Generic Composition

Vonoprazan

Potassium competitive acid blocker

Full Prescribing Information

Indication

Vonoprazan is indicate for: Gastric ulcer, duodenal ulcer, reflux esophagitis, preventing gastric or duodenal ulcers from coming back while taking low-dose aspirin, preventing gastric or duodenal ulcers from coming back while taking nonsteroidal anti-inflammatory drugs (NSAIDs). In addition to getting rid of Helicobacter pylori in the following situations: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer or Helicobacter pylori gastritis.

Therapeutic Class

Potassium competitive acid blocker

Pharmacology

Vonoprazan is a competitive potassium acid blocker (P-CAB) that doesn't need acid to work. It stops H+, K+-ATPase from working in a way that is reversible and competitive for potassium. Vonoprazan is very basic and stays on the part of stomach parietal cells where acid is made for a long time. This stops gastric acid from being made. Vonoprazan has a big effect on stopping mucous damage in the upper part of the GI system from happening. Vonoprazan has neither an effect against Helicobacter pylori nor an effect on Helicobacter pylori urease.

Effects that help get rid of Helicobacter pylori: Vonoprazan is thought to help get rid of Helicobacter pylori by raising intragastric pH, which makes amoxicillin hydrate, clarithromycin, and metronidazole work better against bacteria when given at the same time.

When a healthy adult male is given 10mg or 20mg of Vonoprazan once a day for 7 days, the AUC (0-tau) and Cmax go up as the dose goes up. These gains are a little bigger than the dose ratio. It is thought that the steady state has been reached by the third day of treatment because the trough level of Vonoprazan in the blood stays the same between days 3 and 7. As a result of the review of buildup with regard to AUC(0-tau) and T1/2 of Vonoprazan, it is also thought that the pharmacokinetics of Vonoprazan may not change over time when it is given more than once in a row.

Dosage & Administration

Gastric ulcers and duodenal ulcers: An adult usually takes 20 mg of Vonoprazan orally once a day. This is a treatment for gastric ulcers that lasts 8 weeks and for duodenal ulcers that lasts 6 weeks.

For adults with reflux esophagitis, the normal amount of Vonoprazan taken by mouth is 20 mg once a day for a total of 4 weeks. If that dose isn't enough, it should be given for longer, but no longer than 8 weeks.

For long-term treatment of reflux esophagitis that comes back and comes back, the usual amount of Vonoprazan is 10 mg once a day. But if the effect isn't good enough, the dose of Vonoprazan can be raised up to 20 mg once a day.

Keeping a stomach or peptic ulcer from coming back while taking low doses of aspirin: Vonoprazan is usually taken by mouth once a day, in the form of a 10 mg pill.

Preventing a stomach or duodenal ulcer from coming back while taking a nonsteroidal anti-inflammatory drug (NSAID): Vonoprazan is usually taken by mouth once a day, in the form of a 10 mg pill.

In addition to getting rid of Helicobacter pylori: For seven days, the following three drugs should be taken by mouth at the same time twice a day for adults: 20 mg Vonoprazan, 750 mg Amoxicillin Hydrate, and 200 mg Clarithromycin. Clarithromycin can have its amount raised if it is clinically necessary to do so. But you shouldn't take more than 400 mg twice a day. If trying to get rid of Helicobacter pylori with a three-drug regimen of a proton pump inhibitor, amoxicillin hydrate, and clarithromycin hasn't worked, adults should take 20 mg of Vonoprazan, 750 mg of amoxicillin hydrate, and 250 mg of metronidazole twice a day for seven days as an alternative treatment.

Interaction

When vonoprazan was given along with the antibiotics clarithromycin and amoxicillin, vonoprazan levels went up by up to 1.9-fold. With the combination of metronidazole and amoxicillin, there was no rise.

Contraindication & Precaution

Patients who are allergic to Vonoprazan or any of the other ingredients in the drug.
Patients who take atazanavir sulphate, nelfinavir, or rilpivirine hydrochloride

Side Effect

Constipation, diarrhoea, feeling sick, and a rash are all common side effects.

Rare side effects include hypersensitivity (including allergic shock), liver function problems, stomach pain, a feeling of a swollen belly, a change in taste, stomatitis, a rise in AST (GOT), ALT (GPT), AL-P, LDH, or y-GPT, swelling, or an increase in eosinophils.
Adverse reactions: Following adverse reactions have been reported with the use of Vonoprazan: Diarrhea, constipation, drug hypersensitivity (including anaphylactic shock), drug eruption, urticaria, hepatotoxicity, jaundice, rash, nausea, abdominal distension, gamma-glutamyl transferase increased, AST increased, Liver function test abnormal, ALT increased, ALP increased, LDH increased, γ-GPT increased, edema and eosinophilia.

Pregnancy & Lactation

Vonoprazan shouldn't be given to women who are pregnant or who might be pregnant unless the expected treatment benefit is thought to be greater than any possible risk. Vonoprazan shouldn't be given to women who are nursing or pregnant. But when the management is necessary, the care should stop.

Overdose Effects

Vonoprazan has never been known to cause an excess. Hemodialysis does not get rid of vonoprazan from the blood. If someone takes too much, they should be treated for the symptoms and given help.

Storage Conditions

Don't keep it above 30°C. Keep out the sun and the rain. The expiration date means that the product was handled properly and in the right way. Keep away from children.

Safety Remark

Safe and effective

Composition

Vonoprazan contains Vonoprazan which is a potassium competitive acid blocker (PCAB). Chemically, Vonoprazan is 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]- N-methylmethanamine monofumarate