Haepril 5mg Dai Bac medicine for hypertension, heart failure, myocardial infarction (4 blisters x 14 tablets)

Dosage form Box of 4 blisters x 14 tablets
Specifications Lisinopril

Ingredient

Composition information	Content
Lisinopril	5mg

Uses

Indications

Hypertension: Treatment of hypertension.

heart failure: Treatment of heart failure.

Acute myocardial infarction: Short -term treatment (6 weeks) in patients with stable hemodynamics within the first 24 hours in acute myocardial infarction.

Kidney complications of diabetes: treat kidney disease in patients with hypertension with type 2 diabetes and early kidney complications due to diabetes.

Pharmacokology

Therapy group: Angiotensin transfer inhibitors.

ATC code: c09A A03.

Lisinopril is an enamel inhibitor peptidyl dipeptidase. Lisinopril inhibits Angiotensin (ACE) - Angiotensin I conversion catalyst into vascular peptid is angiotensin II. Angiotensin I increases in a number of diseases such as heart failure and kidney disease, due to response to hypercase. Angiotesin II has the effect of stimulating myocardial growth, causing enlarged heart (myocardial hypertrophy), and vasoconstrictor effect, causing hypertension. Angiotensin II also stimulates aldosteron secretion from the adrenal shell. ACE inhibits reduces angiotensin II concentration, which leads to reduced vasoconstriction and reduction of aldosteron secretion, thus reducing sodium and water stasis, peripheral vessels, reducing peripheral resistance in both weekly and pulmonary circulation. The reduction in aldosteron may increase serum potassium levels.

While Lisinopril's mechanism of hypotension is thought mainly due to the inhibition of the Renin-Anotensin-Aldosteron system, Lisinopril still works to treat hypertension even in patients with hypertension with low levels of Renin. Ace is exactly like Kinase II, which is a dormant yeast. Bradykinin's increased concentration, a vasodilator peptid, plays a role in the therapeutic effect of Lisinopril or not is still a problem that needs to be clarified.

Dynamic pharmacokinetics

Lisinopril is a transgenic inhibitor without sulphydryl, oral use.

absorption

After a dose of lisinopril, the peak concentration of the serum is reached for 7 hours, although the drug tends to reach the blood concentration in the blood slower in patients with acute myocardial infarction. Based on the amount of drugs through the urinary tract, the average level of Lisinopril's absorption is about 25%, with the variation of each patient from 6-60% for research doses (5-80 mg). Absolute bioavailability decreases by about 16% in patients with heart failure. Food does not affect the absorption of Lisinopril.

Distribution

Lisinopril does not seem to be associated with plasma proteins other than angiotensin transfer enzymes in the blood (ACE). Mouse studies show that Lisinopril has less than a blood-flabby barrier.

Elimination

Lisinopril does not pass through metabolism and is excreted in the form of non -constant urine. In the restoration doses, Lisinopril has an effective half -life due to the accumulation of drugs of 12.6 hours. Lisinopril clearance coefficient in healthy people is about 50 ml/minute. The decreasing serum concentration shows a prolonged final stage without contributing to the accumulation of drugs. This final stage can be manifested by saturated connection with ACE and not proportional to the dose.

Patients with liver failure

Liver function damage in cirrhosis patients leads to reduction of Lisinopril absorption (about 30% as determined by urinary tract) but increasing the level and time of exposure to the drug (about 50%) compared to healthy people due to reduction of clearance.

Patients with renal failure

LisinoPril's lesions reduces lisinopril, which is secreted through the kidneys but this decrease is only clinically significant when glomerular filtration is less than 30 ml/min. In patients with mild to moderate renal impairment (Creatinine clearance of 30-80 ml/min), AUC averages only 13%, while in patients with severe renal impairment (Creatinin clearance 5-30 ml/min) AUC is recorded by 4.5 times.

Lisinopril can be eliminated through fertilizer. During 4 hours of hemolysis, lisinopril in plasma decreased by an average of about 60% with the clearance of the fertilizer of 40-55 ml/min.

Patients with heart failure

Patients with heart failure have a larger level of contact and time with Lisinopril than a healthy person (AUC increases an average of 125%), but if based on Lisinopril's quantity of drugs, absorption will decrease by about 16% compared to healthy people.

Children

Lisinopril's pharmacokinetic information is studied in 29 hypertension patients, from 6 to 16 years old, with GFR index of over 30 ml/min/1.73m2. After using the dose of 0.1-0.2 mg/kg, the peak concentration of plasma of Lisinopril reaches a stable state within 6 hours, and the level of absorption is based on the amount of recovery in the urine about 28%, these values are similar to the previous value in adults.

AUC and CMAX in children in this study were in accordance with the observed results in adults.

Elderly

Elderly patients with medication concentration in the blood and the value of the area under the curve representing the drug concentration in plasma over time will be higher than the young patient (an increase of about 60%).

Before taking Haepril 5mg Dai Bac medicine for hypertension, heart failure, myocardial infarction (4 blisters x 14 tablets)

How to use

Should take Lisinopril once a day.

