EQUATOR PILLS 5MG + 10MG

Dosage form

Tablets are round, flat, white or almost white in color, with a facet, with a risk on one side and engraved "A + L" on the other side.

Composition

1 pill contains: lisinopril dihydrate 10.88 mg, which corresponds to the content of lisinopril 10 mg, Amlodipine besilate 6.94 mg, which corresponds to the content of amlodipine 5 mg.
Excipients: Magnesium stearate 1 mg, sodium carboxymethyl starch (type A) 4 mg, microcrystalline cellulose 177.18 mg.

Packing

In the package 30 pcs.

Indications and usage

Essential arterial hypertension (with the need for combination therapy).

Contraindications

- angioedema in history, including caused by the use of other ACE inhibitors;
- hereditary or idiopathic angioedema;
- hemodynamically significant stenosis of the aorta or mitral valve;
- hypertrophic obstructive cardiomyopathy;
- severe hypotension;
- cardiogenic shock;
- pregnancy;
- lactation period;
- children and adolescents under 18 years of age (due to the lack of data on the efficacy and safety of the drug in this age group);
- Hypersensitivity to the components of the drug or to other derivatives of dihydropyridine.

The Equator should be used with caution in cerebrovascular diseases (including those with cerebral circulation insufficiency), IHD, severe bradycardia, tachycardia, chronic heart failure in the decompensation stage, in case of mild or moderate arterial hypotension, SSS, severe autoimmune diseases (in t. including scleroderma, SLE), in the suppression of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, condition after kidney transplantation, renal failure, sodium-restricted diet, in patients with younger age, with liver failure. In acute myocardial infarction and within one month after it.

Pregnancy and Breastfeeding

The drug is contraindicated for use in pregnancy. If pregnancy is detected, treatment should be stopped as soon as possible.
Reception of lisinopril in the II and III trimesters of pregnancy can cause damage and death of the fetus as a result of the influence on its kidneys (arterial hypotension, renal failure, hyperkalemia). Reducing the amount of amniotic fluid can lead to deformation of the skull and face, impaired limb development, lung hypoplasia, and fetal death. Data on similar and other influences in the earlier stages of pregnancy are not available.
Taking the drug during lactation is contraindicated due to the release of amlodipine with breast milk. Data indicating penetration of lisinopril into breast milk are not available.

Dosage and administration

It is recommended to use in cases where the administration of drugs containing the Equator active substances separately in the same doses does not provide the necessary control of blood pressure. The drug is taken orally, regardless of the meal.
For patients not receiving antihypertensive drugs, the daily dose is 1 tablet.
In the case of prior diuretic therapy, 2-3 days before the start of Equator administration, the diuretic should be canceled. If diuretic cancellation is not possible, the initial dose of Equator is 1/2 pill / After taking the drug, the patient is required to provide medical monitoring for several hours due to the possible development of symptomatic hypotension.
With heart failure and severe hypertension, maintenance dose is 1 tablet.
In renal insufficiency and CC 30-70 ml / min, half of the usual initial dose is prescribed (since lisinopril is eliminated by the kidneys). The maintenance dose depends on the individual response of the patient; during therapy, regular monitoring of renal function, the level of potassium and sodium in the blood is required.
In diseases of the liver, the elimination of amlodipine may slow down, so the initial dose of Equator is 1/2 tablet. Special care is required in this category of patients to use the drug.

