Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg (30 tablets)

Name: Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg (30 tablets)
SKU: cd5187b92ac5
Price: 29.00 USD
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$29.00

Sku: cd5187b92ac5

Brand: Gedeon Richter (Hungary)

Ekvator® (Lisinopril + Amlodipine) is a medication used to treat high blood pressure. It is a combination of Lisinopril an ACE inhibitor with Amlodipine a calcium channel blocker. It may be used when blood pressure is not well controlled with each of the two agents alone.

Common brand names: Lisonorm, Dironorm, Amesos, Alis, Amdepin-L, Calchek-L, Inace, Numlo-L, Zelis-AM, Primodil-L

Composition

One tablet contains active substances: Lisinopril 10 mg (as Lisinopril dihydrate 10.88 mg), Amlodipine 5 mg (as Amlodipine besylate 6.94 mg),
Excipients: magnesium stearate, sodium starch glycolate (type A), microcrystalline cellulose type 12, microcrystalline cellulose type 101

Uses of Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg

Essential arterial hypertension

Therapy in adult patients who have previously taken lisinopril 10 mg and amlodipine 5 mg at the same time and have achieved adequate blood pressure control.

Method of administration and dosage

The recommended dose is one Equator® 10 mg / 5 mg tablet daily. The maximum daily dose is one Equator® 10 mg / 5 mg tablet.

In general, fixed-dose combination drugs are not suitable for initial therapy.

Equator® 10 mg / 5 mg is indicated only for those patients for whom the titrated optimal maintenance doses of lisinopril and amlodipine are 10 mg and 5 mg, respectively.

If necessary, dose adjustment can be considered the appropriateness of the selection (titration) of the dose with individual components.

Patients with renal impairment

To select the optimal initial dose and maintenance dose in patients with renal insufficiency, dose titration should be performed individually, using separate components of the drug - lisinopril and amlodipine.

During therapy with Equator® 10 mg / 5 mg, renal function, potassium and sodium levels in the blood serum should be monitored. In case of deterioration of renal function, you should stop taking the drug and replace them with individual components, selected properly. Amlodipine is not excreted by dialysis.

Patients with hepatic impairment

Recommendations regarding doses in patients with mild to moderate hepatic impairment have not yet been developed, therefore, dose selection in such patients should be carried out with caution, and should be started with the lowest dose in the dosing range. To select the optimal initial dose and maintenance dose in patients with hepatic impairment, dose titration should be performed individually using a free combination of lisinopril and amlodipine.

The pharmacokinetics of amlodipine in severe hepatic failure has not been studied. The use of amlodipine in patients with severe hepatic impairment should be started at the lowest dose and titration should be done slowly.

Elderly patients (> 65 years)

In elderly patients, the drug should be used with caution.

In clinical studies, there was no change in the efficacy or safety profile of amlodipine or lisinopril depending on age. To select the optimal maintenance dose in elderly patients, titration of doses should be performed individually using a free combination of lisinopril and amlodipine.

Since food intake does not affect absorption, Equator® 10 mg / 5 mg can be taken regardless of food intake, i.e. before, during or after meals.

Side effects of Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg

Often (≥ 1/100 to <1/10)
- dizziness, headache, drowsiness, increased fatigue
- rapid heartbeat, orthostatic hypotension
- dry cough that stops when the drug is discontinued
- weakness, diarrhea, nausea, vomiting, abdominal pain
- impaired renal function
- peripheral edema, ankle edema, skin hyperemia
Uncommon (≥ 1/1000 to <1/100)
- sleep disturbance, insomnia, mood changes (including anxiety), depression, asthenia, malaise
- paresthesia, hypesthesia, vertigo, tremor, fainting, dysgeusia
- visual disorders (including diplopia)
- noise in ears
- tachycardia, arterial hypotension, myocardial infarction and cerebrovascular accident, probably as a result of excessive arterial hypotension in high-risk patients, Raynaud's syndrome
shortness of breath
- pain in the chest, back, arthralgia, myalgia, tonic muscle cramps
- rhinitis
- dry mouth, dyspepsia, changes in bowel movements (diarrhea, constipation)
- itching, skin rashes, alopecia, purpura, discoloration of the skin, increased sweating, exanthema
- urinary disorder (including frequent urination), nocturia
- impotence, gynecomastia
- increased concentration of creatinine, urea in blood serum, hyperkalemia, increased activity of "liver" enzymes
- increase or decrease in body weight
Rarely (≥ 1/10 000 to <1/1 000)
- syndrome of inappropriate antidiuretic hormone secretion
- confusion of consciousness, mental disorder
- psoriasis, urticaria, hypersensitivity / angioedema of the face, extremities, lips, epiglottis and larynx, tongue
- acute renal failure, uremia
- a slight decrease in hemoglobin and hematocrit with prolonged use of the drug, hyperbilirubinemia, hyponatremia
Very rare (<1 / 10,000)
- oppression of bone marrow hematopoiesis: agranulocytosis, leukopenia, neutropenia, thrombocytopenia; hemolytic anemia, anemia, lymphadenopathies
- autoimmune violations
- hypoglycemia, hyperglycemia
- peripheral neuropathy, hypertonicity
- increased blood pressure
- ventricular tachycardia, bradycardia, atrial fibrillation, arrhythmias, vasculitis
- bronchospasm, allergic alveolitis, eosinophilic pneumonia, sinusitis
- intestinal angioedema
- pancreatitis, gastritis, gingival hyperplasia, hepatocellular or cholestatic jaundice, hepatitis, liver failure
- toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, pemphigus vulgaris, photosensitivity, skin pseudolymphoma, Quincke's edema
- oliguria / anuria

