Hapresval Plus 80/12.5 medicine for hypertension (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Valsartan, hydrochlorothiazid

Ingredient

Composition information	Content
Valsartan	80mg
Hydrochlorothiazid	12.5mg

Uses

indicated

Treatment of idiopathic hypertension in adults. Indications in case the patient does not achieve target blood pressure when treated with Valsartan or Hydrochorothiazid alone.

Pharmacology

Pharmacology classification: Hypertension treatment, Angiotensin II and diuretic groups.

ATC code: C09DA03.

Mechanism of action

valsartan:

Valsartan is an Angiotensin II type 1 receptor antagonist (AT1), not a precursor so the pharmacological effect of the drug does not depend on the hydrolysis reaction in the liver. The affinity of Angiotensin II on AT1 and AT2 receptors is similar, while Valsartan's affinity for the AT1 receptor is about 20,000 times stronger than the affinity of the AT2 receptor. AT1 receptor participates in most or all activities on the heart, kidneys and central nerves. Valsartan selectively inhibits Angiotensin II attached to the AT1 receptor in many different tissues, including blood vessel and adrenal glands, lowering blood pressure by opposing the effects caused by angiotensin II (vasoconstriction, increasing antosteron secretion, increasing catecholamine secretion in the adrenal gland and before the synap, releasing Arginin Vasopressin, causing water hypertension and causing water hypertrophy and water hypertrophy). Valsartan does not inhibit the breaking of Bradykinin, so it does not cause adverse reactions such as persistent dry cough, often occurs with angiotensin transferred enzyme inhibitors.

Hypotension effects about 2 hours after drinking, reaching maximum after 4-6 hours and maintaining the effect for 24 hours. When the dose is repeated, the anti -hypertension effect is clearly shown after 2 weeks, reaching a maximum after 4 weeks and maintained when long -term treatment. The base/vertex ratio of systolic blood pressure and diastolic blood pressure is 78% and 74%, showing that the drug can be used once a day in blood pressure control.

hydrochlorothiazid:

hydrochlorothiazid increases the excretion of sodium chloride and water due to the mechanism of inhibiting the reabsorption of sodium and chlorine ions in the distance, increasing the excretion of potassium, magnesium, bicarbonate ions and may also reduce glomerular filtration speed. Modified diuretic effect.

hydrochlorothiazid has the effect of lowering blood pressure, first due to a decrease in plasma volume and cellular fluid related to sodium cards, then during medication, hypotension effect depends on peripheral resistance, through gradual adaptation of blood vessels against the reduction of sodium ionic concentration. The diuretic effect can be seen after a few hours, and the hypotension effect is slow after 1-2 weeks. The anti -hypertension effect is usually optimal at 12.5 mg and can only achieve sufficient effect after 2 weeks.

In sieve tests, the impact of hypotension is limited by the potassium retention effects of Valsartan.

Dynamic pharmacokinetics

Products combined with valsartan and hydrochlorothiazid:

Hydrontothiazid's bioavailability drops about 30% when coordinated simultaneously with Valsartan, Valsartan's pharmacokinetics are not significantly affected. This interaction does not affect the effectiveness of Valsartan and hydrochlorothiazide combination preparations because of the clinical trials proving the effectiveness of the combined preparation compared to each separate substance or Placebo.

valsartan:

absorption:

Valsartan absorbs fast, the peak concentration in plasma is about 2-4 hours after drinking. Oral bioavailability is about 25%. Food reduces about 40% AUC and about 50% cmax but plasma concentrations after drinking 8 hours similar to each other whether patients are hungry or full. However, AUC decreases without reduced clinical effects. Valsartan's AUC and CMAX increases linear ratio with the dose in the clinical dose range.

Distribution:

Valsartan links about 94 - 97% with plasma proteins, mainly albumin.

Metabolism:

Valsartan is not significantly metabolized, only 20% of the dose found in the form of chemicals. Valeryl-4-Hydroxy Valsartan metabolites are not active in urine and feces. The enzyme has not been determined exactly, but it may not be through the Cyzrom P450 enzyme system.

Era:

Valsartan is eliminated in many phases (t1/2 alpha

hydrochlorothiazid:

absorption:

After taken, hydrochlorothiazid is relatively fast, about 65-75% dose, this ratio can be reduced in people with heart failure. Food can reduce drug absorption.

Distribution:

hydrochlorothiazid is linked 40 - 68% to plasma proteins; accumulated in red blood cells, through the placenta fence, distribution and high concentration in the fetus.

Metabolism:

Hydroclorothiazid is not metabolized.

