Lousartan medicine 50mg/12.5mg Atlantic treatment of hypertension (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Losartan Potassium, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Losartan Potassium | 50mg |
| Hydrochlorothiazide | 12.5mg |
Uses
indications
Lousartan drugs are indicated in the following cases:
Treatment of primary hypertension in patients without blood pressure is not controlled satisfactorily with losartan or single hydrochlorothiazid.
Pharmacokology
Losartan
Losartan is an angiotensin II receptor antagonist (Typt1) oral synthetic form. Angiotensin II, a strong vascular contraction agent, is the main active hormone of the Renin Angiotesin system and plays an important role in the pathophysiology of Augiotensin II hyperlemen associated with AT1 receptors in many tissues (such as blood vessel smooth muscles, adrenal glands, kidneys and heart), causing some important biological effects such as vasoconstriction and release Aldosteron.
Angiotensin II also stimulates smooth muscle cell proliferation. Losartan selects AT1 receptor. In In Vitro In Vivo, Losartan and the metabolism of carboxylic acid has pharmacological activity, without the effects of transportation, no inhibiting other hormone receptors or important cardiovascular channels. In addition, Losartan does not inhibit ACE (Kinase II), which is Bradykinin decomposition enzyme. Therefore, the drug does not increase the frequency of adverse reactions through Bradykinin intermediaries.
During the use of Losartan, the loss of negative effect of Angiotensin II on the Renin secretion reaction, increasing the lyin activity in plasma (Pra). Increasing pra leads to increased angiotensin II in plasma. Despite increased, anti -hypertension activity and inhibition of Aldosteron levels in plasma are still maintained, showing the effect of Angiotensin II collection.
After stopping using Losartan, Pra and Angiotensin II values return to the level before treatment within 3 days. Both Losartan and its main metabolites have a much stronger AT1 receptor than AT2. The active metabolic form is 10-40 times stronger than Losartan when compared by mass.
In a specific study designed to evaluate the cough ratio in patients treated with Losartan compared to patients with ACE inhibitors, the cough rate recorded in patients using Losartan and Hydrochlorothiazid is similar and significantly lower than in patients treated with ACE inhibitors. In addition, in a general analysis of 16 clinical trials of double blind over 4,131 patients, the cough rate is self -reported in patients treated with Losartan (3.1%) similar to the placebo patient (2.6%) or hydrochlorothiazide (4.1%), while this rate for ACE inhibitors is 8.8%.
In patients with hypertension without diabetes with proteinuria, using potassium Losartan significantly reduces proteinuria, albumin and IgG, Losartan maintains the speed of glomerular filtration and reduces glomerular filtration numbers. Typically, Losartan reduces uric acid levels in serum (usually
Losartan does not affect automatic reflexes and does not affect the norepinephrin in plasma. In patients with left ventricular failure, the dose levels of 25 mg and 50 mg Losartan gives positive effects on hemodynamics and nerve hormones, manifested by increasing heart index and reducing pulmonary capillary pressure, systemic vascular resistance, average body blood pressure, heart rate, reducing the level of aldosteron and norepinephrine during the circulation. The degree of hypotension associated with dosage in patients with heart failure.
hydrochlorothizide
hydrochlorothiazid is a thiazid diuretic. The anti -hypertension mechanism of thiazid diuretics has not been fully understood. Thiazids act on electrolyte reabsorption mechanisms in the renal tubules, directly increasing sodium and chlorine elimination in nearly equal amounts. The diuretic effect of hydrochlorothiazid reduces plasma volume, increases lenin activity in plasma and increases aldosteron secretion, resulting in increasing potassium and bicarbonate elimination through the urinary tract, reducing potassium in serum.
Renin - Aldosteron links are done through Angiotensin II intermediaries, so the simultaneous use of an Angiotensin II receptor antagonist tends to reverse potassium elimination caused by thiazid diuretics. After drinking, diuretic effects start within 2 hours, peak after about 4 hours and last 6 to 12 hours. Anti -hypertension effect lasts up to 24 hours.