There is evidence that skin pseudolymphoma syndrome may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia / arthritis, increased levels of antinuclear antibodies (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash , photosensitivity or other changes in the skin.

When using amlodipine, exceptional cases of extrapyramidal syndrome have also been reported.

Contraindications of Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg

- hypersensitivity to lisinopril or other ACE inhibitors
- hypersensitivity to amlodipine or other dihydropyridine derivatives
- hypersensitivity to auxiliary components of the drug
- severe arterial hypotension
- a history of angioedema during therapy with ACE inhibitors
- hereditary or idiopathic angioedema
- obstruction of the outflow tract of the left ventricle (severe aortic stenosis), mitral stenosis / hypertrophic cardiomyopathy
- shock (including cardiogenic shock)
- hemodynamically unstable heart failure after acute myocardial infarction
- pregnancy and lactation
- children and adolescents up to 18 years of age (due to insufficient data on safety and effectiveness)

Drug interactions of Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg

Interactions associated with lisinopril

Diuretics

When a diuretic is added to lisinopril therapy, the antihypertensive effect is usually enhanced. In patients receiving diuretics, and especially in those who have recently been prescribed diuretic treatment, when lisinopril is added to therapy, an excessive decrease in blood pressure may occasionally be observed. The possibility of symptomatic hypotension while taking lisinopril can be minimized by discontinuing the diuretic before starting treatment with lisinopril.

Potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes

Although serum potassium has generally remained in the normal range in clinical studies, hyperkalemia has been observed in some patients. Risk factors for the development of hyperkalemia: renal failure, type 2 diabetes mellitus, and the concomitant use of potassium-sparing diuretics (such as spironolactone, triamterene, or amiloride), potassium-containing food supplements, or potassium-containing salt substitutes. The use of potassium-containing dietary supplements, potassium-sparing diuretics or potassium-containing salt substitutes, especially in patients with renal failure, can lead to a significant increase in serum potassium. If lisinopril is administered concomitantly with a potassium-sparing diuretic, diuretic-induced hypokalemia may be reduced.

Lithium preparations

With the simultaneous administration of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and toxicity were noted. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and increase the already increased lithium toxicity associated with the use of ACE inhibitors. The simultaneous use of lisinopril and lithium preparations is not recommended, but if it is proven necessary to use this combination, the serum lithium content should be carefully monitored.

Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid ≥3 g / day

Long-term use of NSAIDs can reduce the antihypertensive effect of an ACE inhibitor.

NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium levels and can lead to impaired renal function. These effects are usually reversible. In rare cases, acute renal failure may develop, especially in patients at risk of developing impaired renal function (elderly or dehydrated patients).

Gold preparations

Nitritoid reactions (symptoms of vasodilation, including flushing, nausea, dizziness and arterial hypotension, which can be very severe) after administration of an injectable preparation containing gold (for example, sodium aurothiomalate), were recorded more often in patients receiving treatment with ACE inhibitors.

Other antihypertensive drugs

The simultaneous administration of these drugs may increase the hypotensive effect of lisinopril. Simultaneous reception of lisinopril with glyceryltrinitrate (nitroglycerin) and other nitrates or other vasodilators can further lower blood pressure.

Tricyclic antidepressants / antipsychotics (neuroleptics) / anesthetics

The concomitant use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may further lower blood pressure.

Sympathomimetics

Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors.

Hypoglycemic drugs

Epidemiological studies have shown that the simultaneous administration of ACE inhibitors and hypoglycemic drugs (insulins, hypoglycemic drugs for oral administration) can enhance the hypoglycemic effect with the risk of hypoglycemia. The development of this phenomenon is most likely during the first weeks of treatment with a combination of drugs, as well as in patients with renal insufficiency.

Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates

Lisinopril can be used simultaneously with acetylsalicylic acid (in cardiac doses), thrombolytics, beta-blockers and / or nitrates.

Interactions associated with amlodipine

CYP3A4 isoenzyme inhibitors

Concomitant use of amlodipine with potent or moderate inhibitors of the CYP3A4 isoenzyme (protease inhibitors, antifungals of the azole group, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) can cause a significant increase in the concentration of amlodipine. The clinical picture of such variations in pharmacokinetic parameters may be more pronounced in the elderly. In this regard, careful medical supervision and dose adjustment may be required.

