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GlucoVera

GlucoVera (Glimepiride) is an oral blood-glucose-lowering drug of the sulfonylurea class.Glimepiride is an anti-diabetic drug used along with a proper diet and exercise program to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes).
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GlucoVera (Glimepiride)

GlucoVera (Glimepiride) is an oral blood-glucose-lowering drug of the sulfonylurea class.
 
Uses
Glimepiride is an anti-diabetic drug used along with a proper diet and exercise program to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). It works by stimulating the release of your body's natural insulin. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.
 
How to Use
Take this medication by mouth usually once daily, with breakfast or the first main meal of the day. The dosage is based on your medical condition and response to therapy.
 
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Monitor blood glucose levels on a regular basis, and share the results with your doctor.
 
Contraindications
GlucoVera must not be used in:
 
1. Patients with known hypersensitivity to glimepiride.
2. Patients with Insulin Dependent (Type I) Diabetes.
3. Diabetic Ketoacidosis with or without coma (this condition should be treated with insulin).
4. Pregnancy, nursing mothers or in children.
 
Side Effects
1. Eye: especially at the start of treatment, temporary visual impairment may occur due to the change    in blood sugar level.
2. Gastrointestinal: nausea, vomiting, abdominal pain and diarrhea.
3. Hematologic reactions: leucopenia, agranulocytosis, thrombocytopenia,hemolytic anemia,    aplastic anemia and pancytopenia.
4. Metabolic reactions: hepatic porphyria and disulfiram like reactions and hyponatrimia.
 
Hypoglycemia
All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of GlucoVera. A starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those patients. Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy, the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia.
 
Hyperglycemia
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.
 
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
 
Hemolytic anemia
Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Since GlucoVera belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In postmarketing reports, hemolytic anemia has been reported in patients who did not have known G6PD deficiency.
 
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor.
 
Overdose
Overdosage of sulfonylureas (GlucoVera), can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycemia may recur after apparent clinical recovery.
 
Missed Dose
If a dose is missed, take it as soon as got remind. If the time of the next dose is near then skip the missed dose and follow the usual dosing schedule. Do not double the dose to catch up.
 
 

1. What is glimepiride (GlucoVera)?

Glimepiride (GlucoVera) is an oral diabetes medicine that helps control blood sugar levels. This medication helps your body respond better to insulin produced by your pancreas.
 
Glimepiride (GlucoVera) is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Insulin or other diabetes medicines are sometimes used in combination with glimepiride if needed.
 
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2. What are the possible side effects of glimepiride (GlucoVera)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
 
1. seere skin rash, itching, redness, or irritation.
2. pale skin, easy bruising or bleeding, fever, unusual weakness.
3. dark urine, clay-colored stools.
4. upper stomach pain, low fever, jaundice (yellowing of the skin or eyes) or nausea, vomiting, loss of    appetite, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or    seizure.
 
Less serious side effects may include:
 
1. dizziness, headache, tired feeling.
2. mild nausea, vomiting, stomach pain, diarrhea.
3. increased skin sensitivity to sunlight or mild itching or skin rash.
 
Know the signs of low blood sugar (hypoglycemia) and how to recognize them. Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, give an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
 
If your blood sugar gets too high (hyperglycemia), you may feel very thirsty or hungry. You may also urinate more than usual. Call your doctor right away if you have any symptoms of hyperglycemia.
 
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
 
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3. What is the most important information I should know about glimepiride (GlucoVera)?

Do not use this medication if you are allergic to glimepiride, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
 
Take care not to let your blood sugar get too low, which can be caused by stress, skipping a meal, exercising too long, or drinking alcohol.
 
Glimepiride is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
 
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4. What should I discuss with my doctor before taking glimepiride (GlucoVera)?

You should not use this medication if you are allergic to glimepiride, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take glimepiride, tell your doctor if you have:
 
1. heart disease
2. liver or kidney disease
3. an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD)
4. adrenal or pituitary gland problems or if you are under-nourished.
 
FDA pregnancy category C. It is not known whether glimepiride is harmful to an unborn baby. Before using glimepiride, tell your doctor if you are pregnant or plan to become pregnant during treatment.
 
It is not known whether glimepiride passes into breast milk or if it could be harmful to a nursing baby. Do not take glimepiride without telling your doctor if you are breast-feeding a baby
 
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5. How should I take glimepiride (GlucoVera)?

Take glimepiride exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
 
Your dose needs may change if you are ill, if you have a fever or infection, or if you have surgery or a medical emergency.
 
Do not change your dose of glimepiride without first talking to your doctor.
 
Glimepiride is usually taken once a day with breakfast or the first main meal of the day. Follow your doctor's instructions. Take glimepiride with a full glass of water.
 
Store glimepiride at room temperature away from moisture and heat.
 
