Attento tabs 5mg + 20mg #28

Attento instruction

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Composition

Core: active ingredients: olmesartan medoxomil - 40.00 mg, amlodipine besylate - 6.944 mg (in terms of amlodipine base - 5.00 mg).
Excipients: pregelatinized starch - 70 mg, microcrystalline siliconized cellulose - 72.256 mg, croscarmellose sodium - 10 mg, magnesium stearate - 0.8 mg.
Film shell: opadry II yellow 85F22093, consisting of: polyvinyl alcohol - 3.2 mg, titanium dioxide (E 171) - 1.96 mg, macrogol - 1.616 mg, talc - 1.184 mg, dye iron oxide yellow (E 172) - 0.04 mg.
Consists of 98% microcrystalline cellulose and 2% colloidal silicon dioxide.
Tablets, 5 mg + 40 mg.

Pharmacokinetics

After oral administration of Attento, the maximum concentration (Cmax) of olmesartan and amlodipine in blood plasma is achieved after 1.5-2 hours and 6-8 hours, respectively. The speed and degree of absorption of olmesartan medoxomil and amlodipine in the composition of Attento correspond to the speed and degree of absorption of these components in the form of monopreparations. Concomitant food intake does not affect the bioavailability of olmesartan medoxomil and amlodipine.
Olmesartan medoxomil.
Absorption and distribution: olmesartan medoxomil is a prodrug. It is rapidly converted to the pharmacologically active metabolite olmesartan by enzymes (esterases) in the intestinal mucosa and in the portal blood during absorption from the gastrointestinal tract. Olmesartan medoxomil in unchanged form or with an intact medoxomil fragment is not detected in blood plasma and / or feces. The bioavailability of olmesartan averages 25.6%. Concomitant food intake does not significantly affect the bioavailability of olmesartan, therefore, olmesartan medoxomil can be taken regardless of food intake.
Cmax of olmesartan in blood plasma on average is achieved 2 hours after taking olmesartan medoxomil orally and increases approximately linearly with an increase in a single dose to 80 mg.
Olmesartan is characterized by a high degree of binding to blood plasma proteins (99.7%), however, the potential for a clinically significant shift in the value of binding to proteins during the interaction of olmesartan with other highly binding and simultaneously used drugs is low (this is confirmed by the absence of a clinically significant interaction between olmesartan and warfarin). The connection of olmesartan with blood cells is negligible. The mean volume of distribution after intravenous administration is low (16-29 L). Metabolism and excretion: total plasma clearance is usually 1.3 L / h (coefficient of variation - 19%) and is relatively low compared to hepatic blood flow (approximately 90 L / h).
Olmesartan is eliminated in two ways. After a single oral administration of 14C labeled olmesartan medoxomil, 10-16% of the radioactive substance was excreted by the kidneys (most within 24 hours after taking olmesartan medoxomil), and the remaining radioactive substance was excreted through the intestines. Taking into account the systemic bioavailability of 25.6%, it can be calculated that approximately 40% of the absorbed olmesartan is excreted through the kidneys, and about 60% through the hepatobiliary system. The released radioactive material was represented by olmesartan. No other metabolites were found. Intestinal hepatic recirculation of olmesartan is minimal. Since most of olmesartan is excreted through the hepatobiliary system, its use in patients with biliary obstruction is contraindicated. The half-life of olmesartan (T1 / 2) is 10-15 hours after repeated oral administration. The equilibrium state is achieved after taking the first few doses of Attento, after 14 days of repeated use, further cumulation is not observed. Renal clearance is approximately 0.5-0.7 l / h and does not depend on the dose of Attento.
There were no clinically significant differences in the pharmacokinetic parameters of olmesartan depending on gender.
Amlodipine. Absorption and distribution: after oral administration in therapeutic doses, amlodipine is well absorbed, the time to reach the maximum concentration (TCmax) is 6-12 hours after administration. The absolute bioavailability is about 64-80%. The volume of distribution is about 21 l / kg. Plasma protein binding in vitro for amlodipine circulating in the blood is approximately 97.5%. Simultaneous food intake does not significantly affect the absorption of amlodipine.
Metabolism and excretion: after a single dose of T1 / 2 from blood plasma in the terminal phase is about 35-50 hours. Amlodipine is largely metabolized in the liver with the formation of inactive metabolites, 10% of the original substance and 60% of metabolites are excreted by the kidneys.
Pharmacokinetics in patients aged 65 years and older.
In elderly patients (65-75 years old) and old age (75 years and older) with arterial hypertension, the area under the concentration-time curve (AUC) (in equilibrium) for olmesartan is 35% and approximately 44% higher, respectively. compared with the AUC of olmesartan in younger patients, which may be partially related to age-related decline in renal function.
The time to reach Cmax of amlodipine in blood plasma does not differ in elderly patients and in young patients. In elderly patients, there is a tendency to a decrease in amlodipine clearance, which leads to an increase in AUC and an increase in T1 / 2.
Pharmacokinetics in patients with renal insufficiency.
Compared to healthy volunteers in patients with mild, moderate and severe renal insufficiency, the AUC of olmesartan increases by approximately 62%, 82% and 179%, respectively. Renal failure does not significantly affect the pharmacokinetics of amlodipine. Changes in the concentration of amlodipine in blood plasma do not correlate with the degree of renal dysfunction. Amlodipine is not excreted from the body during dialysis.

