Pranstad 1

Rx

Indications:

Pranstad 1 is used as monotherapy as an adjunct for the management of type 2 (noninsulin-dependent) diabetes mellitus (NIDDM) in patients whose hyperglycemia cannot be controlled by diet, an exercise alone.

Pranstad 1 also may be used in combination with metformin in patients who do not achieve adequate glycemic control with diet, exercise, and monotherapy with metformin, a sulfonylurea, repaglinide, or a thiazolidinedione antidiabetic agent.

Dosage:

• Patients not previously treated or whose HbA_1C is < 8%: start with dose of 0.5 mg.
• Patients previously treated with blood glucose-lowering drugs and whose HbA_1C is ≥ 8%: start with dose of 1 or 2 mg.
• The dose should be doubled up to 4 mg until satisfactory blood glucose response is achieved; assess response at least one week after each dose adjustment; use 2, 3, or 4 times a day in response to changes in the patient’s meal pattern, maximum dose is 16 mg.
• Patients can be transferred directly from other oral hypoglycaemic agents: maximum starting dose is 1 mg.
• Combination with metformin: Dosage of each drug should be adjusted to obtain adequate glycemic control, using the minimum effective dosage of each drug.
• Patients with severe renal impairment (e.g., creatinine clearance of 20 – 40 ml/minute): start with 0.5 mg, with subsequent careful dosage titration.

Usage:

Pranstad 1 is administered orally, given within 15 minutes of each meal, may be given as early as 30 minutes prior to each meal up to immediately preceding each meal.

Known hypersensitivity to any of the active substance or excipients.

Patients with type 1 diabetes.

Patients with diabetes complicated by acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; insulin should be used to treat these conditions.

Hypoglycemia; upper respiratory tract infection, sinusitis, rhinitis, bronchitis; nausea, diarrhoea; arthralgia, back pain; headache.

Elderly, debilitated, or malnourished patients and those with adrenal, pituitary, hepatic, or severe renal insufficiency.

Repaglinide is not indicated for use in combination with NPH-insulin.

Hepatic insufficiency may cause elevated repaglinide blood levels and may diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemia.

Children and adolescents < 18 years of age or in patients > 75 years of age: not recommend.

Pregnancy: Pranstad 1 should be used during pregnancy only when clearly needed. Lactation: a decision should be made whether to discontinue nursing or the drug.

Patients should be advised to take precautions to avoid hypoglycemia whilst driving and using machine.