Acantha Plus/Acantha Max

Acantha Plus: Each film-coated tablet contains: Sitagliptin (as phosphate monohydrate) 50 mg, metformin hydrochloride 500 mg.
Acantha Max: Each film-coated tablet contains: Sitagliptin (as phosphate monohydrate) 50 mg, metformin hydrochloride 1 g.

For adult patients with type 2 diabetes mellitus: Sitagliptin and metformin hydrochloride film-coated tablet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Sitagliptin and metformin hydrochloride film-coated tablet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Sitagliptin and metformin hydrochloride film-coated tablet is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
Sitagliptin and metformin hydrochloride film-coated tablet is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Take sitagliptin and metformin hydrochloride film coated tablet orally twice daily with meals.
Individualize the dosage of sitagliptin and metformin hydrochloride film coated tablets on the basis of the patient's current regimen, effectiveness, and tolerability.
The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin HCl.
The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin HCl 850 mg twice daily, the recommended starting dose of sitagliptin and metformin hydrochloride film coated tablet is 50 mg sitagliptin and 1 g metformin HCl twice daily.
Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR).
Do not use in patients with eGFR below 30 mL/min/1.73 m².
Sitagliptin and metformin hydrochloride film coated tablet is not recommended in patients with eGFR between 30 and less than 45 mL/min/1.73 m².
Sitagliptin and metformin hydrochloride film coated tablet may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

In the event of an overdose, it is reasonable to employ supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as indicated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Overdose of metformin has occured, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases.
Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Severe renal impairment (eGFR below 30 mL/min/1.73 m²).
History of a serious hypersensitivity reaction to sitagliptin, or metformin, such as anaphylaxis or angioedema.
Metabolic acidosis, including diabetic ketoacidosis.

Lactic acidosis.
Pancreatitis: There have been post marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue sitagliptin and metformin hydrochloride film coated tablets.
Heart failure: Has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of sitagliptin and metformin hydrochloride film coated tablets in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
Vitamin B deficiency: Metformin may lower vitamin B levels. Measure hematologic parameters annually and vitamin B at 2 to 3 year intervals and manage any abnormalities.
Hypoglycemia with concomitant use with Insulin or Insulin secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required.
Hypersensitivity Reactions: There have been post marketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop sitagliptin and metformin hydrochloride film coated tablets, assess for other potential causes, institute appropriate monitoring and treatment.
Severe and Disabling Arthralgia: Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
Bullous pemphigoid: There have been postmarketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue sitagliptin and metformin hydrochloride film coated tablets.
Acute renal failure: Has been reported post marketing, sometimes requiring dialysis. Before initiating sitagliptin and metformin hydrochloride film coated tablets and at least annually thereafter, assess renal function.
Hepatic impairment: Avoid use in patients with hepatic impairment.
Use in the Elderly: Assess renal function more frequently.

Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy.

The most common adverse reactions reported in ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache.

Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring.
Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use.
Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake.

Store at temperatures not exceeding 30°C.
Special Precautions for Storage: This medicinal product does not require any special storage conditions.
Shelf Life: 24 months.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

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