Vonozan Tablet 10 mg_

VOQUEZNA is indicated: for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults. in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori ( H. pylori ) infection in adults. in combination with amoxicillin for the treatment of H. pylori infection in adults. …

• Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks
• Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months
• Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks
• Treatment of H. pylori Infection: see full prescribing information
• See also full prescribing information for the recommended dosage by indication for patients with renal or hepatic impairment
• Administration Instructions : Take with or without food
• Swallow whole; do not chew or crush
• Recommended Dosage Healing of Erosive Esophagitis The recommended adult oral dosage is VOQUEZNA 20 mg once daily for 8 weeks
• For the treatment of healing of erosive esophagitis and relief of associated heartburn
• Maintenance of Healed Erosive Esophagitis The recommended adult oral dosage is VOQUEZNA 10 mg once daily for up to 6 months for the maintenance of healed erosive esophagitis and relief of associated heartburn
• Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease The recommended adult oral dosage is VOQUEZNA 10 mg once daily for 4 weeks
• Treatment of H. pylori Infection Triple Therapy: The recommended adult oral dosage is VOQUEZNA 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (in the morning and evening, 12 hours apart) for 14 days. …

Tablets: 10 mg of vonoprazan: pale yellow, oval, film-coated tablets debossed V10 on one side and plain on the other side. 20 mg of vonoprazan: pale red, oval, film-coated tablets debossed V20 on one side and plain on the other side. Tablets: 10 mg and 20 mg of vonoprazan. ( 3 )

• The safety and effectiveness of VOQUEZNA have not been established
• In pediatric patients

There were 200 patients aged 65 years and older in the clinical trial for healing and maintenance of healed erosive esophagitis [see Clinical Studies (14.1) ] . Of the total number of vonoprazan-treated patients, there were 93 (18%) patients aged 65 years of age and older and 10 (2%) patients aged 75 years of age and older. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Advise patients of the following: Acute Tubulointerstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions ]
• Clostridioides difficile -Associated Diarrhea To immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ]
• Bone Fracture To report any fractures, especially of the hip, wrist, or spine, to their healthcare provider [see Warnings and Precautions ]. …

• VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA
• Reactions have included anaphylactic shock [see Adverse Reactions and Description ]
• VOQUEZNA is contraindicated with rilpivirine-containing products [see Drug Interactions ] . …

Table 9 and Table 10 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with VOQUEZNA and instructions for preventing or managing them. These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy [see Clinical Pharmacology (12.3) ] . Consult the labeling of concomitantly used drugs to obtain further information about interactions with vonoprazan. …

Gastric Malignancy : Symptomatic response to treatment does not preclude the presence of gastric malignancy; consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Clostridioides difficile -Associated Diarrhea (CDAD) : May be associated with an increased risk; use the shortest duration of treatment appropriate to the condition. ( 5.3 ) Bone Fracture, including Osteoporosis-related Fracture : Use the shortest duration of treatment appropriate to the condition. …

The following serious adverse reactions are described elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Vitamin B12 (Cobalamin) Deficiency [see Warnings and Precautions (5.6) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.7) ] Fundic Gland Polyps [see Warnings and Precautions (5.9) ] Most common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal d …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/ . Risk Summary There are no adequate and well-controlled studies of vonoprazan in pregnant women. …

Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.