Fosinopril Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Although fosinopril may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause serious kidney problems or make them worse. Your doctor will check your kidney function while you are taking fosinopril. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Fosinopril – an ACE inhibitor.

Uses, dosage and side effects

About fosinopril

Fosinopril belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. You may have been prescribed it to reduce high blood pressure (hypertension), or to treat heart failure. Heart failure is a condition where your heart does not work as well as it should.

ACE inhibitors like fosinopril prevent your body from creating a hormone known as angiotensin II. They do this by blocking (inhibiting) a chemical called angiotensin-converting enzyme. This widens your blood vessels and helps to reduce the amount of water put back into your blood by your kidneys. These actions help to decrease blood pressure. Although people with high blood pressure often do not feel unwell, if left untreated, high blood pressure can harm the heart and damage blood vessels, leading to a heart attack or stroke.

In heart failure, there can be too much circulating fluid in your blood vessels because your heart is not working as efficiently as it once did. Fosinopril helps to reduce this. It also appears to have a protective effect on the heart and slows the progression of the heart failure.

Before taking fosinopril

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking fosinopril it is important that your doctor knows:

• If you are pregnant or breastfeeding.
• If you have any problems with the way your kidneys work, or any problems with the way your liver works.
• If you are lacking in fluid in the body (dehydrated) – for example, if you have had diarrhoea or sickness very recently.
• If you have been told you have a build-up of fatty deposits on the walls of your arteries, a condition called atherosclerosis.
• If you have a particular type of poor circulation called peripheral arterial disease.
• If you have collagen vascular disease, this includes conditions such as systemic lupus erythematosus (SLE) and scleroderma.
• If you have been told you have heart muscle disease (cardiomyopathy), or narrowing of the main blood vessel from your heart (aortic stenosis).
• If you have ever had a reaction where your face, tongue or throat swells (angio-oedema).
• If you are having desensitisation treatment to protect against bee and wasp stings.
• If you are having dialysis treatment, or treatment to remove cholesterol from your blood by a machine (LDL apheresis).
• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
• If you have ever had an allergic or unusual reaction to any other ACE inhibitor (such as captopril, ramipril or perindopril), or to any other medicine.

How to take fosinopril

• Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about fosinopril and will provide you with a full list of side-effects which you could experience from taking it.
• Take the tablets exactly as your doctor tells you to. Fosinopril is taken once a day. If you have high blood pressure, your doctor will advise you take your very first dose at bedtime. This is because you can feel quite dizzy when you first start taking it. After the first dose, you can generally take fosinopril at a time of day you find easy to remember. For most people this will be in the morning.
• Try to take your doses at the same time of day each day as this will help you to remember to take your doses regularly. You can take fosinopril tablets either with or without food. It is best to swallow the tablet with a drink of water.
• There are two strengths of fosinopril tablets – 10 mg and 20 mg. It is usual to start by taking the 10 mg strength tablets, although your doctor may increase your dose over the first few weeks. This allows your doctor to make sure that you have the dose that helps your condition and helps to avoid any unwanted side-effects, such as dizziness. Each time you collect a new supply, check to make sure the tablets are the strength that you are expecting.
• If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, leave out the forgotten dose from the previous day and take the dose that is due as normal. Do not take two doses at the same time to make up for a missed dose.

Getting the most from your treatment

• Try to keep your regular appointments with your doctor. This is so your progress can be monitored. Your doctor will want you to have some blood tests from time to time to check that your kidneys are working well.
• It is very important that you follow any dietary and lifestyle advice that you have been given by your doctor. This can include advice about eating a healthy diet, not smoking, and taking regular exercise.
• If you buy any medicines, check with a pharmacist that they are suitable to take with fosinopril. This is because some medicines (such as anti-inflammatory painkillers and indigestion remedies) can interfere with your treatment.
• It is likely that your doctor will advise that you do not to use salt substitutes while you are taking fosinopril. These products have a high content of potassium which could be harmful for you.
• If you drink alcohol, ask your doctor for advice about drinking alcohol while you are on fosinopril. Alcoholic drinks can make you feel light-headed or dizzy, and they may not be advisable for you.
• If you have diabetes you may need to check your blood sugar (glucose) more frequently, as the tablets can lower the levels of sugar in your blood. Your doctor will advise you about this.
• If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking fosinopril. This is because some anaesthetics could cause your blood pressure to drop too low.
• Treatment with fosinopril is often long-term unless you experience an adverse effect. Continue to take the tablets unless you are advised otherwise.

Can fosinopril cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the more common ones associated with fosinopril. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer’s printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer’s information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

Important: if you experience any of the following potentially serious symptoms, stop taking fosinopril and contact your doctor for advice straightaway:

• Any difficulty breathing, or swelling of your face, mouth, tongue or throat. These are signs of an allergic reaction.
• Any yellowing of your skin or the whites of your eyes. These may be signs of a liver problem called jaundice, which is a rare side-effect.

If you experience any other symptoms which you think may be due to the tablets, speak with your doctor or pharmacist for further advice.

How to store fosinopril

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Monopril (fosinopril) dosing, indications, interactions, adverse effects, and more

Fosinopril tablets

What is this medicine?

FOSINOPRIL (foe SIN oh pril) is an ACE inhibitor. This medicine is used to treat high blood pressure and heart failure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Monopril

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bone marrow disease
• heart or blood vessel disease
• if you are on a special diet, such as a low salt diet
• immune system disease like lupus
• kidney or liver disease
• low blood pressure
• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• an unusual or allergic reaction to fosinopril, other ACE inhibitors, insect venom, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. It is best to take this medicine on an empty stomach, at least 1 hour before or 2 hours after meals. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medication with any of the following medications:

This medicine may also interact with the following:

• antacids
• diuretics
• lithium
• medicines for high blood pressure
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• potassium salts or supplements

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her. Call your doctor or health care professional if you notice an irregular or fast heart beat.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Avoid salt substitutes unless you are told otherwise by your doctor or health care professional.

Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the hands, feet, face, lips, throat, or tongue
• decreased amount of urine passed
• difficulty breathing, or difficulty swallowing
• dizziness, light headedness or fainting spells
• fast or irregular heart beat, palpitations, or chest pain
• fever or chills
• numbness or tingling in your fingers or toes
• stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in taste
• cough
• headache
• sun sensitivity
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

APO-Fosinopril – NPS MedicineWise

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about fosinopril. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do not understand in this leaflet,
• if you are worried about taking your medicine, or
• to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APO-Fosinopril. It contains the active ingredient fosinopril.

It is used to treat:

• high blood pressure (hypertension)
• heart failure.

Both of these are long term (chronic) diseases so it is important that you continue to take your medicine every day.

High blood pressure (hypertension):

Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are.

If you have hypertension (high blood pressure), this means that your blood pressure stays higher than is needed, even when you are relaxed.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis.

If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

Heart Failure:

Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops. Heart failure may start off with no symptoms, but as the condition progresses, patients feel short of breath or may get tired easily after light physical activity such as walking. Some patients may wake up short of breath at night. Fluid may collect in different parts of the body, often first noticed as swollen ankles and feet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

How it works

Fosinopril belongs to a class of medicines known as Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening your blood vessels, reducing the pressure in the vessels (reducing ‘blood pressure’) and by making it easier for your heart to pump blood around your body. This helps your heart to work better by increasing the supply of oxygen to your heart, so that when you place extra demands on your heart, such as during exercise, your heart may cope better and you may not get short of breath as easily.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

• You are pregnant.
  
  Fosinopril may affect your developing baby if you take it during pregnancy.
• You have a history of angioedema or angioneurotic oedema, which is swelling of the face, lips, tongue, throat (which may cause difficulty in swallowing or breathing), hands or feet, associated with previous treatment of ACE inhibitors.
• You take aliskiren-containing medications (for high blood pressure) and have diabetes or kidney problems.
• You have had an allergic reaction to fosinopril, any other ACE inhibitor or any of the ingredients listed at the end of this leaflet.
  
  Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms
  If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
• The expiry date (EXP) printed on the pack has passed.
• The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

• family history of swelling of the face, lips, tongue, throat that may cause difficulty in swallowing or breathing
• diabetes
• are undertaking any immunosuppressive therapy
• are taking trimethoprim containing medicines
• kidney problems, or are having dialysis
• liver problems
• low blood pressure, which you may notice as dizziness or lightheadedness
• you are following a very low salt diet
• you are dehydrated, or have recently suffered from excessive vomiting or diarrhoea.
• coughing or skin reactions if you have taken other ACE inhibitors in the past.

3. You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding.
4. You are planning to have surgery or an anaesthetic.
5. You are currently receiving or are planning to receive dental treatment.
6. You are taking or are planning to take any other medicines, This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Taking other medicines

Some medicines may interact with fosinopril. These include:

• water tablets or diuretics (for example frusemide, indapamide, amiloride and hydrochlorothiazide)
• potassium tablets (for example potassium chloride
• potassium-containing salt substitutes
• angiotensin II receptor blockers (e.g. irbesartan, valsartan, telmisartan) or aliskiren-containing medications
• diabetes medication
• lithium or lithium-containing preparations (for example lithium carbonate)
• antacids
• if you are taking fosinopril for high blood pressure do not take any medicine (including ones bought without prescription) for appetite control, asthma, colds, coughs, hayfever or sinus problems unless you have discussed the medicine with your doctor
• anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include non-steroidal anti-inflammatory agents – NSAIDS (for example diclofenac and aspirin) and COX-2 inhibitors (for example celecoxib). Taking a combination of fosinopril with a thiazide diuretic (water tablet) and an anti-inflammatory medicine may damage your kidneys
• medicines that lower your immune system, such as medicines used to prevent rejection of transplant organs
• trimethoprim containing medicines used to treat certain types of injections
• injectable gold or sodium aurothiomalate.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with fosinopril.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Most people will initially start taking a 10 mg dose once daily. Fosinopril is then usually taken at a dose of 10 mg to 40 mg once a day. Your doctor may have prescribed a different dose for you.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

It does not matter if you take it before, with or after food.

If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of fosinopril.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

• you are about to be started on any new medicine
• you are pregnant or are planning to become pregnant
• you are about to have any blood tests
• you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Tell your doctor if you have excessive vomiting or diarrhoea or experience any of the following symptoms:

• light-headed or dizzy
• dry mouth or thirst
• weakness, tiredness or drowsiness
• muscle pain or cramps
• fast heart beat
• passing less urine than normal.

If you experience these symptoms, you may be dehydrated because you are losing too much water. This is more likely to occur when you begin to take fosinopril or if your dose is increased.

Make sure you drink enough water during exercise and hot weather when you are taking fosinopril, especially if you sweat a lot.

If you do not drink enough water while taking fosinopril, your blood pressure may drop suddenly and you may dehydrate. If you experience any of the above symptoms, tell your doctor.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

• Give this medicine to anyone else, even if their symptoms seem similar to yours
• Take your medicine to treat any other condition unless your doctor tells you to
• Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

As with other ACE inhibitor medicines, you may feel light-headed or dizzy when you begin to take fosinopril or after your dose is increased. This is because your blood pressure is dropping suddenly.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. Be careful the first time you take fosinopril, especially if you are elderly.

Be careful when driving or operating machinery until you know how this medicine affects you.

If you drink alcohol, dizziness or light-headedness may be worse.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking fosinopril or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

• feeling light-headed, dizzy or faint
• headache
• tiredness, fatigue or weakness
• dry cough
• feeling sick (nausea) or vomiting
• upset stomach (dyspepsia) or heartburn
• diarrhoea
• stomach pains
• muscle cramps or pains
• taste disturbance.

