Rotalzon 50mg Atlantic medicine for hypertension (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Losartan

Ingredient

Composition information	Content
Losartan	50mg

Uses

Indications

Rotalzon 50 drugs are indicated in the following cases:

Treatment of hypertension: The drug is used alone or in combination with other antihypertensive drugs, including diuretics.

High blood pressure in patients with left ventricular hypertrophy: Rotalzon is indicated to reduce the risk of stroke in patients with hypertension with left ventricular hypertrophy.

Kidney disease in diabetes patients: Rotalzon is indicated for treating kidney disease due to diabetes in the case of serum and proteinuria (albuminuria ratio/creatinin> 300 mg/g) in diabetes patients with a history of high blood pressure. In these patients, Rotalzon reduces the incidence of kidney disease assessed by the serum creatinine index doubled or the final stage of kidney disease (must be feces or must be transplanted with kidney). 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 the main metabolites have a blockage of vasoa and aldosteron secretion of Angiotensin II by preventing Angiotensin II selective, not attached to the AT receptor in many tissues (for example, blood vessel muscle, adrenal glands). In many tissues, there is also AT2 receptor, but it is not clear whether this receptor is related to the cardiovascular air conditioner or not.

Both Losartan and the main active metabolites do not show the local dominant effects in the AT1 receptor and have a much larger AT1 receptor (about 1,000 times) than the AT2 receptor. Losartan is a competitive, reversible inhibitor of AT1 receptor.

The metabolites have 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.

pharmacokinetics

After drinking, Losartan absorbs well and initially metabolized through the liver thanks to the cytochrom P450 enzymes. Losartan's bioavailability is approximately 33%. About 14% of losartan dose taken into active metabolites, this substance is mostly opposing Angiotensin II receptor resistance. Half of Losartan's elimination for 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 the active metabolites are bound to plasma proteins, 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 75 ml/min and 25 ml/min.

After taking Losartan, 14C marks, collecting about 35% of the radioactive in the urine and about 60% in the 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.

Before taking Rotalzon 50mg Atlantic medicine for hypertension (6 blisters x 10 tablets)

How to use

Rotalzon 50 can be taken or not with food, drinking with other anti -blood pressure drugs.

Dosage

Hypertension

The starting and maintenance dose is 50 mg/time/day for most patients. The maximum hypotension effect is achieved after the beginning of treatment is 3-6 weeks. Some patients may see more obvious effects with a dose increasing to 100 mg/time/day.

For patients with reduced circulatory volume (as those treated with high doses of dosage), the starting dose is recommended as 25 mg/time/day.

There is no need to adjust the dose for elderly patients or patients with renal impairment, including those who are being fecal. However, for patients with a history of liver failure, the dose is needed. Reducing the risk of cardiovascular disease and cardiovascular death rate in patients with high blood pressure of left ventricular hypertrophy, the starting dose is 50 mg, 1 time/day.

Should use a low -dose hydrochlorothiazide and/or or increase the dose of 100 mg, 1 time/day based on blood pressure response. With the protection of kidney function in type 2 diabetics with proteinuria, the initial dose is 50 mg, 1 time/day. This dose may increase to 100 mg, 1 time/day based on blood pressure response.

Rotalzon can be used with some other antihypertensive drugs such as diuretics, calcium channel blockers, alpha or beta inhibitors, and some central impact drugs.

The drug can be used with insulin and other common hypoglycemic drugs such as sulfonylurea, glitazone, glucosidase inhibitor.

Use drugs for children

Losartan's hypotension has been established in children with high blood pressure from> 1 month to 16 years old. The use of drugs with this object is proved by evidence of full research and strict control in young children and in adults, as well as have adequate documents about children.

Losartan pharmacokinetics are conducted research on 50 children, from> 1 month to under 16 years old at a dose once a day with a dose of 0.54 to 0.77 mg/kg of weight (meaningful dose).

Active metabolites are also formed in any age group. The pharmacokinetics of Losartan and metabolites are active as the same and in accordance with the researched data in adults.

For patients who have the ability to swallow pills, the dose is 25 mg, once/day with weight from> 20 to

For patients over 50 kg, the starting dose is 50 mg, 1 time/day. The maximum increasing dose is 100 mg, 1 time/day.

Used in the elderly

In clinical studies, there is no difference between age and safety and effectiveness of the drug.

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? These signs may be due to sympathetic stimulation. If there are signs of hypotension, timely measures are required. The method of hematoma can remove losartan and active metabolites.

What to do when forgetting 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 dose to compensate for missed dose.

Side Effects

When using Rotalzon 50, you may experience unwanted effects (ADR).

Losartan is well tolerated in controlled clinical studies in patients with high blood pressure with left ventricular hypertrophy. Side effects related to drugs are largely: dizziness, dizziness, weakness/fatigue.

The drug is also well tolerated in patients with diabetes Type 2 with proteinuria. Side effects are often weak/fatigue, dizziness, hypotension, hyperkalemia.

