(pye oh gli' ta zone)
P : Caution - during pregnancy
L : Contraindicated - during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
Monotherapy and Combination Therapy
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
Important Limitations of Use
Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease.
|Dosage & Administration||
Recommendations for All Patients
Pioglitazone should be taken once daily and can be taken without regard to meals.
The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily.
The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily.
The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c.
After initiation of Pioglitazone or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure.
Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating Pioglitazone. Routine periodic monitoring of liver tests during treatment with Pioglitazone is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of Pioglitazone or who are found to have abnormal liver tests while taking Pioglitazone should be managed as described under Warnings and Precautions.
Concomitant Use with an Insulin Secretagogue or Insulin
If hypoglycemia occurs in a patient co-administered Pioglitazone and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.
If hypoglycemia occurs in a patient co-administered Pioglitazone and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.
Concomitant Use with Strong CYP2C8 InhibitorsCoadministration of Pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of Pioglitazone is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors.
|Contraindications||Hypersensitivity. Type 1 diabetes mellitus, symptomatic or history of heart failure, diabetic ketoacidosis, childn <18 yr. Lactation.|
|Special Precautions||Increased risk of hypoglycaemia when used with insulin or oral hypoglycaemics. Oedema, congestive heart failure, hepatic dysfunction, jaundice, anaemia. May cause ovulation in premenopausal, anovulatory women. Monitor liver function before and during treatment. Monitor glycaemic control. Pregnancy. Caution when oral contraceptives or hormonal replacement therapy is used in diabetics due to increased risk of arterial diseases. Stop treatment if ALT increases and remains >3 times above the upper limit of normal or if jaundice develops.|
|Adverse Drug Reaction(s)||Pharyngitis, oedema, headache, upper resp tract infection, sinusitis, anaemia; GI disturbances, wt gain, visual disturbances, dizziness, arthralgia, haematuria, impotence.|
|Drug Interactions||Ketoconazole and gemfibrozil may increase the plasma concentrations of pioglitazone while enzyme inducers such as rifampicin may decrease the plasma concentrations. Increased risk of fluid retention when used with NSAIDs.
|Lab Interference||Transient elevations in creatine phosphokinase levels were observed.|
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Store at 25Â°C.|
|Pharmacology||Pioglitazone is as a potent and highly selective agonist for the peroxisome proliferator activated receptor-gamma (PPAR). Activation of these receptors promotes the production of gene products involved in lipid and glucose metabolism. It also improves insulin response to target cells witho increasing the pancreatic secretion of insulin.
Absorption: Peak plasma concentrations after 2 hr.
Distribution: Protein-binding: >99%.
Metabolism: Extensively metabolised by hydroxylation and oxidation.
Excretion: Urine (15-30%); faeces (as metabolites); 3-7 hr (elimination half-life, parent drug).
|ATC Classification||A10BG03 - pioglitazone; Belongs to the class of thiazolidinediones. Used in the treatment of diabetes.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ACTOSE||Unimed & Unihealth Manufacturers Ltd.||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||15mg x30's, 30mg x20's: 240.00 & 300.00 MRP|
|ADPAS||General Pharmaceuticals Ltd||Pioglitazone hydrochloride INN 15mg||Tablet||30's: 240.90 MRP|
|DIAGLIT 15||Beximco Pharmaceuticals Ltd||Pioglitazone Hydrochloride INN eq. to Pioglitazone 15mg||Tablet||30's: 240.00 MRP|
|DIAGLIT 30||Beximco Pharmaceuticals Ltd||Pioglitazone Hydrochloride INN eq. to Pioglitazone 30mg||Tablet||30's: 450.00 MRP|
|DIAPIOTAB||Medimet Pharmaceuticals Ltd||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||50's each: 400.00 & 600.00 MRP|
|DIATAG||ACI Ltd.||Pioglitazone hydrochloride INN 15mg, 30mg & 45mg||Tablet||30's each: 240.90, 361.50 & 451.80 MRP|
|GLITAZON||IBN SINA Pharmaceutical Industry Ltd.||Pioglitazone hydrochloride INN 15mg||Tablet||30's: 240.00 IP|
|GLUCOZON||Aristopharma Ltd.||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||15mg x30's, 30mg x20's: 240.00 & 300.00 MRP|
|LIT||The White Horse Pharma||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||30's each: 240.00 & 360.00 MRP|
|OGLI||Kemiko Pharmaceuticals Ltd||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||15mg x30's, 30mg x20's: 240.00 MRP|
|PEEGEE||Jayson Pharmaceuticals Ltd.||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||30's each: 180.60, 301.20 IP|
|PIDUS||The Acme Laboratories Ltd.||Pioglitazone hydrochloride INN 15mg||Tablet||30's: 241.20 MRP|
|PIGLIT||Pacific Pharmaceuticals Ltd.||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||30's each: 240.00 & 360.00 MRP|
