Exforge HCT 5mg/160mg/12.5mg Novartis treatsdate hypertension (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Valsartan, amlodipine, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Valsartan | 160mg |
| Amlodipine | 5mg |
| Hydrochlorothiazide | 12.5mg |
Uses
indications
Exforge HCT drug is indicated in the following cases:
amlodipin
The amlodipine component of Exforge HCT prevents the passing through the membrane of calcium ions into the heart muscle and blood vessel smooth muscle. The mechanism of anti -hypertension effect of amlodipine is due to the effect of direct relaxation of blood vessel smooth muscle, causing reducing the resistance of peripheral blood vessels and reducing blood pressure. Experimental data shows that amlodipine is associated with the position combined with dihydropyridine and not dihydropyridine. The process of heart muscle and blood vessel muscles depends on the movement of calcium ions from extracellular to the inside of these cells through specific ion channels.After taking treatment doses for patients with hypertension, amlodipine relaxes vasodilation, leading to lowering blood pressure when lying on their backs and standing. This decrease in blood pressure is not accompanied by a significant change in heart rate or catecholamine level in plasma when taking the drug for a long time.
Plasma concentration in plasma is correlated with both young and elderly patients.
In patients with hypertension with normal renal function, amlodipine treatment dose leads to reduced resistance of kidney vascular and increases the filtration rate of the glomerular and the amount of plasma through the kidney effectively without changing the filter segment or proteinuria.
As well as other cases of calcium channel blockers, hemodynamic indicators for heart function when resting and when exertion (or step by step) in patients with normal ventricular function are treated with amlodipine often show a slight increase in heart index without significant effects on DP/DT or on the pressure at the end of the centrifugal center in the left ventricular or on blood volume.
In studies on hemodynamics, Amlodipine is not related to the negative insert effect when used at the level of treatment for experimental animals and normal people, even when used in combination with beta blockers for humans.
Amlodipin does not change the function of atrial sinus button or atrial - ventricular in animal or normal people. In clinical studies in which amlodipine is used in conjunction with beta blockers for patients with hypertension or angina, not observing any side effects on parameters on the electrocyte.
Amlodipin has shown clinical beneficial effects in patients with prolonged stable angina, angina due to vascular spasms and coronary artery disease that has been recorded by blood vessels.
valsartan
Valsartan is an Angiotensin II receptor antagonist with activity, strong and specific orally, selective impact on the AT1 receptor type responsible for the known effects of Angiotensin II. The concentration of angiotensin II in plasma increases after the AT1 receptor is inhibited with Valsartan that can stimulate the AT2 receptor not inhibited, which has a counterweight effect with the AT1 receptor. Valsartan does not show any partial active substance at the AT1 receptor and has a much higher affinity (about 20,000 times) for AT1 receptors compared to the AT2 receptor.
Valsartan does not inhibit the enzyme transferring angiotensin (ACE), also known as Kininase II, convert Angiotensin I into angiotensin II and divest bradykinin. Because there is no effect on the enzyme transferring angiotensin and does not increase the potential of Bradykinin or P, Angiotensin II receptor antagonistic drug is not sure to be associated with cough.
In valsartan comparative clinical trials with an angiotensin transfer inhibitor, the rate of dry cough is significantly lower (p
In a clinical trial in patients with a history of dry cough while being treated with Angiotensin transfer inhibitor, 19.5% of the testers were treated with Valsartan and 19% of people who were treated with thiazid diuretics were cough compared to 68.5% of people treated with angiotensin transferring enzyme inhibitors (P
The use of valsartan for patients with hypertension leads to a decrease in blood pressure without affecting the pulse.
In most patients, after taking a single dose, the anti -hypertension effect occurs within 2 hours and the decrease in the peak of blood pressure within 4-6 hours. Anti -hypertension effect lasts more than 24 hours after taking the drug. During the repetition, the maximum reduction of blood pressure at any dose is usually achieved within 2-4 weeks and maintained during the long -term treatment. The sudden Valsartan stops not associated with regression hypertension or other harmful reactions clinically.
Valsartan has been shown to significantly reduce the hospital stay in patients with chronic heart failure (degree II - IV according to the classification of the New York Heart Association - NYHA). The most achieved benefits in patients do not treat angiotensin transferring enzyme or beta blockers. Valsartan also shows reducing cardiovascular mortality in patients clinically stabilized with left ventricular failure or left ventricular dysfunction after myocardial infarction.
hydrochlorothiazide
The position of thiazid diuretics is mainly in the distance of the kidney. It is seen that there is a high -loving receptor in the kidney shell that is the main position for the diuretic effect of thiazid and inhibits the transport of NaCl in the distance. The mechanism of action of thiazid through inhibition of Na+/Cl- transportation system, perhaps due to the competition for the Cl- position, therefore affects the mechanism of electrolyte reabsorption, resulting in a direct increase in sodium and chloride export to an equivalent level. And indirectly due to this diuretic effect reduces plasma volume, resulting in increasing the activity of lenin in plasma, aldosteron secretion and loss of potassium through urine and decreased serum potassium.
