Losartan Plus HCT 50/12.5 Savi Pharm treat hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Losartan Kali, hydrochlorothiazid
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Losartan Kali | 50mg |
| Hydrochlorothiazid | 12.5mg |
Uses
Indication
Savi Losartan Plus HCT 50/12.5 is indicated in the following cases:
Losartan is a receptor antagonist (Type AT1) 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 Aldosterone.
Losartan and main metabolites have a clogging and aldosterone secretion of angiotensin II by preventing Angiotensin II selective, not attached to the AT1 receptor in many tissues (for example, blood vessel muscles, adrenal glands). 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 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.
hydrochlorothiazide
hydrochlorothiazid and thiazide diuretics increase the secretion of sodium chloride and water attached to the mechanism of inhibiting the reabsorption of sodium and chloride ions in the distance. The excretion of other electrolytes also increases, especially potassium and magnesi, and calcium decreases.
hydrochlorothiazid also reduces the carbon dioxide activity, so it increases the secretion of bicarbonate. However, this effect is usually small compared to the effect of secretion of Cl- and does not significantly change the urine pH. Thiazide has 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.
Pharmacokinetics
absorption
After drinking, Losartan absorbs well and initially metabolizes the liver thanks to the cytochrom P450 enzymes. Losartan's biology is approximately 33%.
hydrochlorothiazid after drinking is relatively fast, about 65-75% of the dose of use, but this ratio can decrease in heart failure.
Distribution
Losartan and active metabolites are highly linked to plasma proteins, mainly albumin and they do not pass the bloodstream barrier. The distribution of Losartan is about 34 liters and of the metabolites with an activity of about 12 liters.
hydrochlorothiazid accumulated in red blood cells. Hydrochlorothiazid passes through the placenta but does not pass through the brain blood, distributed and reached high concentrations in the fetus.
Metabolism
About 14% of the dose of losartan oral transformed into active metabolites, this substance is mostly antagonist Angiotensin II.
Elimination
The half -life of Losartan elimination is about 2 hours, and of the metabolite for about 6-9 hours. The average peak concentration of Losartan reaches within 1 hour, and of the metabolites with activity within 3-4 hours.Losartan's total plasma clearance in 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.
hydrochlorothiazide excreted mainly through the kidneys, mostly in the form of non -metabolic. Half -life of hydrochlorothiazide is about 9.5 - 13 hours, but may last in the case of renal failure, so the dose adjustment is needed. At least 61% of oral doses are eliminated without changing within 24 hours. The diuretic effect appears after drinking 2 hours, reaching maximum after 4 hours and lasts 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. The anti -hypertension effect of hydrochlorothiazid is usually optimal at 12.5 mg.
Before taking Losartan Plus HCT 50/12.5 Savi Pharm treat hypertension (3 blisters x 10 tablets)
How to use
oral medication, can be taken with or not with food.
Dosage
Treatment of hypertension
Need to adjust the dose according to the response of each individual.
The usual starting dose of Losartan is 50 mg/day/day.Dosage recommended 25 mg for patients with intravascular volume decline (for example, patients treated with diuretics) and patients with a history of liver failure.
Losartan can be used once or 2 times/day with a daily daily dose from 25 mg to 100 mg. If the lowering effect is measured at the bottom area when using the dosage once a day is not enough, it is necessary to switch to 2 times/day with the same daily dose or the dose can be increased.
Hydroclorothiazid is effective at 12.5 mg to 50 mg/time/day and can be used 12.5 to 25 mg as a combination of L+HCT.
To minimize the independent side effects, the most appropriate is usually the beginning of treatment only for the patient after failing to achieve the desired effect with the monotherapy.
Alternative therapy
Dosage adjustment by clinical effect:
Patients with non -complete blood pressure with single -therapeutic Losartan or Hydrochlorothiazide can be transferred to a combination of L+HCT 50/12.5 (Losartan Kali 50 mg/ hydrochlorothiazide 12.5 mg) once a day. If the blood pressure is still not controlled after about 3 weeks of treatment, the dose may be increased to two tablets combining L+HCT 50/12.5 once a day.
Patients with uncontrolled blood pressure with a 100 mg Losartan therapy can be transferred to a combination of L+HCT 100/12.5 once a day. If the blood pressure is still not controlled after about 3 weeks of treatment, the dose may be increased to two tablets combining L+HCT 50/12.5 once a day.
