China's Keverprazan(盐酸凯普拉生片):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Keverprazan

Keverprazan Hydrochloride Tablets is a National Class I Chemical Innovative Drug developed by Jiangsu Carephar Pharmaceutical Co., Ltd. and produced by Nanjing Carephar Shenghui Pharmaceutical Co., Ltd. It was approved for marketing by the National Medical Products Administration (NMPA) in February 2023 and has independent intellectual property rights in China.

Indications

Keverprazan Hydrochloride Tablets are mainly indicated for the treatment of two digestive system diseases:

Duodenal Ulcer: Inflammatory lesions occurring in the initial segment of the small intestine.

Reflux Esophagitis: Inflammation caused by gastric acid reflux irritating the esophagus.

Overview

Generic Name

Keverprazan Hydrochloride Tablets,盐酸凯普拉生片

Brand Name

倍稳

Drug Type

Rx Drug

Approval No.

10mg:国药准字H20230003;20mg:国药准字H20258150

Active Ingredient

Keverprazan

Dosage Form

10mg*7tablets;20mg*7tablets

Specification

Tablets

Description

Keverprazan Hydrochloride Tablets are film-coated tablets, which appear white or off-white on removal of the coating.

Expiry Date

36 months

Manufacturer

Nanjing Carephar Shenghui Pharmaceutical Co., Ltd.

Storage

Protect from light, seal tightly and store below 30℃.

Dosage and Administration

Swallow the tablet whole; do not chew or crush it. It is recommended to take this product before breakfast.

Duodenal Ulcer

Adults: 20mg once daily, for a continuous treatment of 6 weeks.

Reflux Esophagitis

Adults: 20mg once daily, for a continuous treatment of 8 weeks.

Available data do not support the use of this product for more than 8 weeks.

Eradication of Helicobacter pylori in Combination with Appropriate Antibiotics

Keverprazan 20mg twice daily, usually co-administered with amoxicillin 1000mg, clarithromycin 500mg and bismuth potassium citrate 240mg (calculated as bismuth oxide) – all twice daily – for 14 consecutive days.

Contraindications

The following populations are strictly prohibited from using this drug:

1.Patients allergic to any component of this drug;

2.Patients taking atazanavir, nelfinavir, or rilpivirine;

3.Pregnant women or women who may be pregnant.

Adverse Reactions

Based on clinical trial data of 354 adult patients (involving patients with duodenal ulcer and reflux esophagitis), the following reactions are common when taking 20 mg daily (sorted by frequency of occurrence):

Hepatobiliary System: Common: abnormal liver function; Uncommon: drug-induced liver injury.

Gastrointestinal System: Common: gastric polyps, diarrhea; Uncommon: constipation, abdominal pain, nausea, duodenitis, etc.

Metabolic Abnormalities: Common: elevated blood lipids and uric acid; Uncommon: abnormal appetite.

Cardiovascular System: Common: arrhythmia, bradycardia; Uncommon: heart block.

Abnormal Examination Indicators: Common: elevated transaminases, positive urinary protein; Uncommon: abnormal liver function indicators, changes in blood cell count, etc.

Other Reactions: Uncommon: dizziness and headache, allergic dermatitis, epistaxis (nosebleed), abnormal urinary system, etc.

Special Populations

Pregnancy and Lactation

Pregnancy

No clinical data on the use of this product in pregnant women are available. Keverprazan Hydrochloride can cross the placental barrier. Unless the expected therapeutic benefit is considered to outweigh any potential risks, pregnant women or women who may be pregnant should not take Keverprazan Hydrochloride Tablets.

Lactation

To date, no clinical studies have been conducted to evaluate this product in lactating subjects. It is not clear whether Keverprazan Hydrochloride is excreted into human milk. Animal studies have shown that Keverprazan Hydrochloride can be secreted into milk.

The use of Keverprazan Hydrochloride should be avoided during lactation. If administration is necessary, breastfeeding should be discontinued first.

Pediatric Use

This trial has not been conducted and there are no reliable references.

Geriatric Use

Clinical experience with this product in elderly patients is limited. In two Phase III trials for the treatment of duodenal ulcer and reflux esophagitis, 7 and 16 elderly patients (≥65 years old) received Keverprazan Hydrochloride 20 mg once daily, respectively. The endoscopic healing rate, incidence of adverse events, and common adverse reactions in elderly patients were similar to those in the full analysis set.

Due to the decline in overall physiological functions (such as hepatic and renal function) in elderly patients, this product should be used only after assessment.

For more detailed drug information, please consult the official package leaflet.