Archive for the ‘Amaryl’ Category

AMARYL (Glimepiride) Amaryl-Metformin Combination Therapy

Saturday, October 6th, 2007

If patients do not respond adequately to the maximal dose of Amaryl monotherapy, addition of metformin may be considered. Published clinical information exists for the use of other sulfonylureas including glyburide, glipizide, chlorpropamide, and tolbutamide in combination with metformin.
With concomitant Amaryl and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant Amaryl and metformin therapy, the risk of hypoglycemia associated with Amaryl therapy continues and may be increased. Appropriate precautions should be taken.

Product Description

Most important information about Amaryl

Pharmacokinetics

Possible Side Effects

More information about AMARYL (Glimepiride):

Amaryl-Insulin Combination Therapy

FDA MedWatch Alerts

To buy Amaryl click HERE: My Family Drugstore

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AMARYL (Glimepiride) Possible Side Effects

Friday, October 5th, 2007

Possible side effects
Stop taking glimepiride and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Other, less serious side effects from glimepiride result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency situation.
Low blood sugar may occur when too much glimepiride is taken; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.

Hypoglycemia or Low blood sugar has the following symptoms:

  • shaking;
  • headache;
  • cold sweats;
  • pale, cool skin;
  • anxiety; and
  • difficulty concentrating.

Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
Increased blood sugar may occur when not enough glimepiride is taken; if you eat significantly more food than usual; if you exercise less than usual; if you take other medications; during fever or other illness; and in other situations.

Hyperglycemia or High blood sugar has the following symptoms:

  • increased thirst,
  • increased hunger,
  • and increased urination.

There may be an increased risk of death due to cardiovascular (heart and blood vessels) complications with the use of glimepiride when compared to the treatment of diabetes with diet or diet plus insulin. The long-term use of glimepiride should be discussed with your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Amaryl?
Many other medicines may increase or decrease the effects of glimepiride or affect your condition. Before taking glimepiride, tell your doctor if you are taking any of the following medicines:

  • aspirin or another salicylate such as magnesium/choline salicylate (Trilisate), salsalate (Disalcid, others), choline salicylate (Arthropan), magnesium salicylate (Magan), or bismuth subsalicylate (Pepto-Bismol);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), diclofenac (Voltaren, Cataflam), etodolac (Lodine), indomethacin (Indocin), nabumetone (Relafen), oxaprozin (Daypro), and naproxen (Anaprox, Naprosyn, Aleve);
  • a sulfa-based drug such as sulfamethoxazole-trimethoprim (Bactrim, Septra), sulfisoxazole (Gantrisin), or sulfasalazine (Azulfidine);
  • a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil);
  • a beta-blocker such as propranolol (Inderal), atenolol (Tenormin), acebutolol (Sectral), metoprolol (Lopressor), and others;
  • a diuretic (water pill) such as hydrochlorothiazide (HCTZ, Hydrodiuril), chlorothiazide (Diuril), and others;
  • a steroid medicine such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, Pediapred, others), and others;
  • a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Prolixin, Permitil), prochlorperazine (Compazine), promethazine (Phenergan), and others;
  • phenytoin (Dilantin);
  • isoniazid (Nydrazid);
  • rifampin (Rifadin, Rifamate);
  • or over-the-counter cough, cold, allergy, or weight loss medications.

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with glimepiride or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

 

What should I avoid while taking Amaryl?
Follow diet, medication, and exercise routines closely. Changing any of these things can effect your blood sugar levels.
Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
Do not take any prescription, over-the-counter, or herbal cough, cold, allergy, pain, or weight loss medications without first talking to your doctor.

Contraindications
Amaryl is contraindicated in patients with

  • Known hypersensitivity to the drug.
  • Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Warnings
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term, prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups.
UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2-1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of Amaryl (glimepiride tablets) and of alternative modes of therapy.
Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Precautions

Hypoglycemia
All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of Amaryl. A starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those patients. Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia.

Loss of control of blood glucose
When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with Amaryl or even use insulin monotherapy. The effectiveness of any oral hypoglycemic drug, including Amaryl, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Should secondary failure occur with Amaryl or metformin monotherapy, combined therapy with Amaryl and metformin or Amaryl and insulin may result in a response. Should secondary failure occur with combined Amaryl/metformin therapy, it may be necessary to initiate insulin therapy.