Pharmacokinetics in patients with hepatic impairment

After a single oral administration, the AUC values ​​of olmesartan were 6% and 65% higher in patients with mild and moderate hepatic impairment, respectively, compared with healthy volunteers. The unbound fraction of olmesartan 2 hours after oral administration of a single dose of Attento in healthy volunteers, in patients with mild and moderate hepatic insufficiency was 0.26%, 0.34% and 0.41%, respectively. With repeated oral administration, the AUC of olmesartan in patients with moderate hepatic insufficiency was 65% higher than in healthy volunteers from the control group. The mean Cmax values ​​of olmesartan in patients with liver failure and healthy volunteers were similar. The pharmacokinetics of olmesartan medoxomil in patients with severe hepatic insufficiency has not been studied.
Clinical experience with amlodipine in patients with hepatic impairment is limited. In patients of this group, there is a decrease in amlodipine clearance and an increase in T1 / 2, which leads to an increase in AUC by approximately 40-60%.

Attento: Indications

Essential hypertension (with the ineffectiveness of olmesartan monotherapy with medoxomil or amlodipine).

Method of administration and dosage

Attento is taken orally, 1 time / day, at the same time, regardless of the time of meal, without chewing, drinking a sufficient amount of liquid (for example, a glass of water). Before prescribing a combination drug, it is recommended to pre-select the doses of each of the active ingredients separately (olmesartan medoxomil and amlodipine). The recommended dose is 1 tab. a drug containing 5 mg of amlodipine and 20 mg of olmesartan medoxomil. In the absence of an adequate decrease in blood pressure while taking a combined drug at a dosage of 5 mg + 20 mg, it is possible to use Attento at a dosage of 5 mg + 40 mg (1 tab.) / Day. In the absence of an adequate decrease in blood pressure while taking a combined drug at a dosage of 5 mg + 40 mg, it is possible to use Attento at a dosage of 10 mg + 40 mg (1 tab.) / Day. The maximum daily dose of olmesartan medoxomil is 40 mg. The maximum daily dose of amlodipine is 10 mg. In patients aged 65 years and older with normal renal function, dose adjustment is not required. With an increase in the dose of olmesartan medoxomil to the maximum (40 mg / day) in elderly patients, careful monitoring of blood pressure is necessary. When using Attento in patients with mild to moderate renal failure (CC 20-60 ml / min), it is recommended to periodically monitor the content of potassium and creatinine in the blood plasma. The maximum dose of olmesartan medoxomil for patients with mild to moderate renal insufficiency is 20 mg 1 time / day, since the experience of using higher doses in this category of patients is limited. In patients with severe renal failure (CC less than 20 ml / min), the use of Attento is contraindicated. In patients with mild to moderate hepatic impairment (less than 9 points on the Child-Pugh scale), Attento should be used with caution. With mild to moderate hepatic insufficiency, the maximum dose of olmesartan medoxomil is 20 mg 1 time / day. The use of amlodipine in patients with impaired liver function should be started with a minimum dose (5 mg). With simultaneous use with diuretics and / or other antihypertensive drugs in patients with impaired liver function, careful monitoring of blood pressure and renal function is recommended. The use of Attento is contraindicated in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale) (no experience of use).

