Agilosart-H 100/12.5 Agimexpharm Treatment Treatment (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Hydrochlorothiazide, Losartan Kali
Ingredient Agimexpharm

Ingredient

Thành phần cho 1 viên

Composition information	Content
Hydrochlorothiazid	12.5mg
Losartan Kali	100mg

Uses

indications

Agilosart - H drugs are indicated in the following cases:

Agilosart - H 100/12.5 is a combination of Losartan and hydrochlorothiazide (Losartan 100 mg/hydrochlorothiazide 12.5 mg) to treat hypertension in adults, especially cases of uncontrolled blood pressure with one drug. Agilosart - H 100/12.5 should be able to coordinate with another anti -hypertension drug.

ATC code: C09DA01.

Agilosart - H 100/12.5 has ingredients of two active ingredients Losartan and hydrochlorothiazid used together in the form of oral doses once a day to control high blood pressure. This effect is thought to be the result of the mutual support effects of both ingredients that help the drug have a synergistic effect in lowering blood pressure, reducing blood pressure better when using each separate ingredient.

Losartan is a specific and selective antagonist on Angiotensin II receptor while hydrochlorothiazid is a thiazid diuretic. Both drugs have an impact on blood pressure. The effectiveness of high blood pressure treatment is often higher when combining a small dose of thiazid diuretics such as hydrochlorothiazid with Angiotensin-II receptor antagonist.

Moreover, due to diuretic effects, hydrochlorothiazid increases plasma renin activity, increases aldosteron secretion, reduces serum potassium, and increases angiotensin II levels. Using Losartan will prevent all the physiological effects of Angiotensin II and through Aldosteron inhibitors may tend to reduce the loss of potassium associated with this diuretics.

So the use of Losartan and hydrochlorothiazid combines increases the effect of anti -blood pressure of the drug, this effect is maintained for 24 hours, so it only needs to take it once a day.

losartan:

Losartan is the first substance of the new anti -hypertension drug group, which is a receptor antagonist (Typ1) Angiotensin II.

angiotensin II, made up of angiotensin I in the reaction of the enzyme transferred Angiotensin (ACE) catalyzed, is a strong vascular contract; It is the main hormone that activates the Renin - Angiotensin system, and is an important component in the pathophysiology of hypertension. Angiotensin II also stimulates the adrenal glands of Aldosteron.

Losartan and main metabolites have a clogging and aldosteron secretion of angiotensin II by preventing Angiotensin II selective, not attached to the AT1 receptor contained in many tissues (for example, blood vessel muscles, adrenal glands). Both Losartan and the main active metabolites do not show the local dominant effect in the AT1 receptor and have a much larger AT1 receptor affinity (about 1,000 times) than the AT2 receptor. Losartan is a competitive, reversible inhibitor of the AT1 receptor. The metabolic substance has the activity of drugs 10 to 40 times stronger than Losartan, calculated by weight and is a non -competitive, reversible inhibitor of the AT1 receptor. Angiotensin II antagonists also have hemodynamic effects such as ACE inhibitors, but there is no unwanted effect of the common ACE inhibitors are dry cough.

hydrochlorothiazid:

hydrochlorothiazid is a drug in the group of thiazid diuretics that increases the secretion of sodium chloride and water attached by the mechanism of inhibiting the reabsorption of sodium and chlorine ions in the distance. The excretion of other electrolytes also increases, especially potassium and magnesi, and calcium decreases. Hydroclorothiazid also reduces the activity of the carbon dioxide, so it increases the excretion of bicarbonate but this effect is often weak compared to the effect of CL - and does not significantly change the urine pH. Thiazid diuretics may also reduce the filtration rate of the glomerular. Thiazids have a moderate diuretic effect, because about 90% of sodium ions have been reabsorbed before arriving in the distance is the main position of the drug.

hydrochlorothiazid has the effect of lowering blood pressure, firstly due to a decrease in plasma volume and extracellular fluids related to sodium urine. Then, during the use of the drug, the effect of lowering blood pressure depends on the decrease in peripheral resistance, through the gradual adaptation of blood vessels from the reduction of Na+concentration. Therefore, the hypotension effect of hydrochlorothiazid is shown slowly after 1-2 weeks, while the diuretic effect occurs quickly and can be seen right after a few hours. Hydrochlorothiazid increases the effects of other antihypertensive drugs.

pharmacokinetic

losartan:

After drinking, Losartan absorbs well and initially metabolized through the liver thanks to the cytochrom P450 enzymes (CYP2C9 and CYP3A4). Losartan's bioavailability is approximately 33%. About 14% of losartan dose taken into active metabolites, this substance is mostly opposing the Angiotensin II receptor resistance. Losartan waste sale time is about 2 hours, and of metabolites about 6-9 hours. The average peak concentration of Losartan reaches within 1 hour, and of the metabolites with activity within 3-4 hours.

both Losartan and active metabolites are bound to plasma proteins (> 98%), mainly albumin and they do not pass the blood -brain barrier. Losartan's distribution volume is about 34 liters and of metabolites with an activity of about 12 liters. The total clearance of Losartan's plasma is about 600 ml/ minute and of the active metabolites of 50 ml/ minute; Their clearance in the kidney corresponds to about 75ml/ min and 25ml/ min.