Tell your doctor as soon as possible if you notice any of the following: These may be serious side effects. You may need medical attention.

• changes to your heart rhythm
• infections of your urinary tract, upper respiratory tract, cold or flu symptoms
• severe dizziness (vertigo)
• impotence (inability to get or maintain an erection)
• mild rash or itching
• gout (painful, swollen joints)
• diabetes (symptoms include excessive thirst, greatly increased amount of urine, increase of appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell)
• sore throat and fever
• hepatitis (symptoms include nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine)
• confusion; irregular heartbeat; nervousness; numbness or tingling of the hands, feet or lips; shortness of breath or difficulty breathing; weakness or heaviness of legs (you may experience these symptoms if too much potassium builds up in your body).

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

• fluid filled blisters or itchy rash, especially if it appears quickly
• if you faint or if your skin turns yellow
• sore throat and fever
• chest pain
• not urinating (passing water) as much as usual
• stomach pain with or without nausea.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to fosinopril, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing.
• swelling of the face, lips, tongue, or other parts of the body
• rash, itching or hives on the skin
• fainting
• hayfever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Fosinopril looks like

10 mg tablets:

White, capsule shaped biconvex tablets with indents, engraved APO on one side and FOS-10 on the side.

20 mg tablets:

White, oval, biconvex tablets, engraved APO on one side and FOS-20 on the side.

Fosinopril 10mg and 20mg tablets are packaged in blister packs and bottles of 30 tablets*.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 10 mg or 20 mg of Fosinopril sodium as the active ingredient.

It also contains the following inactive ingredients:

• lactose
• crospovidone
• zinc stearate.

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Fosinopril 10 mg tablet blister pack: AUST R 119874

APO-Fosinopril 10 mg tablet bottle: AUST R 119875

APO-Fosinopril 20 mg tablet blister pack: AUST R 119876

APO-Fosinopril 20 mg tablet bottle: AUST R 119877

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia
Tel: (02) 8877 8333
Web: www1.apotex.com/au

APO and APOTEX are registered trade marks of Apotex Inc.

This leaflet was prepared in: March 2020.

Published by MIMS May 2020

Fosinopril: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: Canada

APO-Fosinopril; CO Fosinopril; Fosinopril-10 [DSC]; Fosinopril-20 [DSC]; JAMP-Fosinopril; PMS-Fosinopril; RAN-Fosinopril; TEVA-Fosinopril

Warning

If your child is or may be pregnant:

• Do not give this drug to your child during pregnancy. Use during pregnancy may cause birth defects or loss of the unborn baby. If your child gets pregnant or plans on getting pregnant while taking this drug, call the doctor right away.

What is this drug used for?

• It is used to treat heart failure (weak heart).
• It is used to treat high blood pressure.
• It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has ever had a very bad or life-threatening reaction called angioedema. Signs may be swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; unusual hoarseness.
• If your child is taking a drug that has aliskiren in it and your child also has diabetes or kidney problems.
• If your child has taken a drug that has sacubitril in it in the last 36 hours.

If your child is breast-feeding a baby:

• Be sure your child does not breast-feed a baby while taking this drug.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
• To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
• Have your child’s blood pressure checked as you have been told.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
• If your child is taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your child’s doctor.
• If your child is on a low-salt or salt-free diet, talk with your child’s doctor.
• If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids.
• Alcohol may interact with this drug. Be sure your child does not drink alcohol.
• Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
• Tell the doctor if your child has too much sweat, fluid loss, throwing up, or diarrhea. This may lead to low blood pressure.
• This drug may not work as well to lower blood pressure in Black patients. Sometimes another drug may need to be given with this drug. If you have any questions, talk with the doctor.
• A severe and sometimes deadly reaction called angioedema has happened. The chance of angioedema may be higher in Black patients.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Very bad dizziness or passing out.
• Cough that does not go away.
• Very bad belly pain.
• Very upset stomach or throwing up.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• Give this drug with or without food.
• Give this drug at the same time of day.
• Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
• Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
• Do not give antacids within 2 hours before or 2 hours after giving this drug.

What do I do if my child misses a dose?

• Give a missed dose as soon as you think about it.
• If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
• Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2020-08-19

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Fosinopril – an overview | ScienceDirect Topics

instructions for use, analogs, composition, indications

Fozinopril is taken orally once a day.Like all other drugs taken once a day, fosinopril is recommended to be taken at the same time every day. The 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 the effect of the dose used is absent within 3-4 weeks of use.The usual maintenance dose is 10–40 mg per day as a single dose. In patients with severe disorders of water-electrolyte metabolism, renal hypertension, severe hypertension at the beginning of therapy, there may be a sharp drop in blood pressure.

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 therapy with fosinopril should be carried out under close medical supervision.

Heart failure:

In patients with symptomatic heart failure, fosinopril should be used as adjunctive 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.

Kidney patents:

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 the glomerular filtration rate below 10 ml / min.

Patients with impaired liver function:

In case of impaired liver function, it is recommended to be careful, the starting dose should not exceed 10 mg / day.The 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.

Elderly Patent Usage:

There were no significant differences in the efficacy and tolerability of fosinopril therapy in patients over 65 years old compared with younger people.Therefore, with intact kidney and liver function, dose adjustment in elderly patients is not required.

Frequency of side effects:

Very often: more than 1/10 Often: from 1/100 to 1/10 Uncommon: from 1/100 to 1/1000 Rarely: 1/1000 to 1/10000

Very rare: less than 1/10000 and isolated cases.
The following side effects have been observed during clinical studies:

Blood and lymphatic system:

Uncommon: transient decrease in hemoglobin level, decrease in gmatocrit. Rarely: transient anemia, eosinophilia, leukopenia, lymphadenopathy, neutropenia, thrombocytopenia. Very rare: agranulocytosis.

