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What is Amaryl (glimepiride)?
- Amaryl (glimepiride) is an oral diabetes medication used in addition to diet and exercise to control blood sugar in adults with type 2 diabetes.
- Management of blood sugar with Amaryl can help decrease the risk of eye, kidney, and nerve damage.
- Amaryl is not used for treating type 1 diabetes.
Common side effects of Amaryl include:
Serious side effects of Amaryl include:
- low blood platelets,
- low sodium,
- sensitivity to sunlight,
- liver dysfunction,
- serious allergic reactions,
- and low blood sugar (hypoglycemia)
Drug interactions of Amaryl include medications that, when given in combination with Amaryl may reduce its ability to lower blood sugar, including:
The following, when given in combination with Amaryl, may increase the risk of low blood sugar (hypoglycemia):
- Nonsteroidal anti-inflammatory drugs (NSAIDs),
- sulfa drugs,
- monoamine oxidase inhibitors (MAOIs),
- quinolone antibiotics,
- and selective serotonin reuptake inhibitors (SSRIs).
Combining Amaryl with insulin may increase risk of heart-related side effects.
In animal studies, Amaryl and other sulfonylureas were associated with a higher risk of fetal death. However, there have been no good studies in women.
Abnormal blood sugar concentrations (high or low) during pregnancy increase the risk of abnormalities in the fetus. Physicians must carefully weigh the benefits and risks of Amaryl treatment during pregnancy. Insulin is the drug of choice for treating diabetes in pregnant women.
It is unknown if Amaryl is excreted in breast milk like other sulfonylureas. Because of the risk of low blood sugar in the infant, it is recommended that Amaryl be discontinued while breastfeeding. If therapy other than diet and exercise is needed, insulin is preferred.
What are the important side effects of Amaryl (glimepiride)?
Common side effects of glimepiride include:
Possible serious side effects of glimepiride include:
- Low blood platelets
- Low sodium
- Sensitivity to sunlight
- Liver dysfunction
- Serious allergic reactions
Low blood sugar (hypoglycemia) can occur during glimepiride therapy. Symptoms of low blood sugar include:
- Heart palpitations
- Numbness around the mouth
- Tingling in the fingers
- Muscle weakness
- Blurred vision
- Excessive yawning
- Loss of consciousness
Glimepiride is a derivative of a sulfonamide drug. People allergic to other sulfonamide-related drugs may develop an allergic reaction to glimepiride. Anyone who has an allergic reaction to sulfa drugs should not take glimepiride.
Amaryl (glimepiride) side effects list for healthcare professionals
The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
- Hemolytic anemia
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Approximately 2,800 patients with type 2 diabetes have been treated with Amaryl in the controlled clinical trials. In these trials, approximately 1,700 patients were treated with Amaryl for at least 1 year.
Table 1 summarizes adverse events, other than hypoglycemia, that were reported in 11 pooled placebocontrolled trials, whether or not considered to be possibly or probably related to study medication. Treatment duration ranged from 13 weeks to 12 months.
Terms that are reported represent those that occurred at an incidence of ≥ 5% among Amaryl-treated patients and more commonly than in patients who received placebo.
Table 1: Eleven Pooled Placebo-Controlled Trials ranging from 13 weeks to 12 months : Adverse Events (Excluding Hypoglycemia) Occurring in ≥ 5% of Amaryl-treated Patients and at a Greater Incidence than with Placebo*
|*Amaryl doses ranged from 1-16 mg administered daily|
†Insufficient information to determine whether any of the accidental injury events were associated with hypoglycemia
- In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Amaryl 1 mg, 4 mg, 8 mg or placebo.
- Patients randomized to Amaryl 4 mg or 8 mg underwent forced-titration from an initial dose of 1 mg to these final doses, as tolerated.
- The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Amaryl 1 mg, 17% for Amaryl 4 mg, 16% for Amaryl 8 mg and 0% for placebo. All of these events were self-treated.
- In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Amaryl or placebo daily.
- The dose of Amaryl was titrated to a target fasting plasma glucose of 90-150 mg/dL. Final daily doses of Amaryl were 1, 2, 3, 4, 6 or 8 mg.
- The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Amaryl vs. placebo was 19.7% vs. 3.2%.
- All of these events were self-treated.
Weight gain: Amaryl, like all sulfonylureas, can cause weight gain.
Allergic Reactions: In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Amaryl-treated patients. These may resolve despite continued treatment with Amaryl. There are postmarketing reports of more serious allergic reactions (e.g., dyspnea, hypotension, shock).
Elevated Serum Alanine Aminotransferase (ALT): In 11 pooled placebo-controlled trials of Amaryl, 1.9% of Amaryl-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.
The following adverse reactions have been identified during post-approval use of Amaryl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson Syndrome
- Hemolytic anemia in patients with and without G6PD deficiency
- Impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.
- Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis
- Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia
- Thrombocytopenia (including severe cases with platelet count less than 10,000/μL) and thrombocytopenic purpura
- Hepatic porphyria reactions and disulfiram-like reactions
- Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone
What drugs interact with Amaryl (glimepiride)?
Drugs Affecting Glucose Metabolism
A number of medications affect glucose metabolism and may require Amaryl dose adjustment and particularly close monitoring for hypoglycemia or worsening glycemic control.
