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INTRODUCTION
DIABETROL TABLET is a combination of Glibenclamide and Metformin which belongs to the group of medicines called Antidiabetic agents. It is used in adults to manage type II diabetes mellitus along with 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 if the body cannot utilize the secreted insulin properly.
Glibenclamide is a sulfonylurea. It reduces blood glucose levels by making the pancreas secrete more insulin. Metformin is a biguanide. It blocks the amount of glucose produced by the liver. It also reduces the absorption of glucose in the intestines and allows the body to utilize the circulating insulin.
Before taking DIABETROL TABLET, inform your doctor if you have any heart, liver, or kidney problems. You must also inform your doctor if you have any hormonal problems or if you are severely dehydrated, malnourished, starved, on an irregular diet.
DIABETROL TABLET is not suitable for use in patients with type I diabetes mellitus. Consult your doctor before taking DIABETROL TABLET if you are pregnant or planning to become pregnant or are breastfeeding.
One of the most common side effects of taking DIABETROL TABLET is hypoglycemia (low blood sugar levels) which can be identified by symptoms such as increased hunger, sweating, shakiness, weakness, or an irregular heartbeat. To avoid this, your doctor will periodically monitor your blood sugar levels and adjust the dose of DIABETROL TABLET accordingly.
You can also carry a sugary snack (such as biscuits, glucose drinks or sweet candies) along with you as a precaution and have them immediately if you experience any signs of hypoglycemia. However, consult your doctor if there is no improvement in your condition. Other common side effects of taking DIABETROL TABLET are headache, dizziness, nausea, weight gain and changes in taste. Contact your doctor if any of these side effect worsens.
USES OF DIABETROL TABLET
It is used in adults along with diet and exercise to:
- Manage type II diabetes mellitus
HOW DIABETROL TABLET WORKS
DIABETROL TABLET effectively controls blood sugar levels in patients with type II diabetes mellitus. It contains two medicines namely glibenclamide and metformin. Glibenclamide helps the pancreas to secrete more insulin (a hormone that digest glucose in the body). It reduces blood glucose levels by increasing the amount of insulin secreted by the pancreas. Metformin blocks the amount of glucose produced by the liver. It also reduces the absorption of glucose in the intestines and allows the body to make better use of insulin.
DIRECTIONS FOR USE
Take DIABETROL TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DIABETROL TABLET should be taken preferably with meals to avoid nausea or stomach upset.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Continue to take DIABETROL TABLET for the stipulated duration instructed by your doctor without any interruption to achieve better results.
SIDE EFFECTS OF DIABETROL TABLET
COMMON
- diarrhoea
- headache
- nausea, vomiting
- stomach pain
- dizziness
- weight gain
- changes in taste
Stop taking DIABETROL TABLET and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reactions (such as swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty in breathing or swallowing)
- symptoms of lactic acidosis (such as vomiting, stomach pain, decreased heartbeat, difficulty in breathing, muscle cramps, general weakness with severe tiredness or reduced body temperature)
- signs of low blood sugar (such as headache, drowsiness, weakness, irritability, slurred speech, hunger, fast heartbeat, confusion, shaking or feeling jittery, mood changes, dizziness, sweating, blurred vision, anxiety, tingling hands)
- signs of liver problems (such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, yellowing of the skin or the whites of the eyes)
HOW TO MANAGE SIDE EFFECTS
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. 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.
Nausea And Vomiting
Take DIABETROL TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedDIABETROL TABLET is generally not recommended for use in pregnant women due to lack of safety data. However, consult your doctor for advice.
BREASTFEEDING
ContraindicatedDIABETROL TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. However, consult your doctor for advice.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any machines if you feel dizzy after taking DIABETROL TABLET.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking DIABETROL TABLET as it may increase your blood sugar levels.
KIDNEY
ContraindicatedDIABETROL TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with other mild to moderate kidney problems. Therefore, consult your doctor for advice.
LIVER
ContraindicatedDIABETROL TABLET is not recommended for use in patients with severe liver problems. It should be used with caution in patients with other mild to moderate liver problems. Therefore, consult your doctor for advice.