CYP3A4 isoenzyme inducers

There are no data regarding the effect of inducers of the isoenzyme CYP3A4 on amlodipine. Concomitant use of inducers of the CYP3A4 isoenzyme (for example, rifampicin, St. John's wort (Hypericum perforatum) may reduce the concentration of amlodipine in the blood plasma. Care should be taken to prescribe amlodipine simultaneously with inducers of the CYP3A4 isoenzyme.

Taking amlodipine with grapefruit or grapefruit juice is not recommended, since in some patients bioavailability may increase and, as a result, the hypotensive effect may increase.

Dantrolene (infusion)

After taking verapamil and intravenous dantrolene, the development of ventricular fibrillation with a lethal outcome and cardiovascular failure, along with hyperkalemia, was observed. Because of the risk of hyperkalemia, it is recommended to avoid the concomitant use of calcium channel blockers such as amlodipine in patients who are prone to malignant hyperthermia and are being treated for malignant hyperthermia.

The effect of amlodipine on other drugs

The antihypertensive effect of amlodipine enhances the corresponding effects of other drugs with antihypertensive properties.

In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin, or cyclosporin.

Simvastatin

Simultaneous administration of repeated doses of 10 mg of amlodipine and 80 mg of simvastatin led to an increase in the concentration of simvastatin by 77% compared with the corresponding concentration during monotherapy with simvastatin. The dose of simvastatin in patients taking amlodipine should be limited to 20 mg per day.

Special precautions for Ekvator® (Lisinopril + Amlodipine) 10 mg/5 mg

There may be significant symptomatic hypotension in patients with hyponatremia and / or hypovolemia due to taking diuretics or loss of large amounts of fluids for another reason (intense sweating, prolonged vomiting, diarrhea). If hypotension occurs, the patient must be given a horizontal position and, if necessary, replenish the fluid (inject saline).

Before starting the course of therapy, it is necessary to compensate for hyponatremia or hypovolemia, and when taking the first doses of the drug, it is necessary to monitor the effect of the drug on blood pressure.

In case of aortic stenosis or hypertrophic cardiomyopathy, like all drugs that dilate blood vessels, Equator® should be used with caution due to narrowing of the mouth of the blood vessels.

Impaired renal function

With stenosis of the renal artery (especially bilateral, or with stenosis of the arteries of a single kidney), hyponatremia and / or hypovolemia, as well as in case of circulatory failure, taking lisinopril can cause deterioration of renal function and acute renal failure, reversible after discontinuation of therapy.
Both taking any drug of the ACE inhibitor group and taking Equator® can cause angioedema of the face, extremities, lips, epiglottis and larynx. In this case, it is necessary to immediately interrupt the drug intake and establish medical supervision of the patient until the symptoms disappear completely. Edema localized to the face, lips and limbs usually disappears spontaneously, but antihistamines are used to reduce the intensity of symptoms.

Angioedema of the larynx can be fatal outcome. Swelling of the tongue, epiglottis or larynx can cause airway obstruction, and requires immediate medical intervention: subcutaneous administration of 0.1% epinephrine solution at a dose of 0.3-0.5 ml (0.3-0.5 mg) or intravenously, slowly , 0.1 ml (0.1 mg) after which it is necessary to enter glucocorticoids, an antihistamine drug under the control of vital body functions.

With extensive surgical interventions, as well as during anesthesia with drugs that cause hypotension, lisinopril prevents the secondary formation of angiotensin-II after compensatory release of renin. Hypotension, which is observed in this case, can be eliminated by the introduction of saline.

Carrying out hemodialysis with a polyacrylonitrile membrane (for example, AN 69) in a patient receiving an ACE inhibitor can provoke anaphylactic shock, so their simultaneous use should be avoided. A different type of membrane or other antihypertensive agent should be used.

With the use of a standard dose of both active ingredients in the elderly, their higher plasma levels were noted, therefore the dose of the drug in such patients should be set with caution, although there was no significant difference in effectiveness in young and elderly patients.
With liver damage, the half-life of amlodipine increases. Due to the fact that there are no precise data, the drug must be used with caution, with an individual assessment of the benefits and risks of therapy.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The drug may affect the ability to drive and operate machinery, especially at the beginning of treatment, when the risk of arterial hypotension is more likely. The dose and dosing regimen at which you can drive a car and perform work associated with an increased risk of injury are set individually.

Overdose

Symptoms: pronounced expansion of peripheral vessels, accompanied by an excessive decrease in blood pressure and reflex tachycardia.

Treatment: symptomatic therapy, gastric lavage. In case of severe hypotension, the patient is given a prone position, the lower limbs must be raised and replacement solutions for infusion must be injected intravenously. If the therapy is insufficient, it is necessary to take peripheral vasoconstrictors (vasopressors), if their use is not contraindicated. Calcium gluconate can be given intravenously to interrupt the blockage of calcium tubules.
Lisinopril can be removed from the body by hemodialysis, but amlodipine, due to the high degree of binding to proteins, is not subjected to hemodialysis.

Storage conditions

In original packaging, at temperatures from + 15 ° C to + 25 ° C, protected from light.
Keep out of the reach of children!

Shelf life - 3 years
Do not use after the expiration date.