China's Memantine(盐酸美金刚口溶膜):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Memantine

Memantine Hydrochloride Oral Soluble Film, developed and filed by Qilu Pharmaceutical Co., Ltd., is the first domestically approved dosage form of memantine hydrochloride oral soluble film in China. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2022 and is classified as a Class 2.2 modified new drug.

Indications

For the treatment of moderate to severe Alzheimer's type dementia.

Overview

Generic Name

Memantine Hydrochloride Oral Soluble Film,盐酸美金刚口溶膜

Brand Name

美思信

Drug Type

Rx Drug

Approval No.

5mg:国药准字H20220012;10mg:国药准字H20220013

Active Ingredient

Memantine Hydrochloride

Dosage Form

5mg*28tablets;10mg*28tablets

Specification

Oral Soluble Film

Description

Penpulimab Injection is a colorless to pale yellow clear liquid, which may be slightly opalescent.

Expiry Date

24 months

Manufacturer

Qilu Pharmaceutical Co., Ltd.

Storage

Store in a sealed container, protected from light, at a temperature not exceeding 30℃.

Dosage and Administration

This preparation should be prescribed and administered under the guidance of physicians experienced in the diagnosis and treatment of Alzheimer's type dementia. Treatment can only be initiated when there is a caregiver around the patient to supervise the patient's medication intake on time. Dementia should be diagnosed in accordance with current diagnostic criteria and guidelines.

The tolerance and dosage of memantine should be reassessed regularly on a routine basis within three months of treatment initiation. Thereafter, the clinical benefit of memantine and the patient's tolerance should be re-evaluated on a routine basis in accordance with current clinical practice guidelines. Maintenance treatment should be continued if the therapeutic benefit is significant and the patient tolerates memantine treatment; otherwise, maintenance treatment with memantine should be discontinued.

This preparation is taken once daily, at the same time each day, and may be taken on an empty stomach or with food.

Contraindications

Contraindicated in patients with hypersensitivity to memantine hydrochloride or any of its excipients.

Adverse Reactions

The common adverse reactions with a higher incidence rate in patients treated with memantine than in the placebo group were as follows: dizziness, headache, constipation, somnolence and hypertension.

Special Populations

Pregnancy and Lactation

Pregnancy: No clinical data are available on the use of this product in pregnant patients. Animal studies have shown that memantine administered at doses equivalent to or slightly higher than the human therapeutic dose may cause fetal intrauterine growth retardation. The potential risk to humans is unknown. This product should not be taken during pregnancy unless clearly necessary.

Lactation: It is unknown whether memantine is excreted in human breast milk, but this possibility exists considering the lipophilicity of memantine. Therefore, breastfeeding women should discontinue breastfeeding when taking this product.