Rosiglitazone + Metformin Hydrochloride: Brands, Price & Uses in Bangladesh

Rosiglitazone + Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Evidence-based use classification

• Established/approved use: Rosiglitazone + Metformin Hydrochloride is approved for patients with type 2 diabetes mellitus who are already being treated with a combination of rosiglitazone and metformin, or whose blood glucose is not adequately controlled on metformin alone or a thiazolidinedione alone, and for whom treatment with both components is considered appropriate.
• Combination therapy requirement: Rosiglitazone + Metformin Hydrochloride is a fixed-dose combination and is not intended as first-line initial therapy for treatment-naive patients; it is generally used after monotherapy with either metformin or rosiglitazone has proven inadequate.
• Not indicated for: Rosiglitazone + Metformin Hydrochloride is not indicated for type 1 diabetes mellitus or for treatment of diabetic ketoacidosis.

Because of cardiovascular safety concerns associated with rosiglitazone, use of Rosiglitazone + Metformin Hydrochloride is subject to significant prescribing restrictions or has been withdrawn in a number of countries; prescribers should confirm current local regulatory status and reserve Rosiglitazone + Metformin Hydrochloride for patients in whom other options are unsuitable.

General principles

The dose of Rosiglitazone + Metformin Hydrochloride should be individualized based on the patient's current therapy, effectiveness, and tolerability. It is not intended for initial therapy in patients who have not previously been treated with either component.

Titration and maximum dose

Doses should be increased gradually to reduce gastrointestinal side effects from the metformin component. Response to the metformin component is typically assessed after 1-2 weeks, and response to the rosiglitazone component after 8-12 weeks, before further dose increases.

The maximum recommended total daily dose is 8 mg rosiglitazone and 2,000 mg metformin hydrochloride, given in divided doses with meals.

Administration

Rosiglitazone + Metformin Hydrochloride should be taken with meals to reduce gastrointestinal upset and should be swallowed whole with water, not crushed or chewed unless specifically directed.

Renal and hepatic considerations

Rosiglitazone + Metformin Hydrochloride is contraindicated in significant renal impairment (see Contraindications) because of the risk of metformin-associated lactic acidosis. It should not be used in patients with hepatic impairment or active liver disease.

Common and serious side effects reported with Rosiglitazone + Metformin Hydrochloride reflect the adverse effect profiles of both components:

Common side effects

• Gastrointestinal upset: nausea, diarrhea, abdominal discomfort, and a metallic taste (metformin component)
• Upper respiratory tract infection
• Headache
• Edema and mild weight gain (rosiglitazone component)
• Mild anemia

Serious side effects (uncommon but require medical attention)

• Lactic acidosis – a rare but life-threatening metabolic complication associated with metformin; symptoms include malaise, muscle pain, respiratory distress, abdominal pain, and unusual sleepiness. Seek immediate medical attention if these occur.
• New-onset or worsening heart failure, sudden weight gain, or fluid retention – associated with rosiglitazone.
• Bone fractures, particularly in women, with long-term use.
• Vitamin B12 deficiency with long-term use, which may present as anemia or peripheral neuropathy.
• Rare reports of myocardial ischemic events have been associated with rosiglitazone in some analyses; discuss cardiovascular risk with your physician.
• Macular edema (rare, associated with thiazolidinediones).