The following are examples of medications that may increase the glucose-lowering effect of sulfonylureas including Amaryl, increasing the susceptibility to and/or intensity of hypoglycemia:
- oral anti-diabetic medications,
- pramlintide acetate,
- angiotensin converting enzyme (ACE) inhibitors,
- H2 receptor antagonists,
- somatostatin analogs,
- anabolic steroids and androgens,
- and those drugs that are highly protein-bound, such as:
When these medications are administered to a patient receiving Amaryl, monitor the patient closely for hypoglycemia. When these medications are withdrawn from a patient receiving Amaryl, monitor the patient closely for worsening glycemic control.
The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including Amaryl, leading to worsening glycemic control:
- protease inhibitors,
- atypical antipsychotic medications (e.g., olanzapine and clozapine),
- and others:
When these medications are administered to a patient receiving Amaryl, monitor the patient closely for worsening glycemic control. When these medications are withdrawn from a patient receiving Amaryl, monitor the patient closely for hypoglycemia.
Beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of Amaryl's glucose-lowering effect.
Both acute and chronic alcohol intake may potentiate or weaken the glucose-lowering action of Amaryl in an unpredictable fashion.
The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as:
- and reserpine.
A potential interaction between oral miconazole and sulfonylureas leading to severe hypoglycemia has been reported. Whether this interaction also occurs with other dosage forms of miconazole is not known.
Cytochrome P450 2C9 Interactions
- There may be an interaction between glimepiride and inhibitors (e.g., fluconazole) and inducers (e.g., rifampin) of cytochrome P450 2C9.
- Fluconazole may inhibit the metabolism of glimepiride, causing increased plasma concentrations of glimepiride which may lead to hypoglycemia.
- Rifampin may induce the metabolism of glimepiride, causing decreased plasma concentrations of glimepiride which may lead to worsening glycemic control.
Concomitant Administration Of Colesevelam
- Colesevelam can reduce the maximum plasma concentration and total exposure of glimepiride when the two are coadministered.
- However, absorption is not reduced when glimepiride is administered 4 hours prior to colesevelam.
- Therefore, Amaryl should be administered at least 4 hours prior to colesevelam.
Amaryl (glimepiride) is an oral diabetes medication used in addition to diet and exercise to control blood sugar in adults with type 2 diabetes. Management of blood sugar with Amaryl can help decrease the risk of eye, kidney, and nerve damage. Amaryl is not used for treating type 1 diabetes. Common side effects of Amaryl include dizziness, headache, nausea, vomiting, rash, allergic reactions, and flu-like symptoms. In animal studies, Amaryl and other sulfonylureas were associated with a higher risk of fetal death. Because of the risk of low blood sugar in the infant, it is recommended that Amaryl be discontinued while breastfeeding.
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Normal Blood Sugar Levels In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Diabetes Symptoms in Men
Early symptoms of diabetes are different in men, such as low testosterone. In many cases, prediabetes that will progress to type 2 diabetes if it is not treated early.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Type 1 vs. Type 2 Diabetes: Differences
Diabetes mellitus is a metabolic condition in which a person's blood sugar (glucose) levels are too high. Over 29.1 million children and adults in the US have diabetes. Of that, 8.1 million people have diabetes and don't even know it. Type 1 diabetes (insulin-dependent, juvenile) is caused by a problem with insulin production by the pancreas. Type 2 diabetes (non-insulin dependent) is caused by: Eating a lot of foods and drinking beverages with simple carbohydrates (pizza, white breads, pastas, cereals, pastries, etc.) and simple sugars (donuts, candy, etc.) Consuming too many products with artificial sweeteners (We found out that they are bad for us!) Lack of activity Exercise Stress Genetics While the signs and symptoms of both types of diabetes are the same, which include: Increased urination Increased hunger Increased thirst Unexplained weight loss. However, the treatments are different. Type 1 diabetes is insulin dependent, which means a person with this type of diabetes requires treatment with insulin. People with type 2 diabetes require medication, lifestyle changes like eating a healthy diet, and getting regular exercise.
Pregnancy and Gestational Diabetes
Gestational diabetes is a form of diabetes that can occur during pregnancy. Pregnant women with gestational diabetes have not had the condition prior to becoming pregnant. Usually, gestational diabetes has no symptoms or signs and of gestational diabetes. Gestational diabetes can cause insulin resistance, hypoglycemia, hypoglycemia, and diabetic ketoacidosis. Treatment of gestational diabetes is managing the condition by checking your blood sugar as recommended, diet changes, getting enough exercise, and monitoring your baby's growth.
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Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
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Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
Gestational Diabetes (Diabetes during Pregnancy))
Learning how to avoid gestational diabetes is possible and maintaining a healthy weight and diet before and during pregnancy can help. Discover risk factors, tests and treatments for, and signs and symptoms of gestational diabetes.
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Type 1 diabetes mellitus (juvenile) is an auto-immune disease with no known cause at this time, although there are a few risk factors. Symptoms of type 1 diabetes include frequent urination, unintentional weight loss, dry and itchy skin, vision problems, wounds that heal slowly, and excessive thirst. Type 1 diabetes is diagnosed with blood tests. A healthy lifestyle and controlling blood glucose levels can improve life expectancy.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
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Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
Diabetes insipidus is a condition in which the patient has frequent urination. Symptoms of diabetes insipidus include irritable, listless, fever, vomiting, or diarrhea due to the loss of large volumes of urine. There are three types of diabetes insipidus, central, nephrogenic, dipsogenic, and gestational. Treatment depends upon the type of diabetes insipidus.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
Diabetes and Kidney Disease
In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Sex, Urinary, and Bladder Problems of Diabetes
Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.