Fosinopril Uses, Side Effects & Warnings

Generic name: fosinopril [ foe-SIN-oh-pril ]
Brand name: Monopril
Dosage form: oral tablet (10 mg; 20 mg; 40 mg)
Drug class: Angiotensin Converting Enzyme Inhibitors

Medically reviewed by Drugs.com on Jun 26, 2023. Written by Cerner Multum.

What is fosinopril?

Fosinopril is used alone or in combination with other medications to treat high blood pressure in adults and children at least 6 years old.

Fosinopril is also used in adults to treat congestive heart failure.

Fosinopril may also be used for purposes not listed in this medication guide.

Warnings

Do not use if you are pregnant. Stop using fosinopril and tell your doctor right away if you become pregnant.

Tell your doctor about all your other medicines. Some drugs should not be used with fosinopril.

Before taking this medicine

You should not use fosinopril if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as captopril, benazepril, enalapril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

If you have diabetes, do not take fosinopril together with any medication that contains aliskiren (a blood pressure medicine).

Do not take fosinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto)

Tell your doctor if you have ever had:

• severe allergic reaction such as angioedema;

• heart disease, heart problems such as a recent heart attack;

• stomach pain;

• low blood pressure;

• if you are on a low-salt diet;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may also need to avoid taking fosinopril with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Fosinopril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

How should I take fosinopril?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take fosinopril with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking fosinopril. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often and you may need frequent blood tests.

fosinopril can affect the results of certain medical tests. Tell any doctor who treats you that you are using fosinopril.

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking fosinopril?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Fosinopril side effects

Get emergency medical help if you have signs of an allergic reaction: hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat.

Fosinopril may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• kidney problems–swelling, urinating less, feeling tired or short of breath;

• low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough;

• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of fosinopril may include:

• chest pain, cough, runny or stuffy nose;

• muscle or joint pain, weakness;

• nausea, vomiting, diarrhea; or

• dizziness, low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fosinopril dosing information

Usual Adult Dose for Hypertension:

Initial dose: 10 mg orally once a day alone or in combination with a diuretic
Maintenance dose: 20 to 40 mg orally once a day; some patients may have further response at 80 mg once a day

Comments:
-Dosages should be adjusted according to blood pressure response at peak (2 to 6 hours post dose) and trough (about 24 hours after dosing) blood levels.
-Consider dividing the daily dose in patients where the trough response is inadequate.
-Stop the diuretic 2 to 3 days prior to beginning therapy with this drug; it may be resumed at a later time if clinically indicated.
-If stopping the diuretic is not possible, careful medical supervision is recommended for several hours until blood pressure has stabilized.

Uses: For the treatment of hypertension alone or in combination with other medications

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 10 mg orally once a day
Target dose range: 20 to 40 mg orally once a day
Maximum dose: 40 mg orally once a day

Comments:
-Patients should be observed under medical supervision for at least 2 hours following the initial dose until blood pressure stabilizes.
-Dosages should be increased over a several week period based on tolerability.
-The presence of hypotension, orthostasis, or azotemia early in dose titration should not preclude further careful dose titration; consider dose reducing concomitant diuretic.

Use: For the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis

Usual Pediatric Dose for Hypertension:

6 to 16 years:
Greater than 50 kg: 5 to 10 mg orally once a day as monotherapy
Less than 50 kg: Appropriate dose not available

What other drugs will affect fosinopril?

Fosinopril can harm your kidneys, especially if you also use certain medicines for infections, cancer, or osteoporosis.

Avoid taking an antacid within 2 hours before or after you take fosinopril.

Tell your doctor about all your other medicines, especially:

• a diuretic or “water pill” that may increase blood potassium such as spironolactone, triamterene, amiloride;

• medicine to prevent organ transplant rejection such as temsirolimus, sirolimus, or everolimus;

• NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• heart or blood pressure medication.

This list is not complete. Other drugs may affect fosinopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Frequently asked questions

• Do ACE inhibitors make COVID-19 worse?

More about fosinopril

• Check interactions
• Compare alternatives
• Pricing & coupons
• Reviews (4)
• Drug images
• Side effects
• Dosage information
• During pregnancy
• Drug class: Angiotensin Converting Enzyme Inhibitors
• Breastfeeding
• En español

Patient resources

• Advanced Reading

Other brands

Monopril

Professional resources

• Prescribing Information

Related treatment guides

• Alport Syndrome
• Diabetic Kidney Disease
• Heart Failure
• High Blood Pressure
• Left Ventricular Dysfunction

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 12.01.