Patients with blood pressure are controlled inadequate with 25 mg hydrochlorothiazid once a day or controlled but hypokalemia with this mode can be transferred to a combination of L+HCT 50/12.5 (Losartan 50 mg/hydrochlorothiazid 12.5 mg) once a day, reducing the dose of hydrochlorothiazid without reducing the overall decrease of the overall pressure of blood pressure. After that, it is advisable to re -evaluate the clinical response to the combination of L+HCT 50/12.5 and if the blood pressure is still not controlled after about 3 weeks of treatment, the dose can be increased to two tablets combining 50/12.5 once a day.
The usual dose of the tablet combined with L+HCT 50/12.5 is once a day. Do not use more than two tablets combining L+HCT 50/12.5 once a day.
The maximum hypotension effect is about 3 weeks after the beginning of treatment.
Used in patients with renal failure
The common regimens for treatment with L+HCT combination may be applied to patients with creatinine clearance> 30 ml/ min. In patients with severe renal impairment, diuretics are preferred than Thiazide, so it should not be used in combination with L+HCT.
Patients with liver failure
The combination of L+HCT is not recommended for adjusting the dose in patients with liver failure because the initial starting dose is suitable for Losartan cannot be 25 mg.
Treatment of severe blood pressure
The starting dose of the combination of L+HCT to start the treatment of severe blood pressure is a combination of L+HCT 50/12.5 once a day.
For patients who do not fully respond to L+HCT 50/12.5 after 2 to 4 weeks of treatment, the dosage can be increased to two tablets combining L+HCT 50/12.5 once a day. The maximum dose is two combinations of L+HCT 50/12.5 once a day.
The combination of L+HCT is not recommended for the starting treatment in patients with liver failure because the appropriate starting dose of Losartan cannot be 25 mg.
recommendations: Do not be used as an initial therapy in patients with intravascular volume impairment (for example, patients treated with diuretics).
Treatment of patients with high blood pressure with left ventricular hypertrophy
Treatment should be started with Losartan Kali 50 mg once a day. If reducing blood pressure is not enough, taking added hydrochlorothiazid 12.5 mg or replaced with a combination of L+HCT 50/12.5.
If you need to reduce blood pressure, use Losartan Kali 100 mg and hydrochlorothiazid 12.5 mg or can be replaced by a combination of L+HCT 100/12.5, followed by 100 mg of Losartan potassium and hydrochlorothiazide 25 mg or combination of L+HCT 100/25. To continue lowering blood pressure, other hypotension can be used.
Children
Safety and effectiveness of tablets combining L+HCT in children has not been set up.
Elderly
There is no overall difference in effectiveness observed between older patients and young patients. The more common side effects in the elderly than young patients when taking Losartan + Hydrochlorothiazide and compared to the verification team.
Race
Life research does not provide evidence that Losartan's benefits when reducing the risk of cardiovascular events in hypertension patients with left ventricular hypertrophy are applied to black skin patients.
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?
Data of overdose is limited in humans.
Extremely manifestations: Hypotension, fast or slow heart rate.
Supporting treatment: Losartan and metabolites are not eliminated by hemolysis.
hydrochlorothiazide
Signs of overdose are usually an electrolyte impairment such as hypokalemia, hypoglycemic chloride, hypoglyc sodium, dehydration due to excessive diuretic. If used simultaneously with digitalis, hypotension may worsen the arrhythmia. It has not yet been proven to remove hydrochlorothiazid by hemolysis.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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
Common, ADR> 1/100
Central nervous system: insomnia, dizziness.
Uncommon, 1/1000 Central nerve: anxiety, loss of air conditioning, confusion, severe, migraine, sleep disorders, dizziness. Genital: helpless, sexual reduction, urination, night urine. Neuropathy: Perception, tremor, bone pain, muscle weakness, joints. ears: tinnitus. Other: sweating. Not determined frequency 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
Contraindicated
Savi Losartan Plus HCT 50/12.5 contraindications in the following cases:
Caution when using
The ratio of fetal/infants suffer from disease and death
Medicines that have a direct impact on the renin-analiotensin system can be fatal to the fetus and child emulsion when used for pregnant women. When detected pregnancy, it is advisable to stop using L+HCT as soon as possible. The use of drugs that has a direct impact on the Renin-Anotensin system in the second and third 3 months of pregnancy is associated with fetal and infant damage, including hypotension, reducing infant, anchuria, recovery or non-recovery and death.
