Vonomax Duo

Vonomax Duo is indicated for the treatment of H. pylori infection in adults.

14 days daily administration for morning, mid-day and night dowing each containing the following two drug products:

• Tablet
• : Vonoprazan 20 mg
• Capsule
• : Amoxicillin 500 mg
• The recommended dosage regimen is
• Morning
• : 1 Vonoprazan 20 mg tablet & 2 Amoxicillin 500 mg capsules
• Midday
• : 2 Amoxicillin 500 mg capsules
• Night

: 1 Vonoprazan 20 mg tablet & 2 Amoxicillin 500 mg capsules with or without food, for 14 days

Most common adverse reactions (22%) were diarrhea, abdominal pain, vulvovaginal candidiasis and nasopharyngitis.

Known hypersensitivity to Vonoprazan, Amoxicillin or any other beta-lactams, or any component of Vonomax Duo.

Rilpivirine-containing products

Hypersensitivity Reactions

: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of Vonomax Duo. If hypersensitivity reactions occur, discontinue Vonomax Duo and institute immediate therapy (eg, anaphylaxis management).

Severe Cutaneous Adverse Reactions (SCAR)

: Discontinue Vonomax Duo at the first signs or symptoms of SCAR or other signs of Hypersensitivity and consider further evaluation.

Clostridioides difficile-associated diarrhea (CDAD)

: Evaluate if diarrhea occurs with Vonomax Duo.

Pediatric Use

: Safety and effectiveness of Vornomax Duo in Pediatric patients have not been established

Renal Impairment

: No dosage adjustment of Vonomer Duo is recommended in patients with mild to moderate renat impelment (eGFR 30 to 89 mL/min). Avoid the use of Vonomax Duo in patients with severe renal impairment (eGFR <30 mL/min)

Hepatic Impairment

: No dosage adjustment of Vonomer Duo is recommended in patients with mild hepatic impairment (Child-Pugh A). Avoid the use of Vonomax Duo in patients with moderate to severe hepatic impairment (Child-Pugh B or C).

Based on findings from animal studies and observational studies in pregnant women with use of Clarithromycin, use of Vonomax Duo is not recommended in pregnant women. Avoid breastfeeding during Voromax Duo therapy.

No information is available on accidental overdosage of Vonomax Duo in humans In case of an overdose, patients should contact a physician poison control center, or emergency room.

Drug-drug interaction may occur with strong or moderate CYP3A inducers. Probenecid, Itraconazole, Allopurinol, Omeprazole, Saquinavir, Ritonavir, Etravirine & Rilpivirine.

Store at below 30°C in a dry place protected from light. Keep out of reach of children.