Monopril - a drug with hypotensive action.
Release form and composition
Monopril is produced in the form of tablets: biconvex, almost white or white, with a risk on one side, almost odorless; on the other side - engraving (pills 10/20 mg) "158" or "609" (in blisters of 10 or 14 pcs .; 1 or 2 blisters in a carton box).
The composition of 1 tablet includes:
- Active ingredient: fosinopril sodium - 10 or 20 mg;
- Auxiliary components: sodium fumarate, povidone, crospovidone, microcrystalline cellulose, anhydrous lactose.
Indications for use
- Heart failure (as part of a combination treatment);
- Arterial hypertension (as monotherapy or in combination with other antihypertensive drugs, in particular with thiazide diuretics).
- Angioedema in history, including after taking other angiotensin converting enzyme inhibitors;
- Age up to 18 years (safety and efficacy of the drug for this age group of patients have not been established);
- Pregnancy and lactation;
- Hypersensitivity to the drug.
Conditions / diseases in which Monopril is prescribed with caution:
- Aortic stenosis;
- Hyponatremia (risk of developing chronic renal failure, arterial hypotension, dehydration);
- Bilateral renal artery stenosis or single kidney artery stenosis;
- Coronary heart disease;
- Renal failure;
- Salt-restricted diets;
- Condition after kidney transplantation;
- Systemic diseases of the connective tissue, including systemic lupus erythematosus, scleroderma (increased risk of agranulocytosis or neutropenia);
- Conditions involving a decrease in circulating blood volume (including diarrhea, vomiting, and prior diuretic therapy);
- Oppression of bone marrow hematopoiesis;
- Chronic heart failure III – IV Art. (according to NYHA classification);
- Cerebrovascular diseases (including cerebrovascular insufficiency);
- Elderly age.
Dosing and Administration
Tablets are taken orally.
The dosage of Monopril is determined individually.
The initial dose in the treatment of hypertension - 10 mg 1 time per day (the dosage is selected depending on the dynamics of lowering blood pressure). The usual dose is 10-40 mg once a day. If the hypotensive effect is absent - additional admission of diuretics is allowed. The initial dose of Monopril in cases where its reception begins on the background of the treatment with diuretics, is not more than 10 mg (this requires careful medical monitoring of the patient's condition).
The initial dose in the treatment of heart failure is 5 mg 1 or 2 times a day. It is allowed to increase the daily dose with a break of 7 days to a maximum of 40 mg, depending on the therapeutic effect.
Reducing the dosage for functional disorders of the kidneys is not required.
There are no differences in the safety and efficacy of monopril therapy in patients aged 65 years and younger patients. However, to exclude greater susceptibility in some elderly patients to the drug can not be, because they may experience an overdose due to the delayed elimination of the drug.
During the period of application of Monopril there may be side effects from some systems and organs:
- Cardiovascular system: fainting, cardiac arrest, hypertensive crisis, flushing to the skin of the face, myocardial infarction, angina pectoris, arrhythmia, palpitations, tachycardia, orthostatic collapse, lowering blood pressure;
- Urinary system: disorders of the prostate gland, proteinuria, the development or worsening of symptoms of chronic renal failure;
- Central nervous system: impaired memory, weakness, headache, dizziness, cerebral ischemia, stroke; when using high doses - paresthesia, drowsiness, confusion, depression, anxiety, insomnia;
- Sense organs: tinnitus, hearing and vision impairment;
- Digestive system: dry mouth, change in body weight, loss of appetite, flatulence, dysphagia, glossitis, stomatitis, anorexia, constipation, vomiting, abdominal pain, cholestatic jaundice, hepatitis, pancreatitis, intestinal obstruction, diarrhea, nausea;
- Respiratory system: nasal bleeding, dysphonia, pharyngitis, rhinorrhea, shortness of breath, bronchospasm, pulmonary infiltrates, dry cough;
- Organs of hematopoiesis: inflammation of the lymph nodes;
- Musculoskeletal system: arthritis;
- Metabolism: gout;
- Allergic reactions: angioedema, pruritus, rash;
- Laboratory indicators: eosinophilia, neutropenia, leukopenia, increased erythrocyte sedimentation rate, decrease in hemoglobin and hematocrit, hyponatremia, hyperkalemia, hyperbilirubinemia, increased activity of liver enzymes, increase in urea, hypercreatininemia;
- Effect on the fetus: hypoplasia of the lungs, contracture of the extremities, oligohydramnios, hypoplasia of the bones of the skull, hyperkalemia, impaired renal function, lowering blood pressure in the fetus and newborn, impaired development of the kidney of the fetus.
Before starting therapy, it is necessary to make an analysis of previously conducted antihypertensive treatment, dietary restrictions on salt and / or fluids, the degree of increase in blood pressure and other clinical circumstances.
A few days before taking Monopril, it is recommended, if possible, to discontinue antihypertensive therapy previously conducted.
To reduce the likelihood of arterial hypotension, it is necessary to cancel diuretics 2-3 days before the start of the drug.
Before and during therapy, blood pressure, electrolyte concentration, urea, creatinine, potassium ions, kidney function, liver enzyme activity in the blood should be monitored.
