Amlodipine, Irbesartan
Sanofi-aventis
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2019-09-19
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Clinical Pharmacology
Pharmacodynamic properties of each of the active substances that make up the drug Aprovac®, irbesartan and amlodipine, contribute to their additive antihypertensive effect when used in combination as compared to those for the use of each of these drugs separately. Both angiotensin II receptor antagonists (ARA II) and slow calcium channel blockers reduce blood pressure by reducing the peripheral resistance of blood vessels, blocking calcium in the cell and reducing the angiotensin II caused by exposure to vasoconstrictor effects that complement each other.
Irbesartan
Irbesartan is a highly selective selective APA II (subtype AT1). Angiotensin II is an important component of the RAAS, which is involved in the pathophysiology of the development of arterial hypertension and in the homeostasis of sodium ions. Irbesartan does not need metabolic activation to manifest its action.
Irbesartan blocks a strong vasoconstrictor and aldosterone-secreting action of angiotensin II due to selective antagonism of angiotensin II receptors (subtype AT1), located in the smooth muscle cells of the vessels and adrenal cortex. Irbesartan has no agonistic activity towards AT1-receptors. Its affinity for AT1-receptors 8500 times more than to AT2-receptors (receptors that have not been shown to link with the maintenance of equilibrium [homeostasis] of the cardiovascular system).
Irbesartan does not inhibit RAAS enzymes (such as renin, ACE), and does not affect other hormonal receptors or ion channels in the cardiovascular system, which are involved in the regulation of blood pressure and sodium ion homeostasis. Blockade with Irbesartan AT1-receptors break the feedback loop in the renin-angiotensin system, increasing plasma concentrations of renin and angiotensin II. When using irbesartan, the plasma concentration of aldosterone is reduced, however, when using the drug in recommended doses, there is no significant change in the serum potassium content (the average increase in serum potassium is less than 0.1 mEq / l). Irbesartan has no significant effect on the concentration of triglycerides, cholesterol or glucose in serum. Irbesartan does not affect the serum concentrations of uric acid or the excretion of uric acid by the kidneys.
The antihypertensive effect of irbesartan develops after taking the first dose and becomes significant within 1–2 weeks of treatment, with a maximum effect occurring after 4–6 weeks. In long-term observational studies, the effect of irbesartan persisted for more than 1 year.
A single dose of irbesartan in doses up to 900 mg / day caused a dose-dependent decrease in blood pressure. A single dose of irbesartan in doses of 150-300 mg / day led to a greater decrease in systolic (AAD) / diastolic (DBP) blood pressure (24 hours after a dose) in the supine or sitting position (an average of 8-13 / 5-8 mm Hg. Art.), than that when receiving a placebo. The effect of the drug 24 hours after the dose was 60-70% of the corresponding maximum reduction in DBP and SBP. Optimum efficacy in reducing blood pressure within 24 hours is achieved with a single dose of the drug per day.
BP decreases to approximately the same degree in standing and lying. The orthostatic effect is rare, and, as with the use of ACE inhibitors, its occurrence can be expected in patients with hyponatremia or hypovolemia.
The antihypertensive effect of irbesartan and thiazide diuretics is additive. In patients who fail to achieve the target BP values with monotherapy with irbesartan, adding small doses of hydrochlorothiazide (12.5 mg) to the administration of irbesartan 1 time / day results in an additional (compared to the placebo effect) reduction of GARDEN / DBP determined after 24 hours after taking them, at 7-10 / 3-6 mm Hg. Art., respectively.
Age and gender do not affect the effectiveness of irbesartan. As in the case of treatment with other drugs that affect the RAAS, patients of the Negroid race have a weaker antihypertensive effect in monotherapy with irbesartan. When irbesartan is taken with small doses of hydrochlorothiazide (for example, 12.5 mg / day) the antihypertensive effect in patients of the Negroid race approaches that in patients of the Caucasian race.
After the abolition of irbesartan, blood pressure gradually returns to its original level. Withdrawal when discontinuing irbesartan was not observed.
Amlodipine
Amlodipine is a blocker of slow calcium channels from the group of dihydropyridine derivatives, which inhibits the transmembrane entry of calcium ions into the cells of the myocardium and vascular smooth muscle. The mechanism of antihypertensive action of amlodipine is associated with a direct relaxing effect on vascular smooth muscle.
