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

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More about fosinopril

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• 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.

Use of fixed combination of fosinopril with hydrochlorothiazide in the treatment of arterial hypertension :: DIFFICULT PATIENT

N.V. Sturov

Department of General and Clinical Pharmacology PFUR, Moscow

The rationality of combining different groups of antihypertensive agents is pathophysiologically substantiated by the need for parallel correction of various pathological links leading to an increase in blood pressure (BP), and has been proven in many clinical trials [1], with the most often, to achieve the target level of blood pressure, they resort to adding a diuretic, usually hydrochlorothiazide, to the prescribed drugs.
The need for widespread use of rational combinations of antihypertensive drugs is dictated by a higher degree of blood pressure control against the background of their appointment. It should be remembered that the achievement of the target level of blood pressure is the main criterion for the quality of treatment of arterial hypertension (AH). However, even in the United States, out of 65 million Americans receiving antihypertensive therapy, only 31% achieve the target BP level [2], and in a significant number of cases the reason is non-compliance with the prescribed drugs. That is why attention is paid to the study of ways to increase adherence to treatment. One of the simple and effective methods of improving compliance is the use of fixed combinations of drugs.
Combinations of angiotensin converting enzyme inhibitors (ACE inhibitors) with thiazide diuretics, such as fosinopril with hydrochlorothiazide, are the most popular.
It is known that with an isolated appointment in monotherapy, the antihypertensive activity of fosinopril gradually increases in the first few weeks of treatment, blood pressure reaches target levels without the manifestation of elements of compensatory cardiac arrhythmias, and drug withdrawal does not lead to a rapid rise in blood pressure. The action of fosinopril, as a rule, does not depend on the age and sex characteristics and body weight of patients [3].
In addition to the actual antihypertensive effect, fosinopril is effective in preventing and reversing left ventricular (LV) hypertrophy in AH, i.e. not only reduces blood pressure, but promotes regression of structural remodeling of the heart chambers. Within 9 months, the mass of the LV myocardium in persons with severe hypertrophy decreases (up to 5 g reduction), and in the comparison group it increases. This observation is very important, since LV wall hypertrophy is one of the key predictors of cardiovascular events [4].
The drug has a positive effect on the course of atherosclerosis of the carotid arteries. It has been shown that the thickness of the intima-media complex in this area of ​​the vascular bed after 36 weeks of regular use of the drug decreases by 0.0278 ± 0.03 mm, while this indicator only increases without taking fosinopril [4].
The results of the double-blind, placebo-controlled study PHYLLIS (The Plaque Hypertension Lipid-Lowering Italian Study) demonstrated an inhibitory effect of fosinopril therapy on the progression of carotid atherosclerosis. The study involved 508 patients with hypertension with asymptomatic atherosclerotic lesions of the carotid basin. The patients were divided into groups depending on the therapy: 127 patients received hydrochlorothiazide at a dose of 25 mg/day, 127 – fosinopril at a dose of 20 mg/day, 126 – 25 mg of hydrochlorothiazide and an additional 40 mg of pravastatin, 128 – 20 mg of fosinopril and 40 mg of pravastatin. The mean follow-up period was 2.6 years. The thickness of the intima-media complex (mainly in the area of ​​bifurcation of the common carotid artery) significantly increased in the group of patients treated with hydrochlorothiazide alone. In patients treated with fosinopril, pravastatin, or both, a significant decrease in the thickness of the atherosclerotic lesion was observed. Thus, it has been shown that fosinopril has an antiatherogenic effect in hypertensive patients [5].
The combination of ACE inhibitors and thiazides is very effective for the treatment of hypertension and is one of the most common and rational. In order to verify this statement, the antihypertensive efficacy and safety of fosinopril and its combination with hydrochlorothiazide were evaluated in a placebo-controlled study. After 4-5 weeks of placebo, 67 patients with mild or moderate hypertension (DBP ranged from 95-110 mmHg) were randomized into 4 parallel groups: fosinopril 20 mg + hydrochlorothiazide 12.5 mg, fosinopril 20 mg, 12 .5 mg hydrochlorothiazide, placebo control. Evaluation of the results was made after 8 weeks of admission. The combination of fosinopril and hydrochlorothiazide appeared to be most effective when compared with these agents alone (p A large, double-blind, placebo-controlled, parallel-group study examined the efficacy of an ACE inhibitor/thiazide diuretic combination in 17 different dosing regimens of fosinopril and hydrochlorothiazide in 550 patients with mild to moderate Hypertension was analyzed using a quadratic response surface model (QRSM), which predicted the required doses during the trial.The combination of fosinopril 10 mg + hydrochlorothiazide 12. 5 mg was found to reduce DBP by 6.3 over 8 weeks mm Hg, and the combination of fosinopril 20 mg + hydrochlorothiazide 12.5 mg – by 9.1 mmHg Art. Both combinations demonstrated a good mutually potentiating effect of the two antihypertensive components [7].
In a double-blind study (following a four- or six-week placebo period in all patients), 418 subjects with grade I-II hypertension were randomized to receive fosinopril 5, 10, 20, or 40 mg once daily by mouth for 4 weeks . After 4 weeks, patients who did not sufficiently respond to the prescribed therapy, the dose of the drug was doubled, and they took fosinopril at a new dosage for the next 4 weeks. If necessary, hydrochlorothiazide was added to therapy in the last 4 weeks. A significant and smooth antihypertensive response (when measuring blood pressure in the sitting and standing position) was demonstrated after 4 weeks of taking 20 or 40 mg of fosinopril, while both dosing regimens gave a similar result. Further analysis showed that in mild to moderate hypertension, the dose of fosinopril can be successfully titrated in the range of 5 to 40 mg once a day with the parallel addition of hydrochlorothiazide. Treatment was interrupted in 3% of patients in the fosinopril group and 1% in the placebo group due to side effects. No abnormalities were noted in laboratory tests throughout the study. Fosinoprilat (the active metabolite of fosinopril) was eliminated in two ways – renal and hepatic [8].
