Actose
Generic Name
Pioglitazone
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| actose 15 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Actose 15 mg tablet contains Pioglitazone, an oral anti-diabetic medication used to improve glycemic control in adults with type 2 diabetes mellitus. It works by decreasing insulin resistance.
Uses & Indications
Dosage
Adults
Initial dose 15 mg or 30 mg once daily. May be increased to 45 mg once daily based on glycemic response.
Elderly
No dosage adjustment generally required, but close monitoring is advised due to potential for fluid retention.
Renal_impairment
No dosage adjustment required.
How to Take
Oral administration. Can be taken with or without food.
Mechanism of Action
Pioglitazone is a thiazolidinedione (TZD) that functions as an agonist for peroxisome proliferator-activated receptor-gamma (PPARγ) 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, leading to reduced insulin resistance in peripheral tissues and in the liver, and decreased hepatic glucose output.
Pharmacokinetics
Onset
Gradual, glycemic control improves over several weeks.
Excretion
Primarily excreted in feces (approximately 55%) and urine (approximately 45%) as metabolites.
Half life
Approximately 3-7 hours for pioglitazone, 16-24 hours for active metabolites.
Absorption
Well absorbed after oral administration; peak plasma concentrations reached within 2 hours. Bioavailability is about 83%.
Metabolism
Extensively metabolized by hepatic cytochrome P450 enzymes (primarily CYP2C8 and CYP3A4) to several active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to pioglitazone or any component of the tablet.
- Heart failure (NYHA Class III or IV).
- Active bladder cancer or history of bladder cancer.
- Diabetic ketoacidosis.
- Severe hepatic impairment.
Drug Interactions
Rifampicin
Concomitant use with rifampicin (a strong CYP2C8 inducer) significantly decreases pioglitazone plasma concentrations; consider increasing pioglitazone dose or alternative therapy.
Gemfibrozil
Concomitant use with gemfibrozil (a strong CYP2C8 inhibitor) significantly increases pioglitazone plasma concentrations; consider reducing pioglitazone dose.
Insulin and sulfonylureas
Increased risk of hypoglycemia when used in combination; dosage adjustment of insulin or sulfonylurea may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in hypoglycemia (especially in combination with insulin or sulfonylureas), fluid retention, and potentially heart failure. Management involves supportive care and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether pioglitazone is excreted in human milk. Exercise caution when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to pioglitazone or any component of the tablet.
- Heart failure (NYHA Class III or IV).
- Active bladder cancer or history of bladder cancer.
- Diabetic ketoacidosis.
- Severe hepatic impairment.
Drug Interactions
Rifampicin
Concomitant use with rifampicin (a strong CYP2C8 inducer) significantly decreases pioglitazone plasma concentrations; consider increasing pioglitazone dose or alternative therapy.
Gemfibrozil
Concomitant use with gemfibrozil (a strong CYP2C8 inhibitor) significantly increases pioglitazone plasma concentrations; consider reducing pioglitazone dose.
Insulin and sulfonylureas
Increased risk of hypoglycemia when used in combination; dosage adjustment of insulin or sulfonylurea may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in hypoglycemia (especially in combination with insulin or sulfonylureas), fluid retention, and potentially heart failure. Management involves supportive care and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether pioglitazone is excreted in human milk. Exercise caution when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Pioglitazone has been evaluated in numerous clinical trials demonstrating its efficacy in improving glycemic control and its effects on cardiovascular outcomes, such as in the PROactive study.
Lab Monitoring
- Liver function tests (ALT) before initiation and periodically thereafter.
- Glycated hemoglobin (HbA1c) and fasting plasma glucose regularly.
- Monitor for signs and symptoms of heart failure.
Doctor Notes
- Closely monitor patients for signs of heart failure, especially those with pre-existing cardiac conditions.
- Regularly assess liver function, particularly if symptoms of hepatic dysfunction appear.
- Counsel patients on the risk of bladder cancer and report any hematuria or dysuria.
- Advise patients on lifestyle modifications including diet and exercise.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Inform your doctor about any swelling, sudden weight gain, or shortness of breath.
- Regularly monitor your blood glucose levels.
- Attend regular follow-up appointments with your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause visual disturbances or hypoglycemia (especially in combination therapy) which could impair the ability to drive or operate machinery. Patients should be advised to take precautions.
Lifestyle Advice
- Maintain a balanced diet and regular exercise routine.
- Avoid smoking and limit alcohol consumption.
- Regularly check your feet for any sores or infections.
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