Application during pregnancy and lactation

Contraindicated during pregnancy.

Attento: Contraindications

    Hepatic failure of severe severity (more than 9 points on the Child-Pugh scale);
    biliary obstruction and cholestasis
    severe arterial hypotension (SBP less than 90 mm Hg);
    shock (including cardiogenic);
    hemodynamically unstable heart failure after myocardial infarction;
    renal failure of severe severity (creatinine clearance (CC) less than 20 ml / min, there is no clinical experience);
    condition after kidney transplantation (there is no clinical experience);
    conditions accompanied by severe impairment of blood outflow from the left ventricle (for example, severe aortic stenosis);
    pregnancy;
    period of breastfeeding;
    age up to 18 years (efficacy and safety have not been established);
    simultaneous use with aliskiren and aliskiren-containing drugs in patients with diabetes mellitus and / or impaired renal function (glomerular filtration rate less than 60 ml / min / 1.73 m2 body surface area).

Carefully

    Stenosis of the aortic and mitral valves;
    hypertrophic obstructive cardiomyopathy;
    simultaneous use with lithium preparations;
    hyperkalemia, hyponatremia;
    hypovolemia (including due to diarrhea, vomiting, or the simultaneous use of diuretics), as well as in patients on a diet with limited salt intake;
    renal failure of mild to moderate severity (CC 20-60 ml / min);
    primary aldosteronism;
    renovascular hypertension (bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney);
    other conditions accompanied by activation of the renin-anginotensin-aldosterone system;
    chronic heart failure (CHF) (NYHA functional class III-IV);
    chronic forms of ischemic heart disease;
    acute forms of coronary heart disease (acute myocardial infarction, including within one month after it; unstable angina pectoris);
    sick sinus syndrome;
    arterial hypotension;
    cerebrovascular diseases;
    mild to moderate liver failure (less than 9 points on the Child-Pugh scale);
    age over 65;
    use in patients of the black race.