Like other disposable drugs of the day, Lisinopril should be taken at the same time of the day. Food does not affect the absorption of Lisinopril tablets.

Dosage depends on the condition and responding to the blood pressure of each individual.

Dosage

Hypertension

Lisinopril can be used individually or in combination with other groups of drugs for hypertension.

Starting dose

In patients with hypertension, the starting dose is recommended by 10 mg. Patients with renin-ankiotensin-aldosteron systems (especially in patients with hypertension due to blood vessel disease, water deficiency and/or lack of salt, heart loss or severe hypertension) may have excessive hypotension after the starting dose. The starting dose of 2.5-5 mg should be used for these patients and the beginning of treatment should be monitored by a doctor. Need to start the starting dose lower when kidney failure (see Table 1 below).

Maintenance dose

The usual maintenance dose is 20 mg, only one daily oral oral. In general, if the desired treatment is not achieved after 2-4 weeks with certain treatments, the dose can be increased. The maximum dose used in long -term clinical trials is 80 mg/day.

Patients taking diuretics

Hypotension with symptoms may occur at the beginning of treatment with lisinopril. This is more likely to happen in patients being treated simultaneously with diuretics. Therefore be cautious because these patients may be dehydrated and/or salt. If possible, diuretics should be stopped 2-3 days before starting treatment with lisinopril. In patients with hypertension can not stop diuretics, lisinopril should be used at a starting dose of 5 mg. Kidney function should be monitored. The next dose of lisinopril should be adjusted depending on the response of blood pressure. If necessary, can continue to use diuretics.

Adjust the dose used in patients with renal failure

Dosage used in renal failure patients must be based on creatinine clearance as described in Table 1 below.

Table 1: Adjustable dose in patients with renal failure fertilizer) 2.5 mg* Pressure

used in children with high blood pressure from 6-16 years old

The recommended starting dose is 2.5 mg once daily in patients weighing from 20kg to

heart failure

In patients with symptoms, Lisinopril should be used as a support for diuretics and, when appropriate, with digitalis or beta blockers. Lisinopril can be used at a starting dose of 2.5 mg, 1 time/day and should be taken when the doctor monitors to determine the first effect of the drug on blood pressure. Lisinopril should be increased:

Each level does not exceed 10 mg. In patients with high risk of hypotension, for example, a patient lacks salt or no sodium hemorrhage, a patient reduces the volume of circulatory or the patient has been actively treated with diuretics, these disorders must be adjusted, if possible, before treatment with Lisinopril. Should monitor kidney function and serum potassium.

acute myocardial infarction

If necessary, patients should be treated with standard medications such as thrombolytic drugs, aspirin and beta blockers. Glyceryl trinitrate can be used in intravenous or cross -skin routes at the same time as lisinopril.

Initial dose (the first 3 days after myocardial infarction)

Lisinopril treatment may start within 24 hours from the onset of symptoms.

The treatment should not start if the systolic blood pressure is lower than 100mmHg. The starting dose of Lisinopril is 5 mg oral, followed by 5 mg after 24 hours, 10 mg after 48 hours and 10 mg once a day for the following days. Patients with low systolic blood pressure (≤ 120mmHg) at the beginning of treatment or within the first 3 days after the heart attack should take a lower doses of oral lower than 2.5 mg.

In patients with renal impairment (creatinine clearance

Maintenance dose

Maintenance dose is 10 mg, 1 time/day. If hypotension occurs (systolic blood pressure ≤ 100mmHg), daily maintenance dose 5 mg should be temporarily reduced to 2.5 mg if necessary. If prolonged hypotension occurs (systolic blood pressure is lower than 90mmHg for more than an hour), lisinopril should be discontinued.

Treatment should be continued for 6 weeks and then patients should be re -evaluated. Patients with symptoms of heart failure should continue to use Lisinopril.

Kidney complications of diabetes

Patients with hypertension with type 2 diabetes and early kidney complications due to diabetes, taking a dose of 10mg of lisinopril once a day, can increase to 20mg once a day, if necessary, to achieve diastolic blood pressure in the sitting position below 90mmg.

In patients with renal failure (creatinine clearance

Children

Information on the effectiveness and safety of lisinopril for children with high blood pressure> 6 years of age is limited, there is no information for other indications. Do not recommend using lisinopril for indications other than high blood pressure.

Do not recommend using lisinopril in children under 6 years old, or children with severe renal failure (GRF

Using drugs in the elderly

In clinical studies, no change is related to the age of patient in effectiveness and safety of the drug. However, when high age is accompanied by reduced kidney function, it is advisable to follow the guidance of Table 1 to determine the starting dose of Lisinopril. After that, the dosage should be adjusted depending on the response of the blood pressure.

used in kidney transplant patients

There is no experience in using lisinopril in new kidney transplant patients. Therefore, it is not recommended to use lisinopril in these patients.

What to do when using overdose?

interrogation of medical staff when using overdose.

