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Enalapril maleate

Product description
Approved date: January 29, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
Inaline maleate instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
 
 
【Drug Name】
 
Common name: enalapril maleate tablets
 
English name: Enalapril Maleate Tablets
 
Pinyin: Malaisuan Yinapuli Pian
 
[Ingredients] The main ingredients of this product are: enalapril maleate. Its chemical name is: N-[(S)-1-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-L-proline maleate.
 
 
 
Molecular formula: C20H28N2O5·C4H4O4
 
Molecular weight: 492.52
 
【Properties】 This product is white or off-white.
 
[indications]
 
    For the treatment of essential hypertension.
 
[Specification] 10mg
 
【Dosage】
 
oral. The starting dose is 5-10 mg (1/2 to 1 tablet) per day, divided into 1 or 2 times. Patients with severe renal impairment (creatinine clearance rate less than 30 ml/min) are 2.5 mg per day (1/4 tablet) ). According to the blood pressure level, the dose can be gradually increased. The general effective dose is 10-20 mg (1~2 tablets) per day. The maximum dose per day should not exceed 40 mg (4 tablets). This product can be combined with other antihypertensive drugs, especially diuretics. In combination, the antihypertensive effect is obviously enhanced, but it is not suitable for use with sputum potassium diuretics.
 
【Adverse reactions】
 
    May have dizziness, headache, lethargy, dry mouth, fatigue, upper abdominal discomfort, nausea, palpitations, chest tightness, cough, flushing, rash and proteinuria. Reduce if necessary. If leukopenia occurs, stop the drug.
 
[taboo]
 
    Those who are allergic to this product or patients with bilateral renal artery stenosis are hanged. Patients with severe renal impairment should be used with caution.
 
【Precautions】
 
    1. Individual patients, especially those who use diuretics or hypovolemia, may cause excessive blood pressure drop, so the first dose should start from 2.5mg.
 
    2. Regular white blood cell count and renal function tests.
 
[Pregnant women and lactating women]
 
    Pregnant women and lactating women should be used with caution.
 
[Children's medication]
 
    Children use with caution.
 
[Geriatric Use]
 
still uncertain.
 
[Drug interactions] are not clear.
 
[Drug overdose] is not clear.
 
【Pharmacology and Toxicology】
 
This product is an angiotensin converting enzyme inhibitor. After oral administration, it is hydrolyzed into enalapril (Enalaprilat), which strongly inhibits angiotensin-converting enzyme, reduces angiotensin II content, causes systemic vasodilation, and causes hypotension. It has significant antihypertensive effect on type II kidney hypertension, type I hypertension and spontaneous hypertensive rat models.
 
【Pharmacokinetics】
 
Enalapril is a prodrug in which the ethyl ester moiety is rapidly hydrolyzed in the liver and converted to its effective metabolite, enalapril, to exert a hypotensive effect. About 68% of oral enalapril was absorbed. This product was taken with food and did not affect its bioavailability. The plasma enalapril concentration peaked 1 hour after taking the drug. After 3.5 to 4.5 hours of administration, the plasma concentration of enalapril reached a peak with a half-life of 11 hours. Hepatic dysfunction is delayed by the conversion of enalapril to enalapril. After 20 minutes of administration, enalapril was widely distributed throughout the body. The liver, kidney, stomach and small intestine had the highest drug concentration and the lowest concentration in the brain. Oral 2 times a day, two days later, enalapril binds to angiotensin-converting enzyme to reach a steady state, and the final half-life is extended to 30-35 hours. Enalapril is mainly excreted by the kidneys. In patients with severe renal insufficiency (creatinine clearance below 30 ml/min) drug accumulation can occur, and the drug can be removed by hemodialysis.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packaging] Composite film for pharmaceutical packaging, 16 pieces per box; 20 pieces per box; 32 pieces per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44024933
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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