Dynamic pharmacokinetics
linear: valsartan, amlodipine and HCTZ show linear pharmacokinetics.
amlodipin
absorption
After taking orally, Amlodipine is solitary with the treatment dose, the peak concentration of amlodipine in plasma is achieved after 6-12 hours. Absolute bioavailability is calculated 64 - 80%. Amlodipin's bioavailability is not affected by food.
Distribution
The distribution volume is about 21 liters/kg. In vitro studies with amlodipine show that about 97.5% of the drug during the circulation associated with plasma proteins.
Biological/metabolic transformation
amlodipine is strongly metabolized (about 90%) in the liver into non -active metabolites.
Elimination
The elimination of amlodipine from plasma has a 2 -phase form with the final selling time of about 30-50 hours. Plasma drug concentration in a stable state is achieved after continuous use for 7-8 days. 10% of the initial amlodipine and 60% of amlodipine metabolic substances are eliminated in the urine.
Valsartan
absorption
After using the lonely oral oral Valsartan, the peak concentration of Valsartan in plasma is achieved after 2-4 hours. Absolute bioavailability is 23%. Food reduces the level of contact with Valsartan (measured by the area under the curve - AUC) by about 40% and the peak concentration in plasma (CMAX) is about 50%, although about 8 hours after taking the drug, Valsartan concentration in the same plasma in the group has eaten and fasting. However, the reduction of the area under this curve is not accompanied by clinical significance of the effectiveness of treatment, so Valsartan can be used or not with food.
Distribution
Valsartan's distribution voltage in a stable state after an intravenous use about 17 liters shows Valsartan is not widely distributed into the tissues. Valsartan is strongly connected to serum protein (94 - 97%), mainly serum albumin.
Biological/metabolic transformation
Valsartan is not changed to a high level because only about 20% of the dose is found in the form of metabolites. A hydroxy metabolite has been found in low plasma (less than 10% of the area below the curve of Valsartan). This metabolic substance has no pharmacological activity.
Elimination
Valsartan shows that the dynamics decay in the form of a polynomial hat function (t about α
hydrochlorothiazid
absorption
After taking a dose of hydrochlorothiazid oral absorption quickly (the time to achieve the highest concentration in plasma - TMAX is about 2 hours). The increase in the area under the curve (AUC) is linearly and proportional to the dose within the treatment dose range. There have been simultaneous reports with the same food that increases and reduces the whole body use of hydrochlorothiazid compared to hunger. These effects are less important and do not have clinical meanings. The absolute bioavailability of hydrochlorothiazid is 60 - 80% after oral use.
Distribution
Dynamic distribution and excretion is usually described as a two -exponential disintegration function, with the final selling time of 6 - 15 hours. The indicator distribution is 4 - 8 liters/kg. Hydrochlorothiazid in the circulation associated with serum protein (40%), mainly with serum albumin. Hydrochlorothiazid also accumulates in red blood cells about 3 times the plasma concentration.
Biological/metabolic transformation
HCTZ is excreted mainly in the form of constant drugs.
Elimination
hydrochlorothiazid is eliminated from plasma with the average selling time of 6-15 hours in the final excretion phase. There is no kinetic change of hydrochlorothiazid when the dose is repeated, and the accumulation of drugs rarely takes the dose 1 time/day. More than 95% of the absorption dose is excreted in the form of a constant compound in the urine.
amlodipin/valsartan/hydrochlorothiazide
After using Exforge HCT oral in normal adults, amlodipin's peaks in plasma is achieved after 6 - 8 hours, Valsartan after 3 hours and HCTZ after 2 hours. The speed and level of absorption of Amlodipine, Valsartan and HCTZ from Exforge HCT is similar to when used in the form of separate cells.
Special patient groups
Elderly patients
Time reaches the peak concentration of amlodipine plasma in the elderly and young people. In elderly patients, Amlodipine's clearance tends to decrease, increasing the area under the curve (AUC) and increasing the selling time.
The level of body contact with Valsartan increases slightly in the elderly when compared to young people, but this does not show any clinical meanings.
The limited data shows that the whole body clearance of hydrochlorothiazid is reduced in both healthy people and hypertension compared to young volunteer young people.
kidney failure
Amlodipine'spharmacokinetics are not significantly affected by kidney failure. There is no clear relationship between renal function (measured by creatinine clearance) and exposure to Valsartan (measured by an area under the curve - AUC) in patients with different levels of renal failure. Therefore, patients with mild to moderate renal failure may use normal starting dose.
In the case of renal failure, peak concentration and AUC value in the average plasma of hydrochlorothiazid increases and the rate of urine excretion decreases. In patients with mild to moderate renal failure, the average disposal time is almost doubled. The kidney clearance of hydrochlorothiazid also decreases to a large extent compared to the renal clearance of about 300 ml/min in patients with normal kidney function. Therefore, it is necessary to be cautious when using Exforge HCT in patients with severe renal failure (glomerular filtration speed (GFR)
Hepatic failure
Patients with hepatic impairment have decreased amlodipine clearance, resulting in an increase in the area of the curve (AUC) about 40 - 60%. On average, in patients with mild to medium chronic liver disease, the contact with Valsartan (measured by the area of the area under the curve) is twice the exposure level seen in healthy volunteers (corresponding to age, gender and weight). Liver disease does not significantly affect the pharmacokinetics of hydrochlorothiazid and do not need to consider reducing the dose. However, it is necessary to be especially cautious when using Exforge HCT in patients with biliary obstruction disorders and severe liver failure.
