Vonobase 20mg Tab

VONOBASE 20MG Tablet

VONOBASE 20MG Tablet is a medication manufactured by Gufic Biosciences Ltd., primarily used to manage various gastrointestinal conditions related to excess stomach acid.

Composition

• Active Ingredient: Vonoprazan 20 mg.

Uses

VONOBASE 20MG Tablet is a potassium-competitive acid blocker (P-CAB) that works by reducing the amount of acid produced in the stomach. It is prescribed for the following conditions:

• Reflux Esophagitis: For healing all grades of erosive esophagitis and providing relief from associated heartburn.
• Gastric Ulcers: To treat sores on the stomach lining.
• Duodenal Ulcers: To treat ulcers that form in the small intestine.
• Helicobacter pylori (H. pylori) Infection: Used in combination with antibiotics (like clarithromycin and/or amoxicillin) to eradicate H. pylori bacteria, which can cause stomach ulcers.
• Prevention of Ulcer Recurrence: Helps prevent the recurrence of gastric or duodenal ulcers, especially during the use of low-dose aspirin or NSAIDs.
• Gastroesophageal Reflux Disease (GERD): For relief of heartburn associated with non-erosive GERD.

Dosage and Administration

The dosage and duration of treatment are determined by a doctor based on the medical condition.

• VONOBASE 20MG Tablet can be taken with or without food.
• Tablets should be swallowed whole with a glass of water; do not break, crush, or chew.
• Typical Adult Dosing Examples:
  • For healing of erosive esophagitis: 20 mg once a day for 8 weeks.
  • For maintenance of healed erosive esophagitis: 10 mg once a day for up to 6 months.
  • For H. pylori infection: 20 mg twice a day for 14 days, in combination with specific antibiotics (e.g., amoxicillin and clarithromycin).
  • For non-erosive GERD heartburn relief: 10 mg once a day for 4 weeks.
• If a dose is missed, take it as soon as remembered. If it is almost time for the next dose (e.g., 12 hours for once-daily or 4 hours for twice-daily), skip the missed dose and continue the regular schedule. Do not double the dose.

Side Effects

Common side effects are usually temporary and may include:

• Diarrhea
• Bloating
• Stomach pain
• Nausea
• Indigestion
• High blood pressure

Serious side effects, though rare, should be reported to a doctor immediately:

• Severe bone pain or fractures (especially with long-term or high-dose use)
• Kidney problems, such as acute tubulointerstitial nephritis (symptoms like low urine output, blood in urine)
• Clostridioides difficile-associated diarrhea (watery, severe diarrhea, stomach cramps, fever)
• Vitamin B12 deficiency (with long-term use)
• Hypomagnesemia (low magnesium in blood, symptoms like seizures, irregular heartbeat, muscle spasms)
• Gastric polyps (benign pre-cancerous lesions with prolonged use)
• Severe skin reactions (skin rash, blistering, peeling, bleeding skin, fever, chills)

Precautions

• Allergies: Inform your doctor about any known allergies to Vonoprazan or other medications.
• Pregnancy and Breastfeeding: Consult a doctor before using VONOBASE if pregnant or breastfeeding. Limited safety information is available, and it is generally not recommended during breastfeeding.
• Pre-existing Medical Conditions: Inform your doctor if you have or have had kidney or liver disorders (dose adjustment or avoidance may be necessary for severe cases), osteopenia, osteoporosis, or low levels of calcium, magnesium, or potassium in your blood.
• Drug Interactions:
  • Do not use with medicines containing rilpivirine.
  • Use with caution with CYP3A4 inhibitors like clarithromycin, as vonoprazan blood concentration may increase.
  • Inform your doctor about all other medications, including nonprescription and herbal products (e.g., iron salt tablets, St. John's Wort).
• Alcohol Consumption: Avoid or limit alcohol while taking VONOBASE, as it may reduce effectiveness and delay ulcer healing.
• Gastric Malignancy: VONOBASE may mask symptoms of gastric malignancy.
• Children: Safety and effectiveness have not been established in children.

Storage

• Store in a cool and dry place, away from direct sunlight.
• Do not store above 30°C.
• Keep out of the sight and reach of children.
• Store the medication in its original packaging.

VONOBASE 20MG TAB, containing Vonoprazan, is a medication primarily used to reduce stomach acid. Below are frequently asked questions about this medicine.

What is VONOBASE 20MG TAB used for?

VONOBASE 20MG TAB is used to treat several gastrointestinal conditions caused by excess stomach acid. These include reflux esophagitis (inflammation of the esophagus due to acid reflux), gastric ulcers (stomach sores), and duodenal ulcers (sores in the small intestine). It also helps prevent the recurrence of gastric or duodenal ulcers, especially during the use of low-dose aspirin or NSAIDs. Additionally, it is used in combination with certain antibiotics to treat Helicobacter pylori (H. pylori) infection, a common cause of ulcers.

