Drugplain

ZITUVIMET XR 1000 mg/1

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

No Recall History
Plain English

Zituvimet XR is a prescription tablet that combines two diabetes medications—sitagliptin (a DPP-4 inhibitor) and metformin—to help control blood sugar levels in patients with type 2 diabetes. This extended-release formulation is taken by mouth once daily.

Key Facts

Brand Name
ZITUVIMET XR
Generic Name
sitagliptin and metformin hydrochloride
NDC Code (Product)
70710-1805
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

drug ineffective5 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 XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIMET XR is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET XR 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 XR [see Warnings and Precautions ( 5.2 )]. ZITUVIMET XR 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: Not for the treatment of type 1 diabetes mellitus. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take ZITUVIMET XR orally once daily with a meal. Patients taking two ZITUVIMET XR tablets should take the tablets together. ( 2.1 ) Individualize the dosage of ZITUVIMET XR 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 extended-release. ( 2.1 ) The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1,000 mg metformin HCl once 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 100 mg and the dose of metformin already being taken once daily. For patients taking metformin HCl 850 mg twice daily or 1,000 mg twice daily, the recommended starting dose of ZITUVIMET XR is two 50 mg sitagliptin and 1,000 mg metformin HCl extended-release tablets once daily. ( 2.1 ) Maintain the same total daily dose of sitagliptin and metformin when changing between sitagliptin and metformin immediate-release or sitagliptin and metform…

Contraindications

4 CONTRAINDICATIONS ZITUVIMET XR 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. A history of a serious hypersensitivity reaction to sitagliptin , metformin, or any of the excipients in ZITUVIMET XR. Serious hypersensitivity reactions including anaphylaxis or angioedema have been reported [see Warnings and Precautions ( 5.7 ) and Adverse Reactions ( 6.2 )]. 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 XR, sitagliptin, or metformin, such as. anaphylaxis or angioedema) ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 4 presents clinically significant drug interactions with ZITUVIMET XR: Table 4: Clinically Significant Drug Interactions with ZITUVIMET XR 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 XR 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 XR. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate t…

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 B 12 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 rea…

Frequently Asked Questions

What is ZITUVIMET XR used for?

Zituvimet XR is a prescription tablet that combines two diabetes medications—sitagliptin (a DPP-4 inhibitor) and metformin—to help control blood sugar levels in patients with type 2 diabetes. This extended-release formulation is taken by mouth once daily.

Is ZITUVIMET XR a controlled substance?

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

What is the generic name for ZITUVIMET XR?

The generic name for ZITUVIMET XR is sitagliptin and metformin hydrochloride. There are 9 other brand versions of sitagliptin and metformin hydrochloride.

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

The NDC (National Drug Code) for ZITUVIMET XR 1000 mg/1 is 70710-1805, listed by Zydus Pharmaceuticals USA Inc..

Product NDC

70710-1805

Package NDC

70710-1805-6

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