Pioglitazone + Glimepiride


Concise Prescribing Info
Indications/Uses
Type 2 DM.
Dosage/Direction for Use
Adult : PO Initial: 1 tab once daily then titrate gradually.
Dosage Details
Oral
Type 2 diabetes mellitus
Adult: Each tab contains pioglitazone 15 mg or 30 mg and glimepiride 2 mg or 4 mg: Initially, 1 tab once daily then titrate gradually as needed.
Elderly: Should start w/ glimepiride 1 mg/day prior to initiating pioglitazone + glimepiride combination.
Renal Impairment
CrCl <22 mL/min: Should start w/ glimepiride 1 mg/day prior to initiating pioglitazone + glimepiride combination.
Hepatic Impairment
Should start w/ glimepiride 1 mg/day prior to initiating pioglitazone + glimepiride combination.
Administration
Should be taken with food. Take w/ 1st main meal of the day.
Contraindications
History of allergic reaction to sulfonamide derivative. Patient w/ established CHF (NYHA class III or IV). Not intended for treatment of type 1 DM or diabetic ketoacidosis.
Special Precautions
Patients w/ prior history of active bladder cancer; anaemia, G6PD deficiency, symptomatic heart failure. Premenopausal/anovulatory females. May exacerbate CHF. Do not initiate in patient w/ active liver disease of ALT >2.5 times the upper limit of normal at baseline. Hepatic and renal impairment. Pregnancy and lactation.
Adverse Reactions
Fracture, macular oedema, hypoglycaemia, wt gain, peripheral oedema, upper resp tract infection, headache, nausea, anaemia, diarrhoea, UTI, limb pain.
Potentially Fatal: CHF, severe hypoglycaemia, oedema, haemolytic anaemia, hepatic failure.
MonitoringParameters
Monitor for signs and symptoms of heart failure (e.g. excessive, rapid wt gain, oedema, dyspnoea) after initiation.
Overdosage
Glimepiride: Symptoms: Severe hypoglycaemia w/ coma, seizure, or neurological impairment. Management: Admin glucagon or IV glucose. Additional carbohydrate intake may be necessary as hypoglycaemia may recur after apparent clinical recovery.
Drug Interactions
Increased plasma levels w/ CYP2C8 inhibitors (e.g. gemfibrozil) and CYP2C9 inhibitors (e.g. fluconazole). Decreased plasma levels w/ CYP2C8 inducers (e.g. rifampicin). Colesevelam may reduce the max plasma concentration and total exposure of glimepiride. Concominant use w/ oral miconazole may lead to severe hypoglycaemia.
Food Interaction
Alcohol may increase hypoglycaemic effect.
Action
Description: Pioglitazone, a thiazolidinedione, reduces blood glucose by improving target cell response to insulin w/o increasing pancreatic insulin secretion and is dependent on the presence of insulin for activity. Glimepiride, a sulfonylurea, stimulates insulin release from the pancreatic β-cells. It also reduces glucose output from the liver and increases insulin sensitivity at peripheral target sites.
Pharmacokinetics:
Absorption: Pioglitazone: Rapidly absorbed from the GI tract. Time to peak plasma concentrations: W/in 2 hr. Bioavailability: >80%. Glimepiride: Completely absorbed from the GI tract. Time to peak plasma concentrations: 2-3 hr.
Distribution: Pioglitazone: Plasma protein binding: >99%. Glimepiride: Highly protein bound.
Metabolism: Pioglitazone: Extensively metabolised mainly by CYP2C8 isoenzyme to both active and inactive metabolites. Glimepiride: Extensively metabolised to hydroxy derivative by CYP2C9 isoenzyme and to carboxy derivative by cytosolic enzymes.
Excretion: Pioglitazone: Via urine and faeces. Plasma half-life: Up to 7 hr. Half-life: Up to 24 hr (active metabolites). Glimepiride: Via urine (approx 60%) and faeces (40%). Half-life: Approx 9 hr (after multiple doses).
Storage
Store at 25°C.
MIMS Class
References
Anon. Pioglitazone and Glimepiride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/06/2014.

Buckingham R (ed). Glimepiride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2014.

Buckingham R (ed). Pioglitazone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2014.

Duetact Tablet (Takeda Pharmaceuticals America, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/07/2014.

Wickersham RM. Pioglitazone/Glimepiride. Facts and Comparisons [online]. St. Louis, MO. Wolters Kluwer Clinical Drug Information, Inc. https://www.wolterskluwercdi.com/facts-comparisons-online/. Accessed 01/07/2014.

Disclaimer: This information is independently developed by MIMS based on Pioglitazone + Glimepiride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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