Metabolic disorders:

Uncommon: decreased appetite, hyperkalemia, gout.

Mental disorders:

Uncommon: depression.
Neurological disorders:

Often: dizziness, headache. Uncommon: stroke, sensitivity disorder characterized by sensations of numbness, tingling sensations, crawling creeps, mild impairment of consciousness, fainting, taste disturbances, tremors, sleep disturbances. Rarely: speech impairment, memory impairment, disorientation.

Organs of vision:

Uncommon: visual impairment

Hearing organs:

Uncommon: pain and ringing in the ears, dizziness.
The cardiovascular system:

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

Respiratory and mediastinal organs.

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

Gastrointestinal tract:

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

Liver:

Rarely: hepatitis. Very rare: liver failure.

Skin and subcutaneous tissue:

Often: rash, acute and transient edema, dermatitis.Uncommon: increased sweating, itching, urticaria. Rare: extensive hemorrhage.

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

Musculoskeletal system: Uncommon: myalgia. Rarely: arthritis

Removal organs:

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

Genital organs:

Uncommon: Sexual dysfunction General symptoms:

Often: chest pain (noncardiac), weakness. Uncommon: fever

peripheral edema, sudden death, chest pain.

Laboratory research results:

Often: an increase in alkaline phosphatase, an increase in bilirubin, an increase in lactate dehydrogenase, an increase in 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 the groups of patients over 65 years old and middle-aged people did not differ significantly.

If the listed adverse reactions occur, consult a doctor immediately. In case of any unusual reactions, be sure to consult with your doctor about the further use of the drug!

Overdose of ACE inhibitors can manifest itself as hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and 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 who received diuretics prior to starting fosinopril therapy have 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 hyperkalemia. In patients with heart failure, diabetes mellitus, who are simultaneously taking potassium-sparing diuretics, potassium, potassium-containing salt substitutes, or other drugs that cause hyperkalemia (for example, heparin), ACE inhibitors increase the risk of an increase in 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. Nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid at a dose of more than 3 g / day): Nonsteroidal anti-inflammatory drugs can reduce the antihypertensive effect of ACE inhibitors, especially in patients with 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 enhance the antihypertensive effect. Concomitant use with nitroglycerin and other nitrates, as well as other vasodilators, can cause a sharp drop in blood pressure.
Tricyclic antidepressants, antipsychotic drugs, anesthetics: c

combined with ACE inhibitors can cause a sharp decrease in blood pressure. Sympathomimetics: may reduce the hypotensive effect of ACE inhibitors. Sugar-lowering drugs: when used together with ACE inhibitors, an increase in the glucose-lowering effect is noted with an increased risk of hypoglycemia. This effect is more often observed during the first weeks of joint use of drugs and in patients with renal failure.
Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates: fosinopril can be used with beta-blockers, nitrates, thrombolytic drugs, acetylsalicylic acid (cardiac dosages).

Immunosuppressants, antibiotics, 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 about it! During treatment with Fosinopril, do not take any other medicines (including those sold without a prescription) without first consulting your doctor. Uncontrolled treatment can harm your health.

The 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 high 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 received diuretics for a long time.
Symptomatic hypotension:

Symptomatic hypertension can be observed in patients with uncomplicated arterial hypertension. The likelihood of hypotension is higher in patients after intensive diuretic treatment, restriction of salt intake with food, during dialysis, disorders of water-salt metabolism due to vomiting or diarrhea. The risk of hypotension is also higher in patients with severe heart failure as a result of prolonged use of high doses of diuretics, in patients with hyponatremia, and in elderly patients.Caution should be exercised when starting therapy with fosinopril in this group of patients. Also, caution should be exercised in patients with ischemic heart disease and cerebrovascular diseases, since a decrease in blood pressure can provoke acute disturbance of the coronary or cerebral circulation in these patients.

If hypotension occurs, it is recommended to put the patient to bed and consult a doctor immediately! 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 dysfunctions:

Renal failure does not require adjustment of the starting dose of fosinopril. Regular monitoring of plasma potassium and creatinine levels 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 go away after treatment is stopped. A dose reduction of the diuretic and / or fosinopril may be required.

Renovascular hypertension is a risk factor for severe hypotension and renal failure.The selection of the dose in these patients should be carried out under close medical supervision. Since taking diuretics can contribute to the development of these complications, it is recommended that diuretics be discontinued and renal function closely monitored during the first weeks of taking fosinopril.

Proteinuria:

Patients with proteinuria prior to taking fosinopril may experience worsening of their condition 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:

It was reported about the development of angioedema in patients with the use of 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. If such reactions develop, you must stop taking the drug and immediately consult a doctor! It is noted that angioedema develops more often in black patients.
The risk of angioedema while taking ACE inhibitors is higher in patients with a history of this condition due to taking other drugs.

Swelling of the intestinal mucosa.

Swelling of the intestinal mucosa was rarely observed while taking ACE inhibitors. These patients complained of abdominal pain (with no nausea and vomiting), in some cases, swelling of the intestinal mucosa occurred without edema of the face, the level of C1-esterases was normal.Symptoms disappeared after discontinuation 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 can be observed in patients with severe hepatic impairment. Very rarely, the use of ACE inhibitors was associated with the occurrence of cholestatic jaundice or hepatitis, which progressed to fatal necrosis.If jaundice appears or the level of transaminases in the blood increases while taking fosinopril, you should stop taking the drug and immediately consult a doctor!

Neutropenia / agranuloitosis:

Perhaps the development of agranulocytosis, neutropenia, thrombocytopenia and anemia during treatment with ACE inhibitors. These cases are observed more often 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:

With the use of ACE inhibitors, a nonproductive cough is often observed, which disappears after discontinuation of therapy.