The exact mechanism by which amlodipine reduces the frequency and severity of angina attacks is not fully established, but amlodipine reduces myocardial ischemia due to the two effects listed below.
1) Amlodipine expands peripheral arterioles and due to this reduces round focal disease, the so-called afterload. Since The heart rate when taking amlodipine practically does not increase, this decrease in the load on the heart muscle reduces the energy consumption of the myocardium and its need for oxygen.
2) The mechanism of the antianginal action of amlodipine is also apparently associated with the expansion of the main coronary arteries and coronary arterioles, both in myocardial zones with normal blood flow and in ischemic myocardial zones. This expansion of the coronary vessels increases the delivery of oxygen to the myocardium in patients with spasm of the coronary arteries (with Prinzmetal angina pectoris or variant angina pectoris).
In patients with arterial hypertension, taking amlodipine once a day provides a clinically significant reduction in blood pressure while lying down and standing for 24 hours. Due to the slow onset of its action, amlodipine is not intended to relieve hypertensive crises.
In patients with angina pectoris, amlodipine is taken once a day during exercise with exercise, which increases the total time for exercise, the time before the onset of angina pectoris and the time before the appearance of ST-segment depression on an ECG of 1 mm depth. In addition, taking the drug reduces the daily number of strokes and the daily need for taking nitroglycerin pills.
When taking amlodipine, no undesirable metabolic effects or changes in blood lipid concentrations were observed. Amlodipine can be prescribed to patients with asthma, diabetes and gout.
Clinical evidence of the efficacy of a combination of fixed-dose irbesartan and amlodipine was obtained in two multicenter, prospective, open-label studies of parallel groups with a blind assessment of performance indicators: the I-ADD and I-COMBINE studies. The results of both studies demonstrated a significantly greater efficacy of combinations with fixed doses of irbesartan and amlodipine compared with amlodipine monotherapy or irbesartan monotherapy.
Indications
Arterial hypertension (with the ineffectiveness of monotherapy with irbesartan or amlodipine).
Composition
Excipients: microcrystalline cellulose 50 microns - 132 mg, croscarmellose sodium - 24 mg, hypromellose 6 mPa.s - 10 mg, microcrystalline cellulose 100 microns - 10 mg, silicon dioxide - 5 mg, magnesium stearate - 5 mg.
The composition of the film shell: white opadry (hypromellose - 62.5%, titanium dioxide (E171) - 31.25%, macrogol 400 - 6.25%) - 20 mg.
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Dosage and Administration
The drug is taken orally. The pill is swallowed with water. Aprovasc® can be taken both simultaneously with a meal, and on an empty stomach (ie, regardless of the time of the meal).
Usually the initial and maintenance dose of the drug Aprovsk® - 1 tab. / Day. Aprovasc® should be used in patients who fail to achieve the target values of blood pressure in monotherapy with irbesartan or monotherapy with amlodipine, or to continue treatment of patients already taking irbesartan and amlodipine in the form of separate pills. Doses should be selected individually, first with the use of individual drugs irbesartan and amlodipine. Doses are selected depending on the response of blood pressure to the therapy and the target value of blood pressure. The maximum recommended dose of the drug Aprovsk® is 150 mg / 10 mg or 300 mg / 10 mg per day (due to the fact that the maximum daily dose of amlodipine is 10 mg).
As a rule, elderly patients and u patients with impaired renal function dose reduction is not required.
Have patients with impaired liver function Aprovasc® should be used with caution, due to the presence in the composition of the drug amlodipine.
Adverse reactions
The frequency of adverse events / reactions (AE / HP) reported in clinical studies on the use of a combination with fixed doses of irbesartan and amlodipine (clinical studies I-ADD, I-COMBINE and I-COMBO), in clinical studies on the use of irbesartan and its post-marketing use, as well as in clinical studies on the use of amlodipine, was determined according to the WHO classification as follows: very often (≥ 10%); often (≥ 1% and <10%); infrequently (≥ 0.1% and <1%); rarely (≥ 0.01% and <0.1%); very rarely (<0.01%), the frequency is unknown - according to the available data it is impossible to estimate the frequency of occurrence of AE / HP.
The frequency of HP reported in post-marketing use of the drug was defined as “frequency unknown”, since information about these HPs came from spontaneous reports, without specifying the number of patients taking the drug.