There are reports of the development of angioedema in patients taking Monopril. In the case of edema of the larynx, pharynx or tongue, the development of airway obstruction is possible with possible death. With the development of such reactions, therapy should be canceled and a solution of epinephrine (epinephrine) in the proportion of 1: 1000 should be injected subcutaneously, as well as other measures of emergency treatment should be applied.
In rare cases, when taking an angiotensin-converting enzyme inhibitor, edema of the intestinal mucosa was observed. These patients had abdominal pain (nausea and vomiting were absent), in some cases with swelling of the intestinal mucosa there was no swelling of the face, and the level of C1-esterase was normal. After withdrawal of therapy, the symptoms disappeared. In patients taking angiotensin-converting enzyme inhibitors complaining of abdominal pain, swelling of the intestinal mucosa should be included in the differential diagnosis.
During therapy, agranulocytosis and bone marrow suppression may occur. Most often, these disorders are observed in patients with functional disorders of the kidneys, especially against the background of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma). Before starting Monopril and during the therapy, it is necessary to determine the total number of leukocytes and leukocyte formula (in the first 3-6 months of treatment and during the first year of use of the drug in patients with an increased risk of neutropenia - 1 time per month).
In the case of an uncomplicated form of arterial hypertension, arterial hypotension may develop during treatment.
Most often, symptomatic hypotension is observed in patients after the application of Monopril after compliance with the salt-restricting diet, intensive diuretic therapy, and also during renal dialysis. After taking measures to hydrate the body, temporary hypotension is not a contraindication for therapy.
In chronic heart failure, taking Monopril can cause an excessive antihypertensive effect leading to azotemia or fatal oliguria. Such patients, especially during the first weeks of treatment, as well as with increasing doses of diuretic or Monopril, should be carefully monitored.
In patients with hyponatremia and patients who have been intensively treated with diuretics earlier, it may be necessary to reduce the diuretic dose. Hypotension is not a contraindication for further use of the drug. Some reduction in systemic blood pressure at the beginning of Monopril with heart failure is a common and desirable effect. The degree of this decrease is maximum in the early stages of therapy and stabilizes within 1-2 weeks. Blood pressure usually returns to the period prior to the start of therapy without reducing therapeutic efficacy.
With the development of a pronounced increase in the activity of liver enzymes and the appearance of noticeable jaundice, the use of Monopril should be discontinued and appropriate therapy should be prescribed.
The concentration of blood urea nitrogen and serum creatinine during treatment may increase in patients with arterial hypertension with bilateral renal artery stenosis or arterial stenosis of the single kidney, as well as with simultaneous use with diuretics without signs of renal vascular disease. As a rule, these effects are reversible and disappear after cessation of therapy, but in some cases it may be necessary to reduce the doses of Monopril or diuretic.
In severe chronic heart failure with altered activity of the renin-angiotensin-aldosterone system, taking the drug can lead to the development of oliguria, progressive azotemia and, in some cases, to acute renal failure with a possible fatal outcome.
Monopril can enhance the hypotensive effect of drugs used during general anesthesia. Before surgical interventions (including dental), you need to warn the doctor about taking the drug.
When driving or while doing other work that requires increased attention, care must be taken, since dizziness may develop when using Monopril, especially after taking the initial dose in patients taking diuretics. You must also be careful when performing physical exercises or in hot weather, which is associated with the risk of dehydration and hypotension due to a decrease in the volume of circulating fluid.
With the simultaneous use of Monopril with certain drugs, the following effects may occur:
- Diuretics (in combination with a strict diet, in which salt intake is restricted or with dialysis): the development of a pronounced decrease in blood pressure, especially in the first hour after taking the initial dose of the drug;
- Potassium-sparing diuretics (triamterene, spironolactone, amiloride), potassium drugs: an increased risk of hyperkalemia. In heart failure and diabetes mellitus, taking such combinations increases the risk of an increase in the concentration of potassium ions in the blood serum;
- Procainamide, immunosuppressants, cytotoxic drugs, allopurinol: the occurrence of the risk of leukopenia.
The effect of fosinopril on drugs / substances with simultaneous use:
- Lithium: an increase in serum lithium concentration at risk of developing lithium intoxication, and therefore such combinations should be used with caution;
- Insulin, sulfonylurea derivatives: enhancing their hypoglycemic effect.
Effect of drugs / substances on fosinopril while applying:
- Estrogens: weakening of the hypotensive effect;
- Preparations for general anesthesia, antihypertensive drugs, narcotic analgesics: increased hypotensive action;
- Nonsteroidal anti-inflammatory drugs: a decrease in the antihypertensive effect, especially in hypertension and a low level of renin in the blood plasma;
- Antacids: decrease in its absorption, in this connection it is necessary to observe an interval at their use not less than 2 hours.
The bioavailability of Monopril does not change when it is used in combination with warfarin, acetylsalicylic acid, digoxin, propanthelin bromide, metoclopramide, cimetidine, hydrochlorothiazide, propranolol, nifedipine and chlorthalidone.
Terms and conditions of storage
Store in a dry place out of reach of children, at a temperature of 15-25 ° C.
Shelf life - 3 years.