Attento: Side Effects

Possible side effects are listed below according to qualifications.
World Health Organization (WHO) in descending order of occurrence: very common (& gt 1/10), often (& gt 1/100).
A combination of amlodipine and olmesartan medoxomil.
From the immune system. Rarely: allergic reactions, hypersensitivity reactions.
From the nervous system.
Often: dizziness, headache.
Uncommon: hypesthesia, paresthesia, postural dizziness, drowsiness.
Rare: syncope.
Mental disorders.
Uncommon: decreased libido.
On the part of the cardiovascular system.
Infrequently: palpitations, tachycardia, marked decrease in blood pressure, orthostatic hypotension.
Rarely: "hot flashes" of blood to the face.
From the respiratory system, chest and mediastinal organs.
Uncommon: cough, dyspnea.
From the organ of hearing and labyrinth disorders.
Uncommon: vertigo.
From the gastrointestinal tract.
Uncommon: dryness of the oral mucosa, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
On the part of the skin and subcutaneous tissues.
Uncommon: skin rash.
Rare: urticaria.
On the part of the musculoskeletal system.
Uncommon: back pain, muscle cramps, pain in the limbs.
From the kidneys and urinary tract.
Uncommon: pollakiuria.
On the part of the genitals and mammary glands.
Uncommon: erectile dysfunction / impotence.
General violations.
Often: increased fatigue, peripheral edema, soft tissue edema.
Uncommon: asthenia.
Rarely: swelling of the face.
On the part of laboratory parameters.
Infrequently: increase / decrease in the content of potassium in the blood plasma, increase in the concentration of uric acid in the blood plasma, increase in the concentration of creatinine in the blood plasma, increase in the activity of gamma glutamyltransferase.
Olmesartan medoxomil (monotherapy).
On the part of the blood and lymphatic system.
Uncommon: thrombocytopenia.
From the immune system.
Uncommon: anaphylactic reactions.
On the part of metabolism and nutrition.
Often: an increase in the concentration of triglycerides in blood plasma, an increase.
Plasma uric acid concentrations.
Rarely: increased plasma potassium.
From the nervous system.
Often: dizziness, headache.
From the respiratory system, chest and mediastinal organs.
Often: pharyngitis, rhinitis, bronchitis, cough.
On the part of the organ of hearing and labyrinth disorders.
Uncommon: vertigo.
From the digestive system.
Often: diarrhea, dyspepsia, gastroenteritis, abdominal pain, nausea.
Uncommon: vomiting.
Very rare: sprue-like enteropathy.
From the liver and biliary tract.
Often: increased activity of "liver" enzymes.
On the part of the skin and subcutaneous tissues.
Uncommon: exanthema, allergic dermatitis, urticaria, skin rash, itching.
Rarely: angioedema.
On the part of the musculoskeletal system.
Often: back pain, bone pain, arthritis.
Uncommon: myalgia.
Rare: muscle cramps.
From the kidneys and urinary tract.
Often: hematuria, urinary tract infections.
Rarely: acute renal failure, renal failure.
On the part of the cardiovascular system.
Uncommon: angina pectoris.
Rarely: marked decrease in blood pressure.
General violations.
Often: chest pain, peripheral edema, flu-like symptoms, fatigue, pain of unspecified localization.
Uncommon: facial edema, asthenia, general malaise.
Rarely: drowsiness.
On the part of laboratory parameters.
Often: an increase in the concentration of urea in the blood plasma, an increase in the activity of creatine phosphokinase.
Rarely: an increase in the concentration of creatinine in the blood plasma.
It was also reported about isolated cases of rhabdomyolysis, which, in terms of development time, was associated with the intake of AT-II receptor antagonists.
Amlodipine (monotherapy).
On the part of the blood and lymphatic system.
Very rare: leukopenia, thrombocytopenia, thrombocytopenic purpura.
From the immune system.
Very rare: hypersensitivity reactions.
On the part of metabolism and nutrition.
Very rare: increased plasma glucose concentration.
From the side of the psyche.
Uncommon: depression, insomnia, irritability, mood lability (including anxiety).
Rarely: confusion.
From the nervous system.
Often: dizziness, headache, drowsiness.
Uncommon: violation of taste, sleep disturbance, hypesthesia, paresthesia, syncope, tremor, ataxia, amnesia, peripheral neuropathy.
Very rare: hypertonicity, parosmia, apathy, agitation.
On the part of the organ of vision.
Uncommon: visual impairment (including diplopia), xerophthalmia, conjunctivitis, eye pain.
On the part of the organ of hearing and labyrinth disorders.
Uncommon: tinnitus.
On the part of the cardiovascular system.
Often: "flushing" of blood to the face, palpitations.
Uncommon: angina pectoris (including exacerbation of coronary heart disease), marked decrease in blood pressure.
Very rare: cardiac arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), development or worsening of CHF, orthostatic hypotension, myocardial infarction, vasculitis.
From the respiratory system, chest and mediastinal organs.
Uncommon: dyspnea, rhinitis, nosebleeds.
Very rare: cough.
From the digestive system.
Often: abdominal pain, nausea.
Uncommon: functional intestinal disorders (including diarrhea and constipation), dryness of the oral mucosa, dyspepsia, vomiting.
Very rare: gastritis, gingival hyperplasia, pancreatitis.
From the liver and biliary tract.
Very rare: increased activity of liver enzymes (in most cases against the background of cholestasis), hepatitis, jaundice, hyperbilirubinemia.
On the part of the skin and subcutaneous tissues.
Infrequently: alopecia, exanthema, increased sweating, itching, skin rash (including hemorrhagic), skin pigmentation disorders.
Very rare: angioedema, erythema polymorphism, exfoliative dermatitis, photosensitivity, Quincke's edema, Stevens-Johnson syndrome, urticaria.
On the part of the musculoskeletal system.
Often: swelling in the ankle area.
Uncommon: arthralgia (joint pain), back pain, myalgia, muscle cramps.
Rarely: myasthenia gravis.
From the kidneys and urinary tract.
Uncommon: frequent urination, painful urge to urinate, nocturia.
Very rare: dysuria, polyuria.
On the part of the reproductive system and mammary glands.
Uncommon: erectile dysfunction / impotence, gynecomastia.
General violations.
Often: increased fatigue, edema.
Uncommon: asthenia, chest pain, general malaise, pain of unspecified localization.
Other violations.
Uncommon: decrease / increase in body weight.
In patients taking amlodipine, isolated cases of extrapyramidal syndrome have also been reported.

