INTRODUCTION
GLUCOSAFE 2.5 contains Glibenclamide which belongs to the group of medicines called Antidiabetic agents. It is used to treat type 2 diabetes mellitus, when diet and physical exercise alone have not been able to control the blood sugar levels.Type 2 diabetes is a disease in which blood sugar levels are too high and the body either doesn't produce enough insulin, or it resists insulin. Symptoms include increased thirst, hunger, urination, feeling tired, blurred vision, numbness or tingling in the feet or hands, sores that do not heal, weight loss.
Glibenclamide lowers blood sugar by helping the pancreas to produce insulin (natural substance needed to break down sugar in the body) so that the body can use insulin efficiently. This will only help lower blood sugar in bodies which produce insulin naturally. Along with this treatment, your doctor might ask you to make certain lifestyle changes such as eating a healthy diet, not skipping meals & regular exercise. Prior to the treatment, your doctor may want you to take several blood tests to understand your existing condition.
Avoid consumption of alcohol during treatment with GLUCOSAFE 2.5, as it may worsen the side effects. Before taking GLUCOSAFE 2.5, inform your doctor if you suffer from low blood sugar attack, have G6PD deficiency, recovering from an operation or stress. GLUCOSAFE 2.5 is not recommended for use in patients who have porphyria, insulin dependent diabetes, diabetic ketoacidosis, diabetic coma, serious problems with kidneys, liver, adrenal glands, or pituitary glands. GLUCOSAFE 2.5 is not recommended for use in pregnant and breastfeeding women. GLUCOSAFE 2.5 is also not recommended for use in children. Consult your doctor before taking it. The most common side effects of taking GLUCOSAFE 2.5 are low blood glucose levels characterized by dizziness, sweating, palpitations, hunger pangs, dry mouth and skin.
USES OF GLUCOSAFE 2.5
- Treats type 2 diabetes mellitus
HOW GLUCOSAFE 2.5 WORKS
GLUCOSAFE 2.5 lowers blood sugar by causing the pancreas to produce insulin (a natural substance that is needed to break down sugar in the body) and helping the body use insulin efficiently. This will only help lower blood sugar in bodies which produce insulin naturally.
DIRECTIONS FOR USE
Take GLUCOSAFE 2.5 as advised by your physician. Swallow the medicine with water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF GLUCOSAFE 2.5
COMMON
- dizziness
- sweating
- palpitations
- hunger pangs
- dry mouth and skin
RARE
- lower blood sugar than normal (hypoglycemia)
- decrease in the number of platelets (which increases risk of bleeding or bruising), white blood cells (which makes infections more likely), red blood cells (can pale the skin and cause weakness, breathlessness)
Stop taking GLUCOSAFE 2.5 and contact your doctor immediately if you experience any of the following side effects:
- allergic (hypersensitivity) reactions (swelling of the lips, face, throat or tongue, skin rash, itching, hives and increased sensitivity to the sun, inflammation of blood vessels, serious reactions like difficulty breathing, fall in blood pressure and sometimes shock)
- abnormal liver function including yellowing of the skin and eyes (jaundice)
- problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure
- severe hypoglycemia including loss of consciousness or seizures
WARNING & PRECAUTIONS
PREGNANCY
GLUCOSAFE 2.5 is not recommended for use in pregnancy. Consult your doctor before taking it.
BREASTFEEDING
GLUCOSAFE 2.5 is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Avoid driving and using machines while taking GLUCOSAFE 2.5 as it may reduce your ability to concentrate or react if your blood sugar is lowered (hypoglycemia).
ALCOHOL
Avoid drinking alcohol while taking GLUCOSAFE 2.5 as it may increase or decrease the blood sugar levels lowering the action of GLUCOSAFE 2.5.
KIDNEY
GLUCOSAFE 2.5 is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with severe kidney disorder. Consult your doctor before taking.
LIVER
GLUCOSAFE 2.5 is not recommended for use in patients with severe liver disease. It should be used with caution in patients with severe liver disorder. Consult your doctor before taking.
ALLERGY
Do not take GLUCOSAFE 2.5 if you are allergic to Glibenclamide.
HEART DISEASE
GLUCOSAFE 2.5 is not recommended for use in patients with coronary artery disease. GLUCOSAFE 2.5 should be used with caution in patients with other heart diseases. Consult your doctor before taking it.
OTHERS
GLUCOSAFE 2.5 is not recommended for use if you:
- have insulin dependent diabetes (type 1 diabetes mellitus)
- have diabetic ketoacidosis (a complication of diabetes with fatigue, nausea, frequent urination and muscular stiffness)
- are in a diabetic coma
- have serious problems with adrenal glands or pituitary glands
- have porphyria (abdominal pain, mental confusion, anxiety, fits, muscle pain etc.)
Before taking GLUCOSAFE 2.5, inform your doctor if you:
- are recovering from an injury, operation, infections with fever or stress.
- are weak. You are more likely to suffer from hypoglycemia (low blood-sugar levels)
- have lactose deficiency (you are unable to digest milk or milk product)
- have G6PD- deficiency (enzyme which protects red blood cells)
- suffer from hormone induced disorders (of the thyroid glands, of the pituitary gland or adrenal cortex)
Use in pediatrics:
GLUCOSAFE 2.5 is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking it.
