A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
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Q-R,
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U-V,
W-Z
Glucotrol Indications, Dosage, Storage, Stability - Glipizide
Glucotrol Indications, Dosage, Storage, Stability - Glipizide
INDICATIONS
Immediate and Extended Release Tablets
Glipizide is indicated as an adjunct
to diet for the control
of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent
diabetes mellitus (NIDDM; type
II), formerly known as maturity-onset diabetes, after an adequate trial
of dietary therapy has proved unsatisfactory.
In initiating treatment
for non-insulin-dependent diabetes, diet
should be emphasized as the primary form
of treatment. Caloric restriction and weight loss
are essential in the obese
diabetic patient. Proper
dietary management alone may be effective in controlling the blood
glucose and symptoms of hyperglycemia.
The importance of regular
physical activity should
also be stressed, and 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 glipizide must be viewed by both the physician
and patient as a treatment
in addition to diet, and
not as a substitute for
diet or as a convenient mechanism
for avoiding dietary restraint. Furthermore, loss
of blood glucose control on
diet alone also may be transient,
thus requiring only short-term administration of glipizide.
During maintenance programs, glipizide
should be discontinued if satisfactory lowering of blood
glucose is no longer achieved.
Judgments should be based on regular
clinical and laboratory evaluations.
In considering the use of glipizide
in asymptomatic patients,
it should be recognized that controlling blood
glucose in non-insulin-dependent
diabetes has not been definitely established to be effective in preventing
the long-term cardiovascular or neural
complications of diabetes. In insulin-dependent diabetes
mellitus controlling blood glucose
has been effective in slowing the progression
of diabetic retinopathy,
nephropathy, and neuropathy.
Extended Release Tablets
Glipizide extended-release is indicated when diet
alone has been unsuccessful in correcting hyperglycemia, but even after
the introduction of the drug in the patients regimen, dietary measures
should continue to be considered as important. In 12 week, well-controlled
studies there was a maximal average net reduction
in hemoglobin A1C
of 1.7% in absolute units
between placebo-treated and glipizide
extended-release-treated patients.
DOSAGE AND ADMINISTRATION
Immediate and Extended Release Tablets
There is no fixed dosage regimen
for the management of diabetes
mellitus with glipizide
or any other hypoglycemic agent. In addition
to the usual monitoring of urinary glucose, the patient's blood
glucose must also be monitored
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 an adequate blood-glucose-lowering response after an initial
period of effectiveness. Glycosylated
hemoglobin levels may also be of value
in monitoring the patient's response
to therapy.
Short-term administration
of glipizide may be sufficient
during periods of transient
loss of control
in patients usually controlled well on diet.
Patients Receiving Insulin: As with other sulfonylurea-class
hypoglycemics, many stable
non-insulin-dependent diabetic
patients receiving insulin may be safely placed on glipizide. When transferring
patients from insulin to glipizide, the following general guidelines should
be considered:
For patients whose daily insulin
requirement is 20 units or less, insulin may be discontinued and glipizide
therapy may begin at usual dosages. Several days should elapse between
glipizide titration
steps.
For patients whose daily insulin
requirement is greater than 20 units, the insulin
dose should be reduced by 50%
and glipizide therapy may
begin at usual dosages. Subsequent reductions in insulin
dosage should depend on individual
patient response. Several
days should elapse between glipizide titration steps.
During the insulin withdrawal
period, the patient should
test urine samples for sugar
and ketone bodies at least
three times daily. Patients should be instructed to contact
the prescriber immediately if these tests are abnormal. In some cases,
especially when patient has
been receiving greater than 40 units of insulin
daily, it may be advisable to consider hospitalization during the transition
period.
Patients Receiving Other Oral Hypoglycemic Agents: As with
other sulfonylurea-class hypoglycemics, no transition
period is necessary when transferring
patients to glipizide. Patients should be observed carefully (1-2 weeks)
for hypoglycemia when
being transferred from longer half-life sulfonylureas (e.g., chlorpropamide)
to glipizide due to potential
over-lapping of drug effect.
Extended Release Tablets
Recommended Dosing: The recommended stating dose
of glipizide extended-release is 5 mg per
day, given with breakfast. The recommended dose for geriatric patients
is also 5 mg per day.