Innocent has also been reported, perhaps due to reduced kidney function of the fetus. Increasing amniotic fluid in this case is associated with fetal limbs shrinkage, face deformity and lungs reduced production. Premature, underdeveloped in the uterus and arterioscleros have also been reported, although it is unclear whether the above incidents are related to exposure to the drug.
Thiazide passes through the placenta and appears in the umbilical cord blood. There is a risk of fetal or jaundice, thrombocytopenia and may have other adverse reactions that occur in adulthood.
Hematoplasty - Patients exhausted epidemic
In patients with exhausted fluid in the vessel (for example, people who are treated with diuretics), may occur with symptoms after starting treatment with a combination of L+HCT. This condition needs to be adjusted before using L+HCT.
Patients with liver failure
Losartan Kali -Hydrochorothiazide: L+HCT combination is not recommended for patients with liver failure - those who require dose adjustment with Losartan potassium. Starting with low -dose Losartan is recommended for patients with liver failure, so it cannot be used with a combination of L+HCT 50/12.5.
hydrochlorothiazid: Thiazide must be used cautiously in patients with liver failure or progressive liver disease, because when a small change in fluid and electrolyte balance can promote liver coma.
Hypersensitivity reaction
Hypersensitivity reaction to hydrochlorothiazid may occur in patients with or without a history of allergies or bronchial asthma, but there is more likely to occur in patients with the aforementioned history.
Red lupus body
Thiazide diuretics have been reported, causing more severe condition or activating the whole body lupus.
Interaction with lithium
Lithium is often not used with Thiazide.
acute myopia and glaucoma of secondary closing angle (glaucoma)
hydrochlorothiazid, a sulfonamide that can cause its own specific reaction, leading to transient myopia and closed angle -enhancer glaucoma. Symptoms include an acute onset of vision loss or blurring of images and usually occur within hours to a few weeks when starting to take the drug. The angle hypertrophy of the angle if left untreated can lead to permanent vision loss.
The main treatment is to stop hydrochlorothiazid as quickly as possible. Suggestions for treatment or surgery may need to be considered if the intraocular pressure is still uncontrolled. Risk factors for developing an angle of glaucoma may include a history of sulfonamide or penicillin allergy.
Caution: Hypersensitivity, eagown
All patients treated with Thiazide should be monitored with clinical signs of mitosis or insomnia of electrolytes: hypoglyc sodium, alkali infection decreased chloride-hypochloremic and hypotension. Determining the electrolyte in serum and urine is especially important when the patient vomits excessively or receives the injection. If the renal failure progresses clearly, it is necessary to consider reducing the dose or not to continue treating with diuretics.
Thiazide has been shown to increase the secretion of urine magnesium, which can lead to hypomagnesemia. Thiazide can reduce calcium secretion in urine. Thiazide can cause continuous and mild hypertopic growth in the absence of calcium metabolic disorders.
The ability to drive and operate machinery
Because the drug has side effects such as stunning, lowering blood pressure, it must be very cautious when taking the drug for the driver and operating machinery.
Pregnancy
Use drugs that work directly on the renin system -. Angiotensin in the middle and last three months of pregnancy can cause less amniotic fluid, lower blood pressure, anuria, urinary discharge, face deformation and death in newborns. Although the use of drugs only in the first three months of pregnancy has not seen the risk of the fetus, but after detecting pregnancy, it is necessary to stop Losartan as soon as possible and must report it during pregnancy to the doctor.
There are many notifications proving, thiazide diuretics (as well as strap diuretics) are even through the placenta into the fetus, causing electrolytes, thrombocytopenia and jaundice in infants. So do not use this group of drugs in the last 3 months of pregnancy.
The period of breastfeeding
It is not known whether Losartan will be secreted into breast milk or not, but there are significant amounts of Losartan and metabolites whether the drug's activity in mouse milk. Due to harmful potential for breastfeeding, deciding to stop breastfeeding or stopping the drug, taking into account the importance of the drug for the mother.
thiazide (hydrochlorothiazid) goes into breast milk with the amount that can be harmful to the child and inhibit milk secretion. Therefore, it is necessary to consider not using medication or stop breastfeeding, depending on the degree of need for the drug for the mother.