Before taking Exforge HCT 5mg/160mg/12.5mg Novartis treatsdate hypertension (4 blisters x 7 tablets)
How to useExforge HCT can be used or not with food. Should use Exforge HCT with a little water.
Dosage
recommended dose is 1 tablet/day.
Patients with blood pressure are not fully controlled when using double therapy of two of the three groups of calcium channel blockers, angiotensin transferring enzymes, thiazid diuretic can be transferred directly to coordinated treatment with Exforge HCT.
For convenience, patients who are using Valsartan, Amlodipin and HCTZ can be shifted from separate tablets to Exforge HCT containing the same dose of these components. Patients with side effects limit the dose of any dual combination of Exforge HCT components that can switch to Exforge HCT containing a lower dose of that component to achieve similar blood pressure decrease.
may increase the dose after 2 weeks. The maximum anti -hypertension effect of Exforge HCT is achieved within 2 weeks after the dose changes. The maximum dose of Exforge HCT is recommended for 10/320/25 mg.
What to do when overdose? The main symptom of the overdose of Valsartan may be hypotension with dizziness. Amlodipine overdose can lead to excessive peripheral vasodilation and can cause reflected tachycardia. There have been reports on hypotension clearly and capable of prolonged, including shock with death.
Clinical hypotension due to amlodipine overdose is required to support the positive cardiovascular support including regular monitoring of heart and respiratory function, raising limbs and paying attention to circulation volume and urine amount.
Plee -causing drugs can be helpful in recovery of vascular tone and blood pressure, provided that it is not contraindicated. If new medication, may consider vomiting or gastric lavage. Using activated carbon for healthy volunteers immediately or up to 2 hours after using amlodipin has shown to significantly reduce the absorption of amlodipine.
Intravenous calcium gluconate can be beneficial in reversing the impact of inhibition of calcium channels.
Both Valsartan and Amlodipin are not sure to be removed by hemolysis while the HCTZ clearance can be achieved due to the fertilizer.
What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Exforge HCT, you may experience some unwanted effects (ADR).
Because clinical studies have been conducted under very different conditions, it is impossible to directly compare the side effect rate in clinical studies of a drug with side effects in clinical studies of another drug and may not reflect the observation rate found in clinical practice.
In an Exforge HCT clinical trial with a maximum dose assessment certificate (10/320/25 mg), safety data has been achieved in 582 patients with hypertension. Side reactions are often mild and transient and rarely need to stop treatment.
General frequency of similar side effects between men and women, young patients (
The most common side effects occurring in the controlled clinical trial with other drugs in at least 2% of patients treated with Exforge HCT are presented in the table below:
The term selected
AML/Vall/HCTZ
10/320/25 mg
n = 582
n (%)
Vall/HCTZ
320/25 mg
n = 559
n (%)
AML/VAL
10/320 mg
n = 566
n (%)
HCTZ/AML
25/10 mg
n = 561
n (%)
48 (8.2)
40 (7.2)
14 (2.5)
23 (4,1)
38 (6.5)
65 (11.5)
63 (11,2)
headache
31 (5.5)
13 (2.2)
5 (0.9)
2 (0.4)
13 (2.2)
15 (2.7)
12 (2.1)
Mechanical spasm
13 (2.2)
5 (0.9)
12 (2.1)
13 (2,3)
5 (0.9)
12 (2.1)
Nausea
12 (2.1)
12 (2.1)
12 (2.1)
13 (2,3)
13 (2,3)
12 (2.1)
Other side effects occur in clinical trials with Exforge HCT (> 0.2%) listed below. It is impossible to determine whether these side effects have a causal relationship with Exforge HCT. eye disorders: blurred vision. Systemic disorders and medication: weakness, chest pain due to heart, chills, discomfort. Infections and parasitic infections: upper respiratory infection, bronchitis, influenza, sore throat, tooth abscess, gastritis caused by viruses, respiratory infections, rhinitis, urinary tract infections. Testing: hyperuricemia, hypertreatin phosphokinase, weight loss. musculoskeletal and connective tissue disorders: pain in the limbs, joint pain, musculoskeletal joints, muscle weakness, musculoskeletal weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, tendonitis. Nervous system disorders: Perception, drowsiness, fainting, wrist syndrome, attention disorders, dizziness posture, taste disorders, discomfort at the head, sleep, headache due to sinusitis, tremor. Mental disorders: anxiety, depression, insomnia. Respiratory disorders, chest and mediastinum: shortness of breath, nasal congestion, cough, sore throat - laryngeal. The following individual cases of clinical side effects are observed in clinical trials: anorexia, constipation, dehydration, difficulty urinating, increasing appetite, virus infection. Amlodipin Amlodipin has been assessed for safety in more than 11,000 patients in the US and clinical trials abroad. The other side effects not listed above have been reported 0.1% of patients in clinical trials with control or under the conditions of open test or according to marketing experience in which causal relationships are uncertain: Central and peripheral nervous system: peripheral neuropathy, tremor. Skin and auxiliary parts: Evaluation, diverse erythema, erythema, lumpy rash. Special senses: abnormal view, conjunctivitis, gravity, eye pain, tinnitus. Automatic nervous system: Increase