Pioglitazone (Generic)

Pioglitazone (Generic)

(Pioglitazone hydrochloride)

PIOGLITAZONE is a thiazolidinedione and is used to manage patients with type 2 diabetes mellitus. It is taken orally and helps to reduce blood glucose levels.

HOW DOES PIOGLITAZONE WORK?

PIOGLITAZONE binds to cell receptors and stimulates the development of fat cells and the movement of fat into body tissue. This decreases the concentration of fatty acids in the bloodstream. The body then starts to use glucose in the blood as a source of energy, leading to lower blood glucose levels. PIOGLITAZONE also decreases resistance to insulin and lowers cholesterol levels.

WHAT ARE THE INDICATIONS FOR PIOGLITAZONE?

PIOGLITAZONE is indicated for the treatment of patients with type 2 diabetes mellitus. It is used together with diet control and exercise to improve blood glucose levels in adults.

WHAT IS THE DOSE OF PIOGLITAZONE?

PIOGLITAZONE is manufactured as a 15 mg, 30 mg and a 45 mg tablet. It is taken once daily. If blood glucose control is not adequate, the dose can be increased to 30 mg and then 45 mg daily as a maximum. In patients with heart failure, the maximum dose is 15 mg once daily.

WARNINGS AND PRECAUTIONS

Starting treatment

PIOGLITAZONE can cause liver dysfunction. Make sure to test liver functions before starting PIOGLITAZONE and do not start the medication if there is evidence of hepatic impairment.

Heart failure

PIOGLITAZONE may cause or worsen cardiac failure. Patients who are started on PIOGLITAZONE should be carefully monitored to determine if they develop signs or symptoms of cardiac failure. This includes fluid retention, development of edema, shortness of breath, or rapid weight gain. If this occurs, patients should be treated according to current treatment standards. In addition, stopping PIOGLITAZONE should be considered. In patients with symptomatic cardiac failure, the use of PIOGLITAZONE is not recommended. Patients who are classified as being in NYHA grade III or IV cardiac failure should not receive PIOGLITAZONE.

Liver failure

PIOGLITAZONE has been reported to cause liver failure, which may be fatal. If liver dysfunction is detected while taking PIOGLITAZONE, consider stopping the medication and treating the underlying causes. Do not restart PIOGLITAZONE if an alternative cause of the liver dysfunction cannot be found.

Edema

PIOGLITAZONE may cause swelling of the lower limbs. This is dose-dependent, with more swelling occurring at higher doses. Rapid onset of edema may be an early warning sign of cardiac failure. Therefore, patients should be warned about this risk and monitored closely.

Hypoglycemia

PIOGLITAZONE, when used together with insulin or drugs that stimulate the secretion of insulin, can cause low blood sugar (hypoglycemia). Therefore, a lower dose of insulin or insulin secretion stimulators should be used in combination with PIOGLITAZONE.

Fractures

PIOGLITAZONE may increase the risk of bone fractures in female patients.

Macular edema

PIOGLITAZONE increases the risk of developing macular edema (swelling of the retina). The development of macular edema can serve as an early warning sign for the development of cardiac failure.

Bladder cancer risk

PIOGLITAZONE may increase the risk of bladder cancer. Do not start PIOGLITAZONE on patients with active bladder cancer. Use PIOGLITAZONE with care in patients who have a history of bladder cancer.

SPECIAL POPULATIONS

Renal Failure or Impairment

PIOGLITAZONE elimination is not affected by renal dysfunction. No dosage adjustments are necessary.

Hepatic Dysfunction

PIOGLITAZONE has been reported to cause liver failure, which may be fatal. If liver dysfunction is detected while taking PIOGLITAZONE, consider stopping the medication and treating the underlying causes. Do not restart PIOGLITAZONE if an alternative cause of the liver dysfunction cannot be found.

Elderly

PIOGLITAZONE blood concentrations are not significantly affected in elderly patients.

Pediatrics

There is little long-term clinical data to determine the safety of PIOGLITAZONE in pediatric patients. Its use in pediatric patients is not recommended.

Pregnancy

PIOGLITAZONE has not been studied in pregnant women, and the amount of drug expressed in breast milk is not known. Use during pregnancy should only be considered if the potential benefit to the mother outweighs the risk to the fetus. PIOGLITAZONE should not be taken when breastfeeding.

CONTRAINDICATIONS

PIOGLITAZONE is contraindicated in:

• Patients with hypersensitivity to PIOGLITAZONE
• Established cardiac failure – NYHA grade III or IV
• Metabolic acidosis
• Diabetic ketoacidosis

SIDE EFFECTS

Common side effects of PIOGLITAZONE include:

• Diarrhea
• Weight gain
• Headache
• Sinusitis
• Muscle pain
• Symptoms similar to a cold – stuffy nose, sinus pain, sneezing
• Mild swelling of the lower limbs

Less common side effects include:

• Changes in vision
• Problems with your heart – a gain of weight, swelling of feet or hands, shortness of breath
• Problems with your liver – abdominal pain, dark urine, jaundice, vomiting, nausea, or tiredness. Suppression of the immune system
• Increased risk for bone fractures
• Changes in eyesight due to edema of the retina
• Urinary tract infections
• Bladder cancer
• Back pain

If you notice swelling of the legs and ankles, shortness of breath, rapid weight increase, or unusual tiredness, you should contact your doctor immediately.

DRUG INTERACTIONS

Certain drugs may interact with PIOGLITAZONE. These include:

• Rifampin
• Gemfibrozil

Care should be taken when using PIOGLITAZONE with other medications that can cause an increase in blood glucose levels. This includes:

• Thiazides
• Diuretics
• Corticosteroids
• Phenothiazines
• Thyroid products
• Estrogens
• Oral contraceptives
• Phenytoin
• Nicotinic acid
• Sympathomimetics
• Calcium channel blocking drugs
• Isoniazid