Fosinopril (Monopril) – Side Effects, Interactions, Uses, Dosage, Warnings

uses

What is Fosinopril (Monopril) used for?

• Congestive Heart Failure
• Hypertension
• Pre-eclampsia/Eclampsia
• Heart Disease
• Cardiovascular Disease
• Hypertensive Congestive Heart Failure
• Hypertensive Heart (w/ CHF) and Renal Disease
• Hypertensive Heart (w/o CHF) and Renal Disease
• Hypertensive Renal Disease
• Hypertensive Retinopathy
• Renovascular Hypertension
• Hypertensive Encephalopathy
• Hypertensive Heart Disease

warnings

What is the most important information I should know about Fosinopril (Monopril)?

You should not use fosinopril if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as captopril, benazepril, enalapril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

You may also need to avoid taking fosinopril with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Fosinopril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

If you have diabetes, do not take fosinopril together with any medication that contains aliskiren (a blood pressure medicine).

Do not take fosinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto)

Tell your doctor if you have ever had:

• severe allergic reaction such as angioedema;
• heart disease, heart problems such as a recent heart attack;
• stomach pain;
• low blood pressure;
• if you are on a low-salt diet;
• liver disease; or
• kidney disease (or if you are on dialysis).

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Side Effects

What are the side effects of Fosinopril (Monopril)?

Get emergency medical help if you have: hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat. signs of an allergic reaction

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• kidney problems–swelling, urinating less, feeling tired or short of breath;
• low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough;
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• chest pain, cough, runny or stuffy nose;
• muscle or joint pain, weakness;
• nausea, vomiting, diarrhea; or
• dizziness, low blood pressure.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Fosinopril (Monopril) if I’m pregnant or breastfeeding?

D

Positive evidence of risk

Based on FDA pregnancy categories

Stop using this medicine and tell your doctor right away if you become pregnant. Fosinopril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

Interactions

What drugs and food should I avoid while taking Fosinopril (Monopril)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Dosage Guidelines & Tips

How to take Fosinopril (Monopril)?

Use Fosinopril (Monopril) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Fosinopril (Monopril)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. take two doses at one time. Do not

Overdose Signs

What happens if I overdose on Fosinopril (Monopril)?

If you think you or someone else may have overdosed on: Fosinopril (Monopril),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Fosinopril (Monopril), call 911

911

Images

9 3, 72 22

Color: white

Shape: rectangular

Imprint: 9 3, 72 22

93, 7223

Color: white

Shape: oblong

Imprint: 93, 7223

93, 7224

Color: white

Shape: round

Imprint: 93, 7224

instructions for use, price, analogues, composition, indications

Each tablet contains 10 or 20 mg of fosinopril sodium, as well as auxiliary ingredients: anhydrous lactose, povidone PVP K-30, crospovidone, microcrystalline cellulose, sodium lauryl sulfate, glyceryl dibehenate.

Fosinopril 10 mg tablets: White or almost white round tablets with dividing lines on both sides, on one side the inscriptions “F” and “10” on opposite sides of the dividing line. There is a chamfer on both sides.

Fosinopril 20 mg tablets: White or almost white biconvex capsule-shaped tablets marked “93” on one side and “7223” on the other side

Fosinopril sodium is a long-acting ACE inhibitor, is an ester. After oral administration, fosinopril is rapidly and almost completely metabolized to the active substance, fosinoprilat.

The drug helps to increase exercise tolerance, reduce the severity of heart failure.

Taking fosinopril in patients with hypertension leads to a decrease in blood pressure without a significant increase in heart rate. With hypertension, the hypotensive effect of fosinopril develops within 1 hour, reaches a maximum after 3-6 hours. When using the recommended dosages, the hypotensive effect of the drug persists for 24 hours after a single dose. When using dosages lower than those recommended in some patients, the severity of the hypotensive effect of the drug by the end of this period may decrease. Orthostatic phenomena and tachycardia are rare, but may occur in patients with hypovolemia or electrolyte imbalance. In some cases, the full development of the hypotensive effect may require 3-4 weeks of therapy.

• Arterial hypertension: monotherapy and in combination with other antihypertensive drugs

• Heart failure: as part of combination therapy.m

• Hypersensitivity reactions to the active substance or any other ingredient of the drug, as well as other drugs from the group of angiotensin-converting enzyme inhibitors;

• Angioedema against the background of the use of other drugs of the ACE inhibitor group in history

• Hereditary or idiopathic angioedema

• Pregnancy

Fosinopril is taken by mouth once a day. Like all once-daily medications, fosinopril is recommended to be taken every day at the same time. Absorption of fosinopril does not depend on food intake. The dosage of the drug is selected individually.