Hypersensitivity reactions: Hypersensitivity reactions, veins include larynx edema, subjects cause airway obstruction and/or face edema, swelling of lips, larynx and/or swollen tongue. These signs are rare in patients treated with Losartan, some of these have been edema when treated with other transferred inhibitors.

Dermatitis includes Henoch-Schoenlein bleeding very rare.

Digestive system: Hepatitis (rare), poor liver function.

Hematology: Anemia, thrombocytopenia (rare).

Bone muscle: muscle inflammation, arthritis.

Nervous/mental system: migraine.

Respiratory: cough.

Dermatology: urticaria, itching.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Rotalzon 50 drugs are contraindicated in cases of patients sensitive to any component of the drug.

Be cautious when using

sensitivity: eagle.

Low blood pressure, imbalance of fluid and electrolytes: In patients with decreased volume of circulatory volume like patients who are taking diuretics, in patients with signs of lowering blood pressure. Need to adjust the dose or reduce the initial dose with the above cases.

Liver functional impairment: Based on pharmacological research data, indicates that Losartan's plasma concentration increases significantly in cirrhosis patients, the decrease in the dose should be considered with patients with poor liver function history.

Renal functional impairment: The result of inhibiting the Renin-Anotensin system has changed the kidney function, including the impaired renal function also reported in some sensitive individuals. This function change can recover when stopping the treatment of other drugs that affect the renin-angiotensin system that may increase blood urea, serum creatinine in patients with kidney stenosis on both sides or on one side of the kidney. The same impact occurs with rotalzon. These changes can recover when stopping treatment.

The ability to drive and operate machinery

Do not drive or operate machinery when taking the drug because the drug can cause dizziness, dizziness, dizziness.

Pregnancy

The drug directly affects the renin-angiotensin system, so when indicated for pregnant women, they can cause death or pathogens to the fetus and newborn babies. According to some documents in the world, there have been reports on these impacts on many cases when taking Angiotensin transferred enzyme inhibitors.

If you find pregnancy, Losartan is detected as soon as possible. Due to the direct impact on the Renin-Anotensin system during the period 2 and 3 of pregnancy, which is associated with fetal and infant damage, including: low blood pressure, reducing infant brain, urinary retention, reduced renal rehabilitation or non-recovery, death. There are also reports on amniotic fluids that can occur, probably because the kidney function of the fetus is impaired, the amniotic fluid is also associated with spasticity, face deformation, and lung reduction. The fetal retardation in the uterus, the artery stenosis also records the report, although it is unclear whether these effects are caused by the exposure of the drug or not only this harmful reaction does not seem to be due to the exposure of the uterus in the uterus because it is limited in the first 3 months of pregnancy.

In the second and 3rd phase of pregnancy, the drug directly acting on the renin-analiotensin system may cause damage to the development of the fetus that can even cause death. If pregnant is detected, it is necessary to stop using Losartan immediately. Although there is no experience in using drugs with pregnant women, but through animal research shows that the drug can be fatal or damaged for the fetus and babies, the mechanism of action is thought to be intermediate impact through the impact of the renin-anidensin system.

Breastfeeding period

There is no evidence that the drug is excreted in milk. Because many drugs are likely to excrete in milk and the risk of harmful reactions to breastfed babies, stop taking the drug, or stop breastfeeding. Need to consider the benefits, harmful effects of the drug and the risk to the mother.

Drug interaction

There is no clinical interaction that has been recorded with Hydrochlorthiazide, Digoxin, Warfarin, Cimetidin, Phenobarbital, Ketoconazole, Erythromycin.

rifampin and fluconazole: There are reports showing a decrease in concentration of activated metabolites. The clinical consequences of these drug interactions have not been evaluated. Need to monitor patients and/or adjust the dose of the drug.

Ace Ingreign inhibitors: Losartan is not a transferred inhibitor but the effect is similar to these drugs. Used in combination with medications inhibited groups can increase blood potassium, kidney failure or more dangerous can cause low blood pressure. Should be cautious when used combined.

Diuretics: Using Losartan in combination with diuretics can reduce excessive blood pressure, often occurs when starting treatment with Losartan. It is necessary to reduce the dose of the drug, start treatment with Losartan at low doses and/or carefully monitor during the medication.

Potassium diuretics: concurrent with Losartan may increase blood potassium concentration. Should be cautious when used combined.

Lithium: simultaneously using lithium with losartan can increase the level of lithium in the blood. The patient should be monitored and regularly checks the blood lithium concentration.

Non-Stose anti-inflammatory drugs: Non-steroid anti-inflammatory drugs including Cycloxygenase-2 (COX-2) inhibitors can reduce the effects of diuretics and other antihypertensive drugs. Therefore, the hypotension of antagonistic antagonists Angiotensin II may be reduced by the effects of NSAIDs including COX-2. In some patients with damaged kidney function being treated with non-steroid anti-inflammatory drugs, COX-2, simultaneous indications with antagonistic antagonists Angiotensin II can cause impaired renal function. All this effect can recover.

Storage

less than 30 ° C. To be out of the reach of children.

Expiry date: 36 months from the date of manufacture. Do not use expired drugs.

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