Era:

hydrochlorothiazid excreted mainly through the kidneys in non -metabolic form. Selling duration of plasma from 9.5 - 13 hours but may last in the case of renal failure.

pharmacokinetics in some special clinical cases:

Elderly:

The AUC value of Valsartan increases slightly in the elderly, but there is no clinical significance. Some documents argue that the clearance of hydrochlorothiazid is reduced in both healthy elderly and hypertension when compared to young people.

Patients with renal failure:

With the recommended dose, no dose adjustment in patients with glomerular filtration speed (GFR) 30 - 70 ml/minute. There is no data that uses Valsartan and hydrochlorothiazid inoculants in patients with severe renal impairment (GFR Mobile pharmacokinetics test in patients with mild to moderate liver failure, the AUC value of Valsartan increases about twice, no research data in patients with severe liver failure. Liver disease does not affect the pharmacokinetics of hydrochlorothiazid.

Before taking Hapresval Plus 80/12.5 medicine for hypertension (10 blisters x 10 tablets)

How to use

take medicine with a glass of water, can use the drug before, during or after meals. Time to use the drug should be fixed every day, usually in the morning.

Do not arbitrarily change the dose or stop using the medication without the doctor's permission.

Hypertension is usually asymptomatic, patients still feel normal. Therefore, you need to follow your doctor's regular examination schedule even if you still feel healthy.

Dosage

Take the drug in accordance with the instructions of the doctor or pharmacist to achieve the best treatment effect and limit the risk of unwanted effects. Check with your doctor or pharmacist if you are not sure about how to take the drug.

The doctor will determine the exact number of drugs you should use, depending on your treatment.

The usual dose of Hapresval Plus is 1 tablet, used only once a day.

In case you have liver or kidney diseases, it is necessary to notify the doctor the doctor may need to adjust your dose.

Do not use Hapresval Plus in children under 18 years of age due to the safety and effectiveness of the drug has not been proven.

What to do when overdose?

Do not use the recommended overdose. In case of overdose, contact with a doctor or pharmacist. If you feel severe dizziness, should lie down and go to the nearest hospital.

What to do when forgetting a dose? If the time to remember is close to the time of taking the next dose, skip the willow forgotten and continue to take the next dose as usual. Do not take double the dose to compensate for the forgotten dose.

Side Effects

Like other drugs, Hapresval Plus can cause some unwanted effects, although not all patients encounter.

stop using the drug and see the doctor immediately if you experience the following unwanted effects:

swelling of the face, tongue, throat; Difficult to swallow, urticaria, shortness of breath. The desire is very dangerous when occurring or unknown frequency.

Uncommon (can affect 1-10 people in 1000 people): cough, hypotension, dizziness, dehydration (symptoms of thirst, dry mouth, dry tongue, irregular urine, black urine, dry skin), muscle pain, fatigue, tingling or numbness in the skin, look open, tinnitus.

Very rare (can affect less than 1 person in 100,000 people): dizziness, diarrhea, muscle pain.

Unknown frequency: Difficulty breathing, reducing urine amounts, reducing blood sodium levels (can cause fatigue, confusion, muscle shock or epilepsy in some serious cases).

Reducing the concentration of potassium in the blood (occasionally causing muscle weakness, muscle contraction, arrhythmia).

Reduces the number of leukemia in the blood (symptoms such as fever, skin infection, sore throat, mouth ulcer due to infection, weakness).

Increased blood bilirubin levels (in severe cases that can cause jaundice, eyes).

Increased concentration of urea nitrogen and creatinine in the blood (signs of renal function abnormalities).

Increased uric acid levels in the sample (in severe cases that can lead to gout).

fainting.

Some other unwanted effects are reported with preparations containing only valsartan or hydrochlorothiazid:

Valsartan

Uncommon (can affect 1 - 10 people in 1000 people): Dizziness, abdominal pain.

Unknown frequency: blistering skin (symptoms of water dermatitis), rash accompanied by symptoms of fever, muscle pain, joint pain, swelling of lymph nodes and/or symptoms like flu; The rash, the appearance of purple nodules on the skin, fever (symptoms of vasculitis), thrombocytopenia (causing bleeding or bruising); Increasing blood potassium concentration (can cause muscle contraction, arrhythmia), allergic reactions (rashes, itching, urticaria, shortness of breath, difficulty swallowing, dizziness), swelling in the face, throat, rash, itching, increasing liver function test results, reducing hemoglobin levels and red blood cell ratio in blood, in several severe chiefs that can cause anemia, nephrotic concentration in blood (can be fatal, fatal, organs. convulsions in some severe cases).

hydrochlorothiazid

Very common (can affect more than 1 person in 10 people): reduce potassium levels, increase blood lipid levels.

Common (can affect 1 - 10 people in 100 people): reduce sodium, magnesium level, increase uric acid levels in the blood, itchy rash and other skin rashes, reduce cravings, nausea, vomiting, dizziness, faint, erectile dysfunction.

