Glimepiride

Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. 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. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

• Glimepiride is available under the following different brand names: Amaryl.

Strength expressed as glimepiride ion.

Tablet

• 1 mg
• 2 mg
• 4 mg

Dosage Considerations – Should be Given as Follows:

Type 2 Diabetes Mellitus

Adult Dosage:

• Initial: 1-2 mg orally each morning after breakfast or with a first meal; may increase the dose by 1-2 mg every 1-2 weeks; not to exceed 8 mg/day
• Conversion from other oral hypoglycemic agents:
  • Observe patients carefully for 1-2 weeks when being converted from long half-life sulfonylureas to glimepiride, because of the potential for overlapping of hypoglycemic effects

Dosing considerations

• Use in monotherapy or, if the glycemic response to glimepiride is inadequate at the maximum dose, with insulin or metformin

Geriatric Dosage:

• Prolonged hypoglycemia reported with use; titrate dose conservatively; monitor for hypoglycemic or hyperglycemic symptoms
• 1 mg orally once per day; titrate dose at weekly intervals to avoid hypoglycemia

Osteoporosis (off-label)

• 30-100 mg sodium glimepiride/day orally

Pediatric Dosage:

• Safety and efficacy not established

Dosing Modifications

• Renal impairment: 1 mg orally once daily; titrate dose based on fasting blood glucose levels
• Hepatic impairment: Not studied; not recommended in severe impairment; initiate therapy with 1 mg orally per day and titrate carefully

Common side effects of Glimepiride include:

• low blood sugar (hypoglycemia)
• dizziness
• weakness
• headache
• nausea
• allergic skin reactions
• reddening of the skin
• rash
• severe itching
• hives
• diarrhea
• gastrointestinal pain
• vomiting
• decreased immunity
• low red blood cells
• reduced blood cells (aplastic anemia)
• reduced white blood cells (leukopenia)
• deficiency in the blood of red cells, white cells, and platelets (pancytopenia)
• low blood platelet count (thrombocytopenia)
• reduction of bile flow (cholestasis)
• elevation of liver enzyme levels
• kidney enzyme deficiency reactions
• disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, spinning sensation [vertigo], and low blood pressure)
• low sodium levels
• weight gain

Rare side effects of Glimepiride include:

• yellowing skin and eyes (jaundice)

Postmarketing side effects of Glimepiride reported include:

• serious hypersensitivity reactions, including severe allergic reaction, rapid swelling (angioedema), and Stevens-Johnson Syndrome
• destruction of red blood cells (hemolytic anemia) in patients with and without G6PD deficiency
• liver impairment (reduction of bile flow, jaundice), as well as hepatitis, which may progress to liver failure
• blistering skin lesions (porphyria cutanea tarda), sensitivity to light reactions, and allergic inflammation of the blood vessels
• reduced white blood cells (leukopenia), reduced immunity (agranulocytosis), reduced blood cells (aplastic anemia), and pancytopenia
• thrombocytopenia (including severe cases with a platelet count under 10,000/mcl) and thrombocytopenic purpura
• kidney enzyme deficiency (hepatic porphyria) reactions and disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, vertigo, and low blood pressure)
• low sodium levels (hyponatremia) and water retention (Syndrome of Inappropriate Antidiuretic Hormone), most often in patients on other medications or have medical conditions known to cause low sodium or increase the release of antidiuretic hormone
• distortion of taste (dysgeusia)
• hair loss (alopecia)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Glimepiride has no known severe interactions with other drugs.
• Serious Interactions of Glimepiride include:
  • aminolevulinic acid
  • ethanol
  • lumacaftor/ivacaftor
  • methyl aminolevulinate
• Glimepiride has moderate interactions with at least 146 different drugs.
• Glimepiride has mild interactions with at least 89 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• This medication contains glimepiride. Do not take Amaryl if you are allergic to glimepiride or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity; sulfa allergy
• Type 1 diabetes
• Diabetic ketoacidosis (with or without coma)
• Complicated gestational diabetes mellitus

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Glimepiride?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Glimepiride?"

Cautions

• Patients with risk of severe low blood sugar: elderly, debilitated, or malnourished; adrenal or pituitary insufficiency; patients with stress due to infection, fever, trauma, or surgery
• If the patient is exposed to stress, it may be necessary to discontinue glimepiride and initiate insulin
• Use caution in liver/kidney impairment
• Pregnancy, lactation
• Increased risk of cardiovascular mortality
• Persons allergic to other sulfonamide derivatives may develop allergic reactions to glimepiride
• Low blood sugar may be difficult to recognize in patients with autonomic neuropathy
• Destruction of red blood cells (hemolytic anemia) may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents
• Fluid retention, which may exacerbate or lead to heart failure, may occur
• Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase the risk of other cardiovascular effects
• The potential risk of ischemic cardiovascular (CV) events relative to placebo reported in meta-analysis studies, but not confirmed in long-term cardiovascular outcome trial versus metformin or sulfonylurea
• Dose-related edema, weight gain, and anemia may occur
• Fluid buildup in the eye (macular edema) reported
• Increased incidence of bone fracture reported
• Postmarketing reports for glimepiride include severe allergic reaction (anaphylaxis), rapid swelling, and Stevens-Johnson Syndrome; promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes

Pregnancy and Lactation

• Use glimepiride during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• Excretion of glimepiride in breast milk is unknown, avoid when breastfeeding