Overdose

Symptoms: in case of an overdose of olmesartan medoxomil, the appearance of such symptoms as a pronounced decrease in blood pressure and tachycardia is most likely; bradycardia can develop in case of parasympathetic stimulation (vagus nerve). In case of an overdose of amlodipine, the most characteristic symptoms are: a pronounced decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation. The risk of developing a pronounced and prolonged decrease in blood pressure, up to the development of shock and death, should be taken into account.

Treatment

The use of activated carbon is recommended, especially during the first 2 hours after an overdose, gastric lavage (in some cases). Taking activated charcoal within 2 hours after taking amlodipine inside significantly reduces its absorption.
With a pronounced decrease in blood pressure, it is recommended to put the patient in a horizontal position, raising his legs and conduct therapy aimed at replenishing the circulating blood volume, maintaining the function of the cardiovascular system and correcting violations of the water-electrolyte balance. It is necessary to monitor the performance of the heart and lungs, control the volume of circulating blood and urine output. To restore vascular tone and blood pressure in the absence of contraindications, it is possible to prescribe vasoconstrictor drugs.
To eliminate the blockade of calcium channels, intravenous administration of calcium gluconate is recommended.
Since amlodipine is highly associated with blood plasma proteins, hemodialysis is ineffective. There are no data on the elimination of olmesartan during hemodialysis.