sweating. Other side effects have been reported to amlodipine at frequency ≤ 0.1% of patients including: heart failure, irregular vessels, extra mind, skin discoloration, urticaria, dry skin, hair loss, dermatitis, muscle weakness, convulsions, loss of air conditioning, hypertonic hypertension, cold skin pain, cold skin and moisture, nose, nose, stool, stool, stool, stool, stool, stool Urology, sense of smell, deviation of taste, abnormal vision regulation and dry eyes. Other reactions that occur irregularly and cannot be distinguished by drugs or simultaneous diseases such as myocardial infarction and angina. Side reactions that have been reported to amlodipine on indications other than hypertension can be found in the complete prescription information of this substance. valsartan Valsartan has been assessed for safety in more than 4,000 hypertension patients in clinical trials. In valsartan comparison tests with an angiotensin (ACE) enzyme inhibitor (ACE) whether or not there is no placebo, a significantly higher rate of dry cough in the group using ACE inhibitors (7.9%) compared to the groups used Valsartan (2.6%) or placebo (1.5%). In a test in 129 patients limited to dry cough patients when they had previously used ACE inhibitors, the cough ratio in patients was used Valsartan, HCTZ or Lisinopril was 20%, 19% and 69% respectively (P Other side effects are not listed above at> 0.2% of patients in clinical trials with Valsartan with control: Genital urology: Help. Other side effects have been reported to Valsartan about other indications other than hypertension that can be found in prescribed information for diovan. hydrochlorothiazide Other side effects not listed above have been reported to hydrochlorothiazid, not related to causal relationship, listed below: Hypersensitivity: light sensitivity, urticaria, necrotic vasculitis (vasculitis and skin capillary), fever, respiratory fall including pneumonia and pulmonary edema, anaphylactic reaction. Skin: A variety of erythema including Stevens - Johnson syndrome, flaking dermatitis including poisoned epidermal necrosis. Test results The test results for Exforge HCT have been achieved in a test with an exforge hCT with a maximum dose of 10/320/25 mg compared to the maximum dose of dual treatments, ie Valsartan/HCTZ 320/25 mg, Amlodipine/Valsartan 10/320 mg and HCTZ/Amlodipine 25/10 mg. The results for the ingredients of Exforge HCT have achieved from other tests. Creatinin: In patients with hypertension, creatinine increases over 50% in 2.1% of patients using Exforge HCT compared to 2.4% of patients using Valsartan/HCTZ, 0.7% patients use amlodipine/valsartan and 1.8% of patients using HCTZ/Amlodipine. In patients with heart failure, creatinine observed increased by more than 50% in 3.9% of patients treated with valsartan compared to 0.9% of patients treated with placebo. In patients after myocardial infarction, the serum creatinine has been observed in 4.2% of patients treated with Valsartan and 3.4% of patients treated with Captopril. Liver function test: Occasionally increase the chemical components of the liver (higher than 150%) occurs in patients treated with Exforge HCT. Hemodiac nitrogen (Bun): In hypertension patients, observed by more than 50% of blood urea nitrogen in 30% of patients treated with Exforge HCT compared to 29% of patients treated with Valsartan/HCTZ, 15.8% of patients treated with amlodipine/valsartan and 18.5% treated with HCTZ/Amlodipin. Most of the blood nitrogen values remain within normal limits. In patients with heart failure, observing an increase of over 50% of blood urea nitrogen in 17% of patients treated with Valsartan compared to 6% of placebo patients. electrolytes in serum (potassium): In patients with hypertension, observed a decrease in over 20% of serum potassium at 6.5% of patients treated with Exforge HCT compared to 3.3% of patients treated with Valsartan/HCTZ, 0.4% of patients treated with amlodipine/valsartan and 19.3% of patients treated with HCTZ/AMLodipine. Observed by more than 20% of potassium in 3.5% of patients treated with Exforge HCT compared to 2.4% of patients treated with Valsartan/HCTZ, 6.2% of patients were treated with amlodipine/valsartan and 2.2% treated with HCTZ/Amlodipine. In patients with heart failure, observed by over 20% of serum potassium in 10% of patients treated with Valsartan compared to 5.1% of patients treated with placebo. Neutral leukemia: neutropenia ( after -sales experience The following additional side effects have been reported according to after -sales experience. Because these reactions are spontaneously reported from an uncertain population group, not always reliable to estimate the frequency or establish a causal relationship about the exposure to the drug. amlodipin With Amlodipin, enlarged breasts in men have been reported irregularly and uncertain causal relationship. Jaundice and increased liver enzyme (most suitable for cholestasis or hepatitis), in some cases weighing enough to be hospitalized have been reported related to the use of amlodipine. valsartan The following additional side effects have been reported after sales experience with Valsartan or Valsartan/Hydrochlorothiazide: The immune system disorder: Hypersensitivity including serum disease. Hypersensitivity: There are rare reports on angioedema; Some patients who have had angels when taking other drugs include ACE inhibitors; Exforge HCT should not be used for patients