Instadip 50/Instadip 100 Dosage & Drug Information

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 Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Sitagliptin

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy, or in combination w/ metformin, sulfonylurea, or PPARγ agonist (ie, thiazolidinediones) as initial therapy, or combination w/ metformin & sulfonylurea, or metformin & PPARγ agonist (ie, thiazolidinediones), when single agent alone or dual therapy, w/ diet & exercise, does not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).

Click to view Instadip 50/Instadip 100 detailed prescribing information

Dosage/Direction for Use

Monotherapy or combination therapy 100 mg once daily. Moderate renal impairment [estimated GFR (eGFR) ≥30 to <45 mL/min/1.73 m²] 50 mg once daily. Severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m²), ESRD (eGFR <15 mL/min/1.73 m²), patients requiring hemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regard to timing of dialysis.

Click to view Instadip 50/Instadip 100 detailed prescribing information

Overdosage

View Instadip 50/Instadip 100 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

Click to view Instadip 50/Instadip 100 detailed prescribing information

Special Precautions

Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Discontinue treatment if hypersensitivity reaction; pancreatitis; bullous pemphigoid is suspected. Serious hypersensitivity reactions including anaphylaxis, angioedema & exfoliative skin conditions including SJS. Acute pancreatitis including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Bullous pemphigoid requiring hospitalization. Risk of sulfonylurea- or insulin-induced hypoglycemia. Assess renal function prior to treatment initiation & periodically thereafter. Not recommended during pregnancy. Not to be used during lactation.

Click to view Instadip 50/Instadip 100 detailed prescribing information

Use In Pregnancy & Lactation

Click to view Instadip 50/Instadip 100 detailed prescribing information

Adverse Reactions

Nausea, vomiting, diarrhea. SJS. Monotherapy: Abdominal pain. Combination therapy: Hypoglycemia, headache, URTI, cough, fungal skin infection, peripheral edema, dyspepsia, flatulence, flu, pancreatitis.

Click to view Instadip 50/Instadip 100 detailed prescribing information

Drug Interactions

Concomitant use w/ digoxin.

Click to view Instadip 50/Instadip 100 detailed prescribing information

Storage

View Instadip 50/Instadip 100 storage conditions for details to ensure optimal shelf-life.

Description

View Instadip 50/Instadip 100 description for details of the chemical structure and excipients (inactive components).

Action

View Instadip 50/Instadip 100 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.

Thai FDA Category

Presentation/Packing

Form

Instadip 100 FC tab 100 mg

Packing/Price

3 × 10's

Form

Instadip 50 FC tab 50 mg

Packing/Price

3 × 10's

Instadip 50/Instadip 100

sitagliptin

Manufacturer:

Ranbaxy

Distributor:

DKLL