Lisinopril, tablets 10 mg 30 pcs

Lisinopril has hypotensive, vasodilatory, cardioprotective, and natriuretic effects.

Indications

Active ingredient

Composition

Active ingredient:

Lisinopril dihydrate (corresponds to lisinopril) 10 mg,

Auxiliary substances:

Milk sugar (lactose);

MCC;

Starch 1500 (pregelatinized);

Aerosil (colloidal silica);

Talc;

Magnesium stearate

How to take, the dosage

Overly, once daily in the morning, regardless of meals, preferably at the same time.

In patients with arterial hypertension who are not receiving other hypotensive agents, 5 mg once daily is prescribed.

If there is no effect, the dose is increased every 2-3 days by 5 mg to an average therapeutic dose of 20-40 mg/day (increasing the dose over 40 mg/day usually does not lead to further BP reduction).

The usual daily maintenance dose is 20 mg.

The maximum daily dose is 40 mg.

The full effect usually develops in 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose.

If there is insufficient clinical effect, the drug may be combined with other hypotensive agents.

If the patient has received prior treatment with diuretics, these drugs should be discontinued 2 to 3 days before starting Lisinopril.

If this is not possible, the starting dose of Lisinopril should not exceed 5 mg daily. In this case, after the first dose, it is recommended that a physician follow up for several hours (maximum effect is reached after about 6 hours), since a marked decrease in BP may occur.

In renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is reasonable to prescribe also a low initial dose of 5 mg daily, under increased medical monitoring (BP control, renal function, serum potassium ion content).

The maintenance dose, while continuing close physician monitoring, should be determined depending on BP progression.

In case of renal impairment, due to the fact that lisinopril is excreted by the kidneys, the starting dose should be determined according to creatinine clearance.

The dose should be adjusted further depending on individual reactions with regular monitoring of renal function, serum potassium, serum sodium.

Creatinine clearance,

mL/min Initial dose,

mg/day

30-70 5-10

10-30 5

(including patients on hemodialysis)

In persistent arterial hypertension, long-term maintenance therapy of 10-15 mg/day is indicated.

In chronic heart failure: the initial dose is 2.5 mg per day, with a gradual increase after 3-5 days to 5-10 mg per day. The maximum daily dose is 20 mg.

Acute myocardial infarction (as part of combined therapy): 5 mg in the first 24 hours, then 5 mg every other day, 10 mg every two days and then 10 mg once a day. The course of treatment is at least 6 weeks.

In case of prolonged significant BP decrease (systolic BP less than 90 mmHg for more than 1 hour), the drug should be discontinued.

Diabetic nephropathy: 10 mg of Lisinopril once daily is indicated in patients with type 2 diabetes.

The dose can be increased to 20 mg once daily, if necessary, to achieve a diastolic BP below 75 mmHg in sitting position.

In patients with type 1 diabetes the dose is the same, with the goal of achieving a diastolic BP below 90 mmHg in the sitting position.

Interaction

The concomitant use of the drug with potassium-saving diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, cyclosporine increases the risk of

Special Instructions

Symptomatic hypotension

The most common manifestation of BP decline is a decrease in circulating blood volume (CBV) caused by diuretic therapy, reduction of dietary salt, dialysis, diarrhea, or vomiting.

In patients with chronic heart failure with or without concomitant renal failure, there may be a marked decrease in BP.

Lisinopril should be used under close medical supervision in patients with coronary heart disease, cerebrovascular insufficiency, in whom a sharp decrease in BP may lead to myocardial infarction or stroke.

Transient arterial hypotension is not a contraindication for the next dose of the drug.

When using Lisinopril, some patients with chronic heart failure but with normal or reduced BP may experience a decrease in BP, which is usually not a reason to discontinue treatment.

Before treatment with the drug, if possible, sodium should be normalized and/or the BOD should be replenished, and the effect of the initial dose of Lisinopril on the patient should be carefully monitored.

In cases of renal artery stenosis (particularly with bilateral stenosis or in the presence of artery stenosis of the sole kidney), as well as circulatory failure due to lack of sodium ions and/or fluid, use of Lisinopril may lead to renal dysfunction, acute renal failure, which is usually irreversible even after drug withdrawal.

In acute myocardial infarction

The use of standard therapy (thrombolytics, acetylsalicylic acid, beta-adrenoblockers) is indicated. Lisinopril may be combined with intravenous or therapeutic nitroglycerin transdermal systems.

Surgery/general anesthesia

Lisinopril, by blocking angiotensin II formation, may cause a marked, unpredictable decrease in BP during major surgical interventions and other BP lowering agents.

In elderly patients, the same dose leads to higher blood concentrations of the drug, so extra caution is required in determining the dose.

Because the potential risk of agranulocytosis cannot be excluded, periodic monitoring of the blood count is necessary.

Anaphylactic shock may occur when the drug is used in dialysis with polyacrylonitrile membranes, so either a different type of dialysis membrane or the administration of other antihypertensive agents is recommended.

Influence on driving and operating ability

There are no data on the effect of Lisinopril on driving and operating ability when used at therapeutic doses, but it should be considered that at the beginning of treatment

possible development of arterial hypotension which may affect the ability to drive vehicles and operate potentially dangerous mechanisms, as well as possible dizziness and somnolence, therefore, caution should be exercised.

Contraindications

Hypersensitivity to lisinopril or other ACE inhibitors; history of angioedema, including from the use of ACE inhibitors, hereditary Quincke’s edema or idiopathic edema; pregnancy, lactation, age under 18 years (safety and effectiveness of use are not defined).

Side effects

The frequency of side effects is described as frequent (1%), rare (1%).

The most common side effects: dizziness, headache, increased fatigue, diarrhea, dry cough, nausea.

Cardiovascular system disorders: frequently – significant decrease of BP, orthostatic hypotension; rarely – chest pain, tachycardia, bradycardia, worsening of symptoms of chronic heart failure, atrioventricular conduction disorders, myocardial infarction.

As to the central nervous system: often – paresthesias, mood lability, confusion, somnolence, convulsive twitching of the muscles of the limbs and lips, rarely – asthenic syndrome.

Hematopoietic organs: rarely – leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with prolonged treatment – anemia (decrease of hemoglobin, hematocrit, erythropenia).

Respiratory system: rarely – shortness of breath, bronchospasm.

Digestive system disorders: rare – dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis.

Skin disorders: rare – urticaria, itching, increased sweating, alopecia, photosensitization.

Urogenital system disorders: rarely – renal dysfunction, oliguria, anuria, acute renal failure, uremia, proteinuria, decreased potency.

Laboratory measures: frequently – hyperkalemia, hyponatremia; rarely – hyperbilirubinemia, increased liver enzymes activity, hypercreatininemia, increased concentration of urea and creatinine.

Allergic reactions: rare – angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx, skin rash, skin itching, fever, false positive results of antinuclear antibody test, increased sedimentation rate of red blood cells (SLE), eosinophilia, leukocytosis.

In rare cases, intestinal angioedema.

Other: arthralgia/arthritis, vasculitis, myalgia.

Overdose

Symptoms (occurring with a single dose of 50 mg): marked decrease in BP, dry mouth, drowsiness, delayed urination, constipation, restlessness, increased irritability.

Treatment: there is no specific antidote. Symptomatic therapy. Gastric lavage, use of enterosorbents and laxatives. Intravenous administration of 0.9% sodium chloride solution is indicated.

In case of bradycardia resistant to treatment, an artificial rhythm driver should be used. BP and water-electrolyte balance parameters should be controlled. Hemodialysis is effective.

Similarities