Information For Patients

Carcinogenesis/ Mutagenesis/ Impairment of Fertility
Studies in rats at doses of up to 5000 ppm in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. In mice, administration of glimepiride for 24 months resulted in an increase in benign pancreatic adenoma formation which was dose related and is thought to be the result of chronic pancreatic stimulation. The no-effect dose for adenoma formation in mice in this study was 320 ppm in complete feed, or 46-54 mg/kg body weight/day. This is about 35 times the maximum human recommended dose of 8 mg once daily based on surface area.
Glimepiride was non-mutagenic in a battery of in vitro and in vivo mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, mouse micronucleus test).
There was no effect of glimepiride on male mouse fertility in animals exposed up to 2500 mg/kg body weight (>1,700 times the maximum recommended human dose based on surface area). Glimepiride had no effect on the fertility of male and female rats administered up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area).

Pregnancy
Teratogenic Effects
Pregnancy Category C. Glimepiride did not produce teratogenic effects in rats exposed orally up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area) or in rabbits exposed up to 32 mg/kg body weight (approximately 60 times the maximum recommended human dose based on surface area). Glimepiride has been shown to be associated with intrauterine fetal death in rats when given in doses as low as 50 times the human dose based on surface area and in rabbits when given in doses as low as 0.1 times the human dose based on surface area. This fetotoxicity, observed only at doses inducing maternal hypoglycemia, has been similarly noted with other sulfonylureas, and is believed to be directly related to the pharmacologic (hypoglycemic) action of glimepiride.
There are no adequate and well-controlled studies in pregnant women. On the basis of results from animal studies, Amaryl (glimepiride tablets) should not be used during pregnancy. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain glucose levels as close to normal as possible.

Nonteratogenic Effects
In some studies in rats, offspring of dams exposed to high levels of glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. Significant concentrations of glimepiride were observed in the serum and breast milk of the dams as well as in the serum of the pups. These skeletal deformations were determined to be the result of nursing from mothers exposed to glimepiride.
Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. Patients who are planning a pregnancy should consult their physician, and it is recommended that they change over to insulin for the entire course of pregnancy and lactation.

Nursing Mothers
In rat reproduction studies, significant concentrations of glimepiride were observed in the serum and breast milk of the dams, as well as in the serum of the pups. Although it is not known whether Amaryl is excreted in human milk, other sulfonylureas are excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, and because of the effects on nursing animals, Amaryl should be discontinued in nursing mothers. If Amaryl is discontinued, and if diet and exercise alone are inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use
The profile of adverse reactions in pediatric patients treated with Amaryl was similar to that observed in adults.
Hypoglycemic events, as documented by blood glucose values <36 mg/dL, were observed in 4% of patients treated with Amaryl and in 1% of patients treated with metformin.

Geriatric Use
The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Elderly patients are particularly susceptible to hypoglycemic action of glucose-lowering drugs. In elderly, debilitated, or malnourished patients, or in patients with renal and hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative based upon blood glucose levels prior to and after initiation of treatment to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents.

Product Description

Most important information about Amaryl

Pharmacokinetics

More information about AMARYL (Glimepiride):

Amaryl-Metformin Combination Therapy

Amaryl-Insulin Combination Therapy

FDA MedWatch Alerts

To buy Amaryl click HERE: My Family Drugstore

  • Share/Bookmark

AMARYL (Glimepiride) Pharmacokinetics

Wednesday, October 3rd, 2007

Absorption
After oral administration, glimepiride is completely (100%) absorbed from the GI tract. Studies with single oral doses in normal subjects and with multiple oral doses in patients with Type 2 diabetes have shown significant absorption of glimepiride within 1 hour after administration and peak drug levels (Cmax) at 2 to 3 hours. When glimepiride was given with meals, the mean Tmax (time to reach Cmax) was slightly increased (12%) and the mean Cmax and AUC (area under the curve) were slightly decreased (8% and 9%, respectively).

Distribution
After intravenous (IV) dosing in normal subjects, the volume of distribution (Vd) was 8.8 L (113 mL/kg), and the total body clearance (CL) was 47.8 mL/min. Protein binding was greater than 99.5%.