Losartan eliminates 35% by urine and about 60% in feces.

In patients with mild to medium cirrhosis, the area under the curve (AUC) of Losartan and of the metabolites has a higher activity, corresponding, 5 times and 2 times higher than in patients with normal liver. Losartan and E-3174 metabolites are not excluded when hemolysis.

hydrochlorothiazid:

After taken, hydrochlorothiazid is relatively fast, about 65 - 75% of the dose of use, but this ratio may decrease in heart failure people. Food can reduce the absorption of the drug. Hydrochlorothiazid accumulated in red blood cells. 40 - 68% of the drug is associated with plasma protein. The drug excreted mainly through the kidneys, mostly in the form of non -metabolic. The sale time of hydrochlorothiazide is about 9.5 - 13 hours, but may last in the case of renal failure, so the dose adjustments need to be adjusted. Hydrochlorothiazid passes through the placenta, distributed and reached high concentrations in the fetus.

Diuretelli effects appear after drinking 2 hours, reaching maximum after 4 hours and lasting about 12 hours.

Anti -hypertension effect is much slower than diuretic effects and can only achieve adequate effect after 2 weeks, even with the optimal dose between 12.5 - 25 mg/day. It is important to know that the anti -hypertension effect of hydrochlorothiazid is usually optimal at 12.5 mg. Modern clinical treatment and clinical trial guidelines emphasize the lowest and optimal use of doses, which reduces the risk of harmful effects. The important issue is to wait enough time to assess the body's response to the hypotension effect of hydrochlorothiazid, because the effect on the peripheral resistance takes time to be clear.

Before taking Agilosart-H 100/12.5 Agimexpharm Treatment Treatment (3 blisters x 10 tablets)

How to use

oral tablets. Take the tablet with a glass of water.

Take medicine once a day. Take medicine does not depend on meals because food only reduces the use of the drug.

Dosage

Adults:

Initial dose and maintenance dose: take 1 capsules once a day.

Do not use this drug in people who lose the volume of circulatory fluid (such as high doses of doses).

Do not recommend this drug for people with severe renal failure (creatinine clearance ≤ 30 ml/min) or liver failure.

No need to adjust the dose of this drug for the elderly. Do not use Losartan 100 mg/hydrochlorothiazid 12.5 mg is the starting dose for this patient group.

Children and teenagers (

Do not use Losartan/hydrochlorothiazide combination form for children and adolescents because they have not determined the safety and effectiveness of these drugs.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when using overdose?

Overdose:

Symptoms:

Extremely manifestations of Losartan: The most common expression of overdose is probably hypotension and tachycardia; It is also possible to experience a slow heart rate due to sympathetic nerve stimulation (vagus nerve).

Extremely manifestations of hydrochlorothiazid: The main manifestation is water and electrolyte disorders due to a lot of urinary tract. The most common signs and symptoms of overdose are nausea and drowsiness. If using digitalis, hypoglycemia increases arrhythmia.

Management:

There is no specific information about treatment when overdose of the drug in combination with losartan and hydrochlorothiazid. Treatment methods are symptomatic and support. Need to stop the drug immediately and carefully monitor patients. The proposed measures are vomiting or gastric lavage if they have just taken medicine; use activated carbon; Water compensation, electrolyte balance; Hepatic coma; Management of reducing blood pressure according to conventional processes. Elimination by hemorrhage is ineffective.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

Like all drugs, Agilosart - H drugs can cause side effects, but many people do not have or have few side effects. The adverse drug reaction is listed below in the order of gradually decreasing according to the frequency of appearance: Very common (≥ 1/10); Common (≥ 1/100 and

Do Losartan:

Most of the unwanted effects because Losartan is light and losing over time.

Common

cardiovascular: lower blood pressure, chest pain Back, leg pain, muscle pain.

Cardiovascular: Hypotenary pressure, chest pain, A - V degree II, chest drum, sinus pace, tachycardia, facial edema, blushing. Bruises, foreign rash. SEARCH, TRUNG, BOM Pain, muscle weakness, joint edema, muscle pain. throat.

