Savi Valsartan Plus HCT 80/12.5 treatment for hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Valsartan, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Valsartan | 80mg |
| Hydrochlorothiazide | 12.5mg |
Uses
Indications
Savi Valsartan Plus HCT 80/12.5 drugs are indicated in the following cases:
Angiotensin II is formed from angiotensin I in a catalytic reaction by the Angiotensin conversion enzyme (ACE, Kininase II). Angiotensin II is the main vasoconstrictor of the Renin - Angiotensin system, with effects including vascular contraction, synthesis and release of aldosteron, stimulating heart and kidney reabsorption of sodium.
Valsartan locks vascular shrinkage and aldosteron secretions of Angiotensin II by selective preventing on Angiotensin II links with AT1 receptors in tissues, such as blood vessel and adrenal muscle. Therefore, its impact is independent of the chain of Angiotensin II biosynthesis reactions.
There is also an AT2 receptor found in many tissues, but it is unclear whether this receptor is related to the heart balance or not. Valsartan has great affinity with AT1 receptors, about 20,000 times higher than the AT2 receptors.
Angiotensin concentration in plasma increases after Valsartan blockade AT1 receptors and this may stimulate the blocking of AT2 receptors. The main metabolites of Valsartan are basically impact and have low affinity with AT2 receptors, only about 1/200 compared to Valsartan.
Sitronage of the Renin - Angiotensin system with ACE inhibitors inhibit the biosynthesis of Angiotensin II from Angiotensin I, widely used in the treatment of hypertension. ACE inhibitors also inhibit Bradykinin's Christmas, a reaction that is also catalyzed by Ace. Because Valsartan does not inhibit ACE (Kininase II), it does not affect the response of Bradykinin. Therefore, this clinical difference has not been well known.
Valsartan is not bound or blocking other hormones or ion channels that are considered to be important in the cardiovascular regulation. The blockade of Angiotensin II receptors inhibits the Renin Angiotensin II recovery reaction, but the result increases the lenin impact in plasma and the level of angiotensin II circulation does not exceed the effects of Valsartan on blood pressure.
hydrochlorothiazid
hydrochlorothiazid is a thiazid diuretic. Thiazid affects the mechanism of reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chloride in almost equal amounts. Indirectly the diuretic effect of hydrochlorothiazid reduces plasma volume with the increase in lenin activity in plasma, increases aldosteron secretion, increases potassium secretion into urine and decreased serum potassium. The relationship between Renin - Aldosteron through Angiotensin II intermediaries, so the use in combination with an Angiotensin II receptor antagonist tend to reverse the impact of potassium caused by diuretics.
The mechanism of hypotension of thiazid is currently unknown.
pharmacokinetic
valsartan
absorption
After taking Valsartan's plasma peaks achieved for 2-4 hours. After the Valsartan intravenous injection displays the hat -decaying pharmacokinetics with the average clearance of the selling cycle of about 6 hours. Absolute bioavailability with capsules of about 25% (from 10% - 35%).
Food reduces the concentration (measured by AUC) of Valsartan by about 40% and the peak of plasma (CMAX) is about 50%. Valsartan's AUC and CMAX values increase linearly with increasing dose through clinical dose range. Valsartan does not accumulate significantly in plasma after repeated use.
Distribution
The volume of distribution in the stable state of Valsartan after small intravenous injection (17 l), shows Valsartan is not widely distributed into the tissues. Valsartan binds with serum protein (95%), mainly serum albumin.
Metabolism
The main metabolites account for about 9% of the dose including Valeryl 4 - Hydroxy Valsartan. In vitro metabolic research is related to recombinant CYP P450 enzymes indicating that enamel enzyme CYP2C9 is responsible for the formation of Valeryl - 4 - Hydroxy Valsartan. Valsartan does not inhibit the enzyme CYP P450 at clinical concentration. Medicinal interaction between Vallsartan and CYP P450 enzyme through intermediaries and shared drugs is not likely to occur because of the low metabolic level.
Elimination
When used in the form of oral solution, most Valsartan is found in feces (about 83% dose) and urine (about 13% dose) mainly in the form of constant only about 20% of the dose is in the form of metabolites. After intravenous intravenous intravenous injection of Valsartan's plasma reaches about 2 l/hour and the renal clearance reaches 0.62 l/hour (about 30% of the total amount of clearance).
hydrochlorothiazid
absorption
Absolute estimates of hydrochlorothiazid after drinking about 70%. The plasma peak concentration of hydrochlorothiazid (CMAX) is achieved within 2-5 hours after drinking. There is no clinical influence on food for bioavailability of hydrochlorothiazid.
Metabolism
Not metabolized.
Elimination
About 70% of the oral dosage of hydrochlorothiazid is excreted into the urine in the form of constant.
Before taking Savi Valsartan Plus HCT 80/12.5 treatment for hypertension (3 blisters x 10 tablets)
How to use
often use oral. Drink 30 minutes before breakfast and afternoon.
Dosage
The usual starting dose of Savi Valsartan Plus HCT 80/12.5 is once a day. The dosage may increase after 1 to 2 weeks of treatment as considered by the doctor based on the patient condition.