Since the cardiovascular system: possibly - orthostatic hypotension; <1% - arrhythmias, heart palpitations,tachycardia (probably as a result of an excessive decrease in blood pressure in patients with a high risk of myocardial infarction, stroke), vasculitis, development or worsening of heart failure.
From the nervous system: 8% - headache; 3% - dizziness; <1% - increased drowsiness, muscular fasciculation of the extremities and lips, asthenia, mood lability, confusion, sensation of heat and flushes to the skin of the face, fatigue, fainting, hypesthesia, paresthesia, peripheral neuropathy, insomnia, unusual dreams, nervousness, depression, anxiety, convulsions, apathy, agitation, ataxia, amnesia.
On the part of the respiratory system: 5% - dry cough; <1% - shortness of breath, rhinitis, nasal bleeding.
From the digestive system: possible - diarrhea, nausea, vomiting; <1% - intestinal dysfunction, dry mouth, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis, gingival hyperplasia, loss of appetite, constipation, flatulence, dyspepsia, anorexia, thirst, gastritis.
From the musculoskeletal system: 1-3% - arthralgia.
Dermatological reactions: possible pruritus, skin rash; <1% - increased sweating, alopecia, dermatitis, xeroderma, impaired skin pigmentation
Allergic reactions: <1% - urticaria; 0.1% - angioedema of the face, extremities, lips, tongue, epiglottis and larynx (in such cases, you should immediately stop treatment and observe the patient until all symptoms disappear).
From the hemopoietic system: <1% - leukopenia, neutropenia, agranulocytosis (exposure to an ACE inhibitor), thrombocytopenia, erythrocytopenia, with prolonged treatment may be a slight decrease in the concentration of hemoglobin and hematocrit.
From the urinary system: <1% - renal dysfunction, frequent urination, painful urination, nocturia, dysuria, polyuria, oliguria, anuria, acute renal failure, uremia, proteinuria.
From the reproductive system: <1% - impotence, gynecomastia.
On the part of the immune system: <1% - lupus-like syndrome with the appearance of antinuclear antibodies, increased ESR and arthralgia, myalgia, erythema multiforme, fever.
From the musculoskeletal system: <1% - muscle cramps, myalgia, back pain, arthrosis, myasthenia.
From the senses: <1% - tinnitus, visual impairment, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, pain in the eyes, taste perversion, parosmia.
From the laboratory indicators: <1% - hyperkalemia, increased levels of creatinine, urea nitrogen, liver enzyme activity and blood bilirubin, especially for kidney disease, diabetes mellitus and renovascular hypertension.
Other: perhaps - weakness, swelling of the ankles, redness of the skin of the face, chest pain; <1% - increase / decrease in body weight, chills.
Side effects caused by the combined drug, occur no more often than in cases of taking each component separately.