Dynamic pharmacokinetics
absorption
losartan
After drinking, Losartan is well absorbed and first metabolized, forming an active carboxylic acid metabolism and other non -active metabolites. The bioavailability of the Losartan tablet form is about 33%. The average peak concentration of Losartan and the active metabolic form is achieved at 1 hour and 3 - 4 hours respectively from the time of use. Losartan concentration in plasma is not clinically affected when the drug is taken at a standard meal.
distribution
losartan
Both Losartan and active metabolic form have the ratio of binding with plasma proteins> 99%, mainly associated with albumin. The distribution of Losartan is 34 liters. Mouse studies show that Losartan rarely passes through the bloody barrier.
hydrochlorothiazide
hydrochlorothiazid overcame the placenta but cannot pass through the brain blood barrier and are secreted into breast milk.
transformation
losartan
About 14% of the losartan dose used by injection or oral oral is transformed into active metabolic form. After oral and injecting potassium Losartan, it is marked by 14C radioactive atoms, the radioactive activity circulates in plasma is mainly due to Losartan and the active metabolic form.
A very small amount of Losartan turns into an active metabolic form recorded in about 1% of patients participating in the research. In addition to the active metabolic form, non -active metabolites are also created, including two main substances formed from the Butyl cylylated hydroxylon reaction in the side circuit and a woman who is the product of the glucuronid complex process with N - 2 Tetrazol.
Elimination
losartan
Losartan's clearance and active metabolic form of plasma are 600 ml/min and 50 ml/min. Losartan clearance and metabolic activity via kidney are about 74 ml/min and 26 ml/min. When used by oral, about 4% of Losartan dose is eliminated in the form of unchanged urine and nearly 6% of the dose is excreted in the form of active metabolism.
losartan pharmacological and active metabolic form is linear with the dose levels up to 200 mg. After drinking, the Losartan concentration and the active metabolic form in the exponent plasma with the last selling time books are nearly 2 hours and 6 - 9 hours respectively. When using a dose of 100 mg, one day does not occur in the accumulation of Losartan or the type of metabolism is active in plasma.
Both secretion through bile and urine contribute to the elimination of Losartan and metabolites. After taking Losartan is marked with 14C radioactive atoms in humans, about 35% of radioactive activity is found in urine and 58% in feces.
hydrochlorothiazide
Hydroclorothiazid is not metabolized but quickly excreted through the kidneys.
Before taking Lousartan medicine 50mg/12.5mg Atlantic treatment of hypertension (6 blisters x 10 tablets)
How to use
can use Lousartan along with other anti -hypertension drugs. Take the Lousartan tablet with a cup of water. Can use Lousartan during or outside meals.
Dosage
Hypertension
Do not use losartan and hydrochlorothiazide such as the initial treatment, only used for patients with blood pressure that is not controlled adequately with Losartan or Hydrochlorothiazid alone. Dosage recommendations for each ingredient (Losartan and hydrochlorothiazide).
When appropriate, clinically, it is possible to consider changing from a monatlearty to a combination drug in patients with blood pressure that has not been controlled satisfactorily. The usual maintenance dose is 1 tablet of Lousartan 50 mg/12.5 mg (Losartan 50 mg/HCTZ 12.5 mg), 1 time.
For patients who do not respond satisfactorily with Lousartan 50 mg/12.5 mg, the dose can be increased to 1 tablet of Lousartan 100 mg/25 mg (Losartan 100 mg/HCTZ 25 mg), 1 time.
The maximum dose is 1 tablet Lousartan 100 mg/25 mg, once a day.
Normally, the anti -hypertension effect of the drug is achieved within 3 to 4 weeks after the beginning of treatment.
Lousartan 100/12.5 (Losartan 100 mg/HCTZ 12.5 mg) takes dose adjustments to patients who need to control more blood pressure.
