Carcinogenesis, Mutagenesis, And 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. In mice, administration of Glycemager for 24 months resulted in an increase in benign pancreatic adenoma formation that was dose-related and was thought to be the result of chronic pancreatic stimulation. No adenoma formation in mice was observed at a dose of 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.
Glycemager was non-mutagenic in a battery of in vitro and in vivo mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, and mouse micronucleus test).
There was no effect of Glycemager 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). Glycemager 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).
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- severe low blood sugar (less than 35 to 40 mg/dL). Symptoms may include:
- mood changes, such as irritability, impatience, anger, stubbornness, or sadness
- confusion, including delirium
- lightheadedness or dizziness
- blurred or impaired vision
- tingling or numbness in your lips or tongue
- weakness or fatigue
- lack of coordination
- nightmares or crying out in your sleep
- anaphylaxis. This is a severe and possibly a life-threatening allergic reaction. Symptoms may include trouble breathing, swelling of your throat or tongue, hives, or difficulty swallowing.
- angioedema. This involves swelling of your skin, the layers under your skin, and your mucous membranes (ins >
Glycemager oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with Glycemager are listed below.
BRAND NAME(S): Amaryl
USES: Glycemager is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glycemager belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.
Drugs that treat depression
These drugs can increase the effect of Glycemager and cause low blood sugar. Examples of these drugs include:
- monoamine oxidase inhibitors (MAOIs), such as:
- isocarboxazid (Marplan)
- phenelzine (Nardil)
- tranylcypromine (Parnate)
The pharmacokinetics, efficacy and safety of Glycemager have been evaluated in pediatric patients with type 2 diabetes as described below. Glycemager tablets are not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.
The pharmacokinetics of a 1 mg single dose of Glimepir >(0-last) (339±203 ng•hr/mL), C max (102±48 ng/mL) and t 1/2 (3.1±1.7 hours) for Glimepir >(0-last) 315±96 ng•hr/mL, C max 103±34 ng/mL and t 1/2 5.3±4.1 hours).
The safety and efficacy of Glimepir >
After 24 weeks, the overall mean treatment difference in HbA 1c between Glycemager and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).
Based on these results, the trial d >1c with Glycemager compared to metformin.
What should I discuss with my healthcare provider before taking Glycemager (Amaryl)?
You should not use Glycemager if you are allergic to it, or if you have:
- an allergy to sulfa drugs; or
- diabetic ketoacidosis (call your doctor for treatment).
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).
Glycemager 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 this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
Medications similar to Glycemager have caused severe hypoglycemia in newborn babies whose mothers used the medicine near the time of delivery. If you take Glycemager during pregnancy, stop taking this medicine at least 2 weeks before your due date.
If you breastfeed while taking Glycemager, 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).
Glycemager is not approved for use by anyone younger than 18 years old.
Why it's used
Glycemager is used to reduce high blood sugar levels in people with type 2 diabetes. It’s used in combination with a healthy diet and exercise.
This medication may be used with insulin or other types of diabetes drugs to help control your high blood sugar.
Concomitant Administration of Colesevelam
Colesevelam can reduce the maximum plasma concentration and total exposure of Glycemager when the two are coadministered. However, absorption is not reduced when Glycemager is administered 4 hours prior to colesevelam. Therefore, Glycemager should be administered at least 4 hours prior to colesevelam.
Alcohol interaction warning
Drinking alcohol while taking Glycemager may affect your blood sugar levels. They can either increase or decrease. Avoid drinking alcohol while taking this medication.
- Use in monotherapy or, if glycemic response to Glycemager is inadequate at maximum dose, with insulin or metformin
What Are Side Effects Associated with Using Glycemager?
