A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rezulin Indications, Dosage, Storage, Stability - Troglitazone (removed from the US market 3/21/00)
Rezulin Indications, Dosage, Storage, Stability - Troglitazone (removed from the US market 3/21/00)
INDICATIONS
Rezulin may be used concomitantly with a sulfonylurea
or insulin to improve
glycemic control. Rezulin, as monotherapy, is indicated as an adjunct
to diet and exercise
to lower blood glucose
in patients with type II
diabetes (see DOSAGE AND ADMINISTRATION
).
Rezulin should not be used as monotherapy
in patients previously well-controlled on sulfonylurea therapy.
For patients inadequately controlled with a sulfonylurea
alone, Rezulin should be added to. not substituted for. the sulfonylurea.
Management of type II
diabetes should include
diet control. Caloric restriction,
weight loss, and exercise
are essential for
the proper treatment of the diabetic
patient. This is important not only in the primary
treatment of type II diabetes,
but in maintaining the efficacy
of drug therapy. Prior
to initiation of Rezulin therapy
secondary causes of
p.o. glycemic control,
eg, infection or p.o.
injection technique,
should be investigated and treated.
DOSAGE AND ADMINISTRATION
Rezulin should be taken with a meal.
Combination Therapy
Sulfony Iureas: Rezulin in combination with a sulfonylurea
should be initiated at 200 mg
once daily. The current
sulfonylurea dose
should be continued upon initiation of Rezulin therapy. For patients
not responding adequate1, the Rezulin dose
should be increased at 2 to 4 weeks. The maximum
recommended dose is 600
mg once daily. The dose
of sulfonylurea may require lowering to optimize therapy.
Insulin: The current
insulin dose
should be continued upon initiation of Rezulin therapy
Rezulin therapy should
be initiated at 200 mg once
daily in patients on insulin
therapy. For patients not responding adequately, the dose
of Rezulin should be increased after approximately 2 to 4 weeks.
The usual dose of Rezulin
is 400 mg once daily. The
maximum recommended daily dose
IS 600 mg It is recommended
that the insulin dose
be decreased by 10% to 25% when fasting
plasma glucose
concentrations decrease to less than 120 mg/dL in patients receiving
concomit ant insulin
and Rezulin. Further adjustments should be individualized based
on glucose lowing response.
Monotherapy
Rezulin monotherapy
in patients not adequately controlled with diet alone should be
initiated at 400 or 600 mg
once daily. For patients not responding to 400 mg
once daily, the Rezulin dose
should be increased to 600 m after 6-8 weeks. For patients not responding
adequately to 600 mg after 6-8 weeks, 9 Rezulin should be discontinued
and alternative therapeutic options should be pursued. See CLINICAL
PHARMACOLOGY, Clinical Studies, Monotherapy.
Patients With Renal Insufficiency: Dose adjustment
in patients with renal
insufficiency
is not re uired (see CLINICAL
PHARMACOLOGY, Pharmacokinetics and Drug Metabolism).
Out of 2938 patients, 148 (5%) had a serum
creatinine 21.5 at
baseline. Of these 148 patients, 145 had creatinine
levels between 1.5 and 2.0, inclusive; only 3 patients had levels
>2. 0. No consistent trend
was seen in any of these adverse events, and no
worsening of renal insufficiency
was observed.
Patients With Hepatic Impairment: Rezulin therapy
should not be initiated if the patient
exhibits clinical or
laboratory evidence
of active liver disease
(eg, ALT> 3 ALT> 3 times the upper limit of normal). See CLINICAL
PHARMACOLOGY, Special Populations, Hepatic
Insufficiency and WARNINGS.
HOW SUPPLIED
Note: FDA removed from
the US market 3/21/00
Rezulin is available in 200, 300 and 400 mg
tablets as follows:
200 mg Tablets: Yellow,
oval, non- scored, film- coated tablet
with “PD 352” debossed on one side, and “200” on the other, available
in: N 0071-0352-15 Bottles of 30 N 0071- 0352- 23 Bottles of 90
N 0071-0352-40 (10 x 10 unit-dose blisters)
300 mg Tablets: White, oval,
non-scored, film-coated tablet
with “PD 357” debossed on one side
and “300” on the other, available in: N 0071-0357-20 Bottles of
60 N 0071-0357-25 Bottles of 120
400 mg Tablets: Tan, oval,
non-scored, film-coated tablet
with “PD 353” debossed on one side, and “400” on the other, available
in: N 0071-0353-15 Bottles of 30 N 0071-0353-23 Bottles of 90 N
0071-0353-40 (10 x 10 unit-dose blisters)
Storage Store at controlled room
temperature 20°
C- 25° C (68° F-77° F). Protect from moisture and humidity.
Caution: Federal law
prohibits dispensing without prescription
top
