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Acantha

Acantha

sitagliptin

Manufacturer:

Fredun Pharmaceuticals

Distributor:

Corbridge
Concise Prescribing Info
Contents
Sitagliptin phosphate
Indications/Uses
Improve glycaemic control in adults w/ type 2 DM as monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination w/ metformin when diet & exercise plus metformin alone do not provide adequate glycaemic control, w/ sulphonylurea when diet & exercise plus maximal tolerated dose of sulphonylurea alone do not provide adequate glycaemic control & when metformin is inappropriate due to contraindications or intolerance, w/ peroxisome proliferator-activated receptor gamma (PPARγ) agonist ie, thiazolidinedione when use is appropriate & when diet & exercise plus PPARγ agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination w/ sulphonylurea & metformin when diet & exercise plus dual therapy do not provide adequate glycaemic control, w/ PPARγ agonist & metformin when use of PPARγ agonist is appropriate & when diet & exercise plus dual therapy do not provide adequate glycaemic control. As add-on to insulin (w/ or w/o metformin) when diet & exercise plus stable insulin dose do not provide adequate glycaemic control.
Dosage/Direction for Use
100 mg once daily. Combination w/ metformin &/or PPARγ agonist Dose of metformin &/or PPARγ agonist should be maintained, & sitagliptin administered concomitantly. Combination w/ sulphonylurea or w/ insulin Consider a lower dose of sulphonylurea or insulin to reduce risk of hypoglycaemia. Patient w/ moderate renal impairment (CrCl ≥30 to <50 mL/min) 50 mg once daily, severe renal impairment (CrCl <30 mL/min), ESRD requiring haemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regard to timing of dialysis.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if hypersensitivity reactions; pancreatitis occur. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Patients w/ history of pancreatitis. Hypoglycemia when used in combination w/ insulin or sulphonylurea. Assess renal function prior to initiation of therapy & periodically thereafter. Exercise care for patients w/ severe hepatic impairment. Should not be used during pregnancy & lactation. Safety & efficacy in childn & adolescents <18 yr has not been established.
Drug Interactions
Altered pharmacokinetics w/ potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) in patients w/ severe renal impairment or ESRD. Inhibited OAT3 mediated transport in vitro w/ probenecid. Small effect on plasma digoxin conc.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BH01 - sitagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Acantha FC tab 100 mg
Packing/Price
30's (P28/film-coated tab)
Form
Acantha FC tab 50 mg
Packing/Price
30's (P27/film-coated tab)
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