Use in geriatrics:
GLUCOSAFE 2.5 should be used with caution in elderly patients above 65 years of age as they are sensitive to hypoglycemic action. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Consult your doctor before taking GLUCOSAFE 2.5.
INTERACTIONS
A. Drug - Drug interactions:
Before taking GLUCOSAFE 2.5, inform your doctor if you are taking any of the following medicines:
- to treat pain and inflammation (Ex. phenylbutazone, glucocorticoids, azopropazone, oxyphenbutazone, aspirin)
- for diabetes mellitus (Ex. insulin or metformin)
- to support muscle build up (anabolics)
- to prevent blood clotting (warfarin)
- to reduce weight (fenfluramine)
- to treat depression (Ex. fluoxetine, MAO inhibitors)
- to treat gout (allopurinol, probenecid, sulfinpyrazone)
- to treat cancer (Ex. cyclophosphamide, ifosfamide, trofosfamide)
- to treat bacterial, fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
- to treat hay fever (tritoqualine)
- to increase circulation (pentoxifylline)
- to treat urinary infections (such as sulfonamides)
- containing female sex hormones (estrogens, progestogens)
- to treat high blood pressure (bosentan, thiazide diuretics, betablockers, clonidine, guanethidine, diazoxide, glucagon, reserpine, ACE inhibitors), antiarrhythmic agents used to control abnormal heartbeat (disopyramide)
- to stimulate the thyroid gland (levothyroxine)
- to treat severe mental disorders (Ex. chlorpromazine, phenothiazine derivatives)
- adrenaline and sympathomimetics
- to treat high cholesterol levels (Ex. nicotinic acid, fibrates)
- to treat constipation (laxatives)
- to treat fits (phenytoin)
- for nervousness, sleep problems (barbiturates)
- to treat infections, tuberculosis (rifampicin)
- for increased pressure in the eye (azetazolamide)
- medicines used for stomach ulcers
Overdosage:
If you or anyone else accidentally take too much of GLUCOSAFE 2.5, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are characterized by faintness, feeling sick, cold sweats and palpitations.
SYNOPSIS
| Drug | : | Glibenclamide |
| Pharmacological Category | : | Sulfonylureas |
| Therapeutic Indication | : | Type 2 diabetes mellitus |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep GLUCOSAFE 2.5 out of reach of children
- Store at 25°C
FAQs ABOUT GLUCOSAFE 2.5
How should GLUCOSAFE 2.5 be used in elderly patients?
GLUCOSAFE 2.5 should be used with extra caution in elderly patients above 65 years of age, because they are at high risk of getting low blood sugar (hypoglycemic event).
Can GLUCOSAFE 2.5 cause hair loss?
No, hair loss is not seen with the use of GLUCOSAFE 2.5. However, diabetes can lead to hair loss. Consult your doctor if you have too much hair loss as it could be due to other underlying conditions or a sign of diabetes getting worsened.
Can I stop taking GLUCOSAFE 2.5?
No, GLUCOSAFE 2.5 should not be skipped as it can make your diabetes condition worse. If you miss the dose by mistake, take it when you remember immediately.
Can GLUCOSAFE 2.5 cause weight gain?
Yes, GLUCOSAFE 2.5 can cause weight gain. Closely monitor your diet and exercise regularly. Avoid skipping your meals as it can cause very low blood sugar levels and you may end up taking more sugar.
REFERENCES
1. KD Tripathi.Insulin, Oral Antidiabetic Drugs and Glucagon.Essentials of Medical Pharmacology. Eighth Edition. 2019. Page –295.
2. Rajiv Goyal; IshwarlalJialal. Diabetes Mellitus Type 2. [Revised in September 2021] [Accessed on 18th May 2022] https://www.ncbi.nlm.nih.gov/books/NBK513253/
3. Sanofi-aventis. U.S. food and drug administration. [Accessed on 18th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf
4. TEVA UK Limited. Glibenclamide. [Revised in March 2015] [Accessed on 18th May 2022] https://www.drugs.com/uk/pdf/leaflet/1084495.pdf
5. Chanelle Medical, Loughrea, Co Galwa. Health Products Regulatory Authority (HPRA). [Revised in May 2016] [Accessed on 18th May 2022] https://www.hpra.ie/img/uploaded/swedocuments/2179143.PA0688_040_002.752e1eeb-1045-476a-97ac-9f7549199666.000001Product%20Leaflet%20Approved%205mg.160725.pdf
6. Teva Pharmaceuticals USA, Inc. Glyburide. [Revised on July 2021] [Accessed on 18th May 2022] https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=50d16f1d-c814-4411-8749-62561321ecce
7. Glibenclamide.MedlinePlus. [Revised on May 2021] [Accessed On 18th May 2022] https://medlineplus.gov/diabetestype2.html
8. Glyburide.MedlinePlus.[Revised in October 2018] [Accessed on 18th May 2022] https://medlineplus.gov/druginfo/meds/a684058.html
USEFUL DIAGNOSTIC TESTS
- Blood tests (glycated hemoglobin test, random blood sugar test, fasting blood sugar test)
- Oral glucose tolerance test
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