Used for patients with renal failure and hemolysis
No initial dose adjustment for patients with average renal impairment (creatinine clearance from 30 - 50 ml/minute). It is not recommended to use losartan and hydrochlorothiazide tablets for patients with hemolysis. Do not use Lousartan/HCTZ tablets for patients with severe renal impairment (creatinine clearance
Used for patients with inner volume reduction
Need to adjust the volume and/or sodium loss before using Lousartan/HCTZ tablets.
Used for patients with liver failure
Contraindicated Lousartan/HCTZ for patients with severe hepatic impairment (see contraindications).
Used for elderly patients
Normally, there is no need to adjust the dose for elderly patients.
Used for children and teenagers (
Inexperienced in using drugs on patients who are children and teenagers. Therefore, it is not advisable to use losartan/hydrochlorothiazide for children and teenagers.
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 overdose? Symptomatic treatment should be treated and supported when overdose occurs, it is necessary to stop using Lousartan and the patient should be closely monitored. Suggested management measures include vomiting if new to medication and adjusting the imbalance of water, electrolytes, liver coma and hypotension.
losartan
There is no data on the overdose of Losartan in humans. The most common manifestation of the overdose of Losartan may be hypotension and tachycardia, slow heart rate that may appear due to sympathetic stimulation (vagus nerves). If symptomic hypotension occurs, supportive treatment should occur. Can not eliminate Losartan or metabolic form of activity from the circulation of blood decentralization.
hydrochlorothiazide
The most common signs and symptoms recorded are the result of power outages (hypotension, hypoglycemia, sodium -decreased blood chlorine) and dehydration due to excessive diuretic effects. If Digitalis is also used, hypotension can aggravate the arrhythmia. It is unclear the ability to eliminate hydrochlorothiazid from circulation thanks to hemolysis.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Lousartan you may experience unwanted effects (ADR).
losartan
Common, ADR> 1/100
Gastrointestinal disorders: abdominal pain, nausea, diarrhea, indigestion.
Uncommon, 1/1000 Heart disorders: hypotension, hypotension with vertical posture, sternum pain, angina, II atrial atrium, cerebral vascular accident, myocardial infarction, chest drum, arrhythmia, slow sinus rhythm, tachycardia, ventricular tachycardia, ventricular vibration. Digestive disorders: constipation, toothache, dry mouth, flatulence, gastritis, vomiting. Kidney and urinary disorders: Night, urination, urinary tract infections. Rare, ADR hydrochlorothiazide Common, ADR> 1/100 Uncommon, 1/1000 Vascular puppet: necrotic arteritis (vasculitis, skin vasculitis). Respiratory, chest and mediastinum disorders: respiratory failure, including interstitial and pulmonary pneumonia. Liver -bile disorders: jaundice in the liver, pancreatitis. Rare, ADR 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
Lousartan drugs contraindicated in the following cases:
Severe liver failure; bile stasis and bile congestion.
Severe renal failure (Creatinine clearance
Caution when using
Losartan
Tharma; Patients with a history of angioedema (swelling of the face, lips, throat and/or tongue) should be closely monitored (see unwanted effect).
Lagging blood pressure and decreased internal volume: Symptomatic hypotension, especially after the first dose, can occur in patients with a decrease in volume and/or sodium loss due to strong diuretic use, applying a diet that limits salt, diarrhea and vomiting. It is necessary to control these conditions before using Lousartan tablets.
Electrolyte imbalance: Electrolyte imbalance is common in patients with renal failure, with or no less according to diabetes and should be noted. Therefore, it is necessary to closely monitor potassium concentration in plasma and creatinine clearance; Especially in patients with heart failure and have creatinine clearance from 30 - 50 ml/min. It is not recommended to simultaneously use potassium diuretics, potassium supplements and salt -containing substances containing potassium along with losartan/hydrochlorothiazide.
Hepatic failure: Dynamic data shows that Losartan concentration in plasma increases significantly in cirrhosis patients, careful when using Lousartan for patients with a history of mild to moderate liver failure. There is no experience in using Losartan for patients with severe liver failure. Therefore, contraindicated Lousartan for patients with severe liver failure.
