Vinca
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Composition
Vinca 10 mg Tablet: Each film coated tablet contains Vonoprazan Fumarate INN equivalent to Vonoprazan 10 mg.
Pharmacology
Vonoprazan is a potassium competitive acid blocker (PCAB) and does not require activation by acid. It inhibits H+, K+-ATPase in a reversible and potassium-competitive manner. Vonoprazan resides on the acid production site of gastric parietal cells for a long time, thereby inhibiting gastric acid production. Vonoprazan exerts a strong inhibitory effect on formation of mucosal damage in upper part of the gastrointestinal tract.
Indication
- Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose
aspirin administration, prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug
(NSAID) administration.
Adjunct to Helicobacter pylori eradication in the following settings:
- 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.
Dose and administration
- Gastric ulcer, duodenal ulcer: The usual adult dosage for oral use is 20 mg of Vonoprazan administered orally once daily
an 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. - Reflux esophagitis: The usual adult dose for oral use is 20 mg of Vonoprazan administered once daily for a total of 4 weeks
of treatment. If that dosing proves insufficient, the administration should be extended, but for no longer than 8 weeks of
treatment.
For the maintenance therapy of reflux esophagitis showing recurrence and recrudescence, the dose for oral use is 10 mg
once daily. However, when the efficacy is inadequate, the dosage may be increase up to 20 mg once daily.
- Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration: The usual adult dosage is one
tablet of 10 mg of Vonoprazan administered orally once daily. - Prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) administration:
The usual adult dosage is one tablet of 10 mg of Vonoprazan administered orally once daily. - Adjunct to Helicobacter pylori eradication: For adults, the following three-drug regimen should be administered orally at the
same time twice daily for seven days: 20 mg dose of Vonoprazan, 750 mg (potency) dose of amoxicillin hydrate and 200
mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage
should not exceed 400 mg (potency)/dose twice daily.
If Helicobacter pylori eradication with a three-drug regimen comprising a proton pump inhibitor, amoxicillin hydrate and clarithromycin has been unsuccessful, as an alternative treatment, adults should be administered the following three drugs orally twice daily for seven days: 20 mg dose of Vonoprazan, 750 mg (potency) dose of amoxicillin hydrate and 250 mg dose of metronidazole.
Contraindication
Vinca is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients. Vinca
tablets should not be co-administered with Atazanavir & Rilpivirine.
Precaution
At the treatment, the course of the disease should closely be observed and the minimum therapeutic necessity should be used according to the disease condition. In the long-term, treatment with Vonoprazan, close observation by such means as endoscopy should be made. In the maintenance of healing of reflux esophagitis, Vonoprazan should be administered only to the patients who repeat recurrence and recrudescence of the condition. When the healing is maintained over a long period and when there is no risk of recurrence, the dose reduction to a dose of 10 mg from a dose 20 mg, or suspension of administration should be considered.
Side Effect
The most common adverse effects are constipation, diarrhea, skin rash & nausea.
Use in Pregnancy & Lactation
Vonoprazan should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. It is advisable to avoid the administration of Vonoprazan to nursing mothers. However, when the administration is indispensable, nursing should be discontinued
Drug Interaction
Effect of Digoxin, Methyldigoxin may be enhanced when administered with Vonoprazan. Effect of Itraconazole, Tyrosine kinase inhibitors, Gefitinib, Nilotinib, Erlotinib may be diminished when administered with Vonoprazan.
Overdose
There have been no reports of overdose with Vonoprazan. In clinical studies, a single dose of 120 mg resulted in no serious adverse reactions. If overdose occurs, treatment should be symptomatic and supportive.
Do not store above 30° C, protect from light & moisture. Keep out of reach of children.
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