Pregnancy and lactation:

Fosinopril is contraindicated in pregnancy. The use of ACE inhibitors during the II and III trimesters of pregnancy causes damage (impaired development of the kidneys of the fetus, decreased blood pressure in the fetus and newborn, impaired renal function, hyperkalemia, underdevelopment of the skull bones, insufficient amniotic fluid in the protective embryo membrane, contracture of the limbs, lung hypoplasia) or death of the developing fetus.
Since fosinopril is found in breast milk, the drug should not be used during breastfeeding.

The drug contains lactose. It is not recommended to use the drug for persons with impaired lactose metabolism.

If the next dose of the drug was missed, you should take the next dose as soon as possible. However, if it is time to take the next dose, do not take the missed dose, but return to your usual treatment regimen. Interruption in treatment or early discontinuation of the drug will reduce the likelihood of treatment success.
The effect of the drug on the ability to drive 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 requiring 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 the concomitant intake of alcohol.Care should be taken when exercising or in hot weather due to the risk of dehydration and arterial hypotension due to a decrease in the volume of circulating fluid.

Fozinopril tab 20mg 30 pcs Izvarino Pharma

To assess the incidence of adverse events, the following classification of the World Health Organization is used:

Very often (> 1/10)

Often (> 1/100 and 1/1000 and 1/10 000 and 1/10 000)

The frequency is unknown (cannot be estimated from the available data).

From the side of the cardiovascular system:

often – tachycardia, marked decrease in blood pressure, orthostatic collapse;

infrequently – angina pectoris, myocardial infarction, palpitations, cardiac arrest, arrhythmia, cardiac conduction disturbances, increased blood pressure, shock, sudden death;

rarely – “hot flushes” of blood to the skin of the face, hemorrhage, peripheral vascular disease.

From the urinary system:

infrequently – renal failure, proteinuria;

rarely – prostate pathology (hyperplasia, adenoma), polyuria, oliguria;

very rare – acute renal failure.

From the genitals and breast:

infrequently – sexual dysfunction.

From the side of the central and peripheral nervous system:

often – dizziness, headache;

Uncommon – cerebral infarction, paresthesia, drowsiness, stroke, fainting, transient ischemic attack, tremor, sleep disturbance, depression, confusion;

rarely – memory impairment, dysphasia, disorientation, anxiety.

From the sensory organs:

infrequently – hearing and visual impairment, tinnitus, ear pain, taste disturbance.

From the digestive system:

often – nausea, vomiting, diarrhea;

infrequently – constipation, dry mouth, flatulence;

rarely – damage to the oral mucosa, pancreatitis, glossitis, bloating, dysphagia, hepatitis, cholestatic jaundice, abdominal pain, anorexia;

very rarely – angioedema of the intestine, (partial) intestinal obstruction, liver failure.

Respiratory system:

often – cough;

infrequently – shortness of breath, rhinitis, sinusitis, tracheobronchitis;

rarely – bronchospasm, nosebleeds, laryngitis / dysphonia, pneumonia, pulmonary infiltrates.

From the side of hematopoietic organs:

infrequently – a temporary decrease in the concentration of hemoglobin, a decrease in hematocrit;

rarely – anemia, eosinophilia, leukopenia, lymphadenitis, neutropenia, thrombocytopenia;

very rare – agranulocytosis.

From the side of the musculoskeletal system:

infrequently – myalgia;

rarely – arthritis.

From the side of metabolism:

infrequently – decreased appetite, exacerbation of gout, hyperkalemia;

Allergic reactions:

often – skin rash, angioedema, dermatitis;

infrequently – hyperhidrosis, pruritus, urticaria;

rarely – ecchymosis.

General disorders and disorders at the injection site:

often – chest pain (non-cardiac), weakness;

infrequently – fever, peripheral edema;

rarely – weakness in one limb, viral infections.

On the part of laboratory parameters:

often – an increase in the activity of alkaline phosphatase, hyperbilirubinemia, an increase in the activity of lactate dehydrogenase, an increase in the activity of “hepatic” transaminases;

infrequently – an increase in body weight, an increase in the concentration of urea in the blood, hypercreatininemia, hyperkalemia;

rarely – hyponatremia.

Influence on the fetus: impaired development of the fetal kidneys, decreased blood pressure of the fetus and newborn, impaired renal function, hyperkalemia, hypoplasia of the bones of the skull, oligohydramnios, contractures of the extremities, hypoplasia of the lungs.

Various symptom complexes have been reported, manifested independently or in combination of the listed symptoms: fever, myalgia, arthralgia / arthritis, increased titer for antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis, skin rash, photosensitization or other dermatological reactions.

With the simultaneous use of ACE inhibitors, incl. fosinopril, patients receiving a gold preparation (sodium aurothiomalate) IV, described a symptom complex, including flushing of the skin of the face, nausea, vomiting and a decrease in blood pressure.

Fosinopril Actavis – instructions for use, dosage, composition, analogs, side effects / Pillintrip

From the cardiovascular system: lowering blood pressure, orthostatic hypotension, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction; chest pain.

From the digestive system: nausea, vomiting, constipation, intestinal obstruction, pancreatitis, hepatitis, stomatitis, glossitis, dyspepsia, abdominal pain, anorexia, cholestatic jaundice.

Respiratory system: dry cough, shortness of breath, pharyngitis, laryngitis, sinusitis, pulmonary infiltrates, bronchospasm, dysphonia.

From the urinary system: development or aggravation of symptoms of chronic renal failure, proteinuria, oliguria.

From the side of the central nervous system: stroke, cerebral ischemia, dizziness, headache, weakness; when used in high doses – insomnia, anxiety, depression, confusion, paresthesia, disorders of the vestibular apparatus.