The efficacy and safety of fosinopril in various age categories, including in combination with hydrochlorothiazide, has been proven in clinical trials. So, in the FOPS study (Fosinopril in Old Patients Study), 757 patients over 60 years old with hypertension took part, the follow-up period was 12 weeks. Target BP was achieved in 80% of patients. The effect of the drug did not depend on the degree of renal dysfunction. In the case of an unsatisfactory result in terms of achieving the indicated therapeutic result, a better effect was observed when 12.5 mg of hydrochlorothiazide was added to the treatment regimen than when the dose of the drug was doubled [9].
The FLAG study (Fosinopril in the Treatment of Arterial Hypertension) evaluated the likelihood of reaching blood pressure targets in patients with mild to moderate hypertension in the outpatient setting when treated with fosinopril (10-20 mg/day) or in combination with hydrochlorothiazide. 2,557 patients were included, of which 26.7% were over 60 years of age. Target BP was achieved in 62.1% of patients. Side effects were noted in 8.3% of patients, and only 5.2% required discontinuation of drugs [10].
The FAOT (Pharmacoeconomic evaluation of the use of fosinopril ACE inhibitor in the outpatient treatment of patients with Complicated Arterial Hypertension) study included 2 596 patients with mild to moderate hypertension and the presence of two risk factors for cardiovascular complications. The effectiveness of fosinopril monotherapy or in combination with hydrochlorothiazide was compared with conventional conventional therapy (diuretics, b-blockers, calcium antagonists) in patients of different ages. Target blood pressure when taking fosinopril and hydrochlorothiazide was achieved in 67.8% of patients. It has been shown that the speed and clinical efficacy of BP normalization under the influence of fosinopril does not differ in elderly and young patients and exceeds the traditional treatment regimen. Compared with other drugs, fosinopril was favorably distinguished by ease of administration and final cost-effectiveness [11].
Of interest is a multicenter (n = 11) and multinational (Denmark, Finland, Iceland, Norway, Sweden), double-blind, randomized study comparing fosinopril in parallel groups with enalapril, one of the most popular ACE inhibitors. The trial involved 195 patients with mild or moderate hypertension (DBP – 95-110 mm Hg. Art.). The study lasted 24 weeks. After discontinuation of all previous antihypertensive drugs, patients received placebo for 4-6 weeks. Subjects were then given fosinopril 20 mg, with a possible increase after 8 weeks to 40 mg (average dose was 25.6 mg) or enalapril at a starting dose of 10 mg, with a possible increase to 20 mg after the same period (average dose turned out to be 12.9mg). Hydrochlorothiazide (12.5 mg) could be added after 16 weeks; this was required in 27% of patients in the fosinopril group and 30% in the enalapril group. All drugs were administered once a day. As a result, in the fosinopril group, SBP decreased from 157 to 143 mm Hg. Art. (p The most important distinguishing feature of fosinopril is a balanced dual route of elimination from the body – renal excretion with urine and hepatic excretion with bile through the gastrointestinal tract [13]. Due to this excretion mechanism, the pharmacokinetics of fosinopril depends little on the state of the liver and kidneys, and the risk of cumulation of the drug practically disappears with rational use [14,15].0005 According to the results of a study of the pharmacokinetics of fosinopril in combination with hydrochlorothiazide, the joint administration of these drugs is possible even in patients with impaired renal function (mean creatinine clearance 55.7 ± 15.6 ml / min × 1.73 m2). The pharmacokinetics of fosinoprilat in patients with impaired and intact renal function on the first day were: the maximum concentration in the blood 387 ± 0.19 and 324 ± 0.25 ng / ml (p = 0.07), the time to reach the maximum concentration of 3. 5 and 3.0 h (p = 0.58), area under the concentration-time curve 3510 ± 0.29and 2701 ± 0.35 ng × h/ml (p = 0.072), cumulative renal excretion 5.08 ± 2.70 and 7.40 ± 2.56% (p = 0.009), respectively. By the fifth day of therapy, only the time to reach the maximum concentration in the blood increased statistically significantly [16].
In addition, fosinoprilat is known to have the lowest accumulation index (1.21) in patients with chronic renal failure with creatinine clearance less than 30 ml / min (this criterion reflects the increase in the area under the concentration-time curve during treatment). This feature is due to the presence of two interchangeable routes of elimination of the drug (hepatic and renal) and is very important in violation of the excretory function of the kidneys. For comparison, the same indicator for the same pathology for enalaprilat is 1.96, for lisinopril – 2.76 [17]. Fosinoprilat is also distinguished by a high degree of lipophilicity (class IIB according to Opie), which ensures sufficient penetration of the drug into tissues, especially the myocardium, which is associated with a pronounced cardioprotective effect, and blockade of the renin-angiotensin-aldosterone system both in the systemic circulation and in individual organs ( heart, kidneys) [18].
The data presented demonstrate the high antihypertensive efficacy of fosinopril and the possibility of achieving the target level of blood pressure in patients who have not sufficiently responded to the prescribed treatment by adding hydrochlorothiazide. The presence of a fixed combination of these drugs (Fozicard N) significantly simplifies patient compliance with the therapy regimen and is one of the ways to improve the quality of antihypertensive therapy.

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14.