Renal failure: As a result of inhibiting the Renin - Angiotensin - Aldosteron system, renal function changes, including renal failure (especially in patients, renal function depends on the Renin - Angiotensin - Aldosteron system as patients with severe heart failure or suffering from kidney function disorders from before). Similarly, when using other drugs that affect the Renin - Angiotensin - Aldosteron system, blood urea and serum creatinine have also been recorded in patients with kidney stenosis on both sides or the nephrotic stenosis on the kidney, these renal function changes can recover when stopped treatment. Caution should be used when using Losartan for patients with kidney stenosis on both sides or the nest stenosis on the nephrotic kidney.
kidney transplantation: Inexperienced treatment for patients with kidney transplant.
primary Aldosteron: Patients with primary Aldosteron intense often do not respond to anti -hypertension drugs effected by inhibiting the Renin - Angiotensin system. Therefore, it is not recommended to use Lousartan tablets for these patients.
coronary artery disease and brain vascular disease: Like any anti -hypertension drug, excessive loss of blood pressure in patients with heart disease and cerebrovascular disease due to ischemia can lead to myocardial infarction or stroke.
Heart failure: Similarly, when using other drugs acting on the Renin - Angiotensin system, patients with heart failure have or without kidney failure may have the risk of severe blood pressure and kidney failure (usually acute).
Aortic stenosis and mitral valve, obstructive hypertrophy of myocardial disease: Similar to other vasodilators, it is necessary to be particularly cautious when using Lousartan for patients with aortic stenosis and mitral valve or congestion heart disease.
Racal factors: Similar to other angiotensin transferring inhibitors, Losartan and Angiotensin antagonists have a lesser blood pressure in black skin patients than other patients, possibly due to the majority of hypertension patients with lower renin pressure.
hydrochlorothiazide
Lagging of blood pressure and insomnia: Like all other anti -hypertension drugs, symptomic hypotension may occur in some patients. The signs of water or electrolyte imbalance should be monitored, such as fluid loss, hypoglyc sodium, alkaline contamination, hypoglycemia, reducing blood magnesium or hypokalemia may occur during diarrhea or vomiting. Periodically check the concentration of electrolytes in serum after appropriate time in these patients. The reduction of blood sodium due to diluted blood may occur patients with edema in hot weather.
Affects metabolism and endocrine: using thiazid diuretics may reduce glucose tolerance. Need to adjust the dose of anti -diabetic drugs including insulin. Potential diabetes can turn to manifestations during thiazid treatment.
Thiazids can reduce calcium excretion through urine and slightly increase serum calcium concentration in batches. Disclosure hypercalcemia may be a manifestation of hidden parathyroid gland. Thiazid should be stopped before performing the adjacent function tests.
Increasing cholesterol and triglyceride levels may be related to the use of thiazid diuretics.
Thiazid may promote hyperuricemia and/or gout in some patients. Because Losartan reduces uric acid, using Losartan in combination with hydrochlorothiazid reduces blood uric acid hypertrophy due to diuretics.
Hepatic failure: Caution should be used when using thiazids for patients with liver failure or progressive liver disease because drugs can cause cholestasis in the liver and due to changes in water and electrolytes can lead to liver coma. Contraindicated Lousartan for patients with severe liver failure.
Other reactions: In patients using thiazid, hypersensitivity reactions may occur whether or not the patient has a history of allergies or bronchial asthma. The aggravation or activation of the system of lupus erythematosus has been recorded when using thiazids.
Colonel: Lousartan tablets contain lactose. Patients with rare diseases are galactose intolerance, lapp - lactase deficiency or malposure - Galactose should not use this drug.
The ability to drive and operate machinery
has not conducted any research on the effect of drugs on driving and operating machinery, however, when driving or operating machinery, it should be noted that patients may experience dizziness or drowsiness when using anti -hypertension drugs, especially dividing or dosage.
