The management of antidiabetic therapy should be individualized. AVANDIA may
be administered either at a starting dose of 4 mg as a single daily dose or
divided and administered
in the morning and evening. For patients who respond inadequately following
8 to 12 weeks of
treatment, as determined by reduction in FPG, the dose may be increased to
8 mg daily as
monotherapy or in combination with metformin. Reductions in glycemic parameters
by dose and
regimen are described under CLINICAL STUDIES. AVANDIA may be taken with or
without
food.
Monotherapy: The usual starting dose of AVANDIA is 4 mg administered either
as a single
dose once daily or in divided doses twice daily. In clinical trials, the 4
mg twice daily regimen
resulted in the greatest reduction in FPG and HbA1c.
Combination Therapy: When AVANDIA is added to existing therapy, the current
dose of a
sulfonylurea, metformin, or insulin can be continued upon initiation of AVANDIA
therapy.
Sulfonylurea: When used in combination with sulfonylurea, the recommended dose
of
AVANDIA is 4 mg administered as either a single dose once daily or in divided
doses twice
daily. If patients report hypoglycemia, the dose of the sulfonylurea should
be decreased.
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.
It is unlikely that
the dose of metformin will require adjustment due to hypoglycemia during combination
therapy
with AVANDIA.
Insulin: For patients stabilized on insulin, the insulin dose should be continued
upon
initiation of therapy with AVANDIA. AVANDIA should be dosed at 4 mg daily.
Doses of
AVANDIA greater than 4 mg daily in combination with insulin are not currently
indicated. It is
recommended that the insulin dose be decreased by 10% to 25% if the patient
reports
hypoglycemia or if FPG concentrations decrease to less than 100 mg/dL. Further
adjustments
should be individualized based on glucose-lowering response.
Maximum Recommended Dose: The dose of AVANDIA should not exceed 8 mg daily,
as
a single dose or divided twice daily. The 8 mg daily dose has been shown to
be safe and effective
in clinical studies as monotherapy and in combination with metformin. Doses
of AVANDIA
greater than 4 mg daily in combination with a sulfonylurea have not been studied
in adequate and
well-controlled clinical trials. Doses of AVANDIA greater than 4 mg daily in
combination with
insulin are not currently indicated.
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 >2.5X upper
limit of normal at
start of therapy) (see PRECAUTIONS, General, Hepatic Effects and CLINICAL
PHARMACOLOGY, Special Populations, Hepatic Impairment). Liver enzyme monitoring
is
recommended in all patients prior to initiation of therapy with AVANDIA and
periodically
thereafter (see PRECAUTIONS, General, Hepatic Effects).
There are no data on the use of AVANDIA in patients younger than 18 years;
therefore, use of
AVANDIA in pediatric patients is not recommended.
Rosiglitazone (avandia)
Fasting insulin levels
Dosage and administration
Supplied
Causes of insulin resistance
For prescriber
Rosiglitazone patient information sheet
Insulin resistance