ZULIP-GP1 - Manufacturers & Suppliers - Third Party Contract Manufacturing - PCD Pharma Franchise
Zulip-GP1 Tablet contains Glimepiride 1 mg + Metformin 500 mg and Pioglitazone 15 mg in Sustain Release form.
Glimepiride is a sulfonylurea anti-diabetic drug. It belongs to third generation anti-diabetic drug.
Metformin
It is also an oral antidiabetic drug which belongs to biguanide class which is the first line treatment for type 2 diabetes mellitus. It causes suppression of glucose production by liver.
Pioglitazone
It belongs to the class thiazolidinedione. It mainly causes hypoglycemic actions to treat diabetes.
Indication
• First line treatment for type 2 diabetes
• Metformin is used in pre-diabetes
• PCOS (polycystic ovary syndrome)
• Gastrointestinal diabetes
• Adjunct to diet and exercise
Dosage : As directed by the physician
Mechanism of action
Glimepiride
It causes the stimulation of insulin release from pancreatic β-cells which causes the inhibition of gluconeogenesis in hepatic cells. It also increases the insulin sensitivity.
Metformin
It decreases gluconeogenesis in liver and also decreases the intestinal absorption of glucose. It also improves the sensitivity of insulin.
Pioglitazone
The drug is agonist for PPAR receptors (peroxisome proliferator-activated receptor) which is important for insulin action. It also causes resistance of insulin in liver which causes decrease in hepatic glucose output.
Pharmacology
• Metformin
Absorption
In fasting condition of the patients, the drug bioavailability is about 50% to 60%. Food decreases the absorption of drug.
Distribution
The volume of distribution is 654±358 L. It rarely bonds to plasma protein. It does not follow hepatic metabolism.
Excretion
It is excreted in unchanged form in urine
• Glimepiride
Absorption
The drug is well absorbed with peak drug concentration attaining in 2 to 3hrs. When drug is administered with food the concentration maximum was decreased by 8%
Distribution
The drug is well distributed in the body and volume of distribution is 8.8 L. the drug is metabolized by oxidative biotransformation. In the biotransformation of glimepiride to M1, cytochrome P450 2C9 is involved. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2).
Excretion
About 60% of the drug is excreted through urine in seven days.
• Pioglitazone
Absorption
After oral administration the drug attains its maximum concentration in 2 hrs.
Distribution
About 99% of the drug is bound to protein. It is metabolized by oxidation and hydroxylation.
Excretion
About 15-30% of the drug is excreted through urine.
Contraindications
• Use is contraindicated in pregnant patient
• In lactating mothers
• Renal dysfunction
• Patient undergoing radiological studies
• Acute or chronic metabolic acidosis
• Hypersensitivity to any of the ingredient.
Precautions
• Renal and hepatic impairment
• Avoid alcohol consumption
• Hypoglycemic episodes
• Lung and liver disease
• Upper respiratory tract infection
• This drug can cause fluid retention when administered with antidiabetic drugs
• Hypoglycemia
• Can effect liver
Introduction