Other effects: Sweating.

hydrochlorothiazid may cause excessive potassium loss. This effect depends on the dose and can be reduced when low doses (12.5 mg/day), the best dose for hypertension treatment, while minimizing harmful reactions. Diuretics also often causes hypoglycemia.

Common

Body: Fatigue, dizziness, dizziness, headache.

circulatory: Hypotenemably posture, arrhythmia. Blood.

Rare

Systemic body: Anaphylaxis, fever. Johnson. Tang. The posture of hypotension may occur when used with alcohol, anesthesia and sedative.

If you experience any side effects, including the above -mentioned side effects, especially there are signs of allergic reactions such as skin rash, swelling of the face, lips, tongue or throat or shortness of breath, difficulty swallowing to stop taking the medication and notify the doctor immediately.

Instructions on how to handle ADR:

Dose reduction or stopping when there are unwanted effects.

Excessive treatment of hypotension: Put the patient on your back, if the severe hypotension is necessary to infusion of the physiological saline solution to increase the volume of fluid.

Notify the physician with unwanted effects when using the drug.

Warnings

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

Contraindicated

Agilosart - H Contraindications in the following cases:

Hypersensitivity to Losartan, with thiazids and sulphonamid derivatives or any ingredients of the drug. mmol/liter or creatinine clearance coefficient ≤ 30 mmol/liter/minute.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Do Losartan:

It is necessary to monitor specially and/or reduce the dose in patients with dehydration, diuretics treatment and patients have other factors that can easily lead to hypotension. Patients with kidney stenosis on both sides or one side, only one kidney is also at high risk of unwanted effects (increased creatinin and blood urea) and should be closely monitored in treatment.

do hydrochlorothiazid:

Due to the drug ingredient with hydrochlorothiazid, the patient must be monitored in serum and urine periodically, especially patients using corticosteroids, acth or digitalis, quinidin (risk of ventricular torsion causing ventricular vibration); Patients with vomiting or infusion. of hydrochlorothiazid increases in patients after sympathetic nerve removal. Note when taking drugs in the elderly because it is easy to imbalance electrolytes.

This drug contains lactose: Patients with rare genetic problems about galactose intolerance, lapp lactase deficiency or glucose-galactose should not be used.

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

as well as other anti -hypertension drugs, so be careful if you use the drug while driving or operating machinery because the drug can cause headaches, dizziness, fatigue, especially when starting treatment or when increasing the dose.

Use drugs for women during pregnancy and lactation

pregnancy:

Contraindicated to use Agilosart - H for pregnant women. Using drugs directly on the Renin - Angiotensin system in the middle and the last three months of pregnancy can cause less amniotic fluid, hypotension, anuria, urinary discharge, face deformation and death in infants. Although, the use of drugs in the first three months of pregnancy has not seen the risk of the fetus, but after detecting pregnancy, the drug must be stopped as soon as possible.

breastfeeding period:

It is not known whether Losartan will be secreted into breast milk, but thiazid can be through breast milk. Because of the harmful effects for breastfeeding, it is necessary to decide or stop breastfeeding or stopping the drug, depending on the importance of using the drug with the mother.

Interactive drug

Interactive drugs with other drugs and other types of interactions:

With other anti -hypertension drugs: Agilosart - H's hypotension effects may be increased when used with other anti -hypertension drugs.

Medicines affecting potassium: The impact of potassium loss of hydrochlorothiazid is reduced due to the potassium retention effect of Losartan. However, this effect of hydrochlorothiazid on serum potassium is likely to occur when used in combination with other drugs that cause potassium loss and hypokalemia (for example, diuretic secretion of potassium urine, corticosteroid, acth, salbutamol, amphoticin). In contrast, when used with diuretics that keep potassium, potassium supplements, salt substitutes containing potassium or other potassium -causing drugs can increase serum potassium.

Lithi: Losartan increases serum lithium levels, in addition to lithium renal clearance reduced by thiazid. Should be cautious when shared lithium and Agilosart - H and carefully monitor serum lithium concentration.

Other information about Losartan's interaction:

Losartan does not affect the pharmacokinetics of Digoxin oral or intravenously. Losartan and of active metabolites. Hypoglycemia, lithium, diuretics keep potassium, rituximab.

Other information about interactions of hydrochlorothiazid: due to Agilosart - H contains hydrochlorothiazid of the thiazid diuretics group, it may occur when used with the following drugs:

Alcohol, barbiturat or addictive sleeping pills: Increasing potential of vertical hypotension. Can reduce the response to hypertension, but not enough to prevent use. So if used, you must monitor to see if the desired effect of diuretic. Thiazid diuretics, reducing the absorption of these drugs through the gastrointestinal tract. Thiazid.

The cavalry of the drug: due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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