6 October

Monopril - instructions for use , indications, dosage

Monopril - angiotensin converting enzyme (ACE).

release form and composition

dosage form - tablets: round biconvex shape with a break line on one side and engraved "609" - on the other, can be almost white or white, without a specific smell (14 pcs in a blister.in a cardboard bundle 2 blisters).

Monoprix active substance - sodium fosinopril in 1 tablet - 20 mg.

Auxiliary ingredients: crospovidone, microcrystalline cellulose, anhydrous lactose, sodium fumarate, povidone.

Indications

  • Hypertension;
  • Combination therapy of heart failure.

Contraindications

  • the age of 18;
  • Lactose intolerance syndrome glucose-galactose malabsorption, lactase deficiency;
  • Hereditary and idiopathic angioedema in history, including treatment with other ACE inhibitors;
  • Pregnancy and breast-feeding;
  • hypersensitivity to the drug and ACE inhibitors in history.

With care should be prescribed Monopril patients with kidney failure, stenosis of the artery to a solitary kidney or bilateral renal artery stenosi

s, hyponatremia (the threat of dehydration, chronic renal failure, hypotension), ischemic heart disease, cerebrovascular disease (including cerebrovascular insufficiency), chronicheart failure III and IV functional class (classification NYHA), aortic stenosis;with inhibition of bone marrow hematopoiesis, desensitization, condition after kidney transplantation, systemic connective tissue disorders (including systemic lupus erythematosus, scleroderma), hemodialysis, diabetes, gout, hyperkalemia, diet with salt restriction, for conditions involving reduction in circulating blood volume (including vomiting, diarrhea), previous treatment with diuretics;in old age.

Dosage and Administration

tablets are taken orally once a day 1.

dose sets the physician based on clinical indications.

recommended daily dosage Monoprix:

  • Hypertension: The initial dose - 10 mg.Dose picked individually, taking into account the dynamics of the reduction in blood pressure (BP), its size may be 10-40 mg.In case of insufficiency of the hypotensive effect of co-administration of diuretics is shown.If the use of start during treatment with diuretics, the initial dose should not exceed 10 mg, and the application must be accompanied by regular medical supervision.The maximum dose - 40 mg per day;
  • Chronic heart failure (in a combination therapy with a diuretic): initial dose - 10 mg.During the first week of treatment should regularly monitor the condition of the patient, his reaction to the drug.If it is well tolerated, the dose is recommended to gradually (1 per week) improve to the maximum allowable - 40 mg.Co-administration of digoxin is optional.

patients with functional disorders of the kidneys or liver, and elderly patients (65 years or older) Dose adjustment is not normally required.

Side effects

  • Cardiovascular system: palpitations, severe decrease in blood pressure, rush of blood to the face, tachycardia, orthostatic hypotension, syncope, angina, arrhythmia, cardiac conduction, peripheral edema, myocardial infarction, increased blood pressure, stopheart, sudden death;
  • Digestive system: violation of appetite, nausea, vomiting, bloating, diarrhea or constipation, abdominal pain, intestinal obstruction, bleeding, hepatitis, pancreatitis, cholestatic jaundice, stomatitis, dysphagia, glossitis, change in body weight, anorexia, dryness of the oral mucosa;
  • Respiratory system: shortness of breath, dry cough, bronchospasm, pneumonia, pulmonary infiltrates, runny nose, hoarseness, laryngitis, sinusitis, pharyngitis, bronchitis, nosebleeds;
  • Urinary system: renal failure, hyperplasia and / or prostate adenoma, proteinuria, oliguria, polyuria;
  • Senses: tinnitus, ear pain, hearing and visual impairment, change in taste;
  • Nervous system: dizziness, headache, cerebral ischemia, stroke, disorders of balance, impaired memory, fatigue, sleep disturbances, depression, anxiety, confusion, paresthesia, drowsiness;
  • lymphatic system: inflammation of the lymph nodes;
  • Metabolism: exacerbation of gout;
  • Musculoskeletal system: muscle weakness in the extremities, myalgia, arthritis, musculoskeletal pain;
  • Allergic reactions: itching, skin rash, dermatitis, angioedema;
  • Laboratory indicators: increase in urea concentration hypercreatininemia, elevated liver enzymes, hyperbilirubinemia, hyponatremia, hyperkalemia, reducing the concentration levels of hematocrit and hemoglobin, increased erythrocyte sedimentation rate (ESR), neutropenia, leukopenia, eosinophilia;
  • Effect on the fetus: contracture of limbs, hypoplasia of the skull bones, lung hypoplasia, impaired development of fetal kidney, impaired renal function, reduction of blood pressure of the fetus and newborn, oligohydramnios, hyperkalemia;
  • Other: rash, fever, sexual dysfunction.

