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Amaryl® (Brand)

AMARYL (glimepiride) is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.


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Uses

AMARYL is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be
controlled by diet and exercise alone. AMARYL may be used concomitantly with metformin when diet, exercise, and AMARYL or metformin alone do not result in adequate glycemic control.
AMARYL is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of AMARYL and insulin may increase the potential for hypoglycemia.
In initiating treatment for noninsulin-dependent diabetes, diet and exercise should be emphasized as the primary form of treatment. Caloric restriction, weight loss, and exercise are essential in the obese diabetic patient. Proper dietary management and exercise alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. In addition to regular physical activity, cardiovascular risk factors should be identified and corrective measures taken where possible.

How to take

There is no fixed dosage regimen for the management of diabetes mellitus with AMARYL or any other hypoglycemic agent. The patient's fasting blood glucose and HbA1c must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels should be performed to monitor the patient's response to therapy.
Short-term administration of AMARYL may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.
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.
Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory
response to therapy.
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.

Side effects

Low blood sugar can occur during AMARYL therapy. Symptoms of low blood sugar include hunger, nausea, tiredness, perspiration, headache, heart palpitations, numbness around the mouth, tingling in the fingers, tremors, muscle weakness, blurred vision, cold temperature, excessive yawning, irritability, confusion, or loss of consciousness. Other side effects include dizziness (1 of every 60 persons), headache (1 of every 75), and nausea or vomiting (1 of every 90). A rash occurs in fewer than 1 of every 100 persons who receive AMARYL.

Precaution

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 7
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 AMARYL with insulin or metformin may increase the potential for hypoglycemia.

Drug interactions

Medicines that can increase blood sugar can reverse the action of AMARYL. These drugs include diuretics [e.g. hydrochlorothiazide, furosemide (Lasix)], corticosteroids such as prednisone and methylprednisolone (Medrol)], phenytoin (Dilantin), niacin, and sympathomimetics such as pseudoephedrine (Sudafed).
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. This notwithstanding, beta-blockers have been used successfully in diabetic patients and have been associated with improved survival in diabetics with high blood pressure.
Rifampin increases the breakdown of two other sulfonylureas, tolbutamide (Orinase) and glyburide (Diabeta, Micronase). This might interfere with the effects of the drugs and result in higher levels of sugar in the blood. Although this same interference has not yet been reported with AMARYL, the possibility that it may occur should be kept in mind.

Missed dose

If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

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