Official FDA label of a drug by brand or generic name: indications, dosage, warn...

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{ "example": { "count": 1, "labels": [ { "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 Wa...", "application_number": "NDA216743", "boxed_warning": "WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning . Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respirato...", "brand_name": "ZITUVIMET", "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...", "dosage_and_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. (...", "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-...", "generic_name": "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE", "indications_and_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: Z...", "label_date": "2026-08-12", "manufacturer": "Zydus Lifesciences Limited", "ndc": [ "70771-1859", "70771-1860" ], "pharm_class": [ "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]" ], "pregnancy": "8.1 Pregnancy Risk Summary Available data with ZITUVIMET and sitagliptin use in pregnant women are not sufficient to inform a ZITUVIMET-associated or sitagliptin-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnancy have not reported a clear a...", "product_type": "HUMAN PRESCRIPTION DRUG", "route": [ "ORAL" ], "rxcui": [ "861769", "861819" ], "set_id": "0098dec4-f0e5-45d5-8aa4-5d0faf9ab142", "substances": [ "SITAGLIPTIN", "METFORMIN HYDROCHLORIDE" ] } ], "note": "Official FDA label text for information only, not medical advice.", "query": "metformin", "source": "openFDA drug labels (CC0)" }, "type": "json" }