Amaryl (Glimepiride)
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Amaryl (Glimepiride)

AMARYL
(glimepiride)

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;
  • upper stomach pain, low fever, jaundice (yellowing of the skin or...

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 »

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

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INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

Recommended Dosing

AMARYL should be administered with breakfast or the first main meal of the day.

The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

The maximum recommended dose is 8 mg once daily.

Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.

HOW SUPPLIED

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.

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