|Piodar 15||Incepta Pharmaceuticals Limited||Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15mg||Tablet||10x3's:MRP 240 Tk|
|Piodar 30||Incepta Pharmaceuticals Limited||Pioglitazone Hydrochloride INN equivalent to Pioglitazone 30mg||Tablet||10x3's:MRP 450 Tk|
|PIOGLIN||Renata Limited||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||15mg x30's, 30mg x10's: 240.00 & 300.00 MRP|
|PIOLIT||Alco Pharma Ltd||Pioglitazone hydrochloride INN 15mg||Tablet||30's: 240.00 MRP|
|PIOZENA||Drug International Ltd||Pioglitazone hydrochloride INN 15mg & 30mg||Tablet||30's each: 240.90 & 301.19 MRP|
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, inform 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 inform 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 supply blood to the heart); a heart attack; an irregular heartbeat; or sleep apnea. Your doctor may inform you not to take pioglitazone or may monitor you carefully during your treatment.
If you develop congestive heart failure, you may experience certain symptoms. inform 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 under your head in order to breathe easier while lying down; frequent dry cough or wheezing; difficulty thinking clearly or confusion; fast or racing heart beat; not able to walk or exercise as well; or increased tiredness.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pioglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http:www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking pioglitazone.
Why is Pioglitazone prescribed?
Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
How should Pioglitazone be used?
Pioglitazone comes as a tablet to take by mouth. It is usually taken once daily with or without meals. Take pioglitazone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pioglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of pioglitazone and gradually increase your dose.
Pioglitazone controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and 2 to 3 months for you to feel the full effect of pioglitazone. Continue to take pioglitazone even if you feel well. Do not stop taking pioglitazone without talking to your doctor.
Other uses for Pioglitazone
- inform your doctor if you are allergic to pioglitazone, any other medications, or any of the ingredients in pioglitazone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: atorvastatin (Lipitor), gemfibrozil, hormonal contraceptives (birth control pills, patches, rings, implants, and injections), insulin or other medications to treat diabetes; ketoconazole (Nizoral), midazolam, nifedipine, and rifampin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- inform your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, or if you have or have ever had bladder cancer, diabetic eye disease, or kidney or liver disease.
- inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pioglitazone, call your doctor. Do not breast-feed while you are taking pioglitazone.
- if you have not yet experienced menopause (change of life; end of monthly periods) you should know that pioglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or if you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
- if you will be having surgery, including dental surgery, inform the doctor or dentist that you are taking pioglitazone.
- ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of pioglitazone you may need.
What special dietary instructions to follow?
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking pioglitazone.
What to do if I forget a dose?
Pioglitazone may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
Pioglitazone may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
pain in the arms or legs
Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
changes in vision
frequent, painful, or difficult urination
cloudy, discolored, or bloody urine
back or abdominal pain
You should know that pioglitazone may cause liver problems. Stop taking pioglitazone and call your doctor right away if you have nausea, vomiting, loss of appetite, pain in the upper right part of the stomach, flu-like symptoms, dark urine, yellowing of the skin or eyes, unusual bleeding or bruising, or lack of energy.
In clinical studies, more people who took pioglitazone for more than one year developed bladder cancer than people who did not take pioglitazone Talk to your doctor about the risk of taking Pioglitazone.
In clinical studies, more women who took pioglitazone developed fractures (broken bones), especially of the hands, upper arms, or feet, than women who did not take pioglitazone. Men who took pioglitazone did not have a greater risk of developing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking Pioglitazone.
Pioglitazone may cause other side effects. Call your doctor if you have any unusual problems while you are taking Pioglitazone.
Pioglitazone may cause other side effects. Consult your doctor if you have any unusual problems while taking this.
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Pioglitazone.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: MedlinePlus, U.S. Natl. Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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