From the senses: hearing and vision impairments, tinnitus.

Allergic reactions: skin rash, itching, angioedema.

On the part of laboratory parameters: hypercreatininemia, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, increased concentration of urea, hyponatremia; decrease in hemoglobin and hematocrit, neutropenia, leukopenia, eosinophilia, increased ESR.

From the CCC: marked decrease in blood pressure, orthostatic hypotension, collapse, tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, flushing of the face, fainting, cardiac arrest.

From the urinary system: development or aggravation of symptoms of chronic renal failure, proteinuria.

From the side of the central nervous system and peripheral nervous system: stroke, cerebral ischemia, dizziness, headache, weakness, memory impairment; when used in high doses – insomnia, anxiety, depression, confusion, drowsiness, paresthesia.

From the senses: hearing and vision impairments, tinnitus.

From the digestive system: nausea, diarrhea, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, abdominal pain, vomiting, constipation, anorexia, stomatitis, glossitis, dysphagia, flatulence, impaired appetite in the mouth, changes in body weight, dryness ; very rarely – intestinal edema.

Respiratory system: dry cough, pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia, nosebleeds.

From the side of hematopoietic organs: lymphadenitis.

From the musculoskeletal system: arthritis.

Metabolic: gout.

Allergic reactions: skin rash, itching, angioedema.

Laboratory indicators: hypercreatininemia, increased concentration of urea, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia; a decrease in the concentration of hemoglobin and hematocrit, an increase in the erythrocyte sedimentation rate, leukopenia, neutropenia, eosinophilia.

Effect on the fetus and newborns: impaired development of the fetal kidneys, decreased blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, contractures of the extremities, hypoplasia of the lungs.

Fosinopril is … What is Fosinopril?

Fosinopril – antihypertensive agent, ACE inhibitor.

Pharmacological action

ACE inhibitor – antihypertensive drug, the mechanism of action is associated with a decrease in the formation of angiotensin II from angiotensin I, a decrease in the concentration of which leads to a direct decrease in the secretion of aldosterone.At the same time, the total peripheral vascular resistance (OPSR), systolic and diastolic blood pressure, post- and preload on the myocardium decrease. Expands arteries to a greater extent than veins, while there is no reflex increase in heart rate. Reduces the degradation of bradykinin, increases the synthesis of Pg. With prolonged use, the left ventricular hypertrophy of the myocardium and the thickness of the interventricular septum decrease. Reduces intraglomerular hypertension, increases the rate of glomerular filtration, slowing down the development of glomerulosclerosis and the risk of chronic renal failure.Fosinopril is a “prodrug” in the wall of the gastrointestinal tract (70%) and liver (30%) is converted into an active metabolite fosinaprilat, which directly inhibits ACE. The onset of the onset of therapeutic action with oral administration is 1 hour, it reaches a maximum after 3-6 hours and lasts up to 24 hours. In some patients, in order to achieve an optimal blood pressure level, therapy is required for 2-3 weeks. In the course of long-term treatment, the effect is preserved. Fosinopril has the highest lipophilicity among the ACE inhibitors ^[1] , ie.That is, penetration into tissues, where 90% of the angiotensin-converting enzyme (tissue ACE) is concentrated. Thanks to this property, it reliably and for a long time maintains the pressure level during the day and has a pronounced organoprotective effect. In a comparative study with pravostatin, fosinopril confirmed its own hypolipodemic properties.

Pharmacokinetics

After oral administration, absorption is 36%. Food intake does not affect absorption. In the wall of the gastrointestinal tract (70%) and liver (30%), it is metabolized to form the active metabolite fosinoprilat.The maximum concentration of fosinoprilat in blood plasma is reached after 3 hours. The connection with plasma proteins of fosinoprilat is 95%. Fosinorilate does not cross the blood-brain barrier. The only one of the ACE inhibitors has a double compensatory route of excretion ^[1] : fosinaprilat is excreted unchanged in the urine and bile with the normal functional state of the excretion organs 50% / 50%. With the defeat of the excretory organs, the ratio can change up to 5% / 95% and, according to some data, vice versa.The half-life is 11.5 hours. In patients with renal insufficiency, there is no noticeable decrease in the pharmacokinetics of fosinopril due to a compensatory increase in its excretion from the liver. In patients with impaired liver function, a slight decrease in the hydrolysis of fosinopril is possible. There is evidence of a compensatory increase in the excretion of fosinopril by the kidneys with a simultaneous decrease in the renal clearance of fosinopril in this category of patients.

Readings

Arterial hypertension – as a means of monotherapy, and in combination treatment with other drugs.

Contraindications

Hypersensitivity to fosinopril or other ACE inhibitors, pregnancy, lactation.