Arterial hypertension:

For monotherapy with fosinopril, a starting dose of 10 mg once daily is recommended. In the future, the dose is selected depending on the dynamics of lowering blood pressure. In general, it is recommended to increase the dose if there is no effect from the dose used within 3-4 weeks of use. The usual maintenance dose is 10-40 mg once a day. In patients with severe disorders of water-electrolyte metabolism, renal hypertension, severe hypertension, a sharp drop in blood pressure may occur at the beginning of therapy.

When you start taking fosinopril against the background of diuretic therapy, the initial dose of the drug should not exceed 10 mg, the start of fosinopril therapy should be carried out under close medical supervision.

Heart failure:

In patients with symptomatic heart failure, fosinopril should be used as adjuvant therapy in combination with diuretics and, if necessary, cardiac glycosides. The recommended starting dose is 10 mg once daily, under close medical supervision. With good tolerance, the dose of the drug can be gradually increased to 40 mg per day once.

Patents with impaired renal function:

In case of impaired renal function, a starting dose of 10 mg is recommended. Caution should be exercised when using fosinopril in patients with a decrease in glomerular filtration rate below 10 ml / min.

Patients with impaired liver function:

In case of impaired liver function, caution is recommended, the starting dose should not exceed 10 mg / day. Available data suggest a compensatory increase in the renal excretion of fosinoprilat with a decrease in its hepatic clearance.

Use in children (under 18 years of age):

The safety and efficacy of fosinopril in children and adolescents has not been studied, the drug is not recommended for use in patients of this age group.

Use in older patents:

There were no significant differences in the efficacy and tolerability of fosinopril therapy in patients over 65 years of age compared with younger individuals. Therefore, with intact renal and hepatic function, dose adjustment in elderly patients is not required.

Frequency of side effects:

Very common: more than 1/10 Common: 1/100 to 1/10 Uncommon: 1/100 to 1/1000 Rare: 1/1000 to 1/10000

Very rare: less than 1/10000 and isolated cases.

The following side effects were observed during clinical studies:

Blood and lymphatic system:

Infrequently: a transient decrease in hemoglobin levels, a decrease in gmatocrit. Rarely: transient anemia, eosinophilia, leukopenia, lymphadenopathy, neutropenia, thrombocytopenia. Very rare: agranulocytosis.

Metabolic disorders:

Infrequently: loss of appetite, hyperkalemia, gout.

Mental disorders:

Uncommon: depression.

Neurological disorders:

Often: dizziness, headache. Infrequently: stroke, sensory disorder characterized by numbness, tingling, crawling, mild confusion, fainting, taste disturbances, tremors, sleep disturbances. Rare: speech disorders, memory impairment, disorientation.

Organs of vision:

Uncommon: visual disturbances

Hearing Organs:

Infrequently: pain and ringing in the ears, dizziness.

The cardiovascular system:

Often: tachycardia, hypotension, a sharp decrease in pressure when moving to a vertical position. Uncommon: angina pectoris, myocardial infarction, atrial fibrillation, cardiac arrest, arrhythmias, conduction disturbances, hypertension, shock, transient ischemia. Rare: hot flashes, hemorrhages, peripheral vascular disease.

Respiratory and mediastinal organs.

Often: cough. Uncommon: respiratory failure, rhinitis, sinusitis, tracheobronchitis. Rare: bronchospasm, epistaxis, laryngitis, pneumonia.

Gastrointestinal tract:

Often: nausea, vomiting, diarrhea. Uncommon: constipation, dry mouth, bloating. Rare: pancreatitis, difficulty swallowing. Very rare: intestinal obstruction.

Liver:

Rare: hepatitis. Very rare: liver failure.

Skin and subcutaneous tissues:

Often: rash, acutely developing and rapidly passing edema, dermatitis. Infrequently: increased sweating, itching, urticaria. Rarely: extensive hemorrhages.

There are reports of a complex that included one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia / arthritis, positive reaction to antinuclear antibodies, increased ESR, eosinophilia, leukocytosis, rash, photosensitivity, other dermatological reactions.

Musculoskeletal system: Infrequently: myalgia. Rare: arthritis

Excretory organs:

Uncommon: renal failure, proteinuria. Rarely: pathology of the prostate gland. Very rare: acute renal failure.

Sex organs:

Uncommon: sexual dysfunction General symptoms:

Often: chest pain (non-cardiac), weakness. Uncommon: fever

peripheral edema, sudden death, chest pain.

