Indications for PRANDIN:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Take within 30 minutes before meals (skip dose if meal is skipped; add dose if meal is added). Treatment-naive, or HbA1c <8%, or severe renal dysfunction (CrCl 20–40mL/min): initially 0.5mg with 2–4 meals daily. Previously treated with antidiabetic agents and HbA1c ≥8%: initially 1–2mg with 2–4 meals daily. For both: titrate by doubling dose at intervals of at least 1 week; range 0.5–4mg with 2–4 meals daily; max 16mg/day. Concomitant clopidogrel: avoid; if unavoidable, initiate 0.5mg before each meal (max 4mg daily). Concomitant cyclosporine: max 6mg daily.
Not for use with NPH-insulin (possible myocardial ischemia). Increased risk of hypoglycemia with changes in physical activity, meal patterns, renal or hepatic impairment: monitor glucose more frequently and may need to adjust dose. Reduced symptomatic awareness of hypoglycemia in longstanding diabetes, diabetic nerve disease, or recurrent hypoglycemia. Hemodialysis or CrCl <20mL/min. Pregnancy. Nursing mothers: not recommended.
See Contraindications. Potentiated by clopidogrel, cyclosporine, CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, clarithromycin), other CYP2C8 inhibitors (eg, trimethoprim, montelukast, deferasirox); adjust dose and monitor (see Adult). Antagonized by CYP3A4 and/or CYP2C8 inducers (eg, carbamazepine, rifampin, barbiturates), atypical antipsychotics, CCBs, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (in oral contraceptives), protease inhibitors, somatropin, sympathomimetics, thyroid hormones; adjust dose and monitor. Antidiabetic agents, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, NSAIDs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics increase risk of hypoglycemia. β-blockers, clonidine, guanethidine, reserpine may mask hypoglycemia.
Hypoglycemia, upper respiratory infection, headache, diarrhea, constipation, arthralgia, back or chest pain.