Hypotension: A pronounced decrease in blood pressure with the development of clinical symptoms can be observed in patients with reduced BCC and / or sodium content due to diuretic administration, fluid loss or for other reasons, for example, with profuse sweating, prolonged vomiting and / or diarrhea. In case of arterial hypotension, the patient should be laid down and the fluid loss (intravenous infusion of a 0.9% sodium chloride solution) should be added if necessary. Preferably, the restoration of fluid and / or sodium loss was carried out before the treatment of the Equator. It is necessary to monitor blood pressure after taking the initial dose.
Aortic and mitral stenosis: Like all vasodilators, Equator® should be used with caution in patients with obstruction of the left ventricular output tract and mitral valve stenosis.
Renal impairment: in some patients with arterial hypertension without pronounced manifestations of renovascular diseases, an increase in serum creatinine and urea levels was observed, in most cases minimal or transient, more pronounced while taking ACE inhibitors and a diuretic. This is most common in patients with a history of kidney disease.
Angioedema persons, limbs, lips, tongue, vocal folds and / or larynx have been reported in patients taking an ACE inhibitor, including lisinopril.In these cases, the reception of the Equator should be immediately stopped and the patient should be carefully monitored until the symptoms disappear. Swelling of the face, lips and extremities usually go away on their own; however, antihistamines should be used to reduce the severity of symptoms. Angioedema, accompanied by swelling of the larynx, can be fatal. If you detect edema of the tongue, pharynx, or larynx, which are the cause of airway obstruction, it is necessary to urgently start emergency measures. Appropriate measures include: subcutaneous injection of 0.3-0.5 mg or slow intravenous administration of 0.1 mg 0.1% solution of epinephrine (adrenaline), followed by intravenous administration of GCS and antihistamines and simultaneous monitoring of vital functions.
Patients treated with ACE inhibitors rarely had edema of the gastrointestinal wall. These patients complained of abdominal pain (with nausea and vomiting or without them); in some cases, no previous edema of the face was observed and the activity of C-1 esterase was within the normal range. Angioedema was diagnosed by computed tomography of the gastrointestinal tract, or after ultrasound, or during surgery, the symptoms disappeared after discontinuation of the ACE inhibitor. Gastrointestinal wall edema should be included in the differential-diagnostic range of abdominal pain in patients taking ACE inhibitors.
Anaphylactic reactions in patients on hemodialysis: in patients who underwent hemodialysis through a polyacrylonitrile membrane (for example, AN 69) and who simultaneously received ACE inhibitors, cases of anaphylactic shock have been reported, therefore such a combination should be avoided. Patients are recommended to use either another type of dialysis membrane or a hypotensive drug of another class.
Anaphylactic reactions in patients during LDL apheresis: rarely, patients who received ACE inhibitors during apheresis of LDL dextran sulfate, developed life-threatening Anaphylactic reactions. Such reactions were prevented by discontinuing the use of ACE inhibitors before each apheresis procedure.
Desensitization with wasp or bee venom: sometimes patients taking ACE inhibitors developed anaphylactic reactions during desensitization with hymenoptera venom (for example, wasps or bees). Such life-threatening situations can be avoided with the timely cancellation of ACE inhibitors.
Hepatotoxicity: in rare cases, the use of ACE inhibitors was accompanied by a syndrome that began with cholestatic jaundice or hepatitis and developed into fulminant necrosis of the liver and in some cases was fatal. The mechanism of this syndrome is unclear. Patients receiving Equator®, and who develop jaundice or an increase in liver enzyme activity, should be abolished by the Equator with subsequent monitoring of their condition.
Liver failure: in patients with impaired liver function, amlodipine T1 / 2 is elongated.Currently, recommendations on the dosage regimen have not been developed, therefore the Equator should be prescribed with caution, having previously evaluated the expected benefits and potential risk of treatment.
Hematologic toxicity: in rare cases, patients receiving ACE inhibitors have neutropenia, agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and in the absence of other aggravating factors, neutropenia is rare. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor. The equator should be used with extreme caution in patients with collagen vascular disease, during immunosuppressive therapy, during treatment with Allopurinol or procainamide, or when a combination of these aggravating factors, especially in the presence of a preceding renal dysfunction. Some of these patients developed serious infectious diseases, which in several cases were not corrected with antibiotic therapy. When prescribing the Equator, it is recommended to periodically monitor the level of white blood cells in such patients, as well as to warn them about the need to report the first signs of an infectious disease.
Cough: during the use of ACE inhibitors often cough was recorded. As a rule, cough is unproductive, persistent and stopped after discontinuation of the drug. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of ACE inhibitors.
Surgery / General Anesthesia: in patients undergoing extensive surgery or during general anesthesia with drugs leading to arterial hypotension, lisinopril may block the formation of angiotensin II after a compensatory renin release. If arterial hypotension develops, probably as a result of the above mechanism, a correction can be made by increasing the BCC.
Elderly patients with impaired renal function should be adjusted dose of the drug Equator.
Hyperkalemia: In some patients treated with ACE inhibitors, an increase in serum potassium was observed. The risk group for the development of hyperkalemia includes patients with renal insufficiency, diabetes, acute heart failure, dehydration, metabolic acidosis, or while taking potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or any other medical drugs that increase serum potassium. blood (for example, heparin). If necessary, the simultaneous reception of the above drugs should be monitored for the concentration of potassium in the serum.
Patients with low body mass, patients of short stature and patients with severe liver dysfunction may require dose reduction.
The equator does not have any adverse effects on the metabolism and plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes mellitus and gout.
During treatment, body weight control and monitoring by a dentist is necessary (to prevent soreness, bleeding, and gingival hyperplasia).
Influence on ability to drive motor transport and control mechanisms: The equator can affect the ability to drive vehicles and complex mechanisms. Transient hypotension and dizziness may occur predominantly at the beginning of treatment. Therefore, at the beginning of treatment, patients are advised to avoid driving, to work with mechanisms and to perform other work that requires concentration.