Laboratory results:

Often: increased alkaline phosphatase, increased bilirubin, increased lactate dehydrogenase, increased transaminases. Uncommon: Weight gain, increased serum urea, increased serum creatinine, hyperkalemia. Rarely: a slight increase in hemoglobin, hyponatremia.

In clinical studies, the incidence and nature of side effects in groups of patients older than 65 years and middle-aged people did not differ significantly.

If any of these side effects occur, contact your doctor immediately. In case of any unusual reactions, be sure to consult your doctor about the further use of the drug!

An overdose of ACE inhibitors may be manifested by hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness, cough. If symptoms of an overdose appear, stop taking the drug and consult a doctor immediately!

Diuretics: The addition of diuretics to fosinopril therapy leads to an increase in the hypotensive effect.

Patients treated with diuretics prior to fosinopril therapy are at a higher risk of excessive lowering of blood pressure. The risk of this complication can be reduced by discontinuing diuretics a few days before starting fosinopril.

Potassium preparations, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of developing hyperkalemia. In patients with heart failure, diabetes mellitus, concomitantly taking potassium-sparing diuretics, potassium, potassium-containing salt substitutes or other drugs that cause hyperkalemia (eg, heparin), ACE inhibitors increase the risk of increasing the concentration of potassium ions in the blood serum.

Lithium: A reversible increase in the plasma concentration of lithium with an increase in its toxic effect has been observed with the combined use of lithium and ACE inhibitors. This effect is enhanced by the use of thiazide diuretics. The use of fosinopril in conjunction with lithium preparations is not recommended. Non-steroidal anti-inflammatory drugs (including acetylsalicylic acid at a dose of more than 3 g / day): Non-steroidal anti-inflammatory drugs can reduce the antihypertensive effect of ACE inhibitors, especially in patients with arterial hypertension and low plasma renin levels. The combined use of non-steroidal anti-inflammatory drugs and ACE inhibitors can cause an increase in potassium in the blood. This effect is reversible. In rare cases, in elderly patients or with dehydration, renal failure may develop.

Other antihypertensive drugs: Combination with other antihypertensive drugs (beta-blockers, methyldopa, calcium antagonists, diuretics) may increase the hypotensive effect. Combined use with nitroglycerin and other nitrates, as well as other vasodilators, can cause a sharp decrease in blood pressure.

Tricyclic antidepressants, antipsychotics, anesthetics: in

combination with ACE inhibitors can cause a sharp decrease in blood pressure. Sympathomimetics: may reduce the hypotensive effect of ACE inhibitors. Hypoglycemic drugs: when used together with ACE inhibitors, there is an increase in hypoglycemic action with an increased risk of hypoglycemia. This effect is more often observed during the first weeks of co-administration of drugs and in patients with renal insufficiency.

Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates: Fosinopril can be used with beta-blockers, nitrates, thrombolytics, acetylsalicylic acid (cardiac dosages).

Immunosuppressants, iostatics, systemic corticosteroids, procainamide, allopurinol: when used together with fosinopril, they increase the risk of developing leukopenia.

Alcohol: enhances the hypotensive effect of fosinopril.

Antaiids (aluminum hydroxide, magnesium hydroxide, dimethicone): may reduce the absorption of fosinopril, the interval between taking antacids and fosinopril should be at least 2 hours.

Laboratory indicators: it is recommended to stop taking fosinopril a few days before the study of parathyroid hormones.

If you are taking any other medicines, be sure to inform your doctor! During treatment with Fosinopril, do not take any other medicines (including those available without a prescription) without first consulting your doctor. Uncontrolled treatment can harm your health.

A starting dose of 10 mg has not been studied in patients over 75 years of age with heart failure and in patients with severe heart failure (NYHA grade IV). Consideration should be given to the greater likelihood of severe hypotension, hyperkalemia and / or a rapid increase in the level of potassium in the blood at the beginning of the use of fosinopril at a dose of 10 mg in patients with severe heart failure or patients with arterial hypertension who have been receiving diuretics for a long time.

Symptomatic hypotension:

Symptomatic hypertension may occur in patients with uncomplicated hypertension. The likelihood of hypotension is higher in patients after intensive treatment with diuretics, restriction of salt intake with food, dialysis, violations of water-salt metabolism due to vomiting or diarrhea. The risk of hypotension is also higher in patients with severe heart failure, as a consequence of long-term use of high doses of diuretics, patients with hyponatremia and elderly patients. Caution should be exercised when starting therapy with fosinopril in this group of patients. Caution should also be exercised in patients with ischemic heart disease and cerebrovascular disease, since a decrease in blood pressure can provoke an acute violation of the coronary or cerebral circulation in these patients.