In clinical studies, compared with fixed-dose combinations of irbesartan / amlodipine with irbesartan or amlodipine monotherapy, the types and frequency of adverse events that occurred during treatment, possibly related to the treatment being studied, were similar to those seen in previous clinical studies or post-marketing messages monotherapy with irbesartan and amlodipine. The most common AEs were peripheral edema, mainly associated with amlodipine.
Adverse events observed during treatment and possibly associated with the study drug in clinical studies of irbesartan / amlodipine (I-ADD, I-COMBINE and I-COMBO)
Irbesartan / Amlodipine Fixed Combination
General reactions: often - peripheral edema, edema; infrequently - asthenia.
On the part of the organ of hearing and labyrinth disorders: infrequently - vertigo.
Since the cardiovascular system: often - palpitations, orthostatic hypotension; infrequently - sinus bradycardia, excessive decrease in blood pressure.
From the nervous system: often - dizziness, headache, drowsiness; infrequently - paresthesia.
From the reproductive system: infrequently - erectile dysfunction.
On the part of the respiratory system: Infrequently - cough.
From the digestive system: often - swelling of the gums; infrequently - nausea, pain in the upper abdomen, constipation.
From the urinary system: often - proteinuria; infrequently - azotemia, hypercreatinemia.
Metabolism: infrequently - hyperkalemia.
From the musculoskeletal system: infrequently - joint stiffness, arthralgia, myalgia.
Adverse events observed with the use of irbesartan in clinical studies (including clinical studies I-ADD, I-COMBINE and I-COMBO) and during its post-marketing use
On the part of the immune system: frequency unknown - hypersensitivity reactions (allergic reactions), incl. angioedema, urticaria.
Metabolism: frequency unknown hyperkalemia.
On the part of the organ of hearing and labyrinth disorders: often vertigo; frequency is unknown - tinnitus.
From the nervous system: often - dizziness, headache *; infrequently - orthostatic dizziness.
* The incidence of headache in the I-ADD, I-COMBINE and I-COMBO studies was rated “infrequently”.
Since the cardiovascular system: infrequently - tachycardia.
Skin and Subcutaneous Tissues: frequency is unknown - leukocytoclastic vasculitis.
On the part of the respiratory system: Infrequently - cough.
From the digestive system: often - nausea / vomiting, pain in the upper abdomen, abnormalities in the tongue, including dysgeusia (taste perversion), glossodynia (burning sensation and soreness in the tongue), glossitis (tongue inflammation); infrequently - diarrhea, dyspepsia, heartburn; frequency is unknown - jaundice, increased liver function tests, hepatitis.
Skin and Subcutaneous Tissues: infrequently - alopecia.
From the musculoskeletal system: frequency unknown - myalgia.
From the urinary system: unknown frequency - impaired renal function, including isolated cases of renal failure in patients with risk factors for its development.
From the reproductive system: infrequently - erectile dysfunction.
General reactions: often - increased fatigue *, edema; infrequently - chest pain; frequency is unknown - asthenia.
* The incidence of fatigue in the I-ADD, I-COMBINE, and I-COMBO studies was rated as “infrequent”.
Injuries, intoxications and complications of manipulations: infrequently - falls.
Adverse events observed with amlodipine in clinical trials (including clinical studies I-ADD, I-COMBINE and I-COMBO)
From the hemopoietic system: very rarely - thrombocytopenia.
On the part of the immune system: very rarely - allergic reactions, incl. angioedema, urticaria.
Metabolism: very rarely - hyperglycemia.
Mental Disorders: infrequently - insomnia, lability of mood.
From the nervous system: often - dizziness, headache *, drowsiness; infrequently - hypoesthesia, paresthesia, tremor, taste perversions, syncopal states; very rarely, peripheral neuropathy.
* The incidence of headache in I-ADD, I-COMBINE and I-COMVO was assessed as “infrequent”.
On the part of the organ of vision: infrequently - visual disorders.
On the part of the organ of hearing and labyrinth disorders: infrequently - ringing in the ears, vertigo.
Since the cardiovascular system: often - a feeling of heartbeat, "flush" of blood to the skin with a sense of heat, redness of the skin *; very rarely - myocardial infarction, cardiac arrhythmias, ventricular tachycardia and atrial fibrillation (atrial fibrillation), vasculitis.
* The incidence of reddening of the skin in the I-ADD, I-COMBINE and I-COMBO studies was rated as “infrequent”.