What to do when you forget 1 dose? Do not double the dose after forgetting the drug once.

Side Effects

The following unwanted effects have been observed and recorded while taking Lisinopril and other enzyme inhibitors with the frequency of the following: Very common (≥10%), common (≥1/100, Blood disorders and lymphatic systems

Rare: reducing haemoglobin, reducing haematocrit.

Very rare: bone marrow failure, anemia, thrombocytopenia, leukopenia, neutropenia, granulocytosis, hemolytic anemia, lymph nodes, autoimmune diseases.

Metabolic and nutrition disorders

Very rare: hypoglycemia.

Nervous and mental disorders:

Common: dizziness, headache.

Less: Change of mood, paresthesia, dizziness, taste disorders, sleep disorders.

Rare: Mental confusion, smell disorders.

Unknown frequency: Symptoms of depression, fainting.

cardiovascular and blood vessel disorders:

Common: posture impact (including hypotension).

Uncommon: myocardial infarction or stroke, perhaps secondary caused by excessive hypotension in patients at high risk, brushing chest drums, tachycardia. Raynaud phenomenon.

respiratory disorders, chest and mediastinum:

Common

cough.

Rare: rhinitis.

Very rare: bronchospasm, sinusitis. Allergic alveoli/ pneumonia.

digestive disorders:

Common

: diarrhea, vomiting.

Less: nausea, abdominal pain and indigestion.

Rare: dry mouth.

Very rare: pancreatitis, angioedema in the intestine, liver or bile stagnation, jaundice and liver failure.

Skin and subcutaneous disorders:

Less: rash, itching.

Rare: urticaria, hair loss, psoriasis, hypersensitivity/ face edema, face edema on the face, limbs, lips, tongue, subjects and/ or larynx.

Very rare: sweating, Pemphigus disease, toxic epidermal necrosis, Stevens-Johnson syndrome, diverse roses, fake lymphoma on the skin.

Symptomatic complexes have been recorded and may include one or more symptoms: fever, vasculitis, muscle pain, joint pain/arthritis, antibody antibodies (ANA) positive, increased blood velocity (ESR), eosinophilia and leukopenia, rash, light sensitivity or other skin manifestations that occur.

kidney and urinary disorders:

Common: Kidney dysfunction.

Rare: Hemorrhage, acute renal failure.

Very rare: Dignt/ Urology.

endocrine disorders:

Rare: Inappropriate anti -diuretic hormone syndrome (SIADH).

Reproductive and mammary disorders:

Less: impotence.

Rare: female mammary glands.

General disorders and local status:

Rare: fatigue, weakness.

Test results:

Unexpected

: increased blood urea, serum creatinine, liver enzyme hyper enzyme, hyperkalemia.

Rare: Increasing serum bilirubin, hypoglycemia.

Safety data from clinical studies shows that Lisinopril is well tolerated in hypertension, and therefore safety information in this age group is equivalent to observing in adults.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

hypersensitivity to lisinopril, or any component of the drug or other enamel inhibitors (ACE).

History of angioedema due to the use of enzyme inhibitors.

genetic or idiopathic angioedema.

Pregnant women in three months between pregnancy and the last three months of pregnancy.

Contraindicated for Lisinopril with Aliskiren -containing drugs in diabetics or renal failure (GRF

Be cautious when using

Tell your doctor or pharmacist before taking Lisinopril if you have or have any medical condition, especially the following conditions:

Aortic stenosis, renal artery stenosis, mitral stenosis, hypertrophic cardiomyopathy.

The effect of the drug on the ability to drive and operate machinery

When driving or operating machinery, it should be noted that occasionally dizziness or fatigue may occur during treatment with Lisinopril.

Use drugs for women during pregnancy and lactation

Pregnant women:

You must notify your doctor if you are pregnant or likely to get pregnant. Doctors will often recommend lisinopril before pregnancy or immediately after knowing you are pregnant will advise you to take another medicine instead of lisinopril. Lisinopril is not recommended to be used during the first pregnancy, and is not taken for more than 3 months of pregnancy, as the drug can cause serious effects on the fetus if used after the third month of pregnancy.

breastfeeding women:

Please inform your doctor if you are breastfeeding. Lisinopril is not recommended for breastfeeding mothers, and your doctor can choose other treatments for you if you want to breastfeed, especially if your baby is an infant, or premature birth.

Medicinal interaction

Tell your doctor or pharmacist if you are or have just used any medicine, including herbal medicine, health food or supplements. The doctor may have to change the dose and/ or other caution: if you are taking Angiotensin II receptor inhibitors (ARB) or Aliskiren.

Tell your doctor if you are taking any of the following medications:

Diuretics (including potassium diuretics).

Other hypertension treatments. Used by injection. These drugs include Ephedrin, Pseudoephedrin and Salbutamol and can be found in some nasal catheter drugs, cure cure/colds and asthma medicine.

Storage

Store at temperatures below 30 ° C, in closed packaging, avoid moisture.

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