If hypotension occurs, it is recommended to lay the patient down and immediately consult a doctor! Temporary arterial hypotension is not a contraindication for the use of the drug after taking measures to hydrate the body, however, in patients with heart failure and initially normal or low blood pressure, hypotension may be a reason to reduce the dose or completely discontinue the drug.

Aortic/mitral stenosis, hypertrophic myocardiopathy:

Like other drugs of the ACE inhibitor group, fosinopril should be used with caution in patients with mitral and aortic stenosis, as well as in hypertrophic myocardiopathy.

Kidney dysfunction:

Renal failure does not require adjustment of the starting dose of fosinopril. Regular monitoring of the level of potassium and creatinine in the blood plasma is recommended.

In patients with heart failure, ACE inhibitor-induced hypotension can lead to acute renal failure, which is usually reversible.

In patients with arterial hypertension with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, as well as with the simultaneous use of diuretics without signs of renal vascular disease during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and disappear after treatment is stopped. Dose reduction of the diuretic and/or fosinopril may be required.

Renovascular hypertension is a risk factor for severe hypotension and renal failure. Dose titration in these patients should be carried out under close medical supervision. Since diuretics may contribute to the development of these complications, it is recommended to stop diuretics and carefully monitor kidney function during the first weeks of taking fosinopril.

Proteinuria:

In patients with proteinuria prior to taking fosinopril, the condition may worsen during treatment. With clinically significant proteinuria (more than 1 g / day), fosinopril should be started only after a thorough assessment of the risk / benefit ratio, under regular monitoring of the clinical condition and laboratory parameters.

Hypersensitivity/angioedema:

Angioedema has been reported in patients using fosinopril. Swelling of the tongue, pharynx, or larynx can lead to airway obstruction, which can be fatal. This complication can develop at any stage of therapy. In the event of the development of such reactions, it is necessary to stop taking the drug and consult a doctor immediately! It is noted that angioedema often develops in black patients.

The risk of angioedema when taking ACE inhibitors is higher in patients with a history of this condition due to taking other drugs.

Edema of the intestinal mucosa.

During the reception of ACE inhibitors, swelling of the intestinal mucosa was rarely observed. These patients complained of pain in the abdomen (nausea and vomiting might not be present), in some cases, swelling of the intestinal mucosa occurred without swelling of the face, the level of C1-esterases was normal. Symptoms disappeared after discontinuation of the use of ACE inhibitors. Edema of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors who complain of abdominal pain.

Liver failure:

High plasma concentrations of fosinopril may be observed in patients with severe hepatic impairment. Very rarely, ACE inhibitors have been associated with cholestatic jaundice or hepatitis progressing to fatal necrosis. If jaundice occurs or the level of transaminases in the blood increases while taking fosinopril, you should stop taking the drug and consult a doctor immediately!

Neutropenia/Agranuloitosis:

Agranulocytosis, neutropenia, thrombocytopenia and anemia may develop during treatment with ACE inhibitors. These cases are more common in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma), with concomitant immunosuppressive therapy.

Cough:

When using ACE inhibitors, an unproductive cough is often observed, which disappears after cessation of therapy.

Pregnancy and lactation:

Fosinopril is contraindicated in pregnancy. The use of ACE inhibitors during the second and third trimesters of pregnancy causes damage (impaired fetal kidney development, decreased blood pressure in the fetus and newborn, impaired renal function, hyperkalemia, underdevelopment of the skull bones, insufficiency of amniotic fluid in the protective germinal membrane, limb contracture, pulmonary hypoplasia) or death of the developing fetus.

Since fosinopril is found in breast milk, the drug should not be used during lactation.

The preparation contains lactose. Persons with impaired lactose metabolism should not use the drug.

If the next dose of the drug was missed, the next dose should be taken as soon as possible. However, if it is time for another dose, do not take the missed dose, but return to your regular treatment regimen. Interruption in treatment or premature discontinuation of the drug reduces the likelihood of treatment success.

The effect of the drug on the ability to drive a car and work with

Mechanisms: Although fosinopril does not directly affect the reaction rate and coordination of movements, care must be taken when driving vehicles or performing other work that requires increased attention, since dizziness may occur, especially at the beginning of fosinopril therapy, in patients taking diuretics, with changing the dosage of the drug, with concomitant alcohol intake. Care should be taken when exercising or in hot weather due to the risk of dehydration and hypotension due to a decrease in the volume of circulating fluid.