How does VONOBASE 20MG TAB work?

VONOBASE 20MG TAB contains Vonoprazan, which belongs to a class of medicines called potassium-competitive acid blockers (P-CABs). It works by directly and reversibly inhibiting the H+, K+-ATPase enzyme system, often called the proton pump, in the parietal cells of the stomach lining. This enzyme is responsible for pumping acid into the stomach. By blocking this pump, Vonoprazan effectively reduces the amount of acid produced in the stomach, allowing ulcers to heal and reducing symptoms like heartburn. Unlike traditional proton pump inhibitors (PPIs), Vonoprazan does not require acid activation and its effects are not significantly influenced by meals.

What is the usual dosage for VONOBASE 20MG TAB?

The dosage of VONOBASE 20MG TAB varies depending on the condition being treated. For the healing of erosive esophagitis, the usual adult dose is 20 mg once daily for 8 weeks, with a maintenance dose of 10 mg once daily for up to 6 months. For gastric ulcers, it is typically 20 mg once daily for 8 weeks, and for duodenal ulcers, 20 mg once daily for 6 weeks. To eradicate H. pylori infection, it is usually taken as 20 mg twice daily for 7 to 14 days, in combination with antibiotics like amoxicillin and clarithromycin. It can be taken with or without food and should be swallowed whole with a glass of water without breaking, crushing, or chewing. Always follow your doctor's specific instructions.

What are the possible side effects of VONOBASE 20MG TAB?

Common side effects of VONOBASE 20MG TAB may include diarrhea, bloating, stomach pain, nausea, and indigestion. These effects are usually temporary. Other reported side effects can include high blood pressure. More serious but less common effects can include a risk of acute tubulointerstitial nephritis (a kidney disorder), Clostridioides difficile-associated diarrhea, and, with long-term or high-dose use, an increased risk of bone fractures (hip, wrist, and spine), vitamin B12 deficiency, or low magnesium levels in the blood (hypomagnesemia). It is important to inform your doctor if any side effects persist or worsen.

Is VONOBASE 20MG TAB safe during pregnancy or breastfeeding?

Limited safety information is available regarding the use of VONOBASE 20MG TAB during pregnancy. If you are pregnant or planning to become pregnant, it is crucial to consult your doctor to discuss the potential risks and benefits. For breastfeeding mothers, it is generally advised not to breastfeed while taking VONOBASE 20MG TAB. Always seek your doctor's advice before using this medication if you are pregnant or breastfeeding.

Can VONOBASE 20MG TAB be taken with other medications?

VONOBASE 20MG TAB can interact with other medications. It is crucial to inform your doctor about all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements you are currently taking. VONOBASE 20MG TAB is not recommended with certain antiretroviral medicines like rilpivirine, nelfinavir, or atazanavir. It may also affect the absorption or effectiveness of drugs that require stomach acid for proper absorption, such as some iron salts and certain antifungal medications like ketoconazole or itraconazole. Additionally, it may interact with medications like cyclosporine, cilostazol, citalopram, clarithromycin, digoxin, and blood thinners like clopidogrel. Your doctor may need to adjust dosages or monitor you closely for interactions.

What precautions should be taken while using VONOBASE 20MG TAB?

Before taking VONOBASE 20MG TAB, tell your doctor if you have allergies to any of its ingredients or if you have a history of kidney or liver disorders, osteopenia, osteoporosis, or low levels of calcium, magnesium, or potassium in your blood. Avoid alcohol consumption and smoking, as these can increase acid production and worsen symptoms. It is also advisable to avoid spicy, acidic, or fatty foods that can trigger acid reflux. Maintaining a healthy lifestyle with smaller, more frequent meals and adequate water intake can be beneficial. Do not lie down immediately after eating, and if you experience dizziness, avoid driving or operating machinery until you know how the medication affects you. VONOBASE 20MG TAB should not be given to children as its safety and effectiveness in this age group have not been established.

What happens if a dose of VONOBASE 20MG TAB is missed?

If you miss a dose, take it as soon as you remember. However, the timing for taking a missed dose varies by condition:

• For erosive esophagitis and heartburn: If it's within 12 hours of your usual time, take the missed dose. If more than 12 hours have passed, skip the missed dose and resume your regular dosing schedule.
• For H. pylori infection: If it's within 4 hours of your usual time, take the missed dose. If more than 4 hours have passed, skip the missed dose and continue with your regular schedule. In any case, do not take a double dose to make up for a missed one, as this may increase the risk of side effects.

How should VONOBASE 20MG TAB be stored?

VONOBASE 20MG TAB should be stored in a cool and dry place, away from direct sunlight. Keep the medicine in its original closed container at room temperature, ideally between 10ºC to 25ºC or below 30ºC. It is essential to keep VONOBASE 20MG TAB out of the sight and reach of children.