Metabolism

 

Glimepiride is completely metabolized by oxidative biotransformation after either an IV or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2). Cytochrome P450 2C9 has been shown to be involved in the biotransformation of glimepiride to M1. M1 is further metabolized to M2 by one or several cytosolic enzymes. M1, but not M2, possesses about 1/3 of the pharmacological activity as compared to its parent in an animal model; however, whether the glucose-lowering effect of M1 is clinically meaningful is not clear. Excretion
When 14C-glimepiride was given orally, approximately 60% of the total radioactivity was recovered in the urine in 7 days and M1 (predominant) and M2 accounted for 80-90% of that recovered in the urine. Approximately 40% of the total radioactivity was recovered in feces and M1 and M2 (predominant) accounted for about 70% of that recovered in feces. No parent drug was recovered from urine or feces. After IV dosing in patients, no significant biliary excretion of glimepiride or its M1 metabolite has been observed.

Special Populations

Geriatric
Comparison of glimepiride pharmacokinetics in Type 2 diabetic patients ?65 years and those >65 years was performed in a study using a dosing regimen of 6 mg daily. There were no significant differences in glimepiride pharmacokinetics between the two age groups. The mean AUC at steady state for the older patients was about 13% lower than that for the younger patients; the mean weight-adjusted clearance for the older patients was about 11% higher than that for the younger patients.

Pediatric
The pharmacokinetics of glimepiride (1 mg) were evaluated in a single dose study conducted in 30 Type 2 diabetic patients (Male = 7; Female = 23) between ages 10 and 17 years. The mean AUC(0-last)(338.8�203.1 ng�hr/mL), Cmax (102.4�47.7 ng/mL) and T1/2(3.1�1.7 hours) were comparable to those previously reported in adults (AUC(0-last) 315.2�95.9 ng�hr/mL, Cmax 103.2�34.3 ng/mL and T1/2 5.3�4.1 hours).

Gender
There were no differences between males and females in the pharmacokinetics of glimepiride when adjustment was made for differences in body weight.

Race
No pharmacokinetic studies to assess the effects of race have been performed, but in placebo-controlled studies of Amaryl (glimepiride tablets) in patients with Type 2 diabetes, the antihyperglycemic effect was comparable in whites (n = 536), blacks (n = 63), and Hispanics (n = 63).

Renal Insufficiency
A single-dose, open-label study was conducted in 15 patients with renal impairment. Amaryl (3 mg) was administered to 3 groups of patients with different levels of mean creatinine clearance (CLcr); (Group I, CLcr = 77.7 mL/min, n = 5), (Group II, CLcr = 27.7 mL/min, n = 3), and (Group III, CLcr = 9.4 mL/min, n = 7). Amaryl was found to be well tolerated in all 3 groups. The results showed that glimepiride serum levels decreased as renal function decreased. However, M1 and M2 serum levels (mean AUC values) increased 2.3 and 8.6 times from Group I to Group III. The apparent terminal half-life (T1/2) for glimepiride did not change, while the half-lives for M1 and M2 increased as renal function decreased. Mean urinary excretion of M1 plus M2 as percent of dose, however, decreased (44.4%, 21.9%, and 9.3% for Groups I to III).
A multiple-dose titration study was also conducted in 16 Type 2 diabetic patients with renal impairment using doses ranging from 1-8 mg daily for 3 months. The results were consistent with those observed after single doses. All patients with a CLcr less than 22 mL/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily. The results from this study suggested that a starting dose of 1 mg Amaryl may be given to Type 2 diabetic patients with kidney disease, and the dose may be titrated based on fasting blood glucose levels.

Hepatic Impairment
No studies were performed in patients with hepatic insufficiency.

Other Populations
There were no important differences in glimepiride metabolism in subjects identified as phenotypically different drug-metabolizers by their metabolism of sparteine. The pharmacokinetics of glimepiride in morbidly obese patients were similar to those in the normal weight group, except for a lower Cmax and AUC. However, since neither Cmax nor AUC values were normalized for body surface area, the lower values of Cmax and AUC for the obese patients were likely the result of their excess weight and not due to a difference in the kinetics of glimepiride.

