Actose
Generic Name
Pioglitazone 30 mg Tablet
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
actose 30 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Actose 30 mg Tablet contains Pioglitazone, an oral antidiabetic medication used to improve blood sugar control in adults with type 2 diabetes mellitus. It helps to lower blood glucose levels by improving the body's sensitivity to insulin.
Uses & Indications
Dosage
Adults
Initial dose is 15 mg or 30 mg once daily, taken orally. The dose may be increased up to a maximum of 45 mg once daily based on glycemic response and tolerability.
Elderly
No specific dose adjustment is generally required, but close monitoring for fluid retention and heart failure symptoms is recommended.
Renal_impairment
No dose adjustment is needed for mild to moderate renal impairment. For severe renal impairment or end-stage renal disease, use with caution and monitor closely.
How to Take
Take Actose 30 mg Tablet orally once daily, with or without food. It is recommended to take it at the same time each day.
Mechanism of Action
Pioglitazone is a thiazolidinedione that acts as a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPAR-gamma). PPAR-gamma receptors are found in adipose tissue, skeletal muscle, and the liver. Activation of PPAR-gamma modulates the transcription of genes involved in the control of glucose and lipid metabolism, leading to improved insulin sensitivity in target tissues.
Pharmacokinetics
Onset
The onset of glucose-lowering effect is gradual, with maximum therapeutic effect typically observed after 2 to 3 weeks of therapy.
Excretion
Primarily excreted via bile and feces (approximately 55%), with a smaller amount (approximately 15%) excreted in the urine.
Half life
The mean terminal elimination half-life of pioglitazone is 16-24 hours. Active metabolites have longer half-lives (up to 24 hours).
Absorption
Rapidly absorbed from the gastrointestinal tract; absolute bioavailability is approximately 80%. Peak plasma concentrations occur within 2 hours.
Metabolism
Extensively metabolized in the liver by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 to several active and inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to pioglitazone or any component of the tablet.
- Heart failure (NYHA Class III or IV).
- History of bladder cancer or current bladder cancer.
- Diabetic ketoacidosis (treat with insulin).
- Severe hepatic impairment.
Drug Interactions
Rifampicin
Coadministration with rifampicin (a potent CYP2C8 inducer) significantly decreases pioglitazone exposure. An increase in pioglitazone dose may be required.
Gemfibrozil
Coadministration with gemfibrozil (a potent CYP2C8 inhibitor) significantly increases pioglitazone exposure. A dose reduction of pioglitazone may be necessary.
Insulin/Sulfonylureas
Increased risk of hypoglycemia when used in combination; dose adjustment of insulin or sulfonylurea may be needed.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive treatment should be initiated. Gastric lavage and activated charcoal may be considered if recent ingestion. Pioglitazone is not dialyzable.
Pregnancy & Lactation
Pregnancy: Limited data on pioglitazone use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Use only if potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether pioglitazone is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Known hypersensitivity to pioglitazone or any component of the tablet.
- Heart failure (NYHA Class III or IV).
- History of bladder cancer or current bladder cancer.
- Diabetic ketoacidosis (treat with insulin).
- Severe hepatic impairment.
Drug Interactions
Rifampicin
Coadministration with rifampicin (a potent CYP2C8 inducer) significantly decreases pioglitazone exposure. An increase in pioglitazone dose may be required.
Gemfibrozil
Coadministration with gemfibrozil (a potent CYP2C8 inhibitor) significantly increases pioglitazone exposure. A dose reduction of pioglitazone may be necessary.
Insulin/Sulfonylureas
Increased risk of hypoglycemia when used in combination; dose adjustment of insulin or sulfonylurea may be needed.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive treatment should be initiated. Gastric lavage and activated charcoal may be considered if recent ingestion. Pioglitazone is not dialyzable.
Pregnancy & Lactation
Pregnancy: Limited data on pioglitazone use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Use only if potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether pioglitazone is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Expired for generic versions
Clinical Trials
Pioglitazone has been extensively studied in numerous clinical trials demonstrating its efficacy in improving glycemic control and its safety profile in patients with type 2 diabetes.
Lab Monitoring
- Liver function tests (ALT) at baseline and periodically thereafter.
- HbA1c levels every 3-6 months.
- Fasting blood glucose levels regularly.
- Monitor for signs and symptoms of heart failure (e.g., edema, rapid weight gain).
Doctor Notes
- Assess cardiovascular risk factors and cardiac status before initiating pioglitazone.
- Monitor for signs and symptoms of fluid retention and heart failure throughout treatment.
- Regularly evaluate liver function tests (ALT) and adjust therapy if abnormalities persist.
- Educate patients on potential risks, including bone fractures and bladder cancer symptoms.
Patient Guidelines
- Take Actose exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel well.
- Report any unusual symptoms like swelling, rapid weight gain, or shortness of breath to your doctor immediately.
- Adhere to your prescribed diet and exercise program.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Pioglitazone itself is not known to cause hypoglycemia when used alone. However, if used in combination with other antidiabetic agents (e.g., insulin, sulfonylurea), it may increase the risk of hypoglycemia which can impair driving ability. Patients should be cautious about driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a balanced diet low in saturated fats and refined sugars.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood glucose levels regularly as instructed.
- Maintain a healthy body weight.
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