ALLERGY
Use with CautionDo not take DIABETROL TABLET if you are allergic to Glibenclamide or Metformin.
HEART DISEASE
ContraindicatedDIABETROL TABLET is not recommended for use in patients with severe heart problems (such as heart failure, recent heart attack, stroke, or other circulation problems). Therefore, consult your doctor for advice.
USE IN PEDIATRICS
ContraindicatedDIABETROL TABLET is generally not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. Therefore, consult your doctor for advice.
USE IN GERIATRICS
Use with CautionDIABETROL TABLET should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor for advice.
OTHERS
DIABETROL TABLET is not recommended for use if you:
- have uncontrollable diabetes
- have type I diabetes mellitus
- are severely dehydrated (due to excessive vomiting, diarrhea, sweating, increased physical activity or if you drink less quantity of fluids)
- have severe systemic infections affecting your lungs or kidneys
- drink large amount of alcohol (alcoholism)
- have diabetic ketoacidosis (increased levels of ketone bodies in the blood)
Before taking DIABETROL TABLET inform your doctor if you:
- are scheduled for any X-ray
- are scheduled for any upcoming surgeries
- have hormonal imbalance (Ex. thyroid problems)
- have problems in adrenal cortex or pituitary gland (Ex. Hyperaldosteronism, Cushing’s syndrome)
- are malnourished, starved, on an irregular diet, or feeling weak
- have G6PD deficiency (a genetic disorder that affects red blood cells in the body)
INTERACTIONS
A. Drug-Drug interactions:
Before taking DIABETROL TABLET, inform your doctor if you are taking any of the following medicines such as:
- other medicines to manage diabetes mellitus (such as insulin, glimepiride, pioglitazone)
- medicines used to manage high blood pressure (Ex. captopril, enalapril, lisinopril, losartan, valsartan, olmesartan, clonidine, guanethidine and reserpine)
- medicines to control blood high cholesterol level (Ex. fenofibrate, colesevalam and nicotinic acid)
- medicines used to manage edema such as diuretics (Ex. furosemide, chlorothiazide)
- medicines used to manage pain and inflammation (such as ibuprofen, celecoxib, phenylbutazone, azopropazone, oxyphenbutazone)
- medicines used to manage asthma (Ex. salbutamol or terbutaline)
- bosentan (a medicine used to manage high blood pressure)
- corticosteroids (used to manage inflammation) Ex. prednisolone
- verapamil (a medicine used to manage heart problems)
- rifampicin (an antibiotic used to manage tuberculosis)
- cimetidine (a medicine used to manage stomach problems)
- medicines to manage bacterial infections (Ex. tetracyclines, chloramphenicol, clarithromycin)
- medicines used to manage fungal infections (Ex. fluconazole, miconazole)
- medicines used for blood thinning (Ex. warfarin)
- medicines used to manage depression (Ex. fluoxetine, escitalopram, sertraline)
- medicines used to manage severe mental disorders (Ex. chlorpromazine)
- medicines used to manage gout (Ex. probenecid, sulfinpyrazone)
- medicines used to manage cancer (Ex. cyclophosphamide, ifosfamide)
- medicines used to manage thyroid deficiency (Ex. thyroxine)
- sympathomimetics (used to improve heartbeat and to manage asthma or nasal congestion) Ex. adrenaline, ephedrine
Overdosage:
If you or anyone else accidentally take too much of DIABETROL TABLET, consult your doctor immediately or go to a hospital straight away. Symptoms of overdose might include rapid breathing, severe drowsiness, slow/irregular heartbeat, passing out or trouble breathing.
SYNOPSIS
| Drug | : | Glibenclamide, Metformin |
| Pharmacological Category | : | Sulfonylureas, Biguanides |
| Therapeutic Indication | : | Type II diabetes mellitus |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep DIABETROL TABLET out of reach of children
- Store at room temperature
FAQs ABOUT DIABETROL TABLET
Q: Does DIABETROL TABLET cause weight gain?
A: Yes. DIABETROL TABLET may cause weight gain in some individuals. To avoid this, follow a healthy diet and regular physical activity as advised by your physician. However, if it bothers you, consult your doctor.
Q: How to take DIABETROL TABLET?
