Drugplain

Sitagliptin and Metformin Hydrochloride 1000 mg/1

sitagliptin and metformin hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Zydus Pharmaceuticals USA Inc.

No Recall History
Plain English

Sitagliptin and Metformin Hydrochloride is a tablet, film coated, extended release containing sitagliptin and metformin hydrochloride at 1000 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals USA Inc..

Key Facts

Brand Name
Sitagliptin and Metformin Hydrochloride
Generic Name
sitagliptin and metformin hydrochloride
NDC Code (Product)
70710-2037
Manufacturer
Zydus Pharmaceuticals USA Inc.
Strength
1000 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA216778
Drug Class
Dipeptidyl Peptidase 4 Inhibitor [EPC]
Marketing Start
10/31/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide4 reports
dizziness4 reports
drug ineffective4 reports
pain in extremity4 reports
abnormal dreams3 reports
diarrhoea3 reports
malaise3 reports
nausea3 reports
somnolence3 reports
anxiety2 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 and Metformin Hydrochloride used for?

Sitagliptin and Metformin Hydrochloride contains sitagliptin and metformin hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Sitagliptin and Metformin Hydrochloride a controlled substance?

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

What is the generic name for Sitagliptin and Metformin Hydrochloride?

The generic name for Sitagliptin and Metformin Hydrochloride is sitagliptin and metformin hydrochloride. There are 10 other brand versions of sitagliptin and metformin hydrochloride.

What is the NDC code for Sitagliptin and Metformin Hydrochloride 1000 mg/1?

The NDC (National Drug Code) for Sitagliptin and Metformin Hydrochloride 1000 mg/1 is 70710-2037, listed by Zydus Pharmaceuticals USA Inc..

Product NDC

70710-2037

Package NDC

70710-2037-6

Other Sitagliptin and Metformin Hydrochloride Dosages

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

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