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Ilaprazole Sodium
Ilaprazole Sodium

Ilaprazole Sodium(注射用艾普拉唑钠)

Ilaprazole Sodium for Injection has equivalent efficacy to traditional PPIs, yet features a lower dosage requirement, does not occupy intravenous access, and has fewer drug-drug interactions, which greatly enhances the convenience of clinical medication.

  • 10mg/vial

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Introduction of Ilaprazole Sodium

As a domestic innovative drug in China that has broken the monopoly in the field of imported PPIs, Ilaprazole Sodium for Injection is an important clinical medication in the digestive system field, providing a highly effective and convenient option of intravenous acid-suppressive treatment for the clinical diagnosis and treatment of diseases associated with upper gastrointestinal bleeding.

Indications

1、Peptic ulcer bleeding.

2、Prevention of stress ulcer bleeding in critically ill patients.

Overview

Generic Name
Ilaprazole Sodium for Injection,注射用艾普拉唑钠
Brand Name
壹丽安
Drug Type
Rx Drug
Approval No.
国药准字H20170019
Active Ingredient
Ilaprazole Sodium
Dosage Form
10mg/vial
Specification
Injection
Description
This product is a white or off-white loose mass or powder.
Expiry Date
24 months
Manufacturer
Livzon Group Livzon Pharmaceutical Factory.
Storage
Protect from light, seal and store below 25°C.

Dosage and Administration

Peptic ulcer bleeding: For intravenous infusion, the initial dose is 20mg, followed by 10 mg once daily for 3 consecutive days. After the course of treatment, oral therapy may be initiated as appropriate.

Prevention of stress ulcer bleeding in critically ill patients: For intravenous infusion, the initial dose is 20mg, followed by 10mg once daily. The initiation and discontinuation of administration shall be determined based on the clinician's judgment on whether the patient is in a critical condition and at risk of stress ulcer bleeding. No clinical trial data is available for administration lasting more than 14 days.

Precautions for Administration

For high-risk patients with spurting bleeding, oozing bleeding, exposed blood vessels and other conditions, endoscopic hemostasis shall be performed first.

This product is for intravenous infusion only: Dissolve 10mg of this product completely in 100ml of 0.9% Sodium Chloride Injection, and administer via intravenous infusion using an infusion set with a filtration device over 30 minutes. For an initial dose of 20mg, dissolve the product in 200ml of 0.9% Sodium Chloride Injection. The prepared solution must be used up within 3 hours.

This product can only be dissolved in 0.9% Sodium Chloride Injection for intravenous use. The prepared solution shall not be mixed with other drugs nor administered through the same infusion device.

Contraindications

Contraindicated in patients with hypersensitivity to ilaprazole and other benzimidazole compounds.

Contraindicated in patients with hypersensitivity to any other ingredients of this product.

Adverse Reactions

Abnormalities of the hepatobiliary system

Common: Elevated alanine aminotransferase, elevated aspartate aminotransferase.

Uncommon: Elevated serum alkaline phosphatase, elevated γ-glutamyl transferase, elevated serum bilirubin.

General disorders and administration site conditions

Common: Fever.

Metabolic and nutritional disorders

Uncommon: Hypocalcemia, hypernatremia.

Gastrointestinal disorders

Uncommon: Hiccups, constipation, abdominal distension.

Investigations

Common: Decreased white blood cell count.

Uncommon: Elevated serum lactate dehydrogenase, elevated serum creatinine, elevated serum urea, decreased platelet count, increased total bile acid.

Special Populations

Pregnancy and Lactation

No clinical trial data on the use of this product in pregnant and lactating women is available to date, and its use is not recommended for this population. If a lactating woman must receive treatment with this product, breastfeeding should be discontinued.

Pediatric Use

No clinical trial data in pediatric patients is available to date.

Geriatric Use

Ilaprazole Sodium for Injection was administered to 151 geriatric patients aged 60 years and above in two clinical trials, and no significant differences in its safety and efficacy were observed between this population and the general population.

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

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