Lisinopril
Potassium-sparing diuretics (for example, spironolactone, amiloride, and triamterene), dietary supplements with potassium, potassium-containing salt substitutes, and other medications that can increase serum potassium (for example, heparin) can lead to hyperkalemia when combined with ACE inhibitors, especially in patients with renal failure and other kidney diseases in history. When prescribing a drug that affects the concentration of potassium, simultaneously with lisinopril, the concentration of potassium in the blood serum should be monitored. Therefore, the simultaneous appointment should be carefully justified and made with extreme caution and regular monitoring of both the level of potassium in the blood serum and kidney function.Potassium-sparing diuretics can be taken in conjunction with the Equator preparation only under the condition of medical control. In the case of the appointment of a diuretic to a patient receiving the Equator, the hypotensive effect is usually enhanced. It is therefore necessary with extreme caution to take Equator® in combination with diuretics. Lisinopril softens the potassium uretic effect of diuretics. With the simultaneous use of other antihypertensive drugs, the hypotensive effect of the drug Equator may be enhanced.
When taken simultaneously with nitroglycerin, other nitrates or vasodilators, a more pronounced decrease in blood pressure is possible.
With the simultaneous use of ACE inhibitors tricyclic antidepressants / antipsychotic drugs, agents for general anesthesia, opioid analgesics: perhaps a more pronounced decrease in blood pressure.
Ethanol enhances the hypotensive effect of the drug. Allopurinol, procainamide, cytotoxic drugs or immunosuppressants (systemic corticosteroids) may increase the risk of leukopenia while being used with ACE inhibitors.
Aitacides and colestyramine, while taking it with ACE inhibitors, reduce the bioavailability of the latter.
Sympathomimetics can reduce the hypotensive effect of ACE inhibitors; it is necessary to carefully monitor the achievement of the desired effect. While taking ACE inhibitors and hypoglycemic drugs (insulin and hypoglycemic agents for oral administration) at the same time, there is an increase in the probability of reducing the concentration of glucose in the blood and the risk of hypoglycemia.Most often this phenomenon occurs during the first week of combined treatment and in patients with renal insufficiency. With prolonged use of NSAIDs, including Acetylsalicylic acid in high doses, it is possible to reduce the effectiveness of ACE inhibitors. The additive effect when taking NSAIDs and ACE inhibitors is manifested by an increase in the level of potassium in the blood serum and can lead to a deterioration in renal function. These effects are usually reversible. Very rarely, the development of acute renal failure is possible, especially in elderly patients and patients in a state of dehydration.
The removal of lithium can be slowed down during simultaneous administration with ACE inhibitors and therefore the concentration of lithium in the blood serum should be monitored during this period. When used together with lithium preparations, it is possible to increase the manifestation of their neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
With the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate), a symptom complex is described in / in, including facial flushing, nausea, vomiting, and hypotension.
Amlodipine
Studies among elderly patients have shown that diltiazem inhibits amlodipine metabolism, probably due to inhibition of the CYP3A4 isoenzyme (plasma concentration increases by almost 50% and the effect of amlodipine increases). It is impossible to exclude the possibility that stronger inhibitors of the isoenzyme CYP3A4 (i.e.ketoconazole, itraconazole, ritonavir) are able to increase the concentration of amlodipine in the blood plasma to a greater extent than diltiazem. Simultaneous use should be carried out with caution.
Simultaneous use with CYP3A4 isoenzyme inducers - with antiepileptic drugs (for example, carbamazepyshum, phenobarbital, phenytoin, phosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort, is punched, it is possible to decrease the concentration of amlodipine in blood plasma. Clinical control was shown with possible dose adjustment of amlodipine during treatment with inducers of the CYP3A4 isoenzyme and after their withdrawal. Simultaneous use should be carried out with caution.
As a monotherapy, amlodipine was well combined with thiazide and "loopback" diuretics, general anesthesia agents, beta-adrenergic blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, Warfarin, Atorvastatin, Sildenafil, ants, antamine, antamine, anthrax, glycerol, digoxin, warfarin, atorvastatin, sildenafil., simethicone, cimetidine, NSAIDs, antibiotics and oral hypoglycemic drugs.
Amlodipine does not significantly affect the pharmacokinetics of ethanol. Calcium preparations can reduce the effect of slow calcium channel blockers. Amlodipine does not cause significant changes in the pharmacokinetics of cyclosporine.It is possible to reduce the hypotensive effect of the Equator, while taking it with estrogen, adrenostimulants. When used concomitantly with Equator®, procainamide, quinidine, and other drugs that prolong the QT interval can contribute to its significant lengthening.

Symptoms: excessive peripheral vasodilation with a pronounced decrease in blood pressure, acute vascular insufficiency, impaired water and electrolyte balance, renal failure, hyperventilation, tachycardia, bradycardia, dizziness, anxiety, cough.
Treatment: symptomatic therapy, control of cardiac activity, blood pressure, diuresis and water-electrolyte balance, if necessary, its correction. With a pronounced decrease in blood pressure, the patient is given a prone position, the lower limbs are raised; with an unsatisfactory therapeutic response to the on / in the introduction of fluid substitutes may require the introduction of dopamine. To stop the action of amlodipine, you can enter / in Calcium gluconate. If necessary, in / in the introduction of angiotensin II. Due to the slow absorption of amlodipine in some cases, the stomach is washed, using activated charcoal. Lisinopril is eliminated by hemodialysis; a strong degree of binding to blood proteins makes amlodipine dialysis ineffective.

Store between 15 ° and 25 ° C.

Equator