Glimepiride + Rosiglitazone

Introduction: Glimepiride + Rosiglitazone is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

How it works: Glimepiride: Initial effect to increase insulin secretion from beta cells; may also decrease rate of hepatic glucose production and increase insulin receptor sensitivity. Rosiglitazone: Lowers glucose by improving target cell response to insulin without increasing pancreatic cell secretion; activates nuclear peroxisome proliferator-activated receptor gamma, which influences the production of gene products involved in glucose and lipid metabolism.

Important Information: Take with food. Take with the first meal of the day. Do not stop without consulting your doctor. Regular blood sugar and liver function tests are recommended.

• Type 2 diabetes mellitus

Combination Oral hypoglycemic preparations

Sulfonylurea + Thiazolidinedione

Glimepiride: Initial effect to increase insulin secretion from beta cells; may also decrease rate of hepatic glucose production and increase insulin receptor sensitivity. Rosiglitazone: Lowers glucose by improving target cell response to insulin without increasing pancreatic cell secretion; activates nuclear peroxisome proliferator-activated receptor gamma, which influences the production of gene products involved in glucose and lipid metabolism.

Glimepiride increases insulin secretion and Rosiglitazone improves insulin sensitivity to lower blood sugar levels.

Adult Dose:

• Starting Dose: 1 tab (4mg/1mg) once daily with first meal of day
• Glimepiride component increased not to exceed 2 mg every 1-2 weeks
• Not to exceed 8 mg rosiglitazone/4 mg glimepiride

Elderly: 1 tab (4mg/1mg) once daily, titrate carefully

Hepatic Impairment: ALT >2.5x ULN: Do not administer

Renal Impairment: 1 tab (4mg/1mg) once daily, titrate carefully

* Use as directed by the registered physician

Oral tablet. Take with food (with the first main meal). Swallow whole, do not chew or crush.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule. Do not double the dose.

Common Side Effects:

• Hypoglycemia (low blood sugar)
• Nausea
• Taste change
• Diarrhea
• Stomach pain
• Headache
• Edema (swelling)
• Weight gain
• Blurred vision
• Bone fracture
• Respiratory tract infection

Precautions:

• Patients with established Class III or IV heart failure is contraindicated.
• Hypoglycemia may occur - always carry sugary food or fruit juice.
• Avoid alcohol (increases hypoglycemia risk).
• Risk of edema and heart failure - caution required.
• Regular liver function tests (ALT monitoring) required.

Contraindications:

• Patients with established Class III or IV heart failure

Drug Interactions:

• Glimepiride: Salicylates, sulfonamides, chloramphenicol, clarithromycin, coumarin anticoagulants, probenecid, CYP2C9 inhibitors, fibric acid derivatives, disopyramide, fluoxetine, quinolones, ACE inhibitors, MAOIs and beta-blockers may potentiate hypoglycaemic action
• Rosiglitazone: Gemfibrozil increases plasma concentration; rifampicin decreases

Food Interactions:

• Unsafe to consume alcohol with Glimepiride + Rosiglitazone.

Use in Pregnancy: May be unsafe during pregnancy. Animal studies have shown harmful effects.

Use in Lactation: Probably safe during breastfeeding. Monitor the breastfed baby's blood sugar.

Pediatric Use: Safety and efficacy in children have not been established.

Geriatric Use: 1 tab (4mg/1mg) once daily, titrate carefully.

Renal Impairment: 1 tab (4mg/1mg) once daily, titrate carefully. Not recommended in severe kidney disease.

Hepatic Impairment: ALT >2.5x ULN: Do not initiate. ALT >3x ULN or jaundice: Discontinue. Not recommended in severe liver disease.

Overdose: Severe hypoglycemia with coma, seizure. Administer glucagon or IV glucose. Hypoglycemia may recur - continue monitoring.

Storage: Store in a cool and dry place. Protect from light and moisture. Keep out of reach of children.

Glimepiride + Rosiglitazone Tablet