who have had angels. Nervous system: fainting. Cases of rare patterns have been reported in patients using Angiotensin II receptor blockers. hydrochlorothiazide The following additional side effects have been reported by after -sales experience with hydrochlorothiazid: Pathological changes in parathyroid glands in patients with hypercalcemia and hypoglycemia have been observed in several prolonged thiazid patients. If increased calcium occurs, further evaluation of diagnosis. Blood disorders and lymphatic systems rare: Very rare: Unknown: Platelet reduction, sometimes the bleeding committee. leukopenia, grain leukemia, bone marrow failure and hemolytic anemia. Soldier anemia. immune system disorders very rare: necrotic vasculitis, hypersensitivity reaction - respiratory failure including pneumonia and pulmonary edema. Very common:Common Rare: Very rare: (mainly in high doses) Hemotental reduction, hyperlipidemia. Hyperred hypoglycemia, hypoglycemia, hyperuricemia, reduced appetite. Hyperculia, hyperglycemia, urinary tract and worse diabetes. Alkaline chlorine infection. Mental disorders rare: Sleep disorders. Nervous system disorders rare: Headache, dizziness, depression and paresthesia. rare: Unknown: Impaired vision, especially in the first few weeks of treatment. glaucoma. heart disorders rare: arrhythmia. Vascular disorders Common Hypotension, can be more serious if used with alcohol, anesthesia or sedative drugs. Rare: Very rare: vomiting and slight nausea. Abdominal discomfort, constipation and diarrhea. Pancreatitis. rare: Molecular or jaundice. Rare: Very rare: Unknown: Hres and other forms of rash. Light sensitive reaction. Poisoned skin necrosis, red -rash lupus reactions on the skin, the activity of lupus erythematosus on the skin. Diverse roses. Unknown: Contracting muscles. Unknown: Acute renal failure, kidney disorders. erectile dysfunction. Unknown: Fever, weakness.
Warnings
Contraindicated
In the history of hypersensitivity to Amlodipine, Valsartan, HCTZ, other drugs derived from Sulfonamid or any component of the excipient.
Pregnant women (see the part of pregnant women, pregnant women, nursing mothers and fertility).
Due to hydrochlorothiazid, contraindicated use of Exforge HCT in patients with anuria.
Concentrated use of angiotensin receptor antagonists (Angiotensin receptor blockers - ARB) - including valsartan - or enzyme inhibitors Angiotensin (ACEI) with Aliskiren in patients with type 2 diabetes.
Be cautious when taking the drug
Read the instructions carefully before use. If you need more information, please consult your doctor.
This drug is only used by a doctor.
Type D toxicity for pregnant women.
Use drugs on the Renin - Angiotensin system in the middle and the last 3 months of pregnancy reduces the kidney function of the fetus, increases disease and death in the fetus and babies. The result of amniotic fluid may be associated with reduced lung and bone deformation in the fetus. The potential side effects in infants include reduced skull production, anuria, hypotension, renal failure and death. When detecting pregnancy, the Exforge HCT must be stopped as soon as possible.
Hypotension in patients decreased volume or salt loss
Excessive hypotension, including vertical hypotension, is recorded in 1.7% of patients treated with the maximum dose of Exforge HCT (10/320/25 mg) compared to 1.8% of patients using Valsartan/HCTZ (320/25 mg), 0.4% patients using amlodipin/valsartan (10/320 mg) and 0.2% of HCTZ/Amlodipine (25/10 mg) in a test) There are control in patients with average hypertension to severe without complications.
In patients with the renin system - Angiotensin is activated as patients with high doses of dietary diuretics reduced volume or salt loss, hypotension symptoms may occur in patients using angiotensin receptor blockers, need to adjust this condition before using Exforge HCT.
Exforge HCT has not been studied in patients with heart failure, recent myocardial infarction or in patients undergoing surgery or fertilizer. Patients with heart failure or after myocardial infarction used Valsartan often have a little lower blood pressure, but the stop treatment due to continuing blood pressure is often unnecessary when adhering to the instructions for drug use.
In control tests in patients with heart failure, the rate of hypotension in patients treated with Valsartan is 5.5% compared to 1.8% in patients treated with placebo. In the valsartan test in acute myocardial infarction (Valiant), hypotension in patients after myocardial infarction leading to permanent stop treatment occurs in 1.4% of patients treated with Valsartan and 0.8% of patients treated with Captopril.
Because vasodilation caused by amlodipine starts slowly, rarely has an acute hypotension report after oral use. Do not start treating with Exforge HCT in patients with aortic stenosis or secondary valve stenosis or obstruction of myocardial disease.
If excessive hypotension occurs with Exforge HCT, the patient should be placed in the back position and if necessary, intravenously salted salt solution. A transient hypotension response is not contraindicated for additional treatment but often can continue to have difficulty when blood pressure has stabilized.
Increased angina and/or myocardial infarction
Increased angina and acute myocardial infarction may appear after the starting dose or increase the dose of amlodipine, especially in patients with severe coronary artery blockage.