On the part of the respiratory system: often cough; infrequently - shortness of breath, rhinitis; very rarely - coughing.
From the digestive system: often - nausea, abdominal pain, glossy, glossitis; infrequently - dyspepsia, vomiting, changes in the rhythm of defecation, dry mucous membranes of the mouth; very rarely - pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice and increased activity of liver enzymes (mainly associated with cholestasis).
Skin and Subcutaneous Tissues: often - contact dermatitis; infrequently - skin rash, itching, purpura, increased sweating, changes in skin pigmentation (the appearance of discolored skin), alopecia; very rarely - erythema multiforme.
From the musculoskeletal system: infrequently - arthralgia, muscle cramps, myalgia, back pain.
From the urinary system: infrequently - an increase in the frequency of urination, painful urge to urinate, nocturia.
From the reproductive system: infrequently - impotence, gynecomastia.
General reactions: often - increased fatigue, edema *, peripheral edema; infrequently - chest pain, asthenia, malaise, pain; rarely - swelling of the face.
* According to I-ADD, I-COMBINE and I-COMBO studies, the frequency of occurrence of edema is "infrequent."
Laboratory and instrumental data: infrequently - weight gain, weight loss.
Contraindications
Carefully:
In patients with hypovolemia and hyponatremia, arising, for example, with intensive treatment with diuretics, hemodialysis, diet with restriction of salt intake, diarrhea, vomiting.
In patients whose kidney function depends on the activity of the RAAS (such as patients with arterial hypertension with stenosis of the renal artery of one or both kidneys, patients with chronic heart failure of the III-IV functional class according to NYHA classification), treatment with drugs affecting the RAAS, was associated with the development of oliguria and / or progressive azotemia and rarely acute renal failure and / or death, the risk of which cannot be excluded when taking APA II, including irbesartan).
In patients with chronic heart failure II-IV functional class according to the NYHA classification of non-ischemic etiology (due to the content of amlodipine in the composition, the use of which in these patients was associated with an increase in reports of the development of pulmonary edema compared to taking placebo, despite the absence of differences in frequency of progression of heart failure).
In patients with hepatic impairment (risk of increasing T1/2 amlodipine).
In patients with renal insufficiency and after kidney transplantation (due to the content of irbesartan in the composition, it is recommended to control the content of potassium and the concentration of creatinine in the blood); after a recent kidney transplant (lack of experience with the clinical use of irbesartan).
In patients with aortic and mitral valve stenosis or hypertrophic obstructive cardiomyopathy (GOKMP).
Patients with coronary artery disease and / or clinically significant atherosclerosis of the cerebral vessels (with an excessive decrease in blood pressure there is a risk of increased ischemic disorders, up to the development of acute myocardial infarction and stroke).
In patients with SSSU (due to the content of amlodipine in the composition of the drug).
Drug interactions
Combination of irbesartan and amlodipine
Based on pharmacokinetic studies in which irbesartan and amlodipine were taken separately and in combination, there were no pharmacokinetic interactions between irbesartan and amlodipine.
No studies have been conducted on drug interaction of the drug Aprovasc® with other drugs.
Irbesartan
Based on in vitro research, one should not expect any interaction with drugs whose metabolism is carried out with the participation of isoenzymes: CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1 or CYP3A4.
Irbesartan is predominantly metabolized with the participation of CYP2C9 isoenzyme, however, during clinical interaction studies, when irbesartan was administered simultaneously with warfarin, which is metabolized by the CYP2C9 isoenzyme, no significant pharmacokinetic interaction was observed.
The pharmacokinetic parameters of irbesartan do not change when used simultaneously with nifedipine and hydrochlorothiazide.
Irbesartan does not alter the pharmacokinetics of simvastatin, which is metabolized by the isoenzyme CYP3A4, or digoxin (a substrate of P-glycoprotein).
Combination drug Aprovasc® with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or moderate and severe renal failure (GFR <60 ml="" min="" 1="" 73="" m="" sup="" gt="" 2="" body="" surface="" and="" is="" not="" recommended="" in="" other="" patients="" --60--="">
Use of the drug Aprovasc® in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended for other patients.
Based on the experience of using other drugs that affect the RAAS, the simultaneous use of potassium-saving diuretics, potassium preparations, or potassium-containing salts may increase the serum concentration of potassium.
