Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 28.343 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; hyprolose; calcium hydrogen phosphate; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lapl is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,? as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with,type 2 diabetes mellitus, when metformin cannot be used.,? as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione,where the use of a thiazolidinedione is considered appropriate.,? as triple combination therapy with metformin and a sulfonylurea when combination therapy with,both agents does not provide adequate glycaemic control.,? as add-on combination therapy with insulin (with or without metformin).

Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - sitagliptin hydrochloride monohydrate, quantity: 113.373 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; magnesium stearate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin lapl is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,? as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with,type 2 diabetes mellitus, when metformin cannot be used.,? as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione,where the use of a thiazolidinedione is considered appropriate.,? as triple combination therapy with metformin and a sulfonylurea when combination therapy with,both agents does not provide adequate glycaemic control.,? as add-on combination therapy with insulin (with or without metformin).

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 56.688 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 56.688 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 28.344 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 28.344 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 113.376 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Australia - English - Department of Health (Therapeutic Goods Administration)

maple healthcare pty ltd - sitagliptin hydrochloride monohydrate, quantity: 113.376 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitagliptin hydrochloride monohydrate is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - sitagliptin as hydrochloride monohydrate - film coated tablets - sitagliptin as hydrochloride monohydrate 100 mg - sitagliptin - sitagliptin s.k. is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin s.k. should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings. sitagliptin s.k. has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin s.k..

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - sitagliptin as hydrochloride monohydrate - film coated tablets - sitagliptin as hydrochloride monohydrate 25 mg - sitagliptin - sitagliptin s.k. is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. important limitations of use: sitagliptin s.k. should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings. sitagliptin s.k. has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin s.k..