DECULIN TABLET 30MG [SIN16882P]

Product Info

DECULIN TABLET 30MG

[SIN16882P]

Indications:

• Pioglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

• Pioglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulfonylurea:

  • In combination with metformin particularly in overweight patient.

  • In combination with a sulfonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.

Recommended Dosage:
Pioglitazone should be taken orally once daily with or without food.

Adults
Pioglitazone may be initiated at 15 mg or 30 mg once daily. The dose may be increased to up to a maximum dose of 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
In combination with metformin, the current metformin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycemia, the dose of metformin should be decreased.
In combination with sulfonylurea, the current sulfonylurea dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycemia, the dose of sulfonylurea should be decreased.
The dose of pioglitazone should not exceed 45 mg once daily in monotherapy or in combination with metformin or sulfonylurea.

Elderly
No dosage adjustment is necessary for elderly patients.

Patients with renal impairment
No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance >4 ml/minute). No information is available from dialyzed patients therefore pioglitazone should not be used in such patients.

Patients with hepatic impairment
Pioglitazone should not be used in patients with hepatic impairment.

Children and adolescents
There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.

Route of Administration:
Oral.

Contraindications:
Pioglitazone is contraindicated in patients with the following conditions:

• known hypersensitivity to pioglitazone or to any of the excipients of the tablet.

• cardiac failure or history of cardiac failure (NYHA stages I to IV).

• hepatic impairment.

• active or history of bladder cancer.

• uninvestigated macroscopic hematuria.

Pioglitazone is also contraindicated for use in combination with insulin.