Cautions

Treatment is required to start after a thorough analysis of the degree of increase in blood pressure, previous antihypertensive therapy, reduction in liquid content of the diet and / or salt and other clinical factors.Previously held antihypertensive treatment, it is advisable to stop for a few days before the application of Monoprix.

To reduce the risk of hypotension, diuretics cancel 2-3 days prior to initiation of therapy.

use of the drug should be accompanied by regular monitoring of blood pressure, renal function, serum creatinine concentration of potassium ions, urea and electrolytes content in liver enzymes in the blood serum.

With the development of angioedema of the lips, face, tongue, larynx or pharynx, mucous membranes and extremities in patients receiving the drug should be discontinued Monopril.discontinuation of treatment often provides the normalization condition of the patient, if the swelling does not go, you must assign the appropriate therapy, including subcutaneous epinephrine solution (adrenaline) (1: 1000).Delayed aid can lead to airway obstruction with the risk of death.

In rare cases, ACE inhibitors can cause intestinal mucosal edema, accompanied by abdominal pain.Since it can occur without any signs of edema the person during normal activity of C1-esterase and absence of nausea or vomiting patient, it must be included in the differential diagnosis of patients complaining of abdominal pain.Symptoms of edema disappear after discontinuation of the drug.

patients with anaphylactic reactions to dialysis against using highly permeable membranes or low-density lipoprotein apheresis with dextran sulphate adsorption on the need to appoint another class antihypertensive drugs or using dialysis membranes of another type.

Due to the risk of anaphylactic reactions during desensitization of patients need to be especially careful.

To prevent the development of bone marrow suppression and agranulocytosis before ACE inhibitors and during therapy should be regularly (1 time per month during the first 3-6 months) to carry out certain leukocytes and leukocyte formula.In patients with increased risk (renal failure, systemic connective tissue disease) continue to conduct research in the first year of therapy.

Against dialysis, intensive care with diuretics, diet, limiting salt intake, the development of symptomatic hypotension occurs frequently.When transient hypotension continued use of the drug after the restoration of circulating blood volume.

The use of ACE inhibitors is indicated in patients with chronic heart failure, but it can cause excessive antihypertensive effect, potentiating the development of azotemia and oliguria, in rare cases - acute renal failure with fatal consequences.Therefore, each increasing the dose of the diuretic or Monoprix in this category of patients requires careful monitoring of their condition, especially during the first two weeks of therapy.Patients with hyponatremia, normal or low blood pressure, previously treated with diuretics may need to decrease the dose of the diuretic.

slight decrease in systemic blood pressure at the beginning of the treatment of patients with chronic heart failure is a typical and desirable effect.The maximum reduction in blood pressure is observed in the early stages of therapy and stabilized for 1-2 weeks without reducing the therapeutic effect.

In rare cases, ACE inhibitors can cause a syndrome that starts with cholestatic jaundice, followed by the onset of fulminant hepatic necrosis (with the risk of death).Since the nature of the syndrome has not been established, with a significant increase in liver enzymes in a patient and the occurrence of visible jaundice drug should be withdrawn and appropriate therapy.

If abnormal liver function can be observed in the blood plasma of the high content of fosinopril.In cirrhosis of the liver total clearance fozinoprilata, seemingly normal, is reduced, and the approximately 2-fold higher than the AUC, compared to patients with normal liver function.

When hypertension in patients with stenosis of the artery to a solitary kidney, or a single or bilateral renal artery stenosis ACE inhibitors may cause a reversible process of increasing the concentration of serum creatinine and blood urea nitrogen (in this case requires removal of the drug).This category of patients require regular monitoring of renal function in the first weeks of therapy.Increased serum concentrations of creatinine and blood urea nitrogen (usually minor and transient) in patients with normal renal function can be caused by the simultaneous reception and diuretics Monopril (in this case, a reduction in dose).

In severe chronic heart failure, ACE inhibitors may be associated with progressive azotemia and / or oliguria, in rare cases -Risks development of acute renal failure with fatal consequences.

a greater risk of hyperkalemia in patients receiving the drug exposed patients with type 1 diabetes mellitus, renal insufficiency, as well as taking kalisodergaszczye supplements, potassium-sparing diuretics, and other means to support increased levels of potassium ions in the blood serum.

In case of cough should be considered taking the drug as a possible cause in the differential diagnosis.

In preparation for surgery, the anesthesiologist must notify the admission of Monoprix.

Patients are advised to carefully perform physical activities, including in hot weather.

Due to the possible occurrence of dizziness, caution should be exercised in the management of vehicles and mechanisms.

Drug Interactions

During treatment Monoprilom simultaneous use of other medicines can be started only after consultation with your doctor, who can evaluate the interaction of drugs that will prevent the development of undesirable effects.

Terms and conditions of storage

Store in a dry place inaccessible to children at a temperature of 15-25 ° C.

Shelf life - 2 years.

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