ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). ACTOS is indicated for monotherapy. ACTOS is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.

Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.

ACTOS should be taken once daily without regard to meals.

The management of antidiabetic therapy should be individualized. Ideally, the response to therapy should be evaluated using HbA_1c which is a better indicator of long-term glycemic control than FPG alone. HbA_1c reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with ACTOS for a period of time adequate to evaluate change in HbA_1c (three months) unless glycemic control deteriorates. After initiation of ACTOS or with dose increase, patients should be carefully monitored for adverse events related to fluid retention (see BOXED WARNING and WARNINGS).

Monotherapy

ACTOS monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. For patients who respond inadequately to the initial dose of ACTOS, the dose can be increased in increments up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.

Combination Therapy

Sulfonylureas: ACTOS in combination with a sulfonylurea may be initiated at 15 mg or 30 mg once daily. The current sulfonylurea dose can be continued upon initiation of ACTOS therapy. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.

Metformin: ACTOS in combination with metformin may be initiated at 15 mg or 30 mg once daily. The current metformin dose can be continued upon initiation of ACTOS therapy. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with ACTOS.

Insulin: ACTOS in combination with insulin may be initiated at 15 mg or 30 mg once daily. The current insulin dose can be continued upon initiation of ACTOS therapy. In patients receiving ACTOS and insulin, the insulin dose can be decreased by 10% to 25% if the patient reports hypoglycemia or if plasma glucose concentrations decrease to less than 100 mg/dL. Further adjustments should be individualized based on glucose-lowering response.

Maximum Recommended Dose

The dose of ACTOS should not exceed 45 mg once daily in monotherapy or in combination with sulfonylurea, metformin, or insulin.

Dose adjustment in patients with renal insufficiency is not recommended (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Drug Metabolism).

Therapy with ACTOS should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy (see PRECAUTIONS, General, Hepatic Effects and CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency). Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with ACTOS and periodically thereafter (see PRECAUTIONS, General, Hepatic Effects).

There are no data on the use of ACTOS in patients under 18 years of age; therefore, use of ACTOS in pediatric patients is not recommended.

No data are available on the use of ACTOS in combination with another thiazolidinedione.

ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows:

15 mg Tablet: white to off-white, round, convex, non-scored tablet with “ACTOS” on one side, and “15” on the other, available in:

NDC 64764-151-04 Bottles of 30
NDC 64764-151-05 Bottles of 90
NDC 64764-151-06 Bottles of 500

30 mg Tablet: white to off-white, round, flat, non-scored tablet with “ACTOS” on one side, and “30” on the other, available in:

NDC 64764-301-14 Bottles of 30
NDC 64764-301-15 Bottles of 90
NDC 64764-301-16 Bottles of 500

45 mg Tablet: white to off-white, round, flat, non-scored tablet with “ACTOS” on one side, and “45” on the other, available in:

NDC 64764-451-24 Bottles of 30
NDC 64764-451-25 Bottles of 90
NDC 64764-451-26 Bottles of 500

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

Manufactured by: Takeda Pharmaceutical Company Limited., Osaka, Japan. Marketed by: Takeda Pharmaceuticals America, Inc. One Takeda Parkway Deerfield, IL 60015. ACTOS® is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc. All other trademark names are the property of their respective owners. August 2007. FDA Rev date: 8/14/2007

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