Glitazon
Generic Name
Glitazone 15 mg Tablet
Manufacturer
MediCare Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| glitazon 15 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Glitazon 15 mg tablet is an oral antidiabetic medicine used to improve glycemic control in adult patients with type 2 diabetes mellitus. It helps your body use insulin more effectively.
Uses & Indications
Dosage
Adults
Initial dose is 15 mg once daily. May be increased to 30 mg once daily after 4-8 weeks if further glycemic control is needed. Maximum daily dose is 45 mg.
Elderly
No specific dose adjustment is required based on age alone, but caution is advised due to potential for comorbidities and reduced renal/hepatic function.
Renal_impairment
No dose adjustment is generally necessary for mild to moderate renal impairment. Use with caution in severe renal impairment; not recommended in end-stage renal disease (ESRD).
Hepatic_impairment
Not recommended in patients with active liver disease or elevated ALT levels (>2.5 times ULN). Baseline and periodic monitoring of liver enzymes is crucial.
How to Take
Take Glitazon 15 mg tablet orally once daily with or without food. It should be swallowed whole with water.
Mechanism of Action
Glitazone is a thiazolidinedione that acts as a potent agonist for peroxisome proliferator-activated receptor gamma (PPARγ) located in adipose tissue, skeletal muscle, and the liver. Activation of PPARγ nuclear receptors modulates the transcription of insulin-responsive genes involved in the control of glucose and lipid metabolism, resulting in reduced insulin resistance in target tissues.
Pharmacokinetics
Onset
Glycemic improvements may take several weeks (typically 2-4 weeks) due to its mechanism of action.
Excretion
Primarily excreted in urine (approx. 15-30%) and feces (approx. 55-65%), mostly as metabolites.
Half life
Approximately 3 to 7 hours for the parent compound; active metabolites have half-lives up to 24 hours.
Absorption
Well absorbed after oral administration, peak plasma concentrations reached within 2 hours. Bioavailability is high (approximately 80-90%).
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (primarily CYP2C8 and CYP3A4) to several active and inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to glitazone or any component of the tablet.
- Patients with moderate to severe heart failure (NYHA Class III or IV).
- Active liver disease or increased serum alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN).
- Diabetic ketoacidosis (DKA).
- History of bladder cancer.
Drug Interactions
Rifampicin
Coadministration with rifampicin (a strong CYP2C8 inducer) significantly decreases glitazone exposure. Efficacy may be reduced.
Gemfibrozil
Coadministration with gemfibrozil (a strong CYP2C8 inhibitor) significantly increases glitazone exposure. A dose reduction of glitazone may be necessary.
Oral Contraceptives
Glitazone may reduce the efficacy of oral contraceptives by affecting their metabolism; an alternative or additional method of contraception is advised.
Other Antidiabetic Agents
Increased risk of hypoglycemia when used in combination with sulfonylureas or insulin.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, the most common effects include exaggerated pharmacological actions such as fluid retention and hypoglycemia (especially if co-administered with sulfonylureas or insulin). Treatment should be symptomatic and supportive. There is no specific antidote for glitazone overdose.
Pregnancy & Lactation
Pregnancy Category C. Glitazone is not recommended during pregnancy or breastfeeding due to insufficient data on safety and potential risks to the fetus/infant. Consult your doctor for alternative treatment options if you are pregnant, planning pregnancy, or breastfeeding.
Side Effects
Contraindications
- Known hypersensitivity to glitazone or any component of the tablet.
- Patients with moderate to severe heart failure (NYHA Class III or IV).
- Active liver disease or increased serum alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN).
- Diabetic ketoacidosis (DKA).
- History of bladder cancer.
Drug Interactions
Rifampicin
Coadministration with rifampicin (a strong CYP2C8 inducer) significantly decreases glitazone exposure. Efficacy may be reduced.
Gemfibrozil
Coadministration with gemfibrozil (a strong CYP2C8 inhibitor) significantly increases glitazone exposure. A dose reduction of glitazone may be necessary.
Oral Contraceptives
Glitazone may reduce the efficacy of oral contraceptives by affecting their metabolism; an alternative or additional method of contraception is advised.
Other Antidiabetic Agents
Increased risk of hypoglycemia when used in combination with sulfonylureas or insulin.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, the most common effects include exaggerated pharmacological actions such as fluid retention and hypoglycemia (especially if co-administered with sulfonylureas or insulin). Treatment should be symptomatic and supportive. There is no specific antidote for glitazone overdose.
Pregnancy & Lactation
Pregnancy Category C. Glitazone is not recommended during pregnancy or breastfeeding due to insufficient data on safety and potential risks to the fetus/infant. Consult your doctor for alternative treatment options if you are pregnant, planning pregnancy, or breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Available in all pharmacies
Approval Status
Approved by DGDA
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have demonstrated Glitazon's efficacy in improving glycemic control and reducing HbA1c in patients with type 2 diabetes. Studies have also evaluated its safety profile and long-term effects, contributing to the understanding of its cardiovascular risks and benefits.
Lab Monitoring
- Liver function tests (ALT) should be performed before initiating therapy and periodically thereafter (e.g., every 2-3 months for the first year, then annually or as clinically indicated).
- Hemoglobin A1c (HbA1c) to assess glycemic control.
- Renal function should be monitored periodically.
- Fluid retention and signs of heart failure should be monitored regularly.
Doctor Notes
- Before initiating Glitazon, assess patient's cardiac risk, especially for a history of heart failure. Exclude patients with NYHA Class III/IV heart failure.
- Monitor liver function tests (ALT) at baseline and periodically. Discontinue if ALT >3 times ULN or if jaundice/symptoms of liver dysfunction occur.
- Counsel patients on signs and symptoms of fluid retention and heart failure. Advise prompt reporting.
- Consider bone fracture risk, particularly in women, and discuss with patients.
Patient Guidelines
- Take Glitazon exactly as prescribed by your doctor.
- Follow your doctor's recommendations for diet and exercise.
- Report any unusual symptoms such as rapid weight gain, swelling, shortness of breath, or dark urine to your doctor immediately.
- Regularly monitor your blood sugar levels as advised by your healthcare provider.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Glitazon itself is unlikely to impair your ability to drive or operate machinery. However, if you experience symptoms of hypoglycemia (low blood sugar), especially when used in combination with other antidiabetic drugs, avoid driving or operating machinery until you feel well.
Lifestyle Advice
- Maintain a balanced diet low in sugar and unhealthy fats.
- Engage in regular physical activity for at least 30 minutes most days of the week.
- Manage your weight to help improve insulin sensitivity.
- Avoid smoking and limit alcohol consumption.
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