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6. What happens if I miss a dose (GlucoVera)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
 
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7. What happens if I overdose (GlucoVera)?

Seek emergency medical attention if you think you have used too much of this medicine. A glimepiride overdose can cause life-threatening hypoglycemia.
 
Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), and coma.
 
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8. What should I avoid while taking glimepiride (GlucoVera)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
 
Avoid exposure to sunlight, sunlamps, or tanning beds. Glimepiride can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.
 
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9. What other drugs will affect glimepiride (GlucoVera)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:
 
1. Albuterol
2. Clonidine
3. Reserpine
4. Guanethidine
5. A beta-blocker such as atenolol, carvedilol, labetalol, metoprolol, nadolol, propranolol, sotalol, and    others.
 
You may be more likely to have hypoglycemia (low blood sugar) if you are taking glimepiride other drugs that lower blood sugar. Drugs that can lower blood sugar include:
 
1. Clarithromycin
2. Probenecid
3. Some nonsteroidal anti-inflammatory drugs (NSAIDs)
4. Aspirin or other salicylates
5. A blood thinner (warfarin, Coumadin and others).
6. A monoamine oxidase inhibitor (MAOI).
7. Sulfa drugs.
 
You may be more likely to have hyperglycemia (high blood sugar) if you are taking glimepiride with other drugs that raise blood sugar. Drugs that can raise blood sugar include:
 
1. Isoniazid
2. Diuretics (water pills)
3. Steroids (prednisone and others)
4. Phenothiazines
5. Thyroid medicine.
6. Birth control pills and other hormones.
7. Seizure medicines.
8. Diet pills.
9. Medicines to treat asthma, colds or allergies.
 
These lists are not complete and there are many other medicines that can increase or decrease the effects of glimepiride on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
 
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10. Where can I get more information?

Your pharmacist can provide more information about Glimepiride. And you can contact us at info@evantapharma.com
 
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
 
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GlucoVera 1 mg tablets
Pink color oblong biplanar shaped tablet engraved B/H on one side other side plain with score line.
GlucoVera 2 mg tablets
Green color oblong biplanar shaped tablet engraved B/H on one side, other side plain with score line
GlucoVera 3 mg tablets
Yellow color oblong biplanar shaped tablet engraved B/H on one side, other side plain with score line
GlucoVera 4 mg tablets
Blue color oblong biplanar shaped tablet engraved B/H on one side, other side plain with score line

Effects of glimepiride on HbA1c and body weight in Type 2 diabetes: results of a 1.5-year follow-up study

Raimund Weitgassera, Monika Lechleitnerb, Anton Lugerc, Anton Klinglerd
 
Received 26 February 2002; received in revised form 7 November 2002; accepted 11 November 2002.
 
Abstract
Sulphonylureas are effective and well tolerated in patients with Type 2 diabetes, but may be associated with weight gain, and lack of compliance due to multiple daily dosing. This open, uncontrolled surveillance study examined the efficacy and safety of glimepiride, a new sulphonylurea, administered once daily in patients with Type 2 diabetes. A total of 1770 patients were enrolled in the study, and 284 patients were selected for follow-up. Patients received 0.5 to >4 mg glimepiride once daily for 1.5 years. HbA1c was reduced from 8.4% at baseline to 7.1% after 4 months and 6.9% after 1 and 1.5 years (median intra-individual change from baseline: −1.4, −1.5, and −1.7%, respectively; P<0.0001). Treatment with glimepiride also resulted in significant and stable weight loss relative to baseline, with the exception of patients with a body mass index of <25 kg/m2.Mean body weight was reduced from 79.8 kg at baseline to 77.9 kg after 4 months, 77.2 kg after 1 year, and 76.9 kg after 1.5 years (mean intra-individual change from baseline: −1.9 kg, P<0.0001; −2.9 kg, P<0.05; −3.0 kg, P<0.005, respectively). Therefore, once daily glimepiride provides effective glycaemic control, and may have advantages over other sulphonylureas, because it exhibits weight neutralizing/reducing effects in patients with Type 2 diabetes.
 
Volume 61, Issue 1, Pages 13-19 (July 2003)
 

Effects of Glimepiride on metabolic parameters and cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus

Dan-yan Xua, Shui-Ping Zhaoa, Qiu-xia Huangb, Wei Dub, Yu-hua Liub, Ling Liua, Xiao-mei Xiec
 
Received 20 September 2007; received in revised form 10 July 2009; accepted 8 December 2009. published online 04 January 2010.
 
Abstract
Background
 
To investigate the effects of Glimepiride on blood glucose in patients with newly diagnosed type 2 diabetes mellitus (T2DM) in connection with plasma lipoproteins and plasminogen activity.
 
