Indication: It is used to treat essential hypertension with elevated plasma homocysteine level. Enalapril maleate can reduce blood pressure in patients with hypertension. Folic acid can reduce plasma homocysteine level. Whether reducing plasma homocysteine level can prevent cardiovascular and cerebrovascular events remains uncle
Item specifications:10mg:0.8mg*7tab/box
Usage and dosage:Different specifications of enalapril maleate and folic acid tablets were selected according to blood pressure control. It is generally recommended that the starting dose is 5mg / 0.4mg per day, and the dosage should be adjusted according to the patient's reaction, or according to the doctor's advice.
Patients with abnormal liver and kidney function and elderly patients should reduce or follow the doctor's advice.
Adverse reactions Enalapril maleate
Generally, enalapril maleate is well tolerated. In clinical studies, the total incidence of adverse reactions of enalapril maleate was similar to that of placebo, most of which were mild and transient and did not need to terminate treatment.
The following adverse reactions were related to enalapril maleate tablets.
1. Dizziness and headache are common. 2% - 3% of patients reported feeling tired and weak. Less than 2% of patients reported other adverse reactions, including hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle spasm, rash and cough. Renal dysfunction, renal failure and oliguria are rare.
2. Allergy / angioneurotic edema
Angioneurotic edema has been reported on the face, limbs, lips, tongue, glottis and / or larynx, but it is rare (see note)
3. The extremely rare adverse reactions occurred in clinical controlled trials or after drug marketing are as follows:
(1) Cardiovascular system
Myocardial infarction or cerebrovascular accident may be secondary to hypotension in high-risk patients (see Precautions)
Chest pain; Palpitations; Arrhythmia; angina pectoris; Reynolds phenomenon.
(2) Digestive system
Intestinal obstruction; pancreatitis; Liver failure; Hepatitis - hepatocyte or cholestasis; Jaundice; Abdominal pain; vomit; indigestion; Constipation; Anorexia; Gastritis.
(3) Nervous / mental system
Depression; Insanity; Drowsiness; Insomnia; neuroticism; Paresthesia; Vertigo; Abnormal dream.
(4) Respiratory system
Lung infiltration; Bronchospasm / asthma; dyspnea; Runny nose; Sore throat and hoarseness.
(5) Skin
hyperhidrosis; Erythema multiforme; Exfoliative dermatitis; Steven Johnson syndrome; The toxic epidermis is necrotic and lax; Pemphigus; itch; Urticaria; Baldness.
(6) Others
Impotence; Red tide; Taste changes; Tinnitus; Glossitis; Blurred vision.
A syndrome with some or all of the following symptoms has been reported: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, positive antinuclear antibody, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis. Rash, photoallergy and other skin diseases may also appear.
Laboratory examination
In clinical practice, the important changes of laboratory standard parameters are rarely related to enalapril maleate administration, but there are increases in blood urea nitrogen and serum creatinine, various liver enzymes and / or serum bilirubin. These are often recovered after discontinuation. Hyperkalemia and hyponatremia have also occurred.
It has also been reported that patients with decreased hemoglobin and hematocrit.
Since the launch of enalapril maleate, neutropenia, thrombocytopenia, myelosuppression and agranulocytopenia have been reported in a few cases, which can not be excluded from the use of enalapril maleate.
folic acid
Adverse reactions were less and allergic reactions were rare. Gastrointestinal symptoms such as fear of food, nausea and abdominal distension may appear after long-term and large-scale medication. Folic acid in large quantities can make urine yellow.
Enalapril maleate folic acid tablets
In clinical trials, the adverse reactions of enalapril maleate folic acid tablets were similar to those of enalapril maleate alone. The main adverse reactions were cough, headache, dry mouth, fatigue, epigastric discomfort, nausea, palpitations, skin rash, etc. Most of the adverse reactions were mild and short-lived, and there was no need to terminate the treatment.
Taboo: It is forbidden for patients who are allergic to any component of this product, or patients who have been treated with a certain angiotensin converting enzyme inhibitor for angioneurotic edema, and patients with hereditary or spontaneous angioneurotic edema.
Patients with severe renal impairment should be cautious.
Matters needing attention: Enalapril maleate
1. symptomatic hypotension
It is rare in patients with hypertension without complications. In patients with hypertension taking enalapril maleate, blood volume is insufficient due to diuretics treatment, diet limit, dialysis, diarrhea or vomiting, etc. (see drug interaction and adverse reactions). In the patients with heart failure, symptomatic hypotension was observed, and the most likely of the patients with severe heart failure. Such patients should be treated under medical monitoring and should be followed up closely whenever the dose of enalapril maleate or / or diuretics is adjusted. The same treatment is also applicable to patients with ischemic heart disease or cerebrovascular disease, because too much blood pressure drop in these patients may lead to myocardial infarction or cerebrovascular accidents.
If hypotension occurs, the patient should lie on his back and intravenous saline if necessary. Transient hypotension is not a contraindication of continued medication. Usually after expanding the blood volume, the blood pressure of the day rises, and it can be given.
Some patients with normal or low blood pressure may have a progressive drop in systemic blood pressure after taking. If hypotension symptoms occur, it is necessary to reduce the dose and / or stop using diuretics and / or this product.