35pt 1pt; text-indent: 0cm; line-height: 13.45pt; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;”> Tablets 10 or 20 mg, 30 tablets (3 PVC/PVDC-aluminum blisters of 10 tablets) are packed in a carton with leaflet.

Store below 25°C in original packaging. Keep out of reach of children

2 years. Do not use after the expiry date stated on the packaging.

By prescription.

Fosinopril Viva Pharm 20 mg No. 28 tab

Instructions for medical use
medicinal product
FOSINOPRIL VIVA PHARM

Trade name
Fosinopril VIVA PHARM

International nonproprietary name
Fosinopril

Dosage form
Tablets 10 mg, 20 mg

900 02 Composition
One tablet contains
active substance – fosinopril sodium 10 mg or 20 mg,
excipients: anhydrous lactose, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone and sodium stearyl fumarate.

Description
White or off-white round biconvex tablets with bevelled edges, scored on one side.

Pharmacotherapeutic group
Agents acting on the renin-angiotensin system. Angiotensin-converting enzyme (ACE) ACE inhibitors.
ATC code C09AA09

Pharmacological properties
Pharmacokinetics
After oral administration, the absorption of the drug is approximately 30-40%. The degree of absorption does not depend on food intake, but the rate of absorption may be slow.
The hydrolytic conversion of fosinopril by esterases to fosinoprilat occurs predominantly in the liver. With impaired liver function, the rate of hydrolysis can be slowed down, and the degree of conversion does not noticeably change. The maximum plasma concentration is reached after approximately 3 hours and does not depend on the dose taken. Fosinoprilat binds to blood proteins by ³ 95%, has a relatively small volume of distribution and is slightly associated with the cellular components of the blood.
Fosinopril is excreted from the body equally through the liver and kidneys. In hypertensive patients with normal renal and hepatic function, the half-life of fosinoprilat is approximately 11.5 hours. In patients with heart failure, the half-life is 14 hours. The clearance of fosinoprilat during hemodialysis and peritoneal dialysis averages 2% and 7%, respectively, in relation to the values ​​of urea clearance.
In patients with impaired renal function (creatinine clearance < 80 ml / min / 1. 73 m2), the total clearance of fosinoprilat from the body is approximately half that in patients with normal renal function. While absorption, bioavailability and protein binding are not markedly altered. Reduced excretion through the kidneys is compensated by increased excretion through the liver. A moderate increase in plasma AUC values ​​(area under the plasma concentration-time curve after a 1 mg dose) (less than twice normal) was observed in patients with renal insufficiency of various degrees, including renal insufficiency in the terminal stage (clearance creatinine < 10 ml/min/1.73 m2). In patients with impaired liver function (with alcoholic or biliary cirrhosis), the rate of hydrolysis of fosinopril may be reduced, but the degree of hydrolysis does not change markedly. The total clearance of fosinoprilat from the body of such patients is approximately half compared with patients with normal liver function.
In men aged 65 to 74 years with clinically normal kidney and liver function, there are no noticeable differences in the pharmacokinetic parameters of fosinoprilat compared with young patients (20-35 years old). Fosinopril is found in breast milk.

Pharmacodynamics
The active substance of Fosinopril VIVA PHARM, fosinopril, is an ester that is hydrolyzed in the body by the action of esterases into the active compound fosinoprilat. Fosinopril, due to the specific connection of the phosphinate group with ACE, prevents the conversion of angiotensin I into the vasoconstrictor angiotensin II, resulting in a decrease in vasopressor activity and aldosterone secretion. The latter effect can lead to a slight increase in the content of potassium ions in the serum (on average 0.1 mEq / l) with a simultaneous loss of sodium ions and fluid from the body.
Fosinopril inhibits the metabolic degradation of the bradykinin peptide, which has a powerful vasodepressor effect; due to this, the antihypertensive effect of the drug may be enhanced.
In heart failure, the positive effects of Fosinopril are achieved mainly by suppressing the renin-aldosterone system. Suppression of angiotensin-converting enzyme leads to a decrease in both preload and afterload on the myocardium. The drug improves symptoms and increases exercise tolerance, reduces the severity of heart failure and reduces the frequency of hospitalizations for heart failure.