In elderly patients, patients with hypovolemia (due to diuretic administration) or with impaired renal function, simultaneous use of NSAIDs, including selective COX-2 inhibitors in conjunction with ARA II, including irbesartan, can lead to deterioration of renal function, including the development of acute renal failure. These effects are usually reversible. Kidney function should be periodically monitored in patients who simultaneously take ARA II and NSAIDs, including selective COX-2 inhibitors.
Against the background of the combined use of irbesartan with lithium preparations, an increase in plasma lithium concentration and the toxic effect of lithium was described. In patients taking irbesartan in conjunction with lithium preparations, plasma concentrations of lithium should be monitored.
Amlodipine
Amlodipine was safely combined with thiazide diuretics, beta-blockers, alpha-blockers, ACE inhibitors, long-acting nitrates, nitroglycerin for sublingual use, NSAIDs, antibiotics and hypoglycemic agents for oral administration.
Data in vitro studies with human blood plasma have shown that amlodipine does not affect the binding of plasma proteins of digoxin, phenytoin, warfarin or indomethacin.
The simultaneous administration of amlodipine and cimetidine did not violate the pharmacokinetics of amlodipine.
The simultaneous intake of 250 mg of grapefruit juice with a single dose of amlodipine 10 mg in 20 healthy volunteers did not have a significant effect on the pharmacokinetics of amlodipine.
When combined with amlodipine and sildenafil, each of the drugs independently showed its effect of reducing blood pressure.
Simultaneous course administration of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg resulted in unreliable changes in the pharmacokinetic parameters of atorvastatin in the state of achievement Css.
Simultaneous administration of amlodipine with digoxin did not change the concentration of digoxin in the blood serum or the renal clearance of digoxin in healthy volunteers.
Simultaneous administration of amlodipine and did not change the prothrombin time while taking warfarin.
Pharmacokinetic studies with cyclosporine have demonstrated that amlodipine does not have a significant effect on the pharmacokinetics of cyclosporine.
Pregnancy and Lactation
There are insufficient and well-controlled studies of the use of the drug Aprovasc.® in pregnant women. The effect on the fetus of ACE inhibitors, which were taken by pregnant women in the second and third trimesters of pregnancy, caused damage and death of the developing fetus. Like any other drugs that directly affect the RAAS, Aprovsk® contraindicated in pregnancy.
Aprovasc® should not be used in women of childbearing age who do not use effective methods of contraception. If pregnancy is detected during treatment with Aprovasc®should stop taking it as soon as possible.
Aprovasc® contraindicated during breastfeeding.
AT preclinical studies when administered orally to pregnant rats from day 0 to day 20 of gestation of irbesartan at doses> 50 mg / kg body weight / day (which, when calculated per kg of body weight, is approximately equivalent to the maximum recommended dose of irbesartan in man [mrdi] of 300 mg / day) transient rat effects (slight or moderate dilatation of the renal pelvis, hydroureter, and / or absence of the renal papillae) were observed in the fetuses of rats.Oral administration of irbesartan in doses of ≥180 mg / kg body weight / day (approximately equivalent to 4 × MRDICH in terms of kg of body weight) pregnant rats developed a subcutaneous edema from day 20 to day 20 of gestation. Since these developmental disorders were not observed with limited oral administration of irbesartan at doses of 50, 150 and 450 mg / kg of body weight / day to pregnant rats from 6 to 15 days of gestation, they are apparently the late gestational effects of irbesartan. In rabbits, the use of irbesartan at a dose of 30 mg / kg body weight / day was associated with maternal mortality and abortion. Surviving females who received a dose equivalent to 1.5 × MRDIC when calculated per kg of body weight had a slight increase in fetal resorption and, accordingly, a decrease in the number of live fetuses in the litter. Irbesartan was found to cross the placental barrier in rats and rabbits. In rats and rabbits no teratogenic effect of amlodipine was detected.
Special instructions
Excessive reduction in blood pressure: patients with hypovolemia and hyponatremia
Irbesartan rarely caused an excessive decrease in blood pressure in patients with arterial hypertension without another concomitant pathology. As with the use of ACE inhibitors, an excessive decrease in blood pressure with appropriate symptoms in patients with hypovolemia and hyponatremia, which include patients undergoing intensive diuretic therapy, and / or patients with restrictions on the consumption of salt or hemodialysis patients can be expected. Hyponatremia and hypovolemia should be adjusted before starting treatment with Aprovasc® or should consider the use of the drug in lower initial doses.
