Indications
Vonobest is indicated for:
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 NSAID administration.
Adjunct to Helicobacter pylori
eradication in the following: 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.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Vonoprazan is a potassium
competitive acid blocker (P-CAB) and does not require activation by acid. It
inhibits H+, K+-ATPase in a reversible and potassium-competitive manner.
Vonoprazan has a strong basicity and 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.
Dosage
Gastric ulcer and duodenal ulcer:
The usual adult dose 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 10mg of Vonoprazan once daily. However, when the efficacy is inadequate, the
dosage may be increase up to 20 mg of Vonoprazan once daily.
Prevention of recurrence of
gastric or duodenal ulcer during low-dose aspirin administration: The usual
adult dose 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 dose 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 of
Vonoprazan, 750 mg of amoxicillin hydrate and 200 mg of clarithromycin. The
dose of clarithromycin may be increased as clinically warranted. However,
dosage should not exceed 400 mg 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 of Vonoprazan, 750 mg of amoxicillin hydrate and
250 mg of metronidazole.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
Vonoprazan can be taken without
regard to food or timing of food.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Contraindications
Vonoprazan is contraindicated in:
Patients with hypersensitivity to
Vonoprazan or to any excipient of the product.
Patients receiving atazanavir
sulphate, nelfinavir or rilpivirine hydrochloride.
Side Effects
Following side effects have been
reported with the use of Vonobest: 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, y-GPT increased, edema and
eosinophilia
Pregnancy & Lactation
Vonoprazan should be used in
pregnant women or women having possibility 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.
Precautions & Warnings
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 Vonobest, close observation by such means as endoscopy should be made.
In the maintenance of healing of
reflux esophagitis, Vonobest should be administered only to the patients who
repeat recurrence and recrudescence of the condition. Administration to the
patients who do not necessitate maintenance of healing should be avoided.
When the healing is maintained
over a long period and when there is no risk of recurrence, the dose reduction
to a dose of 10mg from a dose 20mg, or suspension of administration should be
considered.
Use in Special Populations
Use in the elderly: Since the
physiological functions such as hepatic or renal function are decreased in
elderly patients in general, Vonobest should be carefully administered.
Use in children less than 18
years of age: The safety and efficacy of Vonobest in children and adolescence
have not been established. Therefore, the administration of Vonobest is not
recommended in children and adolescents below 18 years of age.
Patients with renal impairment:
No dose adjustment of Vonobest is recommended in patients with mild to moderate
renal impairment (eGFR 30 to 89 mL/min). Avoid the use of Vonobest in patients
with severe renal impairment (eGFR < 30 mL/min)
Patients with hepatic impairment:
No dose adjustment of Vonobest is recommended in patients with mild hepatic
impairment (Child-Pugh A). Avoid the use of Vonobest in patients with moderate
to severe hepatic impairment (Child-Pugh B or C).
Overdose Effects
There is no experience of
overdose with Vonobest. Vonobest is not removed from the circulation by
hemodialysis. If overdose occurs, treatment should be symptomatic and
supportive.
Therapeutic Class
Potassium competitive acid
blocker
Storage Conditions
Store below 30°C, in a cool and
dry place. Keep away from light. Keep all the medicine out of the reach of
children.
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