Acantha Plus/Acantha Max Special Precautions

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.