Patients with chronic heart failure
In a long-term placebo-controlled study (PRAISE-2) of amlodipine in patients with chronic heart failure of the III-IV functional class (according to NYHA classification) of non-ischemic etiology, amlodipine was associated with an increase in reports of pulmonary edema, despite the absence of a significant difference in the rate of progression of heart failure compared to placebo.
Liver failure
As with other slow calcium channel blockers, T1/2 amlodipine is increased in patients with impaired liver function, and recommendations for its dosing regimen for abnormal liver function have not been established. Therefore, the drug Aprovasc® should be used with caution in these patients.
Hypertensive crisis
Safety and efficacy of Aprovasc® with hypertensive crisis not established.
Impact on kidney function
Due to inhibition of the RAAS, changes in renal function can be expected in susceptible patients. In patients whose kidney function depends on the activity of the RAAS (patients with arterial hypertension with stenosis of the renal artery of one or both kidneys or patients with chronic heart failure of the III-IV functional class [according to the NYHA classification]), treatment with other drugs that affect the RAAS , has been associated with the development of oliguria and / or progressive azotemia, and rarely with renal failure and / or death. It is impossible to exclude the possibility of such an effect when using APA II, including irbesartan.
Double blockade of RAAS in combination with the drug Aprovasc® with aliskiren-containing drugs and an ACE inhibitor
Double blockade of RAAS when using a combination of the drug Aprovasc® with an ACE inhibitor or aliskiren is not recommended, because there is an increased risk of developing a sharp decrease in blood pressure, hyperkalemia and impaired renal function.
In patients with diabetes or renal failure, moderate and severe (with GFR <60 ml="" min="" 1="" 73="" m="" sup="" gt="" 2="" body="" surface="" use="" of="" the="" drug="" aprovasc="">® in combination with aliskiren contraindicated.
Use of the drug Aprovasc is contraindicated in patients with diabetic nephropathy® in combination with ACE inhibitors.
Use in elderly patients
In clinical studies, there was no difference in the efficacy or safety of irbesartan in elderly patients (65 years and older) compared with younger patients.
Use in Pediatrics
Safety and efficacy in children have not yet been established.
Influence on ability to drive motor transport and control mechanisms
The effect of the drug Aprovasc® The ability to drive or engage in other potentially hazardous activities requiring increased attention has not been studied. However, based on the pharmacodynamic properties, the effect of the drug Aprovsk® this ability is unlikely. In the event of dizziness, vertigo, weakness, it is not recommended to drive vehicles or engage in other potentially hazardous activities.
Overdosage
Symptoms: when adults take irbesartan in doses up to 900 mg / day, there is no toxicity.
Available data for amlodipine suggest that severe overdose can lead to severe peripheral vasodilation and, possibly, to the development of reflex tachycardia. It was reported about the development of pronounced and prolonged excessive reduction of blood pressure, up to the development of a shock with a fatal outcome.
Treatment: the patient must be under close medical supervision. Treatment should be symptomatic and maintain the basic vital functions of the body.
There is no specific information for the treatment of irbesartan overdose. Proposed measures for drug overdose Aprovasc® include gastric lavage. The intake of activated carbon by healthy volunteers immediately after or 2 hours after ingestion of 10 mg of amlodipine showed a slight decrease in the absorption of amlodipine.
Due to the fact that amlodipine is characterized by a high degree of binding to blood proteins, and irbesartan is not excreted from the body through hemodialysis, it is unlikely that hemodialysis may be useful in overdose.
In severe overdose, active monitoring of cardiac activity and respiration should begin. Frequent blood pressure measurement is necessary. A clinically significant reduction in blood pressure due to an overdose of amlodipine requires the active maintenance of cardiovascular activity, including giving an elevated position to the extremities. BCC and diuresis should be monitored. May require the introduction of vasoconstrictor drugs to restore vascular tone and blood pressure (provided there are no contraindications to their introduction). In / in the introduction of calcium gluconate may be useful in eliminating the effects of calcium channel blockade.
- Brand name: Aprovasc
- Active ingredient: Amlodipine, Irbesartan
- Dosage form: pills, film coated white, oval, biconvex, with risk and bevel to risk on one side.