Product Description

Most important information about Amaryl

Possible Side Effects

More information about AMARYL (Glimepiride):

Amaryl-Metformin Combination Therapy

Amaryl-Insulin Combination Therapy

FDA MedWatch Alerts

To buy Amaryl click HERE: My Family Drugstore

  • Share/Bookmark

AMARYL (Glimepiride) Most Important Information

Tuesday, October 2nd, 2007

What is the most important information I should know about Amaryl?
Treatment with glimepiride may increase the risk of death from cardiovascular disease compared to treatment of diabetes with diet alone or diet plus insulin. Discuss with your doctor the risks and benefits of treatment with glimepiride.
Know the signs and symptoms of low blood sugar (hypoglycemia), which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
Follow diet, medication, and exercise routines closely. Changing any of them can affect your blood sugar levels.
Do not change your dose of glimepiride without first talking to your doctor.
Avoid alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
What should I discuss with my doctor before taking Amaryl?
Some medical conditions may interact with Amaryl. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, a severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glipizide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
  • if you have a history of stroke or liver, kidney, thyroid, heart, or blood vessel problems
  • if you have stomach or bowel problems (eg, stomach or bowel blockage, stomach paralysis), drink alcohol, or have had poor nutrition
  • if you have type 1 diabetes, very poor health, a high fever, a severe infection, severe diarrhea, or high blood acid levels, or have had a severe injury
  • if you have a history of certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]), or low blood sodium levels
  • if you will be having surgery

You may not be able to take amaryl, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Patients 65 years of age and older may have a stronger reaction to glimepiride and may require a reduced dose.
Glimepiride is in the FDA pregnancy category C. This means that it is not known whether glimepiride will be harmful to an unborn baby. Insulin is usually the drug of choice to control diabetes during pregnancy. Do not take glimepiride without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether glimepiride passes into breast milk. Do not take glimepiride without first talking to your doctor if you are breast-feeding a baby.

Product Description

Pharmacokinetics

Possible Side Effects

More information about AMARYL (Glimepiride):

Amaryl-Metformin Combination Therapy

Amaryl-Insulin Combination Therapy

FDA MedWatch Alerts

To buy Amaryl click HERE: My Family Drugstore

  • Share/Bookmark

AMARYL (Glimepiride) Description

Monday, October 1st, 2007

Drug Name
Amaryl (Glimepiride)

Generic Name
Glimepiride (glye-MEP-i-ride)

Manufacturer / Distributor
Aventis Pharmaceuticals

Looks like
Glimepiride is available with a prescription under the brand name Amaryl. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Amaryl 1 mg-pink, flat-faced, oblong tablets
  • Amaryl 2 mg-green, flat-faced, oblong tablets
  • Amaryl 4 mg-blue, flat-faced, oblong tablets

Dosage Form
Tablets

Route Of Administration
ORAL

Imprint Code
AMA;RYL

Size
10mm

Alternatives
Glucotrol XL

Drug Uses
Amaryl is an anti-diabetic drug (sulfonylurea-type) used along with a proper diet and exercise program to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). It works by stimulating the release of your body’s natural insulin. Effectively controlling high blood sugar.
Helps prevent:

  • heart disease,
  • strokes,
  • kidney disease,
  • blindness,
  • and circulation problems, as well as sexual function problems (impotence).

Drug class
Amaryl is an oral blood sugar-lowering drug in a class of medicines for controlling diabetes called sulfonylureas. Amaryl is related to other sulfonylureas including:

  • glyburide (Micronase; Diabeta),
  • glipizide (Glucotrol),
  • tolbutamide (Orinase)
  • and tolazamide (Tolinase).

Amaryl is used in type II diabetes, the most common type of diabetes that is found in 90% of patients with diabetes. In type II diabetes, insulin usually is not necessary to control the blood sugar. Instead, diet and oral medications often are sufficient. Intolerance to sugar that results in elevated blood sugar is caused by reduced insulin secretion by the pancreas and resistance to insulin’s effects by the body’s cells. Amaryl lowers the sugar level in the blood by stimulating insulin to be secreted from the pancreas into the blood. Insulin causes sugar to leave the blood and enter cells throughout the body.

Contains
Amaryl (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1-mg, 2-mg, and 4-mg strengths for oral administration.
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.