Drug interaction
Losartan Potassium
There is no significant drug interaction about pharmacokinetics found in interactive studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital.
Losartan, treated for 12 days, does not affect pharmacokinetics or pharmacokinetic force of a single dose of Warfarin.
Rifampin reduces the concentration of Losartan potassium and its active metabolites.
Fluconazole reduces about 40% of the AUC of active metabolites, but increases the AUC of Losartan by about 70% after taking many doses.
The conversion of Losartan into active metabolites after intravenous injection is not affected by ketoconazole, an enamel inhibitor P450 3A4.
Take Losartan along with Cimetidine increases the area under the curve (AUC) of Losartan by about 18%, but does not affect the pharmacokinetics of the active metabolites of Losartan.
Take Losartan along with Phenobarbital reduces about 20% of Losartan's AUC and of active metabolites.
Similar to Angiotensin II inhibitors, simultaneous use with potassium diuretics (for example, Spironolactone, Triamterene, Amiloride), Potassium supplements or alternative salt containing potassium can lead to hyperboly serum.
lithium
Similar to other drugs that affect the excretion of sodium, which can reduce lithium secretion. Therefore, the lithium concentration in serum must be carefully monitored when the lithium salt is used simultaneously with Angiotensin II receptor resistant drugs.
Non-steroid anti-inflammatory drugs (NSAIDs) include COX-2 selective inhibitors
Patients who are tall, exhausted (including the above diuretics) or have damaged kidney function: simultaneous use of NSAIDs including selective inhibitors of COX-2 with Angiotensin II receptor antagonistic drugs (including Losartan) that can lead to impaired renal function, including acute renal impairment. These effects often recover.
Periodic kidney function should be checked for patients with Losartan Kali and NSAIDs treatment. The hypotension effect of Angiotensin II receptor antagonists, including Losartan, can impair the effects of NSAIDs, including COX-2 selective inhibitors.
Double blockade of the renin-Anotensin-aldosterone system
There have been reports in documents on patients with atherosclerosis, heart failure, or diabetes that have nerves damage (end organ damage), double blockade of the Renin-Anotensin-aldosterone system is related to a higher frequency of lowering blood pressure, fainting, increased blood potassium and changes in kidney function (including acute impact). Renin-Anotensin-aldosterone.
Dual blockade (for example, by adding an ACE inhibitor to Angiotensin II receptor counterfeiting), which must be limited to cases that need to be determined individually, accompanied by strict monitoring of kidney function.
hydrochlorothiazide
Alcohol, barbiturate or addictive sleeping pills: Increases the likelihood of hypotension.
Diabetes treatment (oral and insulin): The dose should be adjusted due to hyperglycemia.
Other hypotension drugs: have a synergistic effect or increase the ability to lower blood pressure.
corticosteroid, acth or glycyrrhizine (in licorice): causes exhaustion of electrolytes, especially hypokalemia.
Norepinephrine: may reduce the response to hypertension, but not enough to prevent them from using them.
Non -polarized muscle relaxants (such as tubocurarine): may increase response to non -polarized muscle relaxants.
lithium
Do not use with diuretics, because of reducing lithium clearance in the kidneys and increasing the toxicity of this substance. Refer to products that contain lithium before using the above preparations with L+HCT combination.
Non-steroid anti-inflammatory drugs (NSAID) include COX-2 selective inhibitors
can reduce diuretic effects, increase sodium secretion and lower blood pressure effects of diuretics, keep potassium and thiazide in some patients.
In patients with diuretics, simultaneously use NSAIDs with angiotensin receptor blockers, including potassium losartan, which can lead to impaired renal function, including acute renal failure. These effects often recover. Periodic kidney function must be checked for patients using hydrochlorothiazid, losartan and treated with NSAIDs.
quinidine
easily causes torsion, vibration causes death.
Thiazide reduces the effect of anticoagulants, gout treatments.
Thiazide increases the effects of anesthesia, glycosid, vitamin D.
cholestyramine or colestipol
The gastrointestinal absorption of hydrochlorothiazide is reduced when the presence of anion exchange resin. The only dose of plastic or cholestyramine or colestipol associated with hydrochlorothiazide and reduces the absorption through the digestive tract up to 85% and 43%, respectively.
Storage
Store at a temperature not exceeding 30 ° C.
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