Maximum hypotension effect will be achieved within 2 to 4 weeks after the dose changes.
Auxiliary treatment
Patients with blood pressure are not fully controlled with single valsartan (or other Angiotensin II receptor resistant drugs) or single hydrochlorothiazid can be transferred to treatment with Savi Valsartan Plus HCT 80/120.
.Alternative treatment
Savi Valsartan Plus HCT 80/12.5 can replace the titration of the titration.
Starting treatment
Savi Valsartan Plus HCT 80/12.5 is recommended for contraindications such as the starting treatment for patients with intravascular volume impairment.
Treatment along with other hypotension drugs
Savi Valsartan Plus HCT 80/12.5 can be used with other antihypertensive 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 overdose?
Data overdose in people is limited. It is possible that the manifestations of overdose are causing hypotension and tachycardia, slow heart rate that may occur due to sympathetic stimulation (vagus). The degree of depression of consciousness, depravity and shock has been reported. If the symptoms of blood pressure occur, it is advisable to perform supportive treatment. Valsartan is not removed from plasma by feces.
The level of hydrochlorothiazid is removed by artificial dialysis that has not been set up. The most common signs and symptoms in patients are due to electrolyte exhaustion (hypokalemia, blood chloride, hypoglyc sodium hypoglycemia) and dehydration due to excessive diuretic. Because hypokalemia can highlight the arrhythmia, it is possible to use digitalis.
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 Savi Valsartan Plus HCT 80/12.5 you can experience unwanted effects (ADR).
CommonInfection and manifestation: bronchitis, acute bronchitis, influenza, gastritis, sinusitis, upper respiratory infection and urinary tract infection.
Nervous system: dizziness, posture and drowsiness. Less If you experience unwanted reactions, need to stop the medicine and consult immediately with the treating doctor.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Savi Valsartan Plus HCT 80/12.5 contraindications in the following cases:
Be cautious when used
Valsartan is used cautiously for patients with liver failure, cirrhosis or biliary obstruction.
Hypotension in patients with exhaustion of fluid volume and/or electrolyte
Excessive reduction of rare blood pressure has been seen (0.7%) in high -blood pressure patients with uncomplicated treatment with tablets combined with valsartan + hydrochlorothiazid in control tests. In patients with the Renin - Angiotensin system activated, such as exhaustion of fluid mass and/or electrolyte when patients take high doses of diuretics, may occur with symptoms.
The exhaustion should be recovered before taking a combination of valsartan + hydrochlorothiazid or treatment that only starts under tight medical supervision.
If the patient's symptoms of blood pressure occur, the patient should be placed in a backing position and if necessary, intravenously and physiological saline solution. A transient hypotension reaction does not need to be contraindicated during treatment, often can continue without difficulty when blood pressure has stabilized.
kidney failure
Change of renal function, including acute renal failure, can be caused by the Renin - Anpiotensin and diuretic inhibitors. Patients with renal function depend partly on the activities of the Renin - Angiotensin system (for example, patients with kidney artery stenosis, chronic kidney disease, severe congestive heart failure or loss of fluid) may have a special risk of developing acute renal failure with a combination of valsartan + hydrochlorothiazid. Periodic renal function must be monitored for these patients.
Consider retention or discontinue treatment in patients with kidney impaired renal function when treated with a combination of valsartan + hydrochlorothiazide.
Hypersensitivity reaction
hydrochlorothiazid: Hypersensitivity reaction hydrochlorothiazid may occur in patients with or without a history of allergies or bronchial asthma, but most likely occurs in patients with a history.
Lupus erythema body
hydrochlorothiazid: Thiazid diuretics have been reported, causing serious condition or activating the body erythema erythema.
Potassium abnormalities
Combining valsartan + hydrochlorothiazid: In the controlled tests with different doses of the tablet combined with valsartan + hydrochlorothiazid, the rate of high blood pressure patients has developed hypokalemia (serum potassium 5.7 MEQ/L) 0.4%)
hydrochlorothiazid can cause hypotension and hyponatremia. Hypotension can lead to hypokalemia and lead to difficulties in treatment, although potassium is still adequate.
Renin - angiotensin inhibitors can cause hyperkalemia. Must monitor electrolytes in serum periodically.
If hypokalemia comes with clinical signs (such as muscle weakness, paralysis or an electrocardiogram change), it is recommended to stop combining valsartan + hydroelorothiazid. There has been recommendations to adjust any hypotension and decrease in magnesium before starting to use thiazids. Some patients with heart failure have grown to increase potassium with Valsartan therapy. These effects are often light and transient and are more likely to occur in patients with renal failure. Dosage reduction and/or diuretics and/or valsartan may be required.
Negative and grabbuled angle of secondary angle.
hydrochlorothiazid is a sulfonamide, which can cause a unique -style reaction that leads to acute myopia and glaucoma. Symptoms include acute onset of visual sharpness or visual pain and usually occur within hours to a few weeks at the beginning of the drug.