Renal function impairment
Changes in renal function including acute renal failure can be caused by the Renin - Angiotensin and diuretic inhibitors. Patients with renal function depend partly on the activity of the Renin - Angiotensin system (for example, patients with kidney stenosis, chronic kidney disease, severe congestive heart failure or decreased volume) may be especially at risk of developing acute renal failure when using Exforge HCT. Periodic monitoring of kidney function in these patients. Consider to withdraw or stop treatment in patients with clinical reduced renal function when using Exforge HCT.
Avoid the use of Angiotensin receptor blockers (ARB) - including Valsartan - or enzyme inhibitors Angiotensin (ACEI) with Aliskiren in patients with severe renal impairment (Filter speed of glomerular kidney
heart failure
Exforge HCT has not been studied in heart failure patients.
Studies with amlodipin: In general, it is necessary to monitor closely when using calcium channel blockers, including closely monitoring fluid, electrolytes, kidney function and blood pressure in patients with heart failure. Amlodipine (5 - 10 mg/day) has been studied in a control test with a placebo in 1,153 patients with heart failure III or IV degree according to the classification of the New York Heart Association (NYHA) while taking stable doses of Angiotensin (ACE), Digoxin and diuretic inhibitors.
Need to monitor at least 6 months, on average about 14 months. There is no adverse effect in general about the survival rate or the incidence of heart disease (as determined by life -threatening arrhythmia, acute myocardial infarction or hospitalized due to deteriorating heart failure). Amlodipin has been compared to the placebo in 4 studies from 8 to 12 weeks in patients with heart failure II/III according to NYHA's classification, including a total of 697 patients. In these studies, there is no evidence of worsening heart failure based on NYHA's exertion and classification assessments, the symptoms or the left ventricular emulsion (LVEF).
Studies with Valsartan: Some patients with heart failure have developed hyperuremia, creatinine and serum potassium when using Valsartan. These effects are often light, transient and more likely to occur in patients with renal failure. The dose and/or diuretic are required and/or valsartan.
In Valsartan tests in heart failure, of which 93% of patients are used simultaneously with Angiotensin (ACE) enzyme inhibitors, the treatment has been stopped due to increased creatinine or potassium (a total of 1.0% when taking valsartan compared to 0.2% when placebo). In Valsartan tests in acute myocardial infarction (Valiant), the stop treatment due to different types of renal dysfunction occurs in 1.1% of patients treated with Valsartan and 0.8% of patients treated with captopril. The assessment of patients with heart failure or after myocardial infarction must always include kidney function assessment.
Hypersensitivity reaction
Hypersensitivity reaction to hydrochlorothiazid may occur in patients with or without a history of allergies or bronchial asthma, but there is a lot of likelihood in patients with this history.
System Reds
There has been reports on thiazid diuretics that cause acadive or systematic lupus erythematosus.
Interaction with lithium
generally should not use lithium with thiazid.
electrolyte and metabolic imbalance
Amlodipin - Valsartan - Hydrochlorothiazid:
In an Exforge HCT test with a control of average to severe hypertension, the rate of reduced potassium (serum potassium Ratio of hyperkalemia (serum potassium> 5.7 MEQ/l) is 0.4% with Exforge HCT compared to 0.2 - 0.7% with double treatment. Periodically monitor electrolytes in serum based on the use of Exforge HCT and other factors such as kidney function, other drugs or a history of electrolyte imbalance.
hydrochlorothiazide
hydrochlorothiazid may cause hypotension and hypoglycocytes. Reducing blood magnesium can lead to hypokalemia, which seems difficult to treat despite adequate potassium. The Renin - Angiotensin inhibitors can cause hyperkalemia. Periodic monitoring of electrolytes in serum.
If hypotension is accompanied by clinical signs (for example, muscle weakness, mild paralysis or changes on the electrocardiogram (ECG)), the Exforge HCT must be stopped. Recommendation of adjusting blood potassium and any hypoglycemia that coexist before starting thiazid.
hydrochlorothiazid may change glucose tolerance and increase cholesterol and triglycerides in serum.
Hydrochlorothiazid may increase the concentration of uric acid in serum due to reducing the clearance of uric acid, which can cause or worsen uric acid hyperkemis and promote gout in sensitive patients.
hydrochlorothiazid reduces the secretion of calcium in the urine and can increase serum calcium. Calcium concentration should be monitored in patients with hypercalcemia when using Exforge HCT.
acute myopia and secondary closed angle
Hydrochlorothiazid is a sulfonamid that can cause a specific reaction, leading to an acute transient myopia and acute angle glaucoma. Symptoms include an acute onset of vision or eye pain and usually occur within hours to a few weeks when starting the medication. The untreated closed angle Glaucoma can lead to permanent vision loss. The initial treatment is to stop hydrochlorothiazid as quickly as possible. It may be necessary to consider medical or surgical treatments immediately, if you still do not control the pressure in the eye. Risk factors for development of acute angle glaucoma may include a history of allergy to sulfonamid or penicillin.
The ability to drive and operate machinery
There has been no research on impact on the ability to drive and use machinery. When driving or using machines, it can sometimes occur dizziness or fatigue.
