Glitos™
[Pioglitazone]
Description / Properties
GLITOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. GLITOS is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). Pharmacological studies indicate that GLITOS improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. GLITOS improves glycemic control while reducing circulating insulin levels.
Clinical Pharmacology
GLITOS (Pioglitazone) is a thiazolidinedione antidiabetic agent that depends on the presence of insulin for its mechanism of action. GLITOS (Pioglitazone) decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulfonylureas, GLITOS (Pioglitazone) is not an insulin secretagogue. GLITOS (Pioglitazone) is a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPAR g ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPAR g nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.
Indications
GLITOS 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). GLITOS is indicated for monotherapy.
GLITOS 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.
Drug Interactions
Glipizide: Co-administration of GLITOS (Pioglitazone) and 5 mg glipizide administered orally once daily for 7 days did not alter the steady-state pharmacokinetics of glipizide.
Metformin: Co-administration of a single dose of metformin (1000 mg) and GLITOS (Pioglitazone) after 7 days of GLITOS (Pioglitazone) did not alter the pharmacokinetics of the single dose of metformin.
Midazolam: Administration of GLITOS (Pioglitazone) for 15 days followed by a single 7.5 mg dose of midazolam syrup resulted in a 26% reduction in midazolam C max and AUC.
lNifedipine ER: In view of the high variability of nifedipine pharmacokinetics, the clinical significance of this finding is unknown.
Side Effects
Gynaecomastia may develop in association with the use of Spironolactone. The development of gynaecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when Spironolactone is discontinued. In rare instances some breast enlargement may persist.
Other side effect reported less than 1% frequency
Skin and Appendages alopecia, rash and pruritis
Endocrine disorders breast pain and breast neoplasm
Malaise, electrolyte imbalance, Nausea, menstrual disorders, dizziness, confusion, changes in libido, thrombocytopenia, leucopenia and acute renal failure.
Dosage
GLITOS 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). GLITOS is indicated for monotherapy.
GLITOS 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.
Presentations Available
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLITOS (Pioglitazone) is available for oral administration as:
1. GLITOS Tablets 15mg Each Tablet contains;
Pioglitazone…15mg ( as Pioglitazone Hcl)
2. GLITOS Tablets 30mg Each Tablet contains;
Pioglitazone…30mg (as Pioglitazone Hcl)
3. GLITOS Tablets 45mg Each Tablet contains;
Pioglitazone…45mg (as Pioglitazone Hcl)
4. Establishing a diagnosis of primary hyper aldosteronism
5. Short term preoperative treatment of patients with primary hyperaldosteronism.
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