Rare (can affect 1-10 of the 100,000 people): Skin is swollen or blistered (due to light sensitivity); Increasing calcium concentration, blood sugar levels, urinary glucose, aggravating diabetes, constipation, diarrhea, discomfort in the gastrointestinal tract, liver dysfunction, jaundice, yellow eye, arrhythmia, headache, sleep disorders, depression, reduced platelet levels (can cause bleeding and bruises under the skin), dizziness, visual sensation, visual disorders.

Very rare (can affect less than 1 of 100,000 people): Vascular inflammation (rash, burgundy nodules, fever); Hypersensitivity reactions (skin rash, itching, urticaria, shortness of breath, difficulty swallowing, dizziness), lupus erythematosus (rash on the face, joint pain, muscle disorders, fever); Pancreatitis (pain in the upper area of the stomach), shortness of breath accompanied by fever, cough, sneezing, shortness of breath (respiratory failure including pneumonia, pulmonary edema), hemolytic anemia (bruising skin, fatigue, shortness of breath, black urine), leukemia (fever, sore throat, mouth ulcer due to bacterial infection); Alkaline metabolism of chlorine (confusion, fatigue, muscle contraction, muscle vibration, rapid breathing).

Unknown frequency: Anemia is not regenerated (weak, easy to infect and bruises), severe reducing urine (may be a sign of kidney disorders or kidney failure); Diverse roses (rash, red skin, blistering lips, eyes, mouth peeling, fever); Muscle, fever, weakness.

Warnings

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

contraindicated

allergies to Valsartan, hydrochlorothiazid, sulfonamid derivatives or any ingredients of the preparation. bile (bile accumulated in the liver). Use medications containing Aliskinen.

Be cautious when using

In case you are using potassium supplements, potassium diuretics, potassium enhancement (heparin), the doctor needs to check the potassium level in your blood regularly.

Be cautious if you are suffering from heart failure or have had myocardial infarction. Follow the doctor's instructions at the beginning of treatment. Your doctor may need to check your kidney function regularly.

Do not recommend using Hapresval Plus if you are suffering from Aldosteron's disease. This is a disease that adrenal glands produce too much hormone aldosteron.

If you've ever been swollen with tongue and face caused by an allergic reaction (angioedema) when using other medications, it is necessary to notify your doctor. In case you encounter the above symptoms, stop using the drug immediately and not continue to use later.

The drug can cause the onset or worsen the erythema lupus (fever, rash, joint pain).

Need to notify your doctor if you feel pain or vision loss during the use of the drug. Symptoms may be caused by increased pressure in the eye that occurs several hours after using Hapresval Plus. This may cause permanent vision loss if not treated. The risk of increased problems if you have been allergic to penicillin or sulfonamid.

Using hypertension medications such as Aliskiren, Angiotensin enzyme inhibitors (Enalapril, Lisinopril, Ramipril, ...) especially in diabetes patients and have kidney problems. The doctor may periodically check the kidney function, blood pressure, concentration of electrolytes in the blood.

Hapresval Plus may cause light -sensitive reactions.

There is no recommendation to use Hapresval Plus in children under 18.

Hapresval Plus preparations contain lactose, not used if you are diagnosed with diseases in tolerance of some types of sugar (galactose, glucose, ...).

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

haheresval plus can cause dizziness, fatigue, although not everyone encounters. If happening with you, do not drive, operate machinery, work on high or other dangerous jobs that require alertness and concentration.

Use drugs for women during pregnancy and lactation

Pregnant women:

The doctor will ask you to stop using Hapresval Plus before you intend to get pregnant or as soon as you find you pregnant and switch to using other drugs more safely. Do not use Hapresval Plus in the early stages of pregnancy and do not use the drug if you are more than 3 months pregnant because it can cause serious harmful effects on the fetus (impaired renal function, less amniotic fluid, slow formation of skull) and newborn babies (kidney failure, hypotension, increase potassium concentration in blood), even can cause pregnancy.

Do not use Hapresval Plus in breastfeeding women. The doctor may replace other safer treatments if you still want to breastfeed, especially in mothers with babies who have just given birth or premature babies.

Interactive drug

Notice to the doctor or pharmacist the medications you are or have recently used, including non -prescribing drugs and medicinal herbs, because Hapresval Plus can affect the effects of other drugs and vice versa if used simultaneously. In some cases may need to change the dose, caution or stop using one of the combined drugs, especially for the following drugs:

Lithi (drugs for neurological diseases). G. These drugs may increase the impact of Hapresval Plus. Metformin) and insulin. heart). 3g.

tubocurarin. > Cholestyramin and Colestipol (medications to increase blood lipid concentration).

Storage

In a dry place, less than 30 ° C, avoid light
without using the drug after expiry of the expiry date is recorded on the drug box or blister.

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