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Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
Caution is advised when consuming alcohol with Vonoprazan.
CONSULT YOUR DOCTOR
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.
CONSULT YOUR DOCTOR
It is advisable to avoid the administration of Vonoprazan to nursing mothers. However, when the administration is indispensable, nursing should be discontinued.
CONSULT YOUR DOCTOR
Do not drive if you experience any symptoms that affect your ability to concentrate and react. It is not clearly known whether Vonoprazan alters the ability to drive.
SAFE IF PRESCRIBED
Patients with renal impairment: No dose adjustment of Vonoprazan is recommended in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Avoid the use of Vonoprazan in patients with severe renal impairment (eGFR < 30 mL/min).
SAFE IF PRESCRIBED
Patients with hepatic impairment: No dose adjustment of Vonoprazan is recommended in patients with mild hepatic impairment (Child-Pugh A). Avoid the use of Vonoprazan in patients with moderate to severe hepatic impairment (Child-Pugh B or C).
Medicine Overview of Novonil 10mg Tablet
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....
... Show moreAdministration
Vonoprazan can be taken without regard to food or timing of food. Use in the elderly: Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general,Vonoprazan should be carefully administered. Use in children less than 18 years of age: The safety and efficacy of Vonoprazan in children and adolescence have not been established. Therefore, the administration of Vonoprazan is not recommended in children and adolescents below 18 years of age. * Take medicine as per doctor's advice.
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 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, y-GPT increased, edema and eosinophilia
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 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. 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...
... Show moreOverdose Effects
There is no experience of overdose with Vonoprazan . Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive.
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.
Brief Description
Indications
Vonoprazan 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.
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.
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