Methods
 
A total of 565 T2DM patients were received Glimepiride (n = 333) or Glibenclamide (n = 232) for 12 weeks. We observed the level of blood glucose (BG), glycated hemoglobin (HbA1C), the insulin resistance (IR) state, plasma lipoproteins, tissue-type plasminogen activator (t-PA) and plasminogen activator inhibitor type I (PAI-1) before and after a 12 weeks of treatment.
 
Results
 
After 12 weeks with Glimepiride treatment, significant reductions were observed in fasting blood glucose (FBG) and 2-h postprandial BG(PBG), HbA1C (from 8.60 ± 3.10 to 7.10 ± 1.60%) and HOMA-IR (from 4.11 ± 0.85 to 2.42 ± 0.91%). The level of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were significantly decreased, whereas that of high-density lipoprotein (HDL) was increased markedly with statistical significance. In addition, there was an obvious improvement in t-PA activity (from 0.225 ± 0.11 to 0.457 ± 0.177 IU/ml); whereas the PAI-1 activity was decreased significantly (from 0.898 ± 0.168 to 0.533 ± 0.215 AU/ml). No significant changes were observed in plasma lipoprotein profiles and plasminogen activity in Glibenclamide receiving group.
 
Conclusions
 
Glimepiride can rapidly and stably improve glycemic control and lipoprotein metabolism, significantly alleviate insulin resistance and enhance fibrinolytic activity.
 
Volume 88, Issue 1, Pages 71-75 (April 2010)
 

Efficacy of glimepiride in type 2 diabetic patients treated with glibenclamide

Tomoya Hamaguchiab, Takahisa Hirosea, Hideki Asakawaa, Yoshiharu Itoha, Keiji Kamadoa, Katsuto Tokunagaa, Koji Tomitaa, Hiroshi Masudaa, Nobuaki Watanabea, Mitsuyoshi Nambaab
 
Received 4 November 2003; accepted 2 December 2003. published online 26 August 2004.
 
Abstract
Multicentric study was conducted to evaluate the efficacy of glimepiride in the oral hypoglycemic agents therapy of type 2 diabetic patients treated with glibenclamide so far, and to claim an adequate use of this new generation sulfonylurea. In 66 diabetic outpatients, glibenclamide was switched to glimepiride. After 6 months’ therapy, a significant reduction in fasting plasma IRI was observed in relatively hyperinsulinemic patients. In addition, weight reduction was achieved in patients with insulin resistance during this study. These findings suggest that glimepiride improves insulin resistance in hyperinsulinemic patients treated with glibenclamide. Also, glimepiride is favored especially for overweight, insulin-resistant patients inadequately controlled by glibenclamide.
 
Volume 66, Supplement, Pages S129-S132 (December 2004)
 

Glimerpiride in type 2 diabetes mellitus: A review of the worldwide therapeutic experience Massimo Massi-Benedetti MD

Dan-yan Xua, Shui-Ping Zhaoa, Qiu-xia Huangb, Wei Dub, Yu-hua Liub, Ling Liua, Xiao-mei Xiec
 
Dipartimento di Medicina Interna, Università di Perugia, Perugia, Italy
 
Accepted 6 December 2002.
 
Available online 7 July 2003.
 
Abstract
Background :
 
Sulfonylureas (SUs) have been used for many years as first-line therapy for patients with type 2 diabetes mellitus whose blood glucose levels have not been effectively controlled by diet and exercise alone. Glimepiride is a once-daily SU that was introduced in 1995. Since then, a considerable body of evidence has been amassed regarding its use in type 2 diabetes.
 
Objective :
 
This review provides a comprehensive summary of available data on the pharmacology, pharmacokinetics, efficacy, and safety profile of glimepiride in the treatment of type 2 diabetes. It also examines the use of glimepiride to achieve and maintain good glycemic control in patients with type 2 diabetes in current clinical practice.
 
Methods
 
Relevant articles were identified through a search of MEDLINE for English-language studies published from 1990 to 2002. The search terms used were glimepiride, sulfonylureas, and type 2 diabetes mellitus. The manufacturer of glimepiride provided additional information.
 
Results :
 
Glimepiride differs from other SUs in a number of respects. In clinical studies, glimepiride was generally associated with a lower risk of hypoglycemia and less weight gain than other SUs. Results of other studies suggest that glimepiride can be used in older patients and those with renal compromise. There is evidence that glimepiride preserves myocardial preconditioning, a protective mechanism that limits damage in the event of an ischemic event. Glimepiride can be used in combination with other oral antidiabetic agents or insulin to optimize glycemic control.
 
Conclusions :
 
Based on the evidence to date, glimepiride is an effective and well-tolerated once-daily antidiabetic drug and provides an important treatment option for the management of type 2 diabetes.
 
Volume 25, Issue 3, March 2003, Pages 799-816