Common side effects of Glycemager include:
- low blood sugar (hypoglycemia)
- allergic skin reactions
- reddening of the skin
- severe itching
- decreased immunity
- low red blood cells
- reduced blood cells (aplastic anemia)
- reduced white blood cells (leukopenia)
- deficiency in the blood of red cells, white cells and platelets (pancytopenia)
- low blood platelet count (thrombocytopenia)
- reduction of bile flow (cholestasis)
- elevation of liverenzyme levels
- kidney enzyme deficiency reactions
- disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, spinning sensation , and low blood pressure)
- low sodium levels
- weight gain
Rare side effects of Glycemager include:
Post marketing side effects of Glycemager reported include:
- serious hypersensitivity reactions, including severe allergic reaction, rapid swelling (angioedema), and Stevens-Johnson Syndrome
- destruction of red blood cells (hemolytic anemia) in patients with and without G6PD deficiency
- liver impairment (reduction of bile flow, jaundice), as well as hepatitis, which may progress to liver failure
- blistering skin lesions (porphyria cutanea tarda), sensitivity to light reactions and allergic inflammation of the blood vessels
- reduced white blood cells (leukopenia), reduced immunity (agranulocytosis), reduced blood cells (aplastic anemia), and pancytopenia
- thrombocytopenia (including severe cases with platelet count under 10,000/mcl) and thrombocytopenic purpura
- kidney enzyme deficiency (hepatic porphyria) reactions and disulfiram-like reactions (flushing, fast heartbeat, nausea, thirst, chest pain, vertigo and low blood pressure)
- low sodium levels (hyponatremia) and water retention (Syndrome of Inappropriate Antidiuretic Hormone), most often in patients on other medications or have medical conditions known to cause low sodium or increase release of antidiuretic hormone
- distortion of taste (dysgeusia)
- hair loss (alopecia)
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Which drugs or supplements interact with Glycemager?
- Some medications when given with Glycemager may reduce its ability to lower blood sugar. These drugs include diuretics, for example, hydrochlorothiazide (Microzide, and many combinations with other drugs), loop diuretics (for example, furosemide ), corticosteroids such as prednisone and methylprednisolone (Medrol), phenytoin (Dilantin), colesevelam (Welchol), danazol and somatropin (Genotropin). Rifampin increases the breakdown of Glycemager by liver enzymes. This might reduce the effect of Glycemager and result in higher levels of sugar in the blood.
- Beta blockers such as propranolol (Inderal) and atenolol (Tenormin) can cause low or high blood sugar. Additionally, they can directly reverse the sugar-lowering effect of sulfonylureas and render them less effective. Beta blockers also can blunt some of the body's protective responses to low blood sugar, thus making it difficult for patients to recognize reactions due to low blood sugar (hypoglycemia).
- Certain drugs when given with Glycemager may increase the risk of low blood sugar (hypoglycemia). These include nonsteroidal anti-inflammatory drugs or NSAIDs (for example ibuprofen), sulfa drugs, warfarin (Coumadin), miconazole (Oravig), fluconazole (Diflucan), chloramphenicol, cimetidine (Tagamet HB), ranitidine (Zantac), clarithromycin (Biaxin), MAO Inhibitors (for example, isocarboxazid and phenelzine ), mifepristone (Mifeprex), probenecid, quinolone antibiotics and selective serotonin reuptake inhibitors or SSRIs (for example paroxetine , fluoxetine and sertraline ) and voriconazole (Vfend). Blood sugar should be closely monitored when interacting drugs are given with Glycemager.
- Combination Glycemager with insulin and use in patients with congestive heart failure may increase risk of other heart related side effects.
What other drugs will affect Glycemager (Amaryl)?
Glycemager 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 Glycemager dose at least 4 hours before you take colesevelam.
Other drugs may affect Glycemager, 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.
Conversion from other oral hypoglycemic agents
- Observe patients carefully for 1-2 weeks when being converted from long half-life sulfonylureas to Glycemager, because of potential for overlapping of hypoglycemic effects
Dictionary Entries near Glycemager
Cite this Entry
“Glycemager.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Glycemager. Accessed 27 December 2019.
You may need to test your blood sugar levels at home using a blood glucose monitor. You’ll need to learn how to do the following:
- use a blood glucose monitor to test your blood sugar regularly at home
- recognize the signs and symptoms of high and low blood sugar
- treat low and high blood sugar reactions
To check your blood sugar levels, you’ll need to have:
- sterile alcohol wipes
- lancing device and lancets (needles used to prick your finger to test your blood sugar)
- blood sugar test strips
- blood glucose monitor
- needle container for safe disposal of lancets
Lancets are used to test your blood sugar while you’re taking Glycemager. Don’t throw out individual lancets into trashcans or recycling bins, and never flush them down the toilet. Ask your pharmacist for a safe container for disposing used lancets.
Your community may have a program for throwing away lancets. If disposing the container in the trash, label it “do not recycle.”
- monoamine oxidase inhibitors (MAOIs), such as: