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INTRODUCTION
DIABETROL is a combination of Glibenclamide and Metformin which belongs to the group of medicines called Antidiabetic agents. It is used in adults to treat 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, 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 is not suitable for use in patients with type I diabetes mellitus. Consult your doctor before taking DIABETROL if you are pregnant or planning to become pregnant or are breastfeeding.
One of the most common side effects of taking DIABETROL 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 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 are headache, dizziness, nausea, weight gain and changes in taste. Contact your doctor if any of these side effect worsens.
USES OF DIABETROL
It is used in adults along with diet and exercise to:
- Treat type II diabetes mellitus
HOW DIABETROL WORKS
DIABETROL 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 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DIABETROL 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 for the stipulated duration instructed by your doctor without any interruption to achieve better results.
SIDE EFFECTS OF DIABETROL
COMMON
- diarrhoea
- headache
- nausea, vomiting
- stomach pain
- dizziness
- weight gain
- changes in taste
RARE
Stop taking DIABETROL 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
Nausea and Vomiting:
Take DIABETROL 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.
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.
Dizziness:
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.
WARNING & PRECAUTIONS
PREGNANCY
DIABETROL is generally not recommended for use in pregnant women due to lack of safety data. However, consult your doctor for advice.
BREASTFEEDING
DIABETROL 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
Do not drive or operate any machines if you feel dizzy after taking DIABETROL.
ALCOHOL
Avoid consumption of alcohol while taking DIABETROL as it may increase your blood sugar levels.
KIDNEY
DIABETROL 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
DIABETROL 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
Do not take DIABETROL if you are allergic to Glibenclamide or Metformin.
HEART DISEASE
DIABETROL 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.
OTHERS
DIABETROL 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 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)
Use in pediatrics:
DIABETROL 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:
DIABETROL should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor for advice.
INTERACTIONS
A. Drug-Drug Interaction:
Before taking DIABETROL, inform your doctor if you are taking any of the following:
- other medicines to treat diabetes mellitus (such as insulin, glimepiride, pioglitazone)
- medicines used to treat 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 treat edema such as diuretics (Ex. furosemide, chlorothiazide)
- medicines used to treat pain and inflammation (such as ibuprofen, celecoxib, phenylbutazone, azopropazone, oxyphenbutazone)
- medicines used to treat asthma (Ex. salbutamol or terbutaline)
- bosentan (a medicine used to treat high blood pressure)
- corticosteroids (used to treat inflammation) Ex. prednisolone
- verapamil (a medicine used to treat heart problems)
- rifampicin (an antibiotic used to treat tuberculosis)
- cimetidine (a medicine used to treat stomach problems)
- medicines to treat bacterial infections (Ex. tetracyclines, chloramphenicol, clarithromycin)
- medicines used to treat fungal infections (Ex. fluconazole, miconazole)
- medicines used for blood thinning (Ex. warfarin)
- medicines used to treat depression (Ex. fluoxetine, escitalopram, sertraline)
- medicines used to treat severe mental disorders (Ex. chlorpromazine)
- medicines used to treat gout (Ex. probenecid, sulfinpyrazone)
- medicines used to treat cancer (Ex. cyclophosphamide, ifosfamide)
- medicines used to treat thyroid deficiency (Ex. thyroxine)
- sympathomimetics (used to improve heartbeat and to treat asthma or nasal congestion) Ex. adrenaline, ephedrine
Overdosage:
If you or anyone else accidentally took more DIABETROL, contact 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 out of reach of children
- Store DIABETROL at room temperature
FAQs ABOUT DIABETROL
Does DIABETROL cause weight gain?
Yes. DIABETROL 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.
How to take DIABETROL?
You must take DIABETROL as advised by your physician. Try to take DIABETROL preferably after meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
Can DIABETROL be taken with insulin?
Consult your doctor before taking DIABETROL along with insulin, as it may increase the chances of hypoglycemia (decreased blood sugar levels).
How much DIABETROL should I take?
DIABETROL 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.
What should I do if I experience low blood sugar after taking DIABETROL?
Low blood sugar is a common side effect of taking DIABETROL. 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.
Can DIABETROL cause dizziness?
Yes. Dizziness is a common side effect of using DIABETROL. 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.
What are the side effects of DIABETROL?
One of the most common side effects of taking DIABETROL is hypoglycemia (low blood sugar levels). To treat this, you can snack on foods rich in sugars such as biscuits, candies etc. Other common side effects of taking DIABETROL are headache, dizziness, nausea, weight gain and changes in taste. Contact your doctor if any of these side effect worsens.
What precautions do I need to follow while taking DIABETROL?
Before taking DIABETROL, 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 is not suitable for use in patients with type I diabetes mellitus. Consult your doctor before taking DIABETROL if you are pregnant or planning to become pregnant. During therapy with DIABETROL, 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.
Can I take medication for high blood pressure along with DIABETROL?
Consult your doctor before taking any medicines to control blood pressure while taking DIABETROL.
What DIABETROL does to your body?
DIABETROL 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.
What is the use of DIABETROL?
DIABETROL is used in adults to treat 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 06th April 2022] 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 15th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983009/
4. Chanelle Medical. Health Product Regulatory Authority. (HPRA). [Revised in May 2016] [Accessed on 15th July 2022] 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 15th July 2022] 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 06th April 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021178s018lbl.pdf
7. Central Drugs Standard Control Organization. Glibenclamide+Metformin. [Accessed on 15th July 2022] https://cdscoonline.gov.in/CDSCO/Drugs
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
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