- Manufacturer: Sanofi-aventis
- Country of Origin: Mexico
Studies and clinical trials of Amlodipine, Irbesartan (Click to expand)
- An Asian Regional Analysis of Cost-Effectiveness of Early Irbesartan Treatment versus Conventional Antihypertensive, Late Amlodipine, and Late Irbesartan Treatments in Patients with Type 2 Diabetes, Hypertension, and Nephropathy
- The antihypertensive efficacy and safety of Irbesartan compared with amlodipine for the treatment of mild-to-moderate hypertension.
- I-COMBINE Study: Assessment of Efficacy and Safety Profile of Irbesartan/Amlodipine Fixed-Dose Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled With Amlodipine 5 mg Monotherapy: A Multicenter, Phase III, Prospective, Randomized, Open-Label With Blinded–End Point Evaluation Study
- I-ADD Study: Assessment of Efficacy and Safety Profile of Irbesartan/Amlodipine Fixed-Dose Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled With Irbesartan 150 mg Monotherapy: A Multicenter, Phase III, Prospective, Randomized, Open-Label With Blinded–End Point Evaluation Study
- PCV51 IRBESARTAN IS COST-SAVING COMPARED TO AMLODIPINE AND STANDARD BLOOD PRESSURE TREATMENT IN PATIENTS WITH TYPE 2 DIABETES, HYPERTENSION AND NEPHROPATHY IN HUNGARY
- Effects of Lisinopril, Irbesartan, and Amlodipine on the Thrombogenic Variables in the Early and Late Stages of the Treatment in Hypertensive Patients
- Irbesartan/Amlodipine: A Review of its Use in Adult Patients with Essential Hypertension Not Adequately Controlled with Monotherapy
- Irbesartan and amlodipine in the treatment of patients with microalbuminuria, hypertension and type 2 diabetes in Taiwan: a modelling projection over 25 years
- Stability Indicating RP-HPLC Studies for the Estimation of Irbesartan and Amlodipine Besylate in Pharmaceutical Formulations and Identification and Characterization of Degradants Using LC-MS
- Irbesartan but Not Amlodipine Suppresses Diabetes-Associated Atherosclerosis
- Renin Inhibition by Aliskiren Prevents Atherosclerosis Progression: Comparison With Irbesartan, Atenolol, and Amlodipine
- Therapy with the Combination of Amlodipine and Irbesartan Has Persistent Preventative Effects on Stroke Onset Associated with BDNF Preservation on Cerebral Vessels in Hypertensive Rats
- High-performance thin-layer chromatography method for estimating the stability of a combination of irbesartan and amlodipine besylate
- The therapeutic advantage of combination antihypertensive drug therapy using amlodipine and irbesartan in hypertensive patients: analysis of the post-marketing survey data from PARTNER (Practical combination therapy of Amlodin and angiotensin II Receptor blocker; Safety and efficacy in patients with hypertension) study
- Comparison of monotherapy with irbesartan 150 mg or amlodipine 5 mg for treatment of mild-to-moderate hypertension.
- Amlodipine/irbesartan
- Effect of combination tablets containing amlodipine 10 mg and irbesartan 100 mg on blood pressure and cardiovascular risk factors in patients with hypertension
- Synergism of irbesartan and amlodipine on hemodynamic amelioration and organ protection in spontaneously hypertensive rats
- IRBESARTAN/AMLODIPINE FIXED COMBINATION IN PATIENTS UNCONTROLLED ON IRBESARTAN 150 MG (1-ADD STUDY)
- IRBESARTAN/AMLODIPINE FIXED COMBINATION IN PATIENTS UNCONTROLLED ON AMLODIPINE 5 MG (I-COMBINE STUDY)
- Comparative Effects of Irbesartan Versus Amlodipine on Left Ventricular Mass Index in Hypertensive Patients with Left Ventricular Hypertrophy
- Stability-indicating HPLC-DAD Method for Simultaneous Determination of Atorvastatin, Irbesartan, and Amlodipine in Bulk and Pharmaceutical Preparations
- Pharmacological and clinical properties of AIMIX^|^#174; combination tablets LD^|^amp;HD, fixed-dose combination of irbesartan and amlodipine besilate
- Effect of single-pill irbesartan/amlodipine combination-based therapy on clinic and home blood pressure profiles in hypertension with chronic kidney diseases
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