A: You must take DIABETROL TABLET as advised by your physician. Try to take DIABETROL TABLET preferably after meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
Q: Can DIABETROL TABLET be taken with insulin?
A: Consult your doctor before taking DIABETROL TABLET along with insulin, as it may increase the chances of hypoglycemia (decreased blood sugar levels).
Q: How much DIABETROL TABLET should I take?
A: DIABETROL 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: What should I do if I experience low blood sugar after taking DIABETROL TABLET?
A: Low blood sugar is a common side effect of taking DIABETROL TABLET. Try to have sugar rich food items such as fruit juice, glucose tablets or gel, soft drinks, honey, or sugary candy. If you cannot any improvement in your condition or if your condition worsen, contact your doctor.
Q: Can DIABETROL TABLET cause dizziness?
A: Yes. Dizziness is a common side effect of using DIABETROL TABLET. In case you experience dizziness, lie down until it passes, then get up slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid smoking and consumption of alcohol. Do not drive or use machinery to avoid accidents. Consult your doctor if you experience dizziness continuously for a long time after taking DIABETROL TABLET.
Q: What are the side effects of DIABETROL TABLET?
A: One of the most common side effects of taking DIABETROL TABLET is hypoglycemia (low blood sugar levels). To manage this, you can snack on foods rich in sugars such as biscuits, candies etc. Other common side effects of taking DIABETROL TABLET are headache, dizziness, nausea, weight gain and changes in taste. Contact your doctor if any of these side effect worsens.
Q: What precautions do I need to follow while taking DIABETROL TABLET?
A: Before taking DIABETROL TABLET, inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have hormonal problems or if you are malnourished. DIABETROL TABLET is not suitable for use in patients with type I diabetes mellitus. Consult your doctor before taking DIABETROL TABLET if you are pregnant or planning to become pregnant. During therapy with DIABETROL TABLET, follow the diet and lifestyle changes instructed by your doctor. Always carry a sugary snack (such as biscuits, glucose drinks or sweet candies) along with you as a precaution and have them immediately if you experience any signs of hypoglycemia.
Q: What DIABETROL TABLET does to your body?
A: DIABETROL TABLET effectively controls blood sugar levels in patients with type II diabetes mellitus. It reduces blood glucose levels by increasing the amount of insulin secreted by the pancreas and by blocking the amount of glucose produced by the liver. It also reduces the absorption of glucose in the intestines and allows the body to make better use of insulin.
Q: What is the use of DIABETROL TABLET?
A: DIABETROL TABLET is used in adults to manage type II diabetes mellitus along with diet and exercise.
REFERENCES
1. KD. Tripathi. Insulin, Oral Hypoglycaemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 270 & 275.
2. Alan J Garber, Daniel S Donovan Jr, Paresh Dandona, Simon Bruce, Jong-Soon Park. Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. August 2003. [Accessed on 21st November 2023] https://pubmed.ncbi.nlm.nih.gov/12915642/
3. Virendra Rambiritch, Breminand Maharaj and Poobalan Naidoo. Glibenclamide in patients with poorly controlled type 2 diabetes: a 12-week, prospective, single-center, open-label, dose-escalation study. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC. PubMed Central. April 2014. [Accessed on 21st November 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983009/
4. Chanelle Medical. Health Product Regulatory Authority. (HPRA). [Revised in May 2016] [Accessed on 21st November 2023] https://www.hpra.ie/img/uploaded/swedocuments/2179143.PA0688_040_002.752e1eeb-1045-476a-97ac-9f7549199666.000001Product%20Leaflet%20Approved%205mg.160725.pdf
5. Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in June 2020] [Accessed on 21st November 2023] https://www.medicines.org.uk/emc/files/pil.594.pdf
6. Bristol-Myers Squibb Company; U.S. Food & Drug Administration; [Revised on December 2018] [Accessed on 21st November 2023] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021178s018lbl.pdf
7. Central Drugs Standard Control Organization. Glibenclamide+Metformin. [Accessed on 21st November 2023] https://cdscoonline.gov.in/CDSCO/Drugs
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 21 Nov 2023 | 05:23 PM(IST)
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