patients with gall stones. Therefore, consult your doctor before taking it.
ALLERGY
ContraindicatedDo not take SITAZIT M 500 TABLET if you are allergic to Metformin or Sitagliptin.
HEART DISEASE
ContraindicatedSITAZIT M 500 TABLET is not recommended for use in patients with severe heart problems (such as acute heart failure or a recent heart attack). Therefore, consult your doctor before taking it.
USE IN PEDIATRICS
ContraindicatedSITAZIT M 500 TABLET is not recommended for use in children and adolescents (aged below 18 years). However, consult your doctor before taking it.
USE IN GERIATRICS
Use with CautionSITAZIT M 500 TABLET should be used with caution in elderly patients (aged above 65 years). Therefore, consult your doctor before taking it.
OTHERS
SITAZIT M 500 TABLET is not recommended for use if you:
- have severe, uncontrollable diabetes
- have nausea, vomiting, diarrhea or rapid weight loss
- have lactic acidosis or ketoacidosis (buildup of lactic acid or ketones in the body)
- are dehydrated (due to drinking less fluid or had severe vomiting or diarrhea during the recent days)
- have any severe systemic infection
- have shock or problems in blood circulation
- have problems in breathing
- are an alcoholic
- are scheduled for any X-rays in the upcoming days
Before taking SITAZIT M 500 TABLET, inform your doctor if you:
- have or ever had pancreatitis (inflammation of the pancreas)
- have alcohol dependence
- have high blood lipids levels
- have type I diabetes mellitus (insulin-dependent diabetes)
- are about a have a major surgery
- are in fasting
- are malnourished, starved, on an irregular diet or feeling weak
- perform extreme muscle exercises
- have Vitamin B12 deficiency
INTERACTIONS
A. Drug-Drug interactions:
Before taking SITAZIT M 500 TABLET, inform your doctor if you are taking any of the following medicines such as:
- other medicines used to treat diabetes (Ex. glimepiride, glyburide, gliclazide, teneligliptin, rosiglitazone, pioglitazone)
- iodine contrast medium (used during X-rays)
- medicines used to treat asthma (Ex. salbutamol or terbutaline)
- corticosteroids (used to treat pain and inflammation) Ex. hydrocortisone, prednisolone
- diuretics (used to reduce edema and to treat hypertension) Ex. furosemide, hydrochlorothiazide
- medicines used to treat pain and inflammation (such as ibuprofen and celecoxib)
- medicines used to treat high blood pressure (such as atenolol, propranolol, captopril, enalapril, ramipril, lisinopril, losartan, valsartan, olmesartan, telmisartan)
- alcohol containing medicines (such as cough syrups)
- cimetidine (a medicine used to treat stomach ulcer)
- dolutegravir (a medicine used to treat HIV infection)
- ranolazine (a medicine used to treat chest pain)
- trimethoprim (a medicine used to treat bacterial infection)
- digoxin (a medicine used to treat irregular heartbeat)
Overdosage:
If you or anyone else accidentally took more SITAZIT M 500 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscular cramps and fast breathing.
SYNOPSIS
| Drug | : | Metformin, Sitagliptin |
| Pharmacological Category | : | Biguanides, DPP-4 Inhibitors |
| Therapeutic Indication | : | Type II Diabetes mellitus |
| Dosage Forms | : | Tablet, Capsule, Combi pack |
MORE INFORMATION
- Keep SITAZIT M 500 TABLET out of the sight and reach of children
- Store SITAZIT M 500 TABLET below 30°C
FAQs ABOUT SITAZIT M 500 TABLET
Q: What is SITAZIT M 500 TABLET used for?
A: SITAZIT M 500 TABLET is an antidiabetic medicine used as an adjunct to diet and exercise to control blood sugar levels in patients with type II diabetes mellitus.
Q: How and when to take SITAZIT M 500 TABLET?
A: Take SITAZIT M 500 TABLET preferably after meals or as advised by your physician. Swallow the medicine with a glass of water. Do not cursh or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
Q: How long should I take SITAZIT M 500 TABLET?
A: You need to take SITAZIT M 500 TABLET as long as your doctor or physician prescribes you the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
Q: What is the best time to take SITAZIT M 500 TABLET?
A: SITAZIT M 500 TABLET must be taken with meals to avoid gastrointestinal side effects.