Special instructions

It is prescribed with caution to patients with renovascular hypertension, heart failure, patients on hemodialysis, as well as patients with hypovolemia and / or low plasma osmolarity of any etiology. treatment with fosinopril should not be initiated in patients with acute myocardial infarction who are at risk of further serious hemodynamic deterioration after the use of vasodilators.These are patients with systolic blood pressure ≤100 mm Hg. Art. or patients with cardiogenic shock. During the first 3 days after myocardial infarction, the dose should be reduced if systolic blood pressure is ≤120 mm Hg. Art. The maintenance dose should be reduced to 5–2.5 mg if systolic blood pressure is ≤100 mm Hg. Art. If hypotension persists (systolic blood pressure ≤90 mm Hg), fosinopril should be discontinued. During treatment with fosinopril in combination with diuretics in patients without signs of renal vascular disease, a slight increase in serum urea and serum creatinine levels is possible.This effect, however, is more often noted in patients with pre-existing renal failure. A dose reduction of fosinopril may be necessary. Routine monitoring of potassium and creatinine levels is part of routine medical follow-up in these patients. In patients with heart failure, hypotension at the beginning of treatment with ACE inhibitors can lead to additional impairment of renal function. In such cases, ARF may develop, usually of a reversible nature. In acute myocardial infarction, treatment with fosinopril should not be started in patients with diagnosed renal dysfunction, with a serum creatinine concentration of 177 μmol / l and / or proteinuria exceeding 500 mg / 24 h.If renal dysfunction develops during treatment with fosinopril (serum creatinine concentration is 265 μmol / L or if serum creatinine levels are 2 times higher than those before treatment), the doctor should consider discontinuing treatment with fosinopril. There is evidence of anaphylactic reactions in patients receiving ACE inhibitors during hemodialysis using high permeability membranes. In such cases, consideration should be given to the use of a different type of dialysis membrane or the use of a different group of antihypertensive agents.There is evidence of the appearance of cough after the use of ACE inhibitors. Usually, the cough is unproductive, persistent, and stops after the drug is discontinued. During the first month of treatment with an ACE inhibitor, strict control of blood glucose levels is necessary in patients taking oral antidiabetic drugs or insulin. During pregnancy and breastfeeding. It is not known whether fosinopril passes into breast milk. The use of fosinopril during pregnancy and lactation is not recommended. Ability to drive vehicles and operate machinery . Fosinopril does not have or has a slight effect on the ability to drive vehicles or work with equipment. Drivers of vehicles should be aware that sometimes dizziness or fatigue is possible

Dosing regimen

Inside, regardless of food intake. When monotherapy of arterial hypertension – an initial dose of 10 mg 1 time per day. Then the dose is set depending on the dynamics of blood pressure.The maximum dose is 40 mg / day. Well supplemented with a diuretic, which potentiates the effect of fosinopril. In symptomatic heart failure, the initial dose is 5 mg / day with a gradual increase to a maximum dose of 40 mg / day. Since fosinoprilat is excreted both through the kidneys and through the liver in case of impaired renal or liver function, there is no need for dose adjustment.

Side effects

From the digestive system : Dry mouth, decreased appetite, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), intestinal obstruction, pancreatitis, impaired liver function and biliary excretion, hepatitis, jaundice.

From the cardiovascular system : excessive decrease in blood pressure, orthostatic collapse, rarely – chest pain, palpitations.

From the nervous system : dizziness, fainting, headache, weakness, insomnia, anxiety, confusion, fatigue, drowsiness, nervousness, depression, paresthesia.

From the senses : disorders of the vestibular apparatus, hearing and vision disorders, tinnitus.

Respiratory system : very rarely unproductive “dry” cough ^[2] , interstitial pneumonitis, bronchospasm, shortness of breath, rhinorrhea, pharyngitis.

Allergic reactions : skin rash, angioedema of the face, extremities, lips, tongue, glottis and / or larynx, dysphonia, exfoliative dermatitis, pruritus, urticaria, photosensitivity, serositis, vasculitis, myositis, arthralgia, stomatritis, stomatritis glossitis.

From the urinary system : impaired renal function, proteinuria.

Others : violation of taste sensitivity.

Interaction

With the combined use of fosinopril with other antihypertensive drugs, an additive effect is observed, because antihypertensive drugs, diuretics, narcotic analgesics, agents for general anesthesia enhance the hypotensive effect of fosinopril. Potassium supplements, potassium-sparing diuretics increase the risk of hyperkalemia. When taken simultaneously with lithium salts, an increase in the concentration of lithium in the blood is possible.The drug enhances the hypoglycemic effect of sulfonylurea derivatives, insulin. There is a risk of developing leukopenia when used simultaneously with allopurinol, cytostatic drugs, immunosuppressants, procainamide. NSAIDs reduce the severity of the hypotensive effect.

1. ↑ ^{1 2} Heart attack NO / Catalog / The role of fosinopril in the treatment of arterial hypertension
2. ↑ Article about: enalaprilat, cluster, fosinoprilat, flagil, non-lethal, kobalava, clinical and pharmacological, gedeon, iiiv, dahlof, pharmacoeconomics, fosinopril, richter, reninangio …

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90,000 2 reviews, instructions for use

Application during pregnancy and breastfeeding

Application during pregnancy is contraindicated.

During treatment, women of childbearing age should use reliable contraception.

Fozinopril is excreted in breast milk. If it is necessary to use fosinopril during lactation, the issue of stopping breastfeeding should be resolved.

Use in children

The safety of use in children has not been established.

Special instructions

Use with caution in renovascular hypertension, heart failure, hyperkalemia, history of Quincke’s edema, hypovolemia and / or low plasma osmolarity of various etiologies, as well as in patients on hemodialysis.

2-3 days before starting treatment with fosinopril, previous diuretic therapy is recommended to be canceled, with the exception of patients with malignant or difficult to treat arterial hypertension. In such cases, therapy with fosinopril should be started immediately, at a reduced dose, with close medical supervision and a careful increase in the dose.

Symptomatic arterial hypotension with the use of ACE inhibitors most often develops in patients after intensive treatment with diuretics, a diet that restricts the consumption of table salt, or during renal dialysis. Transient arterial hypotension is not a contraindication for continuing treatment after taking measures to restore the BCC.

In patients with chronic heart failure, treatment with ACE inhibitors may produce an excessive antihypertensive effect that can lead to fatal oliguria or azotemia.Therefore, when treating patients with chronic heart failure with fosinopril, careful clinical monitoring is necessary, especially during the first 2 weeks of treatment, as well as with any increase in the dose of fosinopril or a diuretic.

ACE inhibitors rarely cause swelling of the intestinal mucosa. At the same time, patients have abdominal pain (sometimes without nausea and vomiting), swelling of the face may also be absent, the level of C1-esterases is normal. After stopping the use of ACE inhibitors, the symptoms disappear.Edema of the intestinal mucosa should be considered in the differential diagnosis in patients with abdominal pain while taking ACE inhibitors.