Pregnancy
It is not recommended to use Angiotensin II receptor inhibitors (ARA) in the first three months of pregnancy. ARA contraindicated in the middle and final period of pregnancy, unless the continued use of ARA is considered necessary, the patient intends to be pregnant to switch to using other anti -hypertension drugs has been shown to be safe when used during pregnancy. When the patient is determined to be pregnant, it is necessary to stop using Ara immediately, and if appropriate, should start taking the replacement medication.
The period of breastfeeding
There is no information on the use of Lousartan during breastfeeding. Hydrochlorothiazid is secreted into milk. Therefore, it is not recommended to use Lousartan during breastfeeding and should consider using alternative drugs that have been shown to be safe when used during breastfeeding.
Drug interaction
Losartan
rifampicin and fluconazole have been recorded as reducing the activity metabolic concentration of Losartan. The clinical consequences of this interaction have not been evaluated. Similar to angiotensin II inhibitors or the effects of angiotensin II, simultaneous use of potassium diuretics (such as spironolacton, triamteren, amilorid), potassium supplements or salt substances containing potassium can increase potassium concentration in serum blood.
Therefore, these drugs should not be used together with Losartan. Like when using drugs that affect sodium elimination, lithium elimination may also decrease. Therefore, it is necessary to carefully monitor the lithium concentration in serum if the lithium salts are used simultaneously with angiotensin II receptor antagonists.
When using Angiotensin II antagonists simultaneously with NSAID (such as selective inhibitors of COX - 2, acetylsalicylic acid in anti -inflammatory dose and non -selective NSAIDs), anti -hypertension effects can be reduced. Concomitance Angiotensin II antagonistic drugs or diuretics along with NSAID can increase the risk of reducing kidney function including acute renal failure, and increases the concentration of potassium in serum, especially in patients with reduced renal function, caution when used in combination with these drugs, especially in elderly patients.
Patients should be added enough water and note the kidney function after starting to use these drugs and check periodically later. In some patients with reduced renal function being treated with nonsteroidal anti -inflammatory drugs, including cyclooxygenase -2 inhibitors, simultaneous use of Angiotensin II receptor antagonists can worsen the kidney function. These images can recover. Other drugs that cause hypotension such as 3 -round antidepressants, anti -psychotic drugs, baclofen, amifostin: using these drugs simultaneously with drugs that reduce blood pressure, whether this is the main or auxiliary effect, can increase the risk of hypotension.
hydrochlorothiazide
When used simultaneously, the following drugs can interact with thiazid diuretics:
Cholestyramin and Colestipol Resins: Hydrochlorothiazide absorption level may decrease in the presence of anion exchange resin. Adrenalin (like adrenalin): hydrochlorothiazid may reduce response to vascular amines but not to the point of stopping the drug. Treatment of gout (Probenecid, sulfinPyrazon and allopurinol): The adjustment of the dose of drugs that reduces uric acid may be necessary due to hydrochlorothiazid that is at risk for increased uric acid levels in serum. Probenecid or sulfinpyrazon may be increased. Simultaneous use with thiazid may increase the rate of hypersensitivity reactions to allopurinol. Cyclophosphamide, methotrexate): Thiazid can reduce the excretion of kidney cytetics and aggravate bone marrow inhibiting effects. cyclosporin: simultaneously using cyclosporin may increase the risk of hyperuricemia and gout complications of hydrochlorothiazid. Medications affected by serum potassium disorders: Periodically check the concentration of serum potassium and electrocardiogram (ECG) when Losartan/Hydrochlorothiazid is simultaneously used with drugs affected by serum potassium disorders (such as cardiac glycosides and anti -rhythmic drugs) and with drugs that cause ventilation (fast spanning) Hypotension is a factor that causes torsion phenomenon (ventricular tachycardia). Anti -arrhythmia IA (such as Quinidin, Hydroquinidin, Disopyramid). Some anti -psychotic drugs (such as thioridazin, chlopromazin, levomepromazin, trifluoperazin, cyamemazin, sulpid, sultoprid, amisulprid, rayprid, pimozidhugeddol, droperidol).
Storage
Storage below 30 ° C.
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