The period of pregnancy and lactation
as well as any other drug will directly affect the Renin - Angiotensin - Aldosteron (RAAS) system, not to use Exforge HCT in women intending to get pregnant. Health experts who prescribe any drugs on the RAAS system should advise women who are likely to be pregnant about the potential risk of these drugs during pregnancy.
Pregnant women
As with any other drug, it will directly impact on the Renin - Angiotensin - Aldosterone (RAAS) system, not to use Exforge HCT in pregnant women. Due to the mechanism of action of Angiotensin II antagonists, the risk is not excluded. The use of angiotensin (ACE) transferring enzyme inhibitors (is a specific group of effective drugs on the Renin - Angiotensin - Aldosteron) system for pregnant women in the three months between and the last 3 months of pregnancy which has been reported to cause damage and developing pregnancy.In addition, according to rescue data, the use of angiotensin transferring enzymes in the first 3 months of pregnancy is associated with the potential risk of birth defects. Hydrochlorothiazid passes through the placenta. There have been a report on natural miscarriage, little amniotic fluid and kidney dysfunction in newborns when pregnant women accidentally use Valsartan.
There is no enough clinical data with amlodipine in pregnant women. Studies with amlodipine on animals show that toxicity for reproduction at an 8 times the maximum dose recommended for humans is 10 mg. Unknown risk for people.
Infection in the uterus with thiazid diuretics, including hydrochlorothiazid associated with jaundice or platelet reduction in fetus or infant and may be associated with other side effects that occur in adults.
If you find pregnancy during treatment, Exforge HCT must be stopped as soon as possible.
Breastfeeding period
It is unclear whether Valsartan and/or Amlodipin are excreted into breast milk or not. Valsartan excreted the milk of breastfeeding rats. Hydrochlorothiazid is excreted in breast milk. So do not recommend Exforge HCT for women who are breastfeeding.Reproduction
There is no information on the effects of amlodipin, valsartan or hydrochlorothiazid on human fertility. Rat studies do not show any effects of amlodipine, valsartan or hydrochlorothiazid on fertility.
Special subjects (elderly, children, allergies)
Elderly patients (from 65 years of age)
No need to adjust the starting dose for elderly patients aged 65 and older. It is advisable to consider starting with the lowest dose of amlodipine. The minimum content of Exforge HCT contains 5 mg of amlodipine.
Patients with children (under 18 years old)
It is not recommended to use Exforge HCT for patients under 18 years of age due to lack of data on safety and efficiency.
kidney failure
Due to the hydrochlorothiazid component, anti -contraindicated use of Exforge HCT in patients with auria and should be cautious when used in patients with severe kidney disease (glomerular filtration speed (GFR)
Hepatic failure
Due to the components of Valsartan, hydrochlorothiazid and amlodipine, it is necessary to be careful when using Exforge HCT for patients with liver failure or with biliary obstruction disorders. It is advisable to consider starting with the lowest dose of amlodipine. The minimum content of Exforge HCT contains 5 mg of amlodipine.
Drug interaction
valsartan - hydrochlorothiazide
The following drug interactions may appear due to both ingredients (valsartan and/or hydrochlothiazid) of Exforge HCT:
Lithium: Increasing blood lithium concentration can be reversed and toxic has been reported when used simultaneously lithium with ACE inhibitors, Angiotensin II receptor resistant or thiazids. Because lithium's renal clearance decreases due to thiazids, the risk of toxicity of lithium can be increased with Exforge HCT. Therefore, careful monitoring of blood lithium concentration during the recommended coordination treatment process.
amlodipin
simvastatin: simultaneously use simvastatin with amlodipine increases the concentration of simvastatin. The limit for simvastatin on patients taking amlodipine is 20 mg a day.
CYP3A4 inhibitor: When used simultaneously with CYP3A4 inhibitors (average and strong level), increase the concentration of amlodipine and may need to reduce the dose of amlodipine. Need to monitor the symptoms of hypotension and edema when using amlodipine along with CYP3A4 inhibitors to determine the need to adjust the dose. Grapefruit juice: Amlodipine concentration may increase when used simultaneously with grapefruit juice due to CYP3A4 inhibitors. However, the simultaneous use of 240 ml of grapefruit juice with a single dose of 10 mg amlodipine on 20 healthy volunteers has no significant effect on amlodipine pharmacokinetics.
CYP3A4 induction: There is no information on the influence of CYP3A4 induction substances on Amlodipin. Blood pressure monitoring should be monitored when used simultaneously amlodipine with CYP3A4 touch substances.
In single therapy, amlodipin is safe when used with thiazid diuretics, beta blockers, angiotensin transfer enzymes, prolonged nitrates, nitroglycerin under the tongue, Digoxin, Warfarin, Atorvastatin, Sildenafil, Maalox (Hydroxide aluminum aluminum, Gel Magenes, MagnesiDi Simeticone), cimetidine, nonsteroidal anti -inflammatory drugs, antibiotics and drugs that reduce oral blood glucose.
valsartan
The following drug interactions may appear due to Valsartan, ingredients of Exforge HCT:
Potassium: Caution should be careful when used with potassium supplements, potassium diuretics, salt replacement substances containing potassium or other drugs that can increase potassium levels (such as heparin, etc.) and should regularly monitor potassium concentration.
