Trade Name: ADPAS TABLET 15 mg
Generic Name:
Pioglitazone HCI INN
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What is Adpas?
Adpas (Pioglitazone) is an oral antidiabetic agent used in the management of
Type II diabetes mellitus. Pioglitazone belongs to the thiazolidinedione
class of oral antidiabetic agents. Adpas (Pioglitazone HCI) is available as
15 mg tablet for oral administration.
What is mechanism of action of Adpas?
Unlike sulfonylureas, pioglitazone is not an insulin secretagogue. In type-2
DM where the cause of diabetes is the development of insulin resistance in
the periphery and in the liver, adpas (Pioglitazone) decreases the insulin
resistance in the peripheral tissue (Skeletal muscle & adipose tissue) and
in the liver as Pioglitazone is a potent and highly selective agonist for
Peroxisome Proliferator Activated Receptor-gamma (PPARg).
Activation of PPARg nuclear receptors modulates (adjusts or re-establishes)
the transcription (copying) of a number of insulin responsive genes involved
in the control of glucose and lipid metabolism. Thus insulin sensitivity is
increased (or decreasing insulin resistance) in the target cell and
increased insulin dependent glucose disposal and decreased hepatic glucose
output.
(Note : PPARg receptors are found in tissues important for insulin action
such as adipose tissue, skeletal muscle and liver.
What is the
pharmacokinetics of Adpas?
Absorption : In the fasting state, following oral absorption, peak plasma
concentration (Cmax) observed within 2 hours. Food slightly delays the time
for Cmax to 3 to 4 hours, but does not alter the absorption.
Distribution : Pioglitazone is highly protein bound (>99%).
What are the indications?
1) Adpas (Pioglitazone) is indicated as an adjunct to diet and exercise to
improve glycemic control in patients with Type II diabetes mellitus.
2) Adpas (Pioglitazone) is indicated for monotherapy and also indicated for
use in combination with a sulfonylurea, metformin or insulin when diet and
exercise plus single agent dose not result in adequate glycemic control.
What is the dosage and administration?
Adults : Initial dose 15-30mg once daily as monotherapy without regard the
meals. In case of inadequate response, the dose may be increased up to 45mg
(maxi. recommended dose 45mg).
Combination therapy : Adpas in combination with a sulfonylurea or metformin
or insulin may be initiated at 15mg or 30mg once daily.
Children : Dose must be determined by Physician.
Dose adjustment in patients with renal insufficiency is not recommended.
Use of adpas in pediatric patients is not recommended.
Therapy with adpas should not be initiated if the patient exhibits clinical
evidences of liver diasese or increased serum transaminase levels.
How much precautions?
If only Adpas is taken, there is no chance of hypoglycemia
Hypoglycemia : Patients receiving Adpas (Pioglitazone) in combination with
insulin or oral hypoglycemic agents may be at risk for hypoglycemia and a
reduction in dose of the concomitant agent may be necessary.
(Dose reduction of Adpas is not necessary since it is not hypoglycemic
agent; rather it acts by increasing the sensitivity of insulin) |
Edema : Adpas should be used with caution in
patients with edema.
Hepatic effects : No evidence of hepatotoxicity in clinical studies world wide.
(Troglitazone was discontinued due to severe hepatotoxicity)
Information for patients : Adpas can be taken with or without meal once daily.
If a dose is missed on one day, the dose should not be double the next day.
What are the drug interactions?
Administration of another thiazolidinedione with an oral contraceptive
containing ethinyl estradiol and non ethindrone reduced the plasma concentation
of both hormones by approximately 30%.
Patients receiving ketoconazole concomitantly with adpas should be evaluated
more frequently with respect ot glycemic control, since in-vitro, ketoconazole
significatly inhibit the metabolism of pioglitazone.
How supplied?
Each box contains 3x10's Tablet is blister strips.
Where is the positioning of our products?
Edema : Adpas should be used with caution in
patients with edema.
Hepatic effects : No evidence of hepatotoxicity in clinical studies world wide.
(Troglitazone was discontinued due to severe hepatotoxicity)
Information for patients : Adpas can be taken with or without meal once daily.
If a dose is missed on one day, the dose should not be double the next day.
What are the drug interactions?
Administration of another thiazolidinedione with an oral contraceptive
containing ethinyl estradiol and non ethindrone reduced the plasma concentation
of both hormones by approximately 30%.
Patients receiving ketoconazole concomitantly with adpas should be evaluated
more frequently with respect ot glycemic control, since in-vitro, ketoconazole
significatly inhibit the metabolism of pioglitazone.
How supplied?
Each box contains 3x10's Tablet is blister strips.
Where is the positioning of our products?
What are advantages of Adpas (Pioglitazone)?
1. Improves glycosylated hemoglobin (HbA 1C, 7%
normal)
1. Decreases fasting and postprandial glucose level.
2. Improves hepatic and peripheral tissue sensitivity to insulin.
3. Lowers plasma free fatty acid levels and improves lipid profile.
4. Has additive effect when combined with Repaglinide, Metformin, Sulfonylureas
or insulin in poorly controlled diabetic patients.
5. Synergistic effects when combined with lipid lowering durgs.
6. Improves atherosclerotic complication in Type-II diabetes. (Ischaemic heart
disease, CHD)
7. Significant improvement of diabetes dyslipidaemias (increase HDL 19.1%,
lowering of TG 12.4%)
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