Drugplain

Sitagliptin 25 mg/1

Sitagliptin · TABLET, FILM COATED · Apotex Corp.

2 Recalls on Record
Plain English

Sitagliptin is a tablet, film coated containing sitagliptin at 25 mg/1, taken oral. Manufactured by Apotex Corp..

Key Facts

Brand Name
Sitagliptin
Generic Name
Sitagliptin
NDC Code (Product)
60505-3643
Manufacturer
Apotex Corp.
Strength
25 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA202425
Marketing Start
05/28/2026

Recall History

2 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.

TerminatedVoluntary: Firm initiated
Class II03/31/2022

MERCK SHARP & DOHME CORP

Presence of foreign substance: Presence of stainless steel particulates in tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

acute kidney injury929 reports
diarrhoea711 reports
nausea652 reports
fatigue603 reports
dyspnoea591 reports
vomiting590 reports
general physical health deterioration572 reports
lactic acidosis489 reports
drug interaction471 reports
hypoglycaemia447 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Sitagliptin and metformin hydrochloride tablets is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Sitagliptin and metformin hydrochloride tablets is not recommended in patients with type 1 diabetes mellitus. ( 1 ) Sitagliptin and metformin hydrochloride tablets has not been studied in patients with a history of pancreatitis. ( 1 ) Sitagliptin and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin and metformin hydrochloride tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride tablets 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 and metformin hydrochloride tablets. [see Warnings and Precautions ( 5.2 )].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take sitagliptin and metformin hydrochloride tablets orally twice daily with meals. ( 2.1 ) Individualize the dosage of sitagliptin and metformin hydrochloride tablets on the basis of the patient's current regimen, effectiveness, and tolerability. ( 2.1 ) The maximum recommended daily dose is 100 mg of sitagliptin and 2,000 mg of metformin HCl. ( 2.1 ) 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. ( 2.1 ) 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 tablets is 50 mg sitagliptin and 1,000 mg metformin HCl twice daily. ( 2.1 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) ○ Do not use in patients with eGFR below 30 mL/min/1.73 m 2 ○ Sitaglipt…

Contraindications

4 CONTRAINDICATIONS Severe renal impairment: (eGFR below 30 mL/min/1.73 m 2 ) ( 4) Metabolic acidosis, including diabetic ketoacidosis. ( 4 ) History of a serious hypersensitivity reaction to sitagliptin and metformin hydrochloride tablets, sitagliptin, or metformin, such as anaphylaxis or angioedema. (4) Sitagliptin and metformin hydrochloride tablets is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )]. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to sitagliptin, metformin, or any of the excipients in sitagliptin and metformin hydrochloride tablets. Serious hypersensitivity reactions including anaphylaxis or angioedema have been reported. [see Warnings and Precautions ( 5.7 ) and Adverse Reactions ( 6.2 )].

Drug Interactions

7 DRUG INTERACTIONS Table 4 presents clinically significant drug interactions with sitagliptin and metformin hydrochloride tablets: Table 4: Clinically Significant Drug Interactions with sitagliptin and metformin hydrochloride tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with sitagliptin and metformin hydrochloride tablets may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT 2 ] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology ( 12.3 )]. Intervention: Consider the benefits and risks of concomitant use with sitagliptin and metformin hydro…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the prescribing information: Lactic Acidosis [see Warnings and Precautions ( 5.1 )] Pancreatitis [see Warnings and Precautions ( 5.2 )] Heart Failure [see Warnings and Precautions ( 5.3 )] Acute Renal Failure [see Warnings and Precautions ( 5.4 )] Vitamin B12 Deficiency [see Warnings and Precautions ( 5.5 )] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Severe and Disabling Arthralgia [see Warnings and Precautions ( 5.8 )] Bullous Pemphigoid [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse react…

Frequently Asked Questions

What is Sitagliptin used for?

Sitagliptin contains Sitagliptin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Sitagliptin a controlled substance?

Sitagliptin is not classified as a controlled substance by the DEA.

What is the generic name for Sitagliptin?

The generic name for Sitagliptin is Sitagliptin. There are 11 other brand versions of Sitagliptin.

What is the NDC code for Sitagliptin 25 mg/1?

The NDC (National Drug Code) for Sitagliptin 25 mg/1 is 60505-3643, listed by Apotex Corp..

Product NDC

60505-3643

Package NDC

60505-3643-3

Other Sitagliptin Dosages

Other Sitagliptin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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