Dosage adjustment should
be based on laboratory measures of glycemic control. While fasting
blood glucose
levels generally reach steady state following initiation of change in
glipizide XL dosage, a single
fasting glucose determination
may not accurately reflect the response
to therapy. In most cases, hemoglobin
A1C level measured at three month intervals is the preferred
means of monitoring response
to therapy.
Hemoglobin A1C should be measured as glipizide
extended-release therapy is initiated at the 5 mg dose
and repeated approximately three months later. If the result of this test
suggests that glycemic control over the preceding three months was inadequate,
the glipizide extended-release
dose may be increased to 10 mg. Subsequent dosage
adjustments should be made on the basis
of hemoglobin A1C
levels measured at three month intervals. If no improvement is seen after
three months of therapy with a higher dose, the previous dose
should be resumed. Decisions which utilize fasting
blood glucose
to adjust glipizide extended-release
therapy should be based on at least two or more similar, consecutive values
obtained seven days or more after the previous dose
adjustment.
Most patients will be controlled
with 5 mg or 10 mg taken once daily. However, some patients may require
up to the maximum recommended
daily dose of 20 mg. While the glycemic control
of selected patients may improve with doses which exceed 10 mg, clinical
studies conducted to date have not demonstrated an additional group
average reduction
of hemoglobin A1C
beyond what was achieved with the 10 mg dose.
Based on the results of a randomized crossover
study patients receiving immediate release
glipizide may be switched
safely to glipizide extended-release
tablets once-a-day at the nearest equivalent
total daily dose. Patients receiving immediate
release glipizide
also may be titrated to the appropriate dose of glipizide
extended-release starting with 5 mg once daily. The decision to switch
to the nearest equivalent
dose or to titrate
should be based on clinical
judgement.
In elderly patients, debilitated or malnourished patients, and patients
with impaired renal or hepatic
function, the initial and
maintenance dosing should be conservative
to avoid hypoglycemic reactions (see PRECAUTIONS.)
When glipizide extended-release is used in combination with other oral
blood glucose-lowering agents, the second agent should be added at the
lowest recommended dose and patients should be observed carefully. Titration
of the added oral agent should be based on clinical judgment.
Immediate Release Tablets
In general, glipizide should
be given approximately 30 minutes before a meal
to achieve the greatest reduction
in postprandial hyperglycemia.
Initial Dose: The recommended starting dose
is 5 mg, given before breakfast. Geriatric patients or those with liver
disease may be started on
2.5 mg.
Titration: Dosage adjustments should ordinarily be in increments
of 2.5-5 mg, as determined by blood
glucose response. At least
several days should elapse between titration
steps. If response to a single
dose is not satisfactory, dividing that dose
may prove effective. The maximum recommended once daily dose
is 15 mg. Doses above 15 mg should ordinarily be divided and given before
meals of adequate caloric
content. The maximum recommended total daily dose
is 40 mg.
Maintenance: Some patients may be effectively controlled
on a once-a-day regimen, while others wshow
better response with divided
dosing. Total daily doses above 15 mg should ordinarily be divided. Total
daily doses above 30 mg have been safely given on a b.i.d. basis
to long-term patients.
In elderly patients, debilitated or malnourished patients, and patients
with impaired renal or hepatic
function, the initial and
maintenance dosing should be conservative
to avoid hypoglycemic reactions (see PRECAUTIONS).
HOW SUPPLIED
Immediate Release Tablets
Glucotrol tablets are white, dye-free, scored, diamond-shaped, and imprinted
as follows:
- 5 mg-Pfizer 411
- 10 mg-Pfizer 412.
Recommended Storage: Store below 86°F (30°C).
Extended Release Tablets
Glucotrol XL Extended Release Tablets are supplied as follows:
- 5 mg: White, round, biconvex tablet imprinted with
"GLUCOTROL XL 5" in black ink on one side.
- 10 mg: White, round, biconvex tablet imprinted
with "GLUCOTROL XL 10" in black ink on one side.
The tablets should be protected from moisture and humidity and stored
at controlled room temperature,
59° to 86°F (15° to 30°C).
REFERENCES
1. Diabetes, 19, supp. 2: 747-830, 1970.
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