Fliptin Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin

Indications/Uses

Monotherapy as an adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. Combination w/ metformin or PPARγ agonist (eg, thiazolidinediones) to improve glycemic control in patients w/ type 2 DM when monotherapy w/ diet & exercise inadequately provide glycemic control. Combination w/ metformin & sulfonylurea to improve glycemic control in patients w/ type 2 DM when dual therapy w/ these agents w/ diet & exercise inadequately provide glycemic control. Add-on to insulin (w/ or w/o metformin) when diet, exercise & stable insulin dose inadequately provide glycemic control.

Click to view Fliptin detailed prescribing information

Dosage/Direction for Use

Monotherapy or combination therapy w/ metformin or PPARγ agonist (eg, thiazolidinediones), metformin & sulfonylurea, stable insulin dose (w/ or w/o metformin) 100 mg once daily. Renal impairment: eGFR ≥30 to <45 mL/min/1.73 m² 50 mg once daily, ≥15 to <30 mL/min/1.73 m² or ESRD (<15 mL/min/1.73 m²) including those requiring hemodialysis or peritoneal dialysis 25 mg once daily.

Click to view Fliptin detailed prescribing information

Overdosage

View Fliptin overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Ketoacidosis.

Click to view Fliptin detailed prescribing information

Special Precautions

Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Possible acute pancreatitis including fatal & nonfatal hemorrhagic or necrotizing pancreatitis. Carefully observe for signs & symptoms of pancreatitis. Discontinue sitagliptin & other potentially suspect medicinal products if pancreatitis is suspected. Concomitant use w/ insulin or sulfonylurea; may require to use lower dose to reduce risk of hypoglycemia. Tell patients to report blisters or erosions development during treatment. Discontinue use & consider dermatologist referral for diagnosis & appropriate treatment if bullous pemphigoid is suspected. Renal impairment; dosage adjustment is recommended in patients w/ eGFR <45 mL/min/1.73 m² & ESRD patients requiring hemodialysis or peritoneal dialysis. Pregnancy & lactation. Ped patients. Elderly.

Click to view Fliptin detailed prescribing information

Use In Pregnancy & Lactation

Click to view Fliptin detailed prescribing information

Adverse Reactions

Hypoglycemia, nasopharyngitis, URTI, headache, infections, small increase in WBC due increase in neutrophils; hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis & exfoliative skin conditions including SJS; hepatic enzyme elevations; acute pancreatitis including fatal & nonfatal hemorrhagic & necrotizing pancreatitis; constipation; vomiting; worsening renal function including acute renal failure (sometimes requiring dialysis), bullous pemphigoid; arthralgia, myalgia, pain in extremity, back pain, pruritus.

Click to view Fliptin detailed prescribing information

Drug Interactions

Possible hypoglycemia when used in combination w/ insulin or sulfonylurea.

Click to view Fliptin detailed prescribing information

Storage

View Fliptin storage conditions for details to ensure optimal shelf-life.

Description

View Fliptin description for details of the chemical structure and excipients (inactive components).

Action

View Fliptin mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Regulatory Classification

Presentation/Packing

Form

Fliptin FC tab 100 mg

Packing/Price

3 × 10's

Form

Fliptin FC tab 50 mg

Packing/Price

3 × 10's

Fliptin

sitagliptin

Manufacturer:

Ferron