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| Antiepileptic, Antidiabetic, Antianginal, Antifungal |
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Pioglitazone
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| INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY |
| Each uncoated tablet contains: Pioglitazone Hydrochloride Eq. to Pioglitazone15 mg |
Each uncoated tablet contains: Pioglitazone Hydrochloride Eq. to Pioglitazone 30 mg |
| Pioglitazone and other similar medications for diabetes may cause or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; or an irregular heartbeat. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.If you develop congestive heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness. |
PHARMACOLOGICAL CLASSIFICATION |
| P-GLITZ is a thiazolidinedione antidiabetic agent that depends on the presence of insulin for its mechanism of action. P-GLITZ decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulfonylureas, pioglitazone is not an insulin secretagogue. Pioglitazone is a potent agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism. |
| Following oral administration, in the fasting state, pioglitazone is first measurable in serum within 30 minutes, with peak concentrations observed within 2 hours. Food slightly delays the time to peak serum concentration to 3 to 4 hours, but does not alter the extent of absorption. The mean apparent volume of distribution (Vd/F) of pioglitazone following single-dose administration is 0.63 ± 0.41 (mean ± SD) L/kg of body weight. Pioglitazone is extensively protein bound (> 99%) in human serum, principally to serum albumin. Pioglitazone also binds to other serum proteins, but with lower affinity. Metabolites M-III and M-IV also are extensively bound (> 98%) to serum albumin. Pioglitazone is extensively metabolized by hydroxylation and oxidation; the metabolites also partly convert to glucuronide or sulfate conjugates. Following oral administration, approximately 15% to 30% of the pioglitazone dose is recovered in the urine. Renal elimination of pioglitazone is negligible, and the drug is excreted primarily as metabolites and their conjugates. It is presumed that most of the oral dose is excreted into the bile either unchanged or as metabolites and eliminated in the feces. |
Make sure you have told your doctor if you: - if you are pregnant, planning to become pregnant, or are breast-feeding
- if you have allergies to medicines, foods, or other substances
- if you have diabetic ketoacidosis (a severe problem associated with diabetes)
- if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure), or eye or vision problems
- if you have swelling problems (edema)
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You must take your medicine as the doctor tells you. It is important to take P-GLITZ Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The recommended initial dose is 15 mg or 30 mg once daily. |
| Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed. |
WHAT TO DO IF AN OVERDOSE IS TAKEN |
| In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. |
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of P-GLITZ if you are taking any drug: |
Common side effects of P-GLITZ include: - runny nose and other cold symptoms
- headache
- muscle pain
- tooth or mouth pain
- sore throat
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Some side effects can be serious. If you experience any of the following symptoms call your doctor immediately: |
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine; yellowing of the skin or eyes; unexplained nausea, vomiting, or loss of appetite; stomach pain); symptoms of low blood sugar (eg, anxiety, increased sweating, dizziness or drowsiness, headache, chills, tremors, increased hunger); unusual tiredness or weakness. - Keep all medicines out of the reach of children.
- Store in a cool, dry place, away from direct heat and light.
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| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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