AMARYL Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Sanofi-Aventis U.S. LLC

Λέξεις κλειδιά

0039-0221 0039-0222 0039-0223

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1. Indications and Usage

AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use: AMARYL should ...

2. Dosage and Administration

2.1 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 ...

3. 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 ...

4. Contraindications

AMARYL is contraindicated in patients with a history of a hypersensitivity reaction to: Glimepiride or any of the products ingredients [see Warnings and Precautions (5.2)]. Sulfonamide derivatives: ...

5. Warnings and Precautions

5.1 Hypoglycemia All sulfonylureas, including AMARYL, can cause severe hypoglycemia [see Adverse Reactions (6.1)]. The patients ability to concentrate and react may be impaired as a result of ...

6. Adverse Reactions

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1)] Hemolytic anemia [see Warnings and ...

6.1. 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 ...

6.3. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AMARYL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

7.1 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 ...

8.1. Pregnancy

Risk Summary Available data from a small number of published studies and postmarketing experience with AMARYL use in pregnancy over decades have not identified any drug associated risks for major birth ...

8.2. Lactation

Risk Summary Breastfed infants of lactating women using AMARYL should be monitored for symptoms of hypoglycemia (see Clinical Considerations). It is not known whether glimepiride is excreted in ...

8.4. Pediatric Use

The pharmacokinetics, efficacy and safety of AMARYL have been evaluated in pediatric patients with type 2 diabetes as described below. AMARYL is not recommended in pediatric patients because of its adverse ...

8.5. Geriatric Use

In clinical trials of AMARYL, 1053 of 3491 patients (30%) were >65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater ...

8.6. Renal Impairment

To minimize the risk of hypoglycemia, the recommended starting dose of AMARYL is 1 mg daily for all patients with type 2 diabetes and renal impairment [see Dosage and Administration (2.1) and Warnings ...

10. Overdosage

An overdosage of AMARYL, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies ...

11. 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-1-carboxamido)ethyl]phenyl]sulfonyl] ...

12.1. Mechanism of Action

Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, ...

12.2. Pharmacodynamics

In healthy subjects, the time to reach maximal effect (minimum blood glucose concentrations) was approximately 2–3 hours after single oral doses of AMARYL. The effects of AMARYL on HbA1c, fasting plasma ...

12.3. Pharmacokinetics

Absorption Studies with single oral doses of glimepiride in healthy subjects and with multiple oral doses in patients with type 2 diabetes showed peak drug concentrations (Cmax) 2 to 3 hours ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. ...

14. Clinical Studies

14.1 Monotherapy A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating ...

16.1. How Supplied

AMARYL tablets are available in the following strengths and package sizes: 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with AMA RYL on one side) in bottles of 100 (NDC ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 20°C–25°C (68°F–77°F) (see USP Controlled Room Temperature). Dispense in well-closed containers with safety closures.

17. Patient Counseling Information

Hypoglycemia Explain the symptoms and treatment of hypoglycemia as well as conditions that predispose to hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result ...