Glacera Tablets / Film-coated
Pioglitazone
30mg
Riyadh Pharma (Medical and Cosmetic Products Company Ltd.)
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | KSA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 48.00 AED |
Available as:
Indications
Glacera Tablets / Film-coated is used for:
Type 2 DM
Adult Dose
Oral
Type 2 diabetes mellitus
Adult: 15 mg once daily.
Elderly: No dosage adjustment needed.
Hepatic impairment: Moderate to severe: Avoid.
Child Dose
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Type 1 diabetes mellitus, symptomatic or history of heart failure, diabetic ketoacidosis, childn <18 yr. Lactation.
Precautions
I. Liver Enzyme must be monitored regularly
II. History of heart failure and MI should be verified
III. Incidence of bladder cancer should be verified
IV. Not to be used for elderly patients
V. Not to be used continuously more than one year
VI. Use only by Specialist advice.
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.
Lactation: Not known if excreted in breast milk; discontinue drug or do not nurse
Pregnancy-Lactation
Pregnancy: Limited data with pioglitazone in pregnant women are not sufficient to determine a drug- associated risk for major birth defects or miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy; poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
Lactation: There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pioglitazone and any potential adverse effects on the breastfed infant from pioglitazone or from the underlying maternal condition
Interactions
Increased risk of oedema w/ insulin, metformin and sulfonylureas. Increased plasma levels w/ gemfibrozil and ketoconazole. Decreased plasma levels w/ rifampicin.
Adverse Effects
Side effects of Pioglitazone :
>10%
Edema when used in combination with sulfonylurea or insulin (<27%), Hypoglycemia (<27%), Upper respiratory infection (13%)
1-10%
Headache (9%), Heart failure (up to 8%), Sinusitis (6%), Fracture of bone (5%), Pharyngitis (5%), Myalgia (5%)
Frequency Not Defined
Aggravated diabetes, Diabetic macular edema, Hepatic failure (rare), Increased cholesterol, Decreased serum triglycerides, Hematocrit/hemoglobin, Bladder cancer, Decreased visual acuity, Dyspnea, Increased transaminases, Pharyngitis, Sinusitis, Weight gain
Mechanism of Action
Pioglitazone is as a potent and highly selective agonist for the peroxisome proliferator activated receptor-? (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 w/o increasing the pancreatic secretion of insulin.
Note
Glacera 30mg Tablets / Film-coated manufactured by Riyadh Pharma (Medical and Cosmetic Products Company Ltd.). Its generic name is Pioglitazone. Glacera is availble in United Arab Emirates.
Farmaco UAE drug index information on Glacera Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.