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
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