VOCINTI Film-coated tablet Ref.[50552] Active ingredients: Vonoprazan

Source: Health Sciences Authority (SG)  Revision Year: 2019  Publisher: Manufactured by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Hikari Plant, Yamaguchi, Japan. Repacked by KOKANDO CO. LTD, Toyama, Japan Imported by Takeda (Thailand) Ltd., Bangkok, Thailand

Product name and form

Vocinti (Tablet) 10 mg.

Vocinti (Tablet) 20 mg.

Pharmaceutical Form
Available
Pharmaceutical
Forms
StengthsColorShapeMarkings
(upperside)
Film-coated Tablet10 mgPale yellowOval tabletB217
20 mgPale redOval scored tabletB218

Qualitative and quantitative composition

Vocinti (Tablet) 10 mg: Each film-coated tablet contains 10 mg of vonoprazan (as 13.36 mg vonoprazan fumarate).

Vocinti (Tablet) 20 mg: Each film-coated tablet contains 20 mg of vonoprazan (as 26.72 mg vonoprazan fumarate).

For excipients, see section 6.1.

Active Ingredient Description
Vonoprazan

Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production. Vonoprazan does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan binds to the active pumps in a noncovalent and reversible manner.

List of Excipients

D-Mannitol
Microcrystalline cellulose
Hydroxypropylcellulose
Fumaric acid
Croscarmellose sodium
Magnesium stearate
Hypromellose
Macrogol 6000*
Titanium oxide
Red ferric oxide (20 mg tablet only)
Yellow ferric oxide (10 mg tablet only)

* Macrogol 6000 is a name in the Japanese Pharmacopoeia. Its average molecular mass is approximately 8300. Therefore it is different from Macrogol 6000 in European Pharmacopoeia (Ph.Eur.) or Polyethylene Glycol 6000 in US National Formulary (NF) whose average molecular mass is 6000 and it is equivalent to Macrogol 8000 in Ph. Eur. and Polyethylene Glycol 8000 in NF.

Pack sizes and marketing

Polyvinyl chloride (PVC) film/Aluminum foil blister, one blister contains 10 tablets.

Marketing authorization holder

Manufactured by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Hikari Plant, Yamaguchi, Japan.

Repacked by KOKANDO CO. LTD, Toyama, Japan

Imported by Takeda (Thailand) Ltd., Bangkok, Thailand

Marketing authorization dates and numbers

Vocinti 10 mg: Reg.No.1C 15049/61(NC)
Vocinti 20 mg: Reg.No.1C 15050/61(NC)

6 July 2018

Drugs

Drug Countries
VOCINTI Singapore

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