Drugplain

ZITUVIO 25 mg/1

Sitagliptin · TABLET · Zydus Pharmaceuticals (USA) Inc.

No Recall History
Plain English

ZITUVIO is a tablet containing sitagliptin at 25 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals (USA) Inc..

Key Facts

Brand Name
ZITUVIO
Generic Name
Sitagliptin
NDC Code (Product)
70710-1240
Manufacturer
Zydus Pharmaceuticals (USA) Inc.
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA211566
Drug Class
Dipeptidyl Peptidase 4 Inhibitor [EPC]
Marketing Start
11/30/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

acute kidney injury842 reports
diarrhoea587 reports
general physical health deterioration543 reports
dyspnoea523 reports
nausea522 reports
fatigue517 reports
vomiting498 reports
lactic acidosis431 reports
drug interaction423 reports
anaemia382 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ZITUVIO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIO is not recommended in patients with type 1 diabetes mellitus. ZITUVIO 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 ZITUVIO. [see Warnings and Precautions (5.1) ]. ZITUVIO is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: ZITUVIO is not recommended in patients with type 1 diabetes mellitus. ( 1 ) ZITUVIO has not been studied in patients with a history of pancreatitis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage of ZITUVIO is 100 mg orally once daily. ZITUVIO can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Dosage Adjustment in Patients with Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily 25 mg once daily 2.1 Recommended Dosage The recommended dosage of ZITUVIO is 100 mg orally once daily. ZITUVIO can be taken with or without food. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of ZITUVIO and periodically thereafter. For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustment for ZITUVIO is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dosage of ZITUVIO is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/m…

Contraindications

4 CONTRAINDICATIONS ZITUVIO is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin or any of the excipients in ZITUVIO. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with sitagliptin. [see Warnings and Precautions (5.5) ; Adverse Reactions (6.2) ]. History of a serious hypersensitivity reaction to sitagliptin or any of the excipients in ZITUVIO, such as anaphylaxis or angioedema ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Insulin Secretagogues or Insulin Sitagliptin lowers blood glucose in patients with type 2 diabetes mellitus. Coadministration of ZITUVIO with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [see Warnings and Precautions (5.4) ].

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Acute Renal Failure [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥5%) are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. ( 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 reaction rates observed in the clinical trials of a drug cannot be directly co…

Frequently Asked Questions

What is ZITUVIO used for?

ZITUVIO contains Sitagliptin. It is a tablet taken oral. Consult your doctor for specific uses.

Is ZITUVIO a controlled substance?

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

What is the generic name for ZITUVIO?

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

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

The NDC (National Drug Code) for ZITUVIO 25 mg/1 is 70710-1240, listed by Zydus Pharmaceuticals (USA) Inc..

Product NDC

70710-1240

Package NDC

70710-1240-3

Other ZITUVIO Dosages

Other Sitagliptin Brands

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

Data from openFDA · Public domain (CC0 1.0)