Indications for use
– arterial hypertension (can be used both for monotherapy and in combination with other antihypertensive drugs, in particular with thiazide diuretics)
– heart failure (as part of combination therapy)

Dosage and administration
Dosage drug should be selected individually.
Arterial hypertension:
The recommended initial dose of the drug is 10 mg once a day. The dose must be selected depending on the dynamics of lowering blood pressure. The usual dose is 10 to 40 mg once a day. In the absence of a sufficient hypotensive effect, an additional appointment of diuretics is possible.
If treatment with Fosinopril VIVA PHARM is started against the background of ongoing diuretic therapy, then its initial dose should not exceed 10 mg. To reduce the likelihood of hypotension, diuretics should be discontinued 2-3 days before the start of treatment with Fosinopril VIVA PHARM.
Heart failure:
The recommended starting dose is 10 mg once daily. Depending on the therapeutic efficacy, the dose may be increased at weekly intervals up to a maximum dose of 40 mg once daily. Fosinopril VIVA PHARM is recommended to be used in combination with a diuretic.
Hypertension and heart failure with impaired renal or hepatic function
Since the excretion of the drug from the body occurs in two ways, dose reduction in patients with impaired renal or hepatic function is usually not required.
Geriatric patients
Differences in the efficacy and safety of treatment with the drug in patients aged 65 years and older and younger patients are not observed. However, a greater susceptibility of older patients to the drug cannot be ruled out.

Side effects
– nausea, vomiting, stomatitis, glossitis, anorexia, abdominal pain, constipation, hepatitis, cholestatic jaundice, pancreatitis, intestinal obstruction
– dry cough, shortness of breath, pharyngitis, laryngitis, sinusitis, pulmonary infiltrates, bronchospasm, dysphonia
– decrease in blood pressure, orthostatic hypotension, tachycardia, palpitations, arrhythmias, myocardial infarction
– skin rash, itching, angioedema
– development or aggravation of symptoms of chronic renal failure, proteinuria, oliguria
– hypercreatininemia, increased urea concentration, increased activity of “liver” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia; decrease in the concentration of hemoglobin and hematocrit, neutropenia, leukopenia, eosinophilia, increased erythrocyte sedimentation rate (ESR)
– stroke, cerebral ischemia, dizziness, headache, weakness; when used in high doses – insomnia, anxiety, depression, confusion, paresthesia
– hearing and vision impairment, tinnitus, disorders of the vestibular apparatus.

Contraindications
– hypersensitivity to fosinopril or any other substance that is part of the drug
– hereditary or idiopathic angioedema, including history, after taking other ACE inhibitors
– pregnancy (use of ACE inhibitors during the second and third trimesters pregnancy causes damage or even death of the developing fetus)
– lactation
– children under 18 years of age

Drug interactions
Antihypertensives, diuretics, narcotic analgesics, general anesthesia agents increase the hypotensive effect of Fosinopril VIVA PHARM.
The drug enhances the hypoglycemic effect of sulfonylurea derivatives, insulin, the risk of developing leukopenia when used simultaneously with allopurinol, cytostatic drugs, immunosuppressants, procainamide.
Antacids. Simultaneous use of antacids (for example, aluminum or magnesium hydroxide, semitecon) may reduce the absorption of Fosinopril VIVA PHARM. Therefore, it is necessary to use these drugs with an interval of at least 2 hours.
Lithium. With the simultaneous use of ACE inhibitors with lithium salts, serum lithium concentrations and the risk of developing lithium intoxication may increase, therefore, Fosinopril VIVA PHARM and lithium should be used with caution at the same time.
Non-steroidal anti-inflammatory drugs. It has been reported that indomethacin may reduce the antihypertensive effect of other ACE inhibitors, especially in patients with low-renin hypertension. Other non-steroidal anti-inflammatory drugs (eg, aspirin) may have a similar effect.
Diuretics. With the simultaneous use of the drug Fosinopril VIVA PHARM with diuretics or in combination with a strict diet that limits salt intake, or with dialysis, a pronounced hypotensive reaction may develop, especially in the first hour after taking the initial dose of fosinopril.
Potassium-sparing diuretics and potassium supplements. To avoid the risk of developing hyperkalemia, use Fosinopril VIVA PHARM simultaneously with drugs such as spironolactone, amiloride, triamterene, etc. and with potassium supplements should be used with caution. It is necessary to determine the concentration of potassium in the serum of a patient at short intervals.
Interaction with other drugs. The bioavailability of the drug when used simultaneously with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanteline, digoxin, aspirin and warfarin does not change.

