INDICATIONS
Glimepiride is indicated as an adjunct to diet and exercise
to lower the blood glucose in patients with noninsulin-dependent
(Type II) diabetes mellitus (NIDDM) whose hyperglycemia
cannot be controlled by diet and exercise alone. Glimepiride
may be used concomitantly with metformin when diet, exercise,
and glimepiride or metformin alone do not result in adequeate
glycemic control.
Glimepiride 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 glimepiride 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.
If this treatment program fails to reduce symptoms and/or
blood glucose, the use of an oral sulfonylurea or insulin
should be considered. Use of glimepiride must be viewed
by both the physician and patient as a treatment in addition
to diet and exercise and not as substitute for diet and
exercise or as a convenient mechanism for avoiding dietary
restraint. Furthermore, loss of blood glucose control
on diet and exercise alone may be transient, thus requiring
only short-term administration of glimepiride.
During maintenance programs, glimepiride monotherapy
should be discontinued if satisfactory lowering of blood
glucose is no longer achieved. Judgements should be based
on regular clinical and laboratory evaluations. Secondary
failures to glimepiride monotherapy can be treated with
glimepiride-insulin combination therapy.
In considering the use of glimepiride in asymptomatic
patients, it should be recognized that blood glucose control
in NIDDM has not definitely been established to be effective
in preventing the long-term cardiovascular and neural
complications of diabetes. However, the Diabetes Control
and Complications Trial (DCCT) demonstrated that control
of HbA1c and glucose was associated with a decrease in
retinopathy, neuropathy, and nephropathy for insulin-dependent
diabetic (IDDM) patients.
DOSAGE AND ADMINISTRATION
There is no fixed dosage regimen for the management of
diabetes mellitus with glimepiride 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 glimepiride 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 glimepiride as initial therapy
is 1 to 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. (See PRECAUTIONS for
patients at increased risk.)
No exact dosage relationship exists between glimepiride
and the other oral hypoglycemic agents. The maximum starting
dose of glimepiride 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 to 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.
Glimepiride-Metformin Combination Therapy
If patients do not respond adequately to the maixmal
dose of glimepiride 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 glimepiride 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 glimepiride and metformin
therapy, the risk of hypoglycemia associated with glimepiride
therapy continues and may be increased. Appropriate precautions
should be taken.
Glimepiride-Insulin Combination Therapy
Combination therapy with glimepiride and insulin may
be used in secondary failure patients. The fasting glucose
level for instituting combination therapy is in the range
of >150 mg/dl in plasma or serum depending on the patient.
The recommended glimepiride dose is 8 mg once daily administered
with the first main meal. After starting with low-dose
insulin, upward adjustments of insulin can be done approximately
weekly as guided by frequent measurements of fasting blood
glucose. Once stable, combination-therapy patients should
monitor their capillary blood glucose on an ongoing basis,
preferably daily. Periodic adjustments of insulin may
also be necessary during maintenance as guided by glucose
and HbA1c levels.
Specific Patient Populations
Glimepiride tablets are not recommended for use in pregnancy,
nursing mothers, or children. In elderly, debilitated,
or malnourished patients, or in patients with renal or
hepatic insufficiency, the initial dosing, dose increments,
and maintenance dosage should be conservative to avoid
hypoglycemic reactions. (See CLINICAL PHARMACOLOGY, Special
Populations and PRECAUTIONS, General.)
Patients Receiving Other Oral Hypoglycemic Agents
As with other sulfonylurea hypoglycemic agents, no transition
period is necessary when transferring patients to glimepiride.
Patients should be observed carefully (1 to 2 weeks) for
hypoglycemia when being transferred from longer half-life
sulfonylureas (e.g., chlorpropamide) to glimepiride due
to potential overlapping of drug effect.
HOW SUPPLIED
Amaryl Tablets
1 mg: Pink, flat-faced, oblong with notched
sides at double bisect, imprinted with "AMA RYL"
on one side and the Hoechst logo on both sides of the bisect
on the other side.
2 mg: Green, flat-faced, oblong with notched
sides at double bisect, imprinted with "AMA RYL"
on one side and the Hoechst logo on both sides of the bisect
on the other side.
4 mg: Blue, flat-faced, oblong with notched
sides at double bisect, imprinted with "AMA RYL"
on one side and the Hoechst logo on both sides of the bisect
on the other side.
Storage: Store between 59-86°F (15-30°C).
Dispense in well-closed containers with safety closures.
PRODUCT LISTING
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| 100's |
Amaryl, Hoechst Marion Roussel
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00039-0221-10
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| 100's |
Amaryl, Hoechst Marion Roussel
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00039-0222-10
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| 100's |
Amaryl, Hoechst Marion Roussel
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00039-0223-10
|
REFERENCES 1. Diabetes, 19 supp. 2: 747-830,
1970.
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