Interaction

A combination of amlodipine and olmesartan medoxomil.
The antihypertensive effect of Attento may be enhanced by concomitant use with other antihypertensive drugs (for example, alpha-blockers, diuretics).
Olmesartan medoxomil. Concomitant use with potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, or other drugs that increase plasma potassium levels (for example, non-steroidal anti-inflammatory drugs (NSAIDs) (including selective inhibitors of cyclooxygenase-2 (COX-2)) is not recommended , immunosuppressants (for example, cyclosporine or tacrolimus), trimethoprim, angiotensin-converting enzyme (ACE) inhibitors, heparin. If necessary, the simultaneous use of these drugs and olmesartan medoxomil requires careful monitoring of the potassium content in the blood plasma.
Clinical research data show that double blockade of the renin-angiotensin-aldosterone system (RAAS) with the simultaneous use of ACE inhibitors, ARA II or aliskiren is associated with a higher incidence of side effects such as arterial hypotension, hyperkalemia and decreased renal function (including development of acute renal failure) than when using only one drug that affects the RAAS. Thus, the simultaneous use of ACE inhibitors, ARA II or aliskiren is not recommended.
The simultaneous use of olmesartan medoxomil and preparations containing aliskiren is contraindicated in patients with diabetes mellitus and renal failure (at a glomerular filtration rate of less than 60 ml / min / 1.73 m2 of body surface area).
In patients with diabetic nephropathy, ACE inhibitors and ARA II should not be used simultaneously.
In the case when the simultaneous use of two agents affecting the RAAS is necessary, their use should be carried out under the supervision of a physician and accompanied by regular monitoring of renal function, blood pressure and electrolyte content in blood plasma.
With simultaneous use with antacids (magnesium and aluminum hydroxide), a moderate decrease in the bioavailability of olmesartan medoxomil is observed.
With the simultaneous use of olmesartan medoxomil does not have a clinically significant effect on the pharmacokinetics and pharmacodynamics of warfarin or the pharmacokinetics of digoxin.
The simultaneous use of olmesartan medoxomil with pravastatin in healthy volunteers did not have clinically significant effects on the pharmacokinetics of each of the drugs.
There are reports of a reversible increase in the concentration of lithium in the blood plasma and the manifestation of toxicity with the simultaneous use of lithium preparations with ACE inhibitors and with ARA II, therefore the use of olmesartan medoxomil in combination with lithium preparations is not recommended. If necessary, the use of appropriate combination therapy is recommended to regularly monitor the concentration of lithium in the blood plasma.
A clinically significant inhibitory effect of olmesartan on isoenzymes CYP1A1 / 2, CYP2A6, CYP2C8 / 9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 of the human cytochrome P450 system in vitro has not been revealed, in relation to rat cytochrome P450, a minimal or no clinical significant interactions with the simultaneous use of olmesartan medoxomil and drugs metabolized with the participation of the above isoenzymes of the cytochrome P450 system.
With the simultaneous use of NSAIDs, including non-selective NSAIDs, selective COX-2 inhibitors, acetylsalicylic acid (at a dose of more than 3 g / day), and ARA II, there may be an increase in the risk of developing acute renal failure, therefore, it is recommended to monitor renal function, especially at the beginning of use, and also regular patient intake of a sufficient amount of fluid.
At the same time, the simultaneous use of NSAIDs and ARA II can lead to a weakening of the antihypertensive effect of ARA II, leading to a partial loss of their therapeutic efficacy.
Colesevelam (bile acid sequestrant). With the simultaneous use of colesevelam hydrochloride (a sequestrant of bile acids) and olmesartan medoxomil, a weakening of the systemic action of olmesartan medoxomil, a decrease in its Cmax and T1 / 2, is noted. Taking olmesartan medoxomil at least 4 hours before taking colesevelam hydrochloride leads to a weakening of this interaction. Olmesartan medoxomil should be taken at least 4 hours before taking colesevelam hydrochloride.
Amlodipine. With the simultaneous use of amlodipine and other antihypertensive drugs, their antihypertensive effects are summarized.With the simultaneous use of amlodipine with potent or moderate inhibitors of the CYP3A4 isoenzyme (protease inhibitors, azole antifungal drugs, macrolides such as erythromycin or clarithromycin, veraplodamil, a significant increase in blood concentration is possible or diltiazemil) ... The clinical manifestations of this interaction may be more pronounced in elderly patients, which may require additional monitoring of the patient's condition and dose adjustment.
There are no data on the effect of inducers of the isoenzyme CYP3A4 on the pharmacokinetics of amlodipine. However, it should be borne in mind that when used simultaneously with inducers of the isoenzyme CYP3A4 (such as rifampicin, St. John's wort), a decrease in the concentration of amlodipine in blood plasma is possible. Amlodipine should be used concomitantly with inducers of the CYP3A4 isoenzyme with caution.In animal studies after taking BMCC (verapamil) and intravenous administration of dantrolene (a drug for the treatment of malignant hyperthermia) against the background of the development of hyperkalemia, cases of ventricular fibrillation and the development of cardiovascular failure with a fatal outcome were noted.
Due to the risk of developing hyperkalemia in patients prone to malignant hyperthermia, as well as against the background of the use of dantrolene in malignant hyperthermia, it is recommended to avoid the use of BMCC, such as amlodipine. Despite the fact that with the use of amlodipine, a negative inotropic effect is usually not observed, some BMCCs can enhance the severity of the negative inotropic effect of antiarrhythmic drugs that cause prolongation of the QT interval (for example, amiodarone, quinidine).
A single dose of sildenafil at a dose of 100 mg in patients with essential hypertension does not affect the parameters of the pharmacokinetics of amlodipine.
Single and repeated administration of amlodipine at a dose of 10 mg does not affect the pharmacokinetics of ethanol.
Antiviral drugs (eg, ritonavir) increase plasma concentrations of BMCA, including amlodipine.
Antipsychotics and isoflurane enhance the antihypertensive effect of BMCC derivatives of dihydropyridine.
Calcium supplements can reduce the effect of BMCC.
Cimetidine does not affect the pharmacokinetics of amlodipine.
The simultaneous use of aluminum or magnesium-containing antacids does not significantly affect the pharmacokinetics of amlodipine.
In clinical studies on the subject of drug interactions, the effect of amlodipine on the pharmacokinetics of atorvastatin, digoxin, warfarin or cyclosporin was not observed.
The simultaneous use of amlodipine (10 mg) and simvastatin (80 mg) for a long time led to an increase in the concentration of simvastatin in blood plasma by 77% compared to taking simvastatin alone. The dose of simvastatin in patients taking amlodipine should not exceed 20 mg per day.
The simultaneous use of amlodipine and grapefruit juice is not recommended, because in some patients, it is possible to increase the bioavailability and increase the antihypertensive effect of amlodipine.
With the simultaneous use of amlodipine can increase the toxic effect of tacrolimus, or cyclosporine, therefore it is necessary to control the concentration of cyclosporine and tacrolimus in blood plasma and adjust the dose if necessary.

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