Chemical formula
Chemically, glimepiride is identified as 1 – [[p - [2 - (3 - ethyl - 4 - methyl - 2 - oxo - 3 - pyrroline - 1 - carboxamido)ethyl]phenyl]sulfonyl] – 3 – (trans – 4 – methylcyclohexyl)urea. The CAS Registry Number is 93479-97-1.
[Image]

Mechanism of Action
The primary mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, extrapancreatic effects may also play a role in the activity of sulfonylureas such as glimepiride. This is supported by both preclinical and clinical studies demonstrating that glimepiride administration can lead to increased sensitivity of peripheral tissues to insulin. These findings are consistent with the results of a long-term, randomized, placebo-controlled trial in which Amaryl therapy improved postprandial insulin/C-peptide responses and overall glycemic control without producing clinically meaningful increases in fasting insulin/C-peptide levels. However, as with other sulfonylureas, the mechanism by which glimepiride lowers blood glucose during long-term administration has not been clearly established.
Amaryl is effective as initial drug therapy. In patients where monotherapy with Amaryl or metformin has not produced adequate glycemic control, the combination of Amaryl and metformin may have a synergistic effect, since both agents act to improve glucose tolerance by different primary mechanisms of action. This complementary effect has been observed with metformin and other sulfonylureas, in multiple studies.

How Taken
Take amaryl exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Amaryl is usually taken once a day, with breakfast or the first main meal. Follow your doctor’s instructions.
It is important to take amaryl regularly to get the most benefit.
Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests.
Do not change your dose of glimepiride without first talking to your doctor.

Dosage and Administration
ADULTS
The usual starting dose is 1 to 2 milligrams taken once daily with breakfast or the first main meal. The maximum starting dose is 2 milligrams.
If necessary, your doctor will gradually increase the dose 1 or 2 milligrams at a time every 1 or 2 weeks. Your diabetes will probably be controlled on 1 to 4 milligrams a day; the most you should take in a day is 8 milligrams. If the maximum dose fails to do the job, your doctor may add Glucophage to your regimen. Weakened or malnourished people and those with adrenal, pituitary, kidney, or liver disorders are particularly sensitive to hypoglycemic drugs such as Amaryl and should start at 1 milligram once daily. Your doctor will increase your medication based on your response to the drug.

CHILDREN
Safety and effectiveness in children have not been established.

Usual Starting Dose
The usual starting dose of Amaryl as initial therapy is 1-2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully.
No exact dosage relationship exists between Amaryl and the other oral hypoglycemic agents. The maximum starting dose of Amaryl should be no more than 2 mg.

Usual Maintenance Dose
The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a dose of 2 mg, dosage increases should be made in increments of no more than 2 mg at 1-2 week intervals based upon the patient’s blood glucose response. Long-term efficacy should be monitored by measurement of HbA1c levels, for example, every 3 to 6 months.

Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Overdose
Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately.
Symptoms of a glimepiride overdose include hunger, nausea, anxiety, cold sweats, weakness, drowsiness, unconsciousness, and coma.

Storage
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

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, either imprinted with “AMA RYL” on one side) or imprinted with “AMA RYL” on one side and the Hoechst logo on both sides of the bisect on the other side)
    [Bottles of 100] [(NDC 0039-0221-10)]
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, either imprinted with “AMA RYL” on one side) or imprinted with “AMA RYL” on one side and the Hoechst logo on both sides of the bisect on the other side)
    [Bottles of 100] [(NDC 0039-0222-10)]
    [Unit Dose Cartons (100)] [(NDC 0039-0222-11)]
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, either imprinted with “AMA RYL” on one side, or imprinted with “AMA RYL” on one side and the Hoechst logo on both sides of the bisect on the other side)
    [Bottles of 100] [(NDC 0039-0223-10)]
    [Unit Dose Cartons (100)] [(NDC 0039-0223-11)]

Most important information about Amaryl

Pharmacokinetics

Possible Side Effects

More information about AMARYL (Glimepiride):

Amaryl-Metformin Combination Therapy

Amaryl-Insulin Combination Therapy

FDA MedWatch Alerts

To buy Amaryl click HERE: My Family Drugstore

  • Share/Bookmark