Special instructions
Patients with severe arterial hypertension or concomitant decompensated chronic heart failure should start treatment with Fosinopril VIVA PHARM in a hospital setting.
Before and during drug treatment, it is necessary to control blood pressure, kidney function, potassium concentration, hemoglobin, creatinine, urea, electrolyte concentration and the activity of “liver” enzymes in the blood.
Angioedema. Angioedema has been reported in patients treated with ACE inhibitors, including Fosinopril VIVA PHARM. Swelling of the tongue, pharynx, or larynx can lead to airway obstruction, which can be fatal. In such cases, a rapid subcutaneous injection of a solution of adrenaline (1:1000) and other emergency measures are necessary. Patients should be informed about the discontinuation of the drug and immediately report to the attending physician about the appearance of edema on the face, eyes, lips and tongue, spasm of the muscles of the larynx or shortness of breath.
Anaphylactic reactions during desensitization. Care must be taken when treating patients with ACE inhibitors during desensitization procedures.
Anaphylactic reactions during dialysis through highly permeable membranes. Anaphylactic reactions have been reported in patients receiving ACE inhibitors during hemodialysis through high-permeability membranes, as well as during low-density lipoprotein apheresis with adsorption to dextran sulfate. In these cases, consideration should be given to using a different type of dialysis membrane or other medical treatment.
Neutropenia/agranulocytosis. In rare cases, cases of agranulocytosis and bone marrow suppression have been reported during treatment with ACE inhibitors. These cases were observed more often in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (systemic lupus erythematosus or scleroderma). It is necessary to monitor the content of white blood cells in such patients.
Arterial hypotension. In rare cases, in patients with uncomplicated arterial hypertension, the development of arterial hypotension was associated with the use of Fosinopril VIVA PHARM.
Symptomatic hypotension with ACE inhibitors is most likely in patients following intensive diuretic treatment and/or a salt-restricting diet, or undergoing renal dialysis. A temporary hypotensive reaction is not a contraindication for the use of the drug after taking measures to hydrate the body.
In patients with chronic heart failure with or without renal insufficiency, treatment with ACE inhibitors may cause an excessive antihypertensive effect, which may lead to oliguria or azotemia, and in rare cases, acute renal failure and death. Therefore, in the treatment of chronic heart failure with Fosinopril VIVA PHARM, it is necessary to carefully monitor patients, especially during the first two weeks of treatment, as well as with any increase in the dose of fosinopril or diuretic.
Patients with normal or low blood pressure who have previously been intensively treated with diuretics and with low blood sodium levels may require a reduction in the dose of the diuretic. Arterial hypotension is not a contraindication for further use of Fosinopril VIVA PHARM. Some decrease in systemic arterial pressure is a common and desirable effect at the beginning of the use of the drug in heart failure. The degree of this decrease is maximal in the early stages of treatment and stabilizes within one or two weeks of treatment. Blood pressure usually returns to pre-treatment levels without loss of therapeutic efficacy.
Impaired liver function. If there is a noticeable icterus and a pronounced increase in the activity of liver enzymes, treatment with Fosinopril VIVA PHARM should be discontinued and appropriate treatment should be prescribed.
Impaired renal function. In patients with arterial hypertension with stenosis of the renal artery of one or both kidneys, as well as with the simultaneous use of diuretics without signs of renal vascular disease during treatment with ACE inhibitors, the level of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and disappear after treatment is stopped. It may be necessary to reduce the dose of the diuretic and/or Fosinopril VIVA PHARM.
In patients with severe chronic heart failure, in whom renal function may be dependent on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors may lead to oliguria or progressive azotemia and, in rare cases, to acute renal failure and / or death.
Hyperkalemia. In patients with heart failure, diabetes mellitus, concomitantly taking potassium-sparing diuretics, potassium dietary supplements, potassium-containing salt substitutes, or other drugs that increase serum potassium ion concentrations (eg, heparin), ACE inhibitors increase the risk of an increase in serum potassium ion concentration.
Surgery/anesthesia. ACE inhibitors may enhance the antihypertensive effect of drugs used for general anesthesia.
Features of influence on the ability to drive vehicles and potentially dangerous mechanisms
Care must be taken when driving vehicles or performing any work that requires increased attention due to the possible occurrence of dizziness, especially after the initial dose of the drug in patients taking diuretic drugs.

Overdose
Symptoms: pronounced decrease in blood pressure, bradycardia, shock, impaired water and electrolyte status, acute renal failure, stupor.
Treatment: the drug should be discontinued, gastric lavage, sorbents (eg, activated charcoal), vasodepressors, infusions of 0.9% sodium chloride solution, and further symptomatic and supportive treatment are indicated. With a decrease in blood pressure – intravenous administration of catecholamines, angiotensin II; with bradycardia – the use of a pacemaker. The use of hemodialysis is ineffective.