Q: What to do if I forgot to take a dose of SITAZIT M 500 TABLET?
A: If you forgot to take a dose of SITAZIT M 500 TABLET, take it as soon as you remember. However, if it is time for the next dose of SITAZIT M 500 TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of SITAZIT M 500 TABLET to compensate the missed ones.
Q: What are the most common side effects of taking SITAZIT M 500 TABLET?
A: The most common side effects of taking SITAZIT M 500 TABLET are low blood sugar levels, stomach upset, constipation, flatulence, metallic taste in mouth, sore throat, stuffy nose and joint pain. Consult your doctor if they bother you.
Q: Can I stop taking SITAZIT M 500 TABLET without consulting your doctor?
A: No. You should not stop taking SITAZIT M 500 TABLET without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using SITAZIT M 500 TABLET, consult your doctor for advice.
Q: Will taking a higher dose of SITAZIT M 500 TABLET be more effective?
A: No, taking a higher dose of SITAZIT M 500 TABLET will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
Q: What precautions do I need to follow while taking SITAZIT M 500 TABLET?
A: Before taking SITAZIT M 500 TABLET inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have high blood cholesterol levels, severe systemic infections or are severely dehydrated due to excessive vomiting or diarrhea recently. Along with the therapy, follow the diet and lifestyle changes advised by your doctor to achieve better results. Consult your doctor before taking SITAZIT M 500 TABLET if you are pregnant or breastfeeding.
Q: Can I take medication for high blood pressure along with SITAZIT M 500 TABLET?
A: It is not advisable to take medicines to control blood pressure while taking SITAZIT M 500 TABLET without consulting your doctor. Therefore, consult your doctor before taking any antihypertensive such as beta blockers (Ex. atenolol, propranolol) along with SITAZIT M 500 TABLET as they have known interactions with SITAZIT M 500 TABLET.
Q: What should I do if I experience low blood sugar after taking SITAZIT M 500 TABLET?
A: Low blood sugar is a common side effect of taking SITAZIT M 500 TABLET. If you experience any signs of low blood sugar levels (such as increased hunger, sweating, shakiness, weakness or an irregular heartbeat), consume a sugary snack or sugar drink immediately. Consult your doctor if the symptom did not improve.
Q: Can SITAZIT M 500 TABLET be taken with insulin?
A: Co-administration of SITAZIT M 500 TABLET with insulin is considered risky as they increase the chance of hypoglycemia (decreased blood sugar levels). Therefore, consult your doctor before taking it.
Q: Can SITAZIT M 500 TABLET be used in pregnant women?
A: SITAZIT M 500 TABLET is not recommended for use in pregnant women. Therefore, consult your doctor for advice.
Q: How to take SITAZIT M 500 TABLET?
A: You must take SITAZIT M 500 TABLET as advised by your physician. Try to take this medicine preferably after meals and swallow it with a glass of water. Do not crush or chew the medicine.
Q: How much SITAZIT M 500 TABLET should I take?
A: SITAZIT M 500 TABLET should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.
Q: Can SITAZIT M 500 TABLET cause constipation?
A: Yes. Constipation is a common side effect of using SITAZIT M 500 TABLET. Eat plenty of fiber rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly when taking this medicine. Contact your doctor if this side effect bothers you.
REFERENCES
1. KD. Tripathi. Insulin, Oral Hypoglycaemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 274 & 275.
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. PMC. PubMed Central. December 2012. [Accessed on 21st October 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. Libertas Academica. 2013. [Accessed on 21st October 2022] https://journals.sagepub.com/doi/pdf/10.4137/CMED.S7314
4. Merck Sharp & Dohme (UK) Limited. Electronic Medicines Compendium (EMC) [Revised in February 2022] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.564.pdf
5. Merck & Co., Inc. JANUMET® (sitagliptin and metformin hydrochloride) tablets, for oral use. [Revised in July 2022] [Accessed on 21st October 2022] https://www.merck.com/product/usa/pi_circulars/j/janumet/janumet_pi.pdf
6. Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in June 2020] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.594.pdf
7. Rx Farma Limited. Electronic Medicines Compendium (EMC). [Revised in September 2019] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.11951.pdf
8. Organon Pharma (UK) Limited. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.7887.pdf
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 18 Oct 2023 | 05:05 PM(IST)
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