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Acantha Plus/Acantha Max

Acantha Plus/Acantha Max

metformin + sitagliptin

Manufacturer:

Fredun Pharmaceuticals

Distributor:

Corbridge
Concise Prescribing Info
Contents
Per Acantha Plus 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 500 mg. Per Acantha Max 50 mg/1 g FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 1 g
Indications/Uses
Adult w/ type 2 DM as adjunct to diet & exercise to improve glycaemic control in patients inadequately controlled on their max tolerated dose of metformin alone or those already being treated w/ the combination of sitagliptin & metformin. As triple combination therapy w/ sulphonylurea as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose; w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (ie, thiazolidinedione) as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose. As add-on to insulin (ie, triple combination therapy) as adjunct to diet & exercise to improve glycaemic control in patients when stable dose of insulin & metformin alone do not provide adequate glycaemic control.
Dosage/Direction for Use
Individualized dosage. Max recommended daily dose is sitagliptin 100 mg & metformin 2,000 mg. Patient not currently treated w/ metformin Initially sitagliptin 50 mg & metformin 500 mg bid w/ gradual dose escalation to reduce GI side effects. Patient already treated w/ metformin Sitagliptin 50 mg bid & dose of metformin already being taken. Patient taking metformin HCl 850 mg bid Initially sitagliptin 50 mg & metformin 1 g bid.
Administration
Should be taken with food.
Contraindications
History of serious hypersensitivity reaction (eg, anaphylaxis or angioedema). Metabolic acidosis, including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m2).
Special Precautions
Hypersensitivity reactions; promptly stop medication & institute appropriate monitoring & treatment. Lactic acidosis. Discontinue if pancreatitis is suspected. Discontinue therapy if severe & disabling arthralgia or bullous pemphigoid has been reported. Consider risks & benefits in patients who have known risk factors for heart failure. Risk of hypoglycemia when used in combination w/ insulin &/or insulin secretagogue. Discontinue at time of, or prior to, iodinated contrast imaging procedures. Avoid use in patients w/ hepatic impairment. Not recommended in patients w/ eGFR between 30 & <45 mL/min/1.73 m2. Assess renal function w/ eGFR prior to initiation, & at least annually. Acute renal failure sometimes requiring dialysis. Potential unintended pregnancy in premenopausal females. Metformin: May lower vit B levels. Measure hematologic parameters annually & vit B at 2-3 yr intervals.
Drug Interactions
Increased risk of lactic acidosis w/ carbonic anhydrase inhibitors. Metformin: May increase metformin accumulation w/ drugs that reduce metformin clearance (eg, ranolazine, vandetanib, dolutegravir & cimetidine). Potentiated effect on lactate metabolism w/ alcohol.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Acantha Max 50 mg/1 g FC tab
Packing/Price
100's (P20.5/film-coated tab)
Form
Acantha Plus 50 mg/500 mg FC tab
Packing/Price
100's (P19.5/film-coated tab)
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