Product Overview
[Drug Name]
Generic Name: Perindopril tert-butylamine Tablets
Former Name: Perindopril Tablets
Trade Name: Yashida
Chinese Pinyin: Peiduopuli Shudingan Pian
English Name: Perindopril Tablets (Acertil)
[Ingredients]
Chemical Name: Perindopril tert-butylamine, (2S, 3aS, 7aS)-1{(S)-N-[(S)-1-carboethoxybutyl]alanyl}octahydro-1H-indole-2-carboxylic acid, tert-butylamine salt (1:1)
[Properties]
This product is a white strip-shaped tablet with an indentation in the middle.
[Strength]
4 mg (calculated as perindopril tert-butylamine, C₁₆H₃₂N₂O₅)
[Indications]
For the treatment of hypertension and congestive heart failure.
[Usage and Dosage]
It is recommended to take once daily before dawn. The dosage can be individualized based on the patient's specific condition and hypertensive response. (Please refer to the package insert for details.)
[Adverse Reactions]
The following adverse reactions have been observed during treatment with perindopril, listed in order of frequency:
Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1000, <1/100); Rare (>1/10,000, <1/100); Very rare (<1/100,000); Unknown (unable to assess based on available data). (Please refer to the package insert for details.)
[Contraindications]
Hypersensitivity to perindopril, any of the excipients, or other ACE inhibitors. History of angioedema associated with ACE inhibitor use. Hereditary or idiopathic angioedema. Pregnancy during the fourth to ninth trimester.
[Precautions]
Because this drug contains lactose, it is contraindicated in patients with congenital galactosemia, glucose and galactose malabsorption syndrome, or lactose deficiency. (Please refer to the package insert for details.)
[Use in Pregnant and Breastfeeding Women]
Perindopril should not be used during the first three months of pregnancy. Perindopril is contraindicated during the fourth to ninth months of pregnancy.
[Use in Children]
The efficacy and safety of this medication in children and adolescents have not been established. Therefore, it is not intended for use in children and adolescents.
[Use in the Elderly]
The elderly should start with 2 mg and gradually increase to 4 mg after one month. If necessary, the dose may be increased to 8 mg based on renal function (see Dosage and Administration for details).
[Storage] Store in a sealed container below 30°C.
[Packaging] 4 mg: Aluminum-plastic packaging, 10 tablets/box.
[Expiration Period] 24 months
[Approval Number] National Medicine Standard H20034053
[Manufacturer] Servier (Tianjin) Pharmaceutical Co., Ltd.