If not treated with acute angle hypertension may lead to permanent vision loss. The main treatment is to stop hydrochlorothiazid as quickly as possible. Medical treatment or surgery may also have to be considered if the pressure is still uncontrolled. Acute risk growth factors may include a history of allergy to sulfonamide or penicillin.
Metabolic disorders
hydrochlorothiazid may change glucose tolerance, increasing cholesterol and triglycerides.
hydrochlorothiazid may increase serum uric acid levels due to reducing uric acid clearance and can cause or worsen blood uric acid hyperkemis and cause uric acid precipitate in gout of sensitive patients.
hydrochlorothiazid reduces calcium secretion into the urine and can cause serum calcium. Need to monitor calcium levels in patients with hypercalcemia when receiving a combination of valsartan + hydrochlorothiazid.
The ability to drive and operate machinery
The drug has the ability to affect the alertness when driving or operating machinery.
Pregnancy
Contraindications for drug use during pregnancy.
breastfeeding period
should avoid using the drug for breastfeeding. Because there are many drugs excreted in the mother's milk and because of the adverse breast -feeding reactions from tablets combined with valsartan + hydrochlorothiazid, decide to stop breastfeeding or stopping the drug, taking into account the importance of the drug for the mother.
Drug interaction
Valsartan
There is no clinical pharmacokinetics interactions observed when Valsartan pharmaceuticals are used with amlodipine, atenolol, cimetidine, digoxin, furosemid, glyburid, hydrochlorothiazid hoaic indomethacin. The combination of Valsartan and Atenolol causes more blood pressure lower than any ingredient, but does not reduce the lower heart rate as when the atenolol single treatment.
Shared Warfarin with Valsartan does not change Valsartan's pharmacokinetics or Warfarin's anticoagulant time.
Interaction with CYP P450
In the study of in vitro metabolism shows that CYP P450 intermediaries intermediaries between Valsartan and combined medications not to interact because of the low level of metabolism.
Transport enzymes
Results from an in vitro study with human liver cells show that Valsartan is the substrate of the enzyme that is absorbed into the OATP liver and the enzyme is transported to the liver MRP2.
Concentrated with transportation inhibitors absorbed into the liver (such as rifampin, cyclosporin) or transportation out of the liver (such as ritonavir) may increase the levels of valsartan.
Anti -inflammatory anti -inflammatory drugs (NSAIDs) include selective inhibitors Cycloxygenase - 2 (Cox inhibitor - 2)
In patients with elderly people with blood volume depleted (including those who are treated with diuretics) or suffer from kidney function, when using the Angiotensin II receptor receptor counter like Valsartan with NSAIDs, including COX -2 selective inhibitors, can lead to impaired renal function, including acute kidney failure. These effects often recover. Periodic renal function should be monitored in patients with treatments using Valsartan and NSAIDs. The hypotension effect of Angiotensin II receptor antagonists including Valsartan may be impaired by NSAID including selective inhibitors COX - 2.
Additional potassium
Simultaneous use Valsartan with other Renin - Angiotensin systems such as potassium diuretics (e.g. Spironolacton, triamteren, amilorid) or potassium supplements or salt replacement (NaCl) with potassium -containing products can lead to serum hyperpassing and in patients with serum hypercipation. If this drug is considered to be considered necessary, patients must be monitored with serum potassium.
Dual blockade of the Renin - Angiotensin (RAS) system
The dual blockade of the RAS system for Angiotensin receptor blockers, transferred inhibitors or Aliskiren is associated with increased risk of hypotension, hyperkalemia and renal function changes (including acute renal failure) compared to monomers. Strictly monitoring blood pressure, renal and electrolyte function in patients with the combination of valsartan + hydrochlorothiazid and other agents affecting RAS.Contraindicated Aliskiren with a combination of valsartan + hydrochlorothiazid in patients with diabetes. Avoid using Aliskiren with a combination of valsartan + hydrochlorothiazid in patients with renal impairment (GFR glomerular filtration speed
Interaction with enamel inhibitors and beta blockers
Use simultaneously increases mortality.
hydrochlorothiazid
When used simultaneously, the following drugs can interact with thiazid diuretics:
Diabetes (oral and insulin drugs) may have to adjust the dose of diabetes.
lithium
Diuretics increases the risk of lithium poisoning. It is necessary to refer to the instructions for using lithium preparations before use with a combination of valsartan + hydrochlorothiazid. Serum lithium concentration should be monitored during simultaneous use.
Steroid anti-inflammatory drugs (NSAIDs and COX-2 inhibitors)
When a combination of valsartan + hydrochlorothiazid and nonsteroidal anti -inflammatory drugs simultaneously, patients need to be closely monitored to determine the effectiveness obtained from the desired diuretics.
carbamazepine
can lead to symptomatic hypoglycatromiasis.
ion exchange resin
When shared, the dosage of hydrochlorothiazid has occurred and ion exchange resin (for example, cholestyramin, colestipol); Therefore, hydrochlorothiazid should be used at least 4 hours before or 4 - 6 hours after using plastic to minimize impact.
cyclosporin
Concentrated with cyclosporin may increase the risk of hyperuricemia and complications of gout.Storage
In a dry place, the temperature does not exceed 30 ”c. Avoid light.
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