Dosage

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Administration

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 a dose of 10mg from a dose 20mg, or suspension of administration should be considered.

Overdose 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.

Safety Advice

CONSULT YOUR DOCTOR – Alcohol: Caution is advised when consuming alcohol with Vonoprazan.
CONSULT YOUR DOCTOR – Pregnancy: 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.\n
CONSULT YOUR DOCTOR – Breastfeeding: 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 – Driving: 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 – Kidney: 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 – Liver: 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).