Drugplain

ZITUVIMET 1000 mg/1

Sitagliptin and Metformin Hydrochloride · TABLET, FILM COATED · Zydus Pharmaceuticals (USA) Inc.

No Recall History
Plain English

Zituvimet is a prescription tablet used to treat type 2 diabetes and contains two active ingredients: sitagliptin (a dipeptidyl peptidase 4 inhibitor) and metformin. It works by helping your body control blood sugar levels through different mechanisms and is taken by mouth.

Key Facts

Brand Name
ZITUVIMET
Generic Name
Sitagliptin and Metformin Hydrochloride
NDC Code (Product)
70710-1787
Manufacturer
Zydus Pharmaceuticals (USA) Inc.
Strength
1000 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA216743
Drug Class
Dipeptidyl Peptidase 4 Inhibitor [EPC]
Marketing Start
03/14/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective6 reports
completed suicide4 reports
dizziness4 reports
nausea4 reports
pain in extremity4 reports
abnormal dreams3 reports
diarrhoea3 reports
malaise3 reports
somnolence3 reports
abdominal pain2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ZITUVIMET 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: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ( 1 ) ZITUVIMET has not been studied in patients with a history of pancreatitis. ( 1 ) ZITUVIMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET 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 ZITUVIMET. [see Warnings and Precautions ( 5.2 )].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take ZITUVIMET orally twice daily with meals. ( 2.1 ) Individualize the dosage of ZITUVIMET 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 ZITUVIMET 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 ○ ZITUVIMET is not recommended in patients with eGFR between 30 and less than 45 mL/min/1.73 m 2 . ZITUVIMET may need to be d…

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 ZITUVIMET, sitagliptin, or metformin, such as anaphylaxis or angioedema. (4) ZITUVIMET 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 ZITUVIMET. 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 ZITUVIMET: Table 4: Clinically Significant Drug Interactions with ZITUVIMET 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 ZITUVIMET 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 ZITUVIMET. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of …

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 ZITUVIMET used for?

Zituvimet is a prescription tablet used to treat type 2 diabetes and contains two active ingredients: sitagliptin (a dipeptidyl peptidase 4 inhibitor) and metformin. It works by helping your body control blood sugar levels through different mechanisms and is taken by mouth.

Is ZITUVIMET a controlled substance?

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

What is the generic name for ZITUVIMET?

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

What is the NDC code for ZITUVIMET 1000 mg/1?

The NDC (National Drug Code) for ZITUVIMET 1000 mg/1 is 70710-1787, listed by Zydus Pharmaceuticals (USA) Inc..

Product NDC

70710-1787

Package NDC

70710-1787-6

Other ZITUVIMET 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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