Amaryl is an oral diabetes medicine that helps control blood sugar levels.

Amaryl is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

Insulin or other diabetes medicines are sometimes used in combination with Amaryl if needed.

You should not use Amaryl if you have diabetic ketoacidosis ((call your doctor for treatment with insulin).

Before taking Amaryl, tell your doctor if you are allergic to sulfa drugs, or if you have heart disease, liver disease, kidney disease, an enzyme deficiency (G6PD), adrenal or pituitary gland problems, or if you are under-nourished.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Before taking this medicine

You should not use Amaryl if you are allergic to glimepiride, sulphonamides, or if you have:

• an allergy to sulfa drugs; or

• diabetic ketoacidosis (call your doctor for treatment).

To make sure Amaryl is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver or kidney disease; or

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Amaryl may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Follow your doctor's instructions about using Amaryl if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. However, you may need to stop taking Amaryl for a short time just before your due date.

Medications similar to glimepiride have caused severe hypoglycemia in newborn babies whose mothers used the medicine near the time of delivery. If you take glimepiride during pregnancy, stop taking this medicine at least 2 weeks before your due date.

If you breastfeed while taking glimepiride, call your doctor if your baby shows signs of hypoglycemia (extreme drowsiness, feeding problems, mottled skin, blue lips, feeling cold or jittery, or having a seizure).

Amaryl is not approved for use by anyone younger than 18 years old.

Take Amaryl exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Amaryl is usually taken once a day with breakfast or the first main meal of the day. Follow your doctor's instructions. Take the tablet with a full glass of water.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Amaryl is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 1 to 2 mg orally once a day
Maintenance dose: Increase in 1 or 2 mg increments no more frequently than every 1 to 2 weeks based on glycemic response
Maximum dose: 8 mg per day

Comments:
-Administer with breakfast or first main meal of the day.
-In patients who are at increased risk for hypoglycemia, start with 1 mg orally once a day and titrate slowly.
-When patients are being transferred to this drug from a longer half-life sulfonylurea, monitor 1 to 2 weeks for overlapping drug effect.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Usual Geriatric Dose for Diabetes Type 2:

Initial dose: 1 mg orally once a day; titrate slowly and monitor closely

Usual Pediatric Dose for Diabetes Type 2:

Not recommended because of adverse effects on body weight and hypoglycemia.

You should not use Amaryl if you are allergic to glimepiride, sulphonamides, or if you have:

• an allergy to sulfa drugs; or

• diabetic ketoacidosis (call your doctor for treatment).

To make sure Amaryl is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver or kidney disease; or

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Amaryl may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Follow your doctor's instructions about using Amaryl if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. However, you may need to stop taking Amaryl for a short time just before your due date.

Medications similar to glimepiride have caused severe hypoglycemia in newborn babies whose mothers used the medicine near the time of delivery. If you take glimepiride during pregnancy, stop taking this medicine at least 2 weeks before your due date.

If you breastfeed while taking glimepiride, call your doctor if your baby shows signs of hypoglycemia (extreme drowsiness, feeding problems, mottled skin, blue lips, feeling cold or jittery, or having a seizure).

Amaryl is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Amaryl overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Avoid exposure to sunlight or tanning beds. Glimepiride can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Amaryl (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine;

• confusion, weakness; or

• fever.

Common Amaryl side effects may include:

• headache;

• dizziness, weakness;

• nausea; or

• low blood sugar.

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.

Amaryl may not work as well when you use other medicines at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you also take colesevelam, take your Amaryl dose at least 4 hours before you take colesevelam.

Other drugs may interact with glimepiride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.