During treatment with ACE inhibitors during hemodialysis using highly permeable membranes, as well as during LDL apheresis with adsorption to dextran sulfate, anaphylactic reactions may develop. In these cases, consideration should be given to using a different type of dialysis membrane or other antihypertensive therapy.

Possible development of agranulocytosis and suppression of bone marrow function 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). Before starting therapy with ACE inhibitors and during treatment, the total number of leukocytes and the leukocyte formula are determined (once a month in the first 3-6 months of treatment and in the first year of treatment in patients with an increased risk of neutropenia).

With the appearance of noticeable jaundice and a pronounced increase in the activity of liver enzymes by treatment with fosinopril, the appropriate treatment should be discontinued.

With arterial hypertension in patients with bilateral renal artery stenosis or stenosis of an artery of a solitary kidney, as well as with the simultaneous use of diuretics without signs of impaired renal function during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and go away after treatment is stopped. A dose reduction of the diuretic and / or fosinopril may be required.

In patients with severe chronic heart failure, with altered RAAS activity, treatment with ACE inhibitors can lead to oliguria, progressive azotemia and, in rare cases, to acute renal failure and possible death.

During therapy with fosinopril, the patient should be careful when performing physical exercises or in hot weather due to the risk of dehydration and arterial hypotension due to a decrease in the BCC.

No special correction of the dosage regimen of fosinopril in elderly patients is required. The safety of use in children has not been established.

Before and during treatment with the drug, it is necessary to control blood pressure, renal function, potassium content, hemoglobin, creatinine, urea, electrolyte concentration and hepatic transaminase activity in the blood.

Influence on the ability to drive vehicles and use mechanisms

Care must be taken when driving or performing other work requiring increased attention, because dizziness is possible, especially after the initial dose of fosinopril.

Fosinopril: Instructions for Use

Fosinopril is used alone or in combination with other drugs to treat high blood pressure. The drug is also used in combination with other drugs to treat heart failure.Fosinopril is a class of medications called angiotensin converting enzyme inhibitors.

High blood pressure can damage the brain, heart, blood vessels, kidneys, and other organs. Damage to these organs can lead to heart disease, heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medications, lifestyle changes can also help control blood pressure. These changes include a diet low in fat and salt, maintaining a healthy weight, exercising for at least 30 minutes daily, quitting smoking and drinking too much alcohol.

Fosinopril: Usage

Fosinopril is available as an oral tablet. The drug is usually taken once or twice a day at the same time. Follow the directions in the directions, or ask your doctor or pharmacist for more information. Take the drug exactly as directed in the leaflet. Do not take more or less of it, or more often than prescribed by your doctor.

Your doctor will probably prescribe a low dose of fosinopril at the beginning of your treatment and gradually increase the dose.Keep taking fosinopril even if you feel well. Do not stop taking this medicine without talking to your doctor.

Other uses of fosinopril

This medicine may be prescribed for other uses; talk with your doctor or pharmacist for more information.

Fosinopril: contraindications and interactions with other drugs

Before taking fosinopril, tell your doctor and pharmacist if you are allergic to fosinopril; other ACE inhibitors such as benazepril, captopril, enalapril, lisinopril, moexipril, perindopril, quinapril, ramipril and trandolapril; any other medicines or ingredients of fosinopril.Ask your pharmacist for a list of the ingredients in the drug.

Tell your doctor if you have diabetes and are taking aliskiren. Also tell your doctor and pharmacist what prescription and over-the-counter medicines, vitamins, dietary supplements, and herbal products you are taking. Be sure to mention any of the following medicines: diuretics; lithium; potassium supplements. Your doctor may need to change the doses of your medications or monitor closely for side effects.

If you are taking antacids (maalox and others), use them 2 hours before or after fosinopril.

Tell your doctor if you have or have ever had lupus; scleroderma; heart failure; high blood pressure; diabetes; liver or kidney disease.

Tell your doctor if you are breastfeeding.

Talk to your doctor about using potassium-containing salt substitutes. If your doctor prescribes a low salt or sodium diet for you, follow the directions carefully.

Fosinopril: side effects

Fosinopril may cause side effects. Tell your doctor if you have any of these symptoms:

• dizziness,
• cough,
• indigestion,
• vomiting,
• diarrhea,

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• headache,
• excessive fatigue,
• weakness.

Some side effects can be serious.If you experience any of the following symptoms, call your doctor:

• swelling of the face, throat, tongue, lips, eyes, hands, feet,
• hoarseness,
• difficulty breathing or swallowing,
• yellowing of the skin or eyes,
• fever, sore throat, chills and other signs of infection,
• syncope.

The drug may cause other side effects. Tell your doctor if you have any unusual problems while using it.Misuse of this medication increases the risk of serious side effects. Follow the dosage directions carefully.

What to do if you miss a dose of fosinopril

If your doctor has ordered you to use this medicine regularly, use the missed doses as soon as you remember. However, if it’s time for your next dose, skip over the missed doses and continue on your schedule. Do not use a double dose to catch up.

Fosinopril: storage and disposal

Keep the drug in the container tightly closed, out of reach of children. Store at room temperature, away from excess heat and moisture (not in the bathroom). Do not freeze. Throw away medications that are outdated or no longer needed. Talk to your pharmacist about how to properly dispose of them.

Fosinopril Overdose, Emergencies – What to Do

In case of overdose, poisoning, call an ambulance or contact your doctor immediately.Overdose of certain drugs can lead to health risks and death.

Note: This review article on the use of fosinopril is not a substitute for the complete manufacturer’s instructions for the drug, serves solely for brief information purposes and cannot be a definitive guide to action. Any actions related to the treatment and use of medications should be carried out solely on the basis of the prescription of your attending physician.