Amaryl

DRUG DESCRIPTION

AMARYL is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

AMARYL (glimepiride) Structural Formula Illustration

AMARYL tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose (hydrous), sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, AMARYL 1 mg tablets contain Ferric Oxide Red, AMARYL 2 mg tablets contain Ferric Oxide Yellow and FD&C Blue #2 Aluminum Lake, and AMARYL 4 mg tablets contain FD&C Blue #2 Aluminum Lake.

What are the possible side effects of glimepiride (Amaryl)?

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:

  • severe skin rash, itching, redness, or irritation;
  • pale skin, easy bruising or bleeding, fever, unusual weakness;
  • numbness or tingly feeling;
  • trouble breathing;
  • feeling like you might pass out;
  • dark urine, clay-colored stools;
  • ...

Read All Potential Side Effects and See Pictures of Amaryl

What are the precautions when taking glimepiride (Amaryl)?

Before taking glimepiride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: metabolic conditions (e.g., diabetic ketoacidosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, thyroid disease, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance...

Read All Potential Precautions of Amaryl


Amaryl Consumer (continued)

SIDE EFFECTS: Nausea or upset stomach may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes or skin, stomach/abdominal pain, dark urine, unusual tiredness or weakness, easy bleeding or bruising, signs of infection (e.g., fever, persistent sore throat), mental/mood changes, unusual or sudden weight gain, seizures.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking glimepiride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: metabolic conditions (e.g., diabetic ketoacidosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, thyroid disease, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance (hyponatremia).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication may be required.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially hypoglycemia.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.

Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Amaryl Patient Information Including Side Effects

Brand Names: Amaryl

Generic Name: glimepiride (Pronunciation: glye MEP ir ide)

  • What is glimepiride (Amaryl)?
  • What are the possible side effects of glimepiride (Amaryl)?
  • What is the most important information I should know about glimepiride (Amaryl)?
  • What should I discuss with my doctor before taking glimepiride (Amaryl)?
  • How should I take glimepiride (Amaryl)?
  • What happens if I miss a dose (Amaryl)?
  • What happens if I overdose (Amaryl)?
  • What should I avoid while taking glimepiride (Amaryl)?
  • What other drugs will affect glimepiride (Amaryl)?
  • Where can I get more information?

What is glimepiride (Amaryl)?

Glimepiride 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 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.

Glimepiride may also be used for other purposes not listed in this medication guide.

What are the possible side effects of glimepiride (Amaryl)?

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:

  • severe skin rash, itching, redness, or irritation;
  • pale skin, easy bruising or bleeding, fever, unusual weakness;
  • numbness or tingly feeling;
  • trouble breathing;
  • feeling like you might pass out;
  • dark urine, clay-colored stools;
  • 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:

  • dizziness, headache, tired feeling;
  • mild nausea, vomiting, stomach pain, diarrhea;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about glimepiride (Amaryl)?

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.

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, use 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.

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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