2. aortic stenosis / hypertrophic heart disease
Caution should be taken when using ACE inhibitors in patients with left ventricular outflow tract infarction.
3. renal insufficiency
The hypotension after the treatment with the inhibitors of angiotensin converting enzyme can further damage the renal function of some patients. This has been reported to cause acute renal failure, but it is usually reversible.
Patients with renal dysfunction may need to reduce dosage and / or reduce the number of medications (see dosage and usage). In the patients with bilateral renal artery stenosis or renal artery stenosis, the increase of urea nitrogen and serum creatinine was observed in patients with renal artery stenosis, and the treatment stopped usually could be reversed; This is especially true for patients with renal dysfunction.
In some patients who had not previously had a significant renal disease, when enalapril maleate and diuretics were used simultaneously, there was usually a slight or excessive increase in urea nitrogen and serum creatinine, which may require a reduction in dose and / or discontinuation of diuretics and / or enalapril maleate.
4. allergic / vascular neuroedema
It is reported that patients with ACE inhibitors occasionally report vascular neuroedema in the face, limbs, lips, tongue, glottis and / or throat. It can occur at any time during the treatment period. At this time, the product should be stopped immediately and proper monitoring should be given to ensure that the symptoms of the patients completely subside before discharge. When swelling is limited to the surface and lip, it can be disappeared without treatment. Antihistamines are useful in relieving symptoms.
Vascular neuroedema with laryngeal edema may lead to death. When edema occurs in the tongue, glottis and / or throat, which may cause airway obstruction, appropriate treatment should be given immediately, including measures such as hypodermic syringe 1:1000 adrenaline solution (0.3 ml-0.5 ml) and / or immediate measures to keep the respiratory tract unobstructed.
In people with a history of vascular neuroedema unrelated to the treatment of ACE inhibitors, the risk of angioneuroedema increases when using ACE inhibitors (see contraindications).
5. allergic reaction when desensitization with venom of Hymenoptera
When desensitization of patients treated with ACE inhibitors with the venom of Hymenoptera, life-threatening allergic reactions may occur, which is rare. Before each desensitization, temporarily stopping the ACE inhibitor can avoid this reaction.
6. hemodialysis patients
Patients who were treated with high permeability membrane (such as AN69) and treated with ACE were reported to have anaphylaxis. For such patients, another type of dialysis membrane or another type of antihypertensive drug should be considered.
7. cough
It is reported that the use of ACE inhibitors can cause cough, which is characterized by no phlegm, continuous and may disappear after stopping the drug. In differential diagnosis of cough, the possibility of coughing caused by angiotension converting enzyme inhibitors should be considered.
8. operation / anesthesia
Enalapril blocks the production of angiotensin II due to compensatory renin release in patients undergoing major surgery or anesthesia with anesthetics that may cause hypotnsion. If hypotension occurs and the above mechanism is considered, the blood volume should be expanded to correct.
Serum potassium - see drug interactions
folic acid
During the period of taking this product, please consult your doctor for other compound vitamins or health food containing folic acid.
Enalapril maleate folic acid tablets
1. the effect of folic acid on homocysteine was significantly affected by the polymorphism of C677T of MTHFR gene. The results showed that the patients with pure mutation (TT genotype) had better effect after taking enalapril maleate tablets.
2. * this product can be used with other antihypertensive drugs, especially diuretics, and its antihypertensive effect is enhanced.
3. some patients, especially those who use diuretics or reduced blood volume, may cause excessive blood pressure drop. Therefore, the first dose should start with low dose or follow the doctor's instructions.
4. the leukocyte count and renal function test were performed regularly.
5. it is forbidden to use when the character of the product changes.
Please place the product in a place where children cannot reach..
Medication for pregnant and lactating women: Enalapril maleate
1. Pregnancy
This drug is not recommended during pregnancy. If you are found to be pregnant, stop using this product immediately unless it is necessary to save the mother's life.
The use of angiotensin converting enzyme inhibitors during the middle and last trimester of pregnancy can cause fetal and neonatal morbidity and mortality. The use of ACE inhibitors during this period is associated with a variety of fetal and neonatal injuries, including hypotension, renal failure, hyperkalemia, and / or neonatal craniohypoplasia. If the patient uses this product, the potential harm to the fetus should be explained to the patient.
In the first three months of pregnancy, uterine exposure to this angiotensin converting enzyme inhibitor does not cause the above adverse reactions in embryos and fetuses.
In rare cases where angiotensin-converting enzyme inhibitors must be used during pregnancy, a series of ultrasound examinations should be performed to evaluate the amniotic membrane. If you find oligohydramnios, you should stop using this product. Both patients and doctors should be aware that when oligohydramnios occurs, the fetus has suffered irreversible damage.
Infants born to mothers who have used this product should be closely observed to see if they have hypotension, oliguria and hyperkalemia. Enalapril can pass through the placenta, peritoneal dialysis can remove it from the fetal blood circulation, in theory, it can be removed by exchange transfusion.
2. Nursing mothers
Enalapril and enalaprila (the hydrolysate of enalapril) are secreted in human milk. Nursing mothers should be cautious when using this product.
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