Non -steroid anti -inflammatory drugs (NSAID) include selective inhibitors Cycloxygenase - 2 (COX - 2 inhibitors): When using Angiotensin II antagonists simultaneously with NSAID drugs, the reduction of possible hypotension may occur. Moreover, in elderly patients, decreased volume (including patients treated with diuretics), or kidney function damage, simultaneous use of Angiotensin II and NSAID antagonists can lead to an increased risk of severe kidney failure. Therefore, it is recommended to monitor kidney function when starting or when changing treatment in patients using Valsartan simultaneously with NSAID.
Transport agent: The result from an in vitro study with human liver tissue shows that Valsartan is an OatP1B1 substrate that is the transportation of drugs into the liver and the substrate of MRP2 is the transportation of drugs out of the liver. Use a combination of inhibitors inhibitors (for example: rifampin, ciclosporin) or transportation (for example: ritonavir) may increase the body contact level with Valsartan.
In single therapy with Valsartan, no clinical drug interactions have not been seen when used with the following drugs: Cimetidin, Warfarin, Furosemid, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazid, Amlodipin, Glibennclamid.
hydrochlorothiazide
The following drug interactions may appear due to hydrochlorothiazid, ingredients of Exforge HCT:
Other anti -hypertension drugs: Thiazids have strengthened the anti -hypertension effect of other anti -hypertension drugs (e.g. guanethidin, methyldopa, beta blockers, vasodilators, calcium channel blockers, angiotensin transferring enzymes, angiotensin receptor blockers (ARB) and direct lenin inhibitors (DRIS)).
Mechanical relaxants: Thiazids, including hydrochlorothiazid, strengthen the muscle relaxation effect as the derivatives of curare.
Medications that affect serum potassium concentration: The effect of reducing potassium potassium of diuretics can increase due to simultaneous use with diuretics to excrete potassiumuria, corticosteroids, actheric, amphoticin, carbenoxolon, penicillin g, derivatives of salicylic acid or anti -arrhythmia.
Medications that affect serum sodium levels: The effect of reducing sodium hemorrhage of diuretics may increase due to simultaneous use with drugs such as antidepressants, anti -psychotic drugs, anti -epileptic drugs, etc.
anti -diabetic drugs: Thiazids can change glucose tolerance. The insulin dose may be adjusted and oral diabetes treatments.
glycoside digitalis: Hypotension or reduction of blood magnesium due to thiazid may occur in the form of unwanted effects, making it easy to develop rhythmic due to digitalis.
Non -steroid anti -inflammatory (NSAID) and COX - 2 inhibitors: simultaneously use with NSAIDs (for example, salicylic acid, indomethacin derivatives that can weaken the diuretics and anti -hypertension of the thiazid ingredient in Exforge HCT. Reducing blood volume at the same time can cause acute renal failure.
Allopurinol: Concomitance with thiazid diuretics (including hydrochlorothiazid) may increase the hypersensitivity reaction rate with allopurinol.
Amantadin: Concomitant use with thiazid diuretics (including hydrochlorothiazid) may increase the risk of Amantadin side effects.
Anti -born anti -tumor drugs (for example, cyclophosphamide, methotrexate): simultaneously used with thiazid diuretics can reduce the excretion of kidney -toxic toxicity drugs and enhance the inhibition effect.
anti -cholinergic drugs: The bioavailability of thiazid diuretics may be increased by anti -cholinergic drugs (e.g. atropine, biperiden), which seemed to be due to reduced stomach - intestinal motility and stomach empty speed. In contrast, peristalsis support (Prokinetic) such as Cisaprid can reduce the bioavailability of thiazid diuretics.
Resin ion exchange: The absorption of thiazid diuretics, including hydrochlorothiazid, is reduced by cholestyramine or colestipol. However, alternating doses of hydrochlorothiazid and resin by using hydrochlorothiazid at least 4 hours before or 4-6 hours after using resin will be able to minimize interaction.
Vitamin D: Using thiazid diuretics, including hydrochlorothiazid, with vitamin D or calcium salts, can increase serum calcium.
ciclosporin: Concomitant treatment with ciclosporin may increase the risk of increased blood uric acid and gout complications.
Calcium salt: Concomitant use with thiazid diuretics can lead to hypercalcemia due to increased calcium reabsorption in the renal tubules.
diazoxide: thiazid diuretics can increase the effect of hyperglycemia of diazoxide.
Methyldopa: There is a report in hemolytic anemia occurring when using simultaneously hydrochlorothiazid and methyldopa.
Alcohol, barbiturat or sleeping pills: Concomitance thiazid diuretics with alcohol, barbiturates or sleeping pills can increase the vertical hypotension.
Vasoma amines: hydrochlorothiazid can reduce response to vascular amines like noradrenalin. The clinical significance of this effect is unknown and not enough to prevent them from using them.
Storage
Do not store over 30 ° C, avoid moisture. Keep the medicine in the original packaging.
Do not use Exforge HCT Expiring expiry date is written "exp" on the packaging.
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