INDICATIONS
Avandia is indicated as monotherapy as an adjunct
to diet and exercise to improve glycemic control in patients
with type 2 diabetes mellitus.
Avandia is also indicated for use in combination with metformin
when diet, exercise, and Avandia alone or diet, exercise,
and metformin alone do not result in adequate glycemic control
in patients with type 2 diabetes. For patients inadequately
controlled with a maximum dose of metformin, Avandia should
be added to, rather than substituted for, metformin. Management
of type 2 diabetes should include diet control. Caloric
restriction, weight loss, and exercise are essential for
the proper treatment of the diabetic patient because they
help improve insulin sensitivity. This is important not
only in the primary treatment of type 2 diabetes, but also
in maintaining the efficacy of drug therapy. Prior to initiation
of therapy with Avandia, secondary causes of p.o. glycemic
control, e.g., infection, should be investigated and treated.
DOSAGE AND ADMINISTRATION
The management of antidiabetic therapy should be
individualized.
Monotherapy
The usual starting dose of Avandia is 4 mg administered
either as a single dose once daily or in divided doses twice
daily. For patients who respond inadequately following 12
weeks of treatment as determined by reduction in FPG, the
dose may be increased to 8 mg administered as a single dose
once daily or in divided doses twice daily. Reductions in
glycemic parameters by dose and regimen are described under
CLINICAL PHARMACOLOGY, Clinical Efficacy. In clinical trials,
the 4 mg twice daily regimen resulted in the greatest reduction
in FPG and HbA1c.
Combination Therapy with Metformin
The usual starting dose of Avandia in combination
with metformin is 4 mg administered as either a single dose
once daily or in divided doses twice daily. The dose of
Avandia may be increased to 8 mg/day following 12 weeks
of therapy if there is insufficient reduction in FPG. Avandia
may be administered as a single daily dose in the morning,
or divided and administered in the morning and evening.
Avandia may be taken with or without food.
No dosage adjustments are required for the elderly.
No dosage adjustment is necessary when Avandia is used as
monotherapy in patients with renal impairment. Since metformin
is contraindicated in such patients, concomitant administration
of metformin and Avandia is also contraindicated in patients
with renal impairment.
Therapy with Avandia should not be initiated if the patient
exhibits clinical evidence of active liver disease or increased
serum transaminase levels (ALT 2.5 times the upper limit
of normal at start of therapy (See PRECAUTIONS,
Hepatic Effects and CLINICAL PHARMACOLOGY,
Hepatic Impairment). Liver enzyme monitoring is recommended
in all patients prior to initiation of therapy with Avandia
and periodically thereafter (See PRECAUTIONS,
Hepatic Effects).
There are no data on the use of Avandia in patients under
18 years of age; therefore, use of Avandia in pediatric
patients is not recommended.
HOW SUPPLIED
Tablets: Each pentagonal film-coated TiltabÒ
tablet contains rosiglitazone as the maleate as follows:
2 mg–pink, debossed with SB on one side and 2 on the
other; 4 mg–orange, debossed with SB on one side and
4 on the other; 8 mg–red-brown, debossed with SB on
one side and 8 on the other.
2 mg bottles of 30: NDC 0029-3158-13
2 mg bottles of 60: NDC 0029-3158-18
2 mg bottles of 100: NDC 0029-3158-20
2 mg bottles of 500: NDC 0029-3158-25
2 mg SUP 100s: NDC 0029-3158-21
4 mg bottles of 30: NDC 0029-3159-13
4 mg bottles of 60: NDC 0029-3159-18
4 mg bottles of 100: NDC 0029-3159-20
4 mg bottles of 500: NDC 0029-3159-25
4 mg SUP 100s: NDC 0029-3159-21
8 mg bottles of 30: NDC 0029-3160-13
8 mg bottles of 100: NDC 0029-3160-20
8 mg bottles of 500: NDC 0029-3160-25
8 mg SUP 100s: NDC 0029-3160-21
STORAGE
Store at 25° C (77° F); excursions 15°
–30° C (59° – 86° F). Dispense in
a tight, light-resistant container.
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