What is Monopril used for. How does Monopril work to treat high blood pressure and heart failure. What are the important precautions and side effects to be aware of when taking Monopril.

Understanding Monopril: An ACE Inhibitor for Hypertension and Heart Failure

Monopril, containing the active ingredient fosinopril sodium, is a prescription medication belonging to a class of drugs called ACE (angiotensin-converting enzyme) inhibitors. It is primarily used to treat two chronic cardiovascular conditions: high blood pressure (hypertension) and heart failure.

How does Monopril work?

Monopril works by inhibiting the action of ACE, an enzyme responsible for producing angiotensin II, a substance that narrows blood vessels. By blocking this enzyme, Monopril helps to:

• Widen blood vessels
• Reduce pressure in blood vessels
• Make it easier for the heart to pump blood
• Increase oxygen supply to the heart

These effects contribute to lowering blood pressure and improving heart function in patients with heart failure.

Treating High Blood Pressure with Monopril

Hypertension, or high blood pressure, is a common but serious condition that often has no noticeable symptoms. If left untreated, it can lead to severe health complications such as stroke, heart disease, and kidney failure.

Why is regular blood pressure monitoring important?

Regular blood pressure checks are crucial because hypertension typically doesn’t cause noticeable symptoms. By monitoring your blood pressure, you can detect and manage high blood pressure before it leads to more serious health issues.

How effective is Monopril in treating hypertension?

Monopril has been shown to be effective in reducing blood pressure in many patients. However, its effectiveness can vary from person to person. Your doctor will monitor your response to the medication and may adjust the dosage as needed.

Monopril in the Management of Heart Failure

Heart failure is a condition where the heart muscle cannot pump blood effectively to meet the body’s needs. It doesn’t mean the heart has stopped working, but rather that it’s not functioning as efficiently as it should.

What are the common symptoms of heart failure?

Common symptoms of heart failure include:

• Shortness of breath, especially during physical activity or when lying down
• Fatigue and weakness
• Swelling in the legs, ankles, and feet
• Rapid or irregular heartbeat
• Reduced ability to exercise
• Persistent cough or wheezing

Monopril can help manage these symptoms by improving the heart’s pumping efficiency and reducing the workload on the heart.

Important Precautions When Taking Monopril

Before starting Monopril, it’s crucial to inform your healthcare provider about your medical history and any medications you’re currently taking. This helps prevent potential interactions and ensures the medication is safe for you to use.

Who should not take Monopril?

Monopril is contraindicated in certain individuals. You should not take Monopril if:

• You are allergic to fosinopril sodium or any other ingredients in Monopril
• You have had an allergic reaction to any other ACE inhibitor in the past
• You have a history of angioedema (swelling of the face, lips, tongue, throat, hands, or feet)
• You are pregnant or planning to become pregnant
• You are breastfeeding

Are there any drug interactions with Monopril?

Monopril can interact with several medications. It’s important to inform your doctor about all medicines you’re taking, including over-the-counter drugs, supplements, and herbal products. Some medications that may interact with Monopril include:

• Diuretics (water pills)
• Potassium supplements
• Lithium
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Diabetes medications

Potential Side Effects of Monopril

Like all medications, Monopril can cause side effects, although not everyone experiences them. It’s important to be aware of potential side effects and report any unusual symptoms to your healthcare provider.

What are the common side effects of Monopril?

Common side effects of Monopril may include:

• Dizziness or lightheadedness, especially when first starting the medication
• Headache
• Fatigue
• Dry cough
• Nausea
• Diarrhea

These side effects are usually mild and may disappear as your body adjusts to the medication. However, if they persist or worsen, consult your healthcare provider.

Are there any serious side effects to watch for?

While rare, some serious side effects can occur with Monopril. Seek immediate medical attention if you experience:

• Swelling of the face, lips, tongue, or throat
• Difficulty breathing or swallowing
• Severe dizziness or fainting
• Chest pain
• Irregular heartbeat
• Yellowing of the skin or eyes (jaundice)
• Signs of infection (fever, chills, sore throat)

Proper Usage and Dosage of Monopril

To ensure maximum benefit and minimize side effects, it’s crucial to take Monopril exactly as prescribed by your healthcare provider.

How should Monopril be taken?

Monopril is typically taken once daily, with or without food. The dosage may vary depending on your condition and response to treatment. Always follow your doctor’s instructions regarding dosage and timing.

What if a dose is missed?

If you miss a dose of Monopril, take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Monitoring Your Progress on Monopril

Regular check-ups and tests are essential when taking Monopril to ensure the medication is working effectively and to monitor for any potential side effects.

What tests might be needed while taking Monopril?

Your healthcare provider may recommend periodic tests to monitor your progress on Monopril. These may include:

• Blood pressure checks
• Blood tests to check kidney function and electrolyte levels
• Echocardiogram or other heart function tests for patients with heart failure

Regular monitoring helps ensure that Monopril is effectively managing your condition and allows for timely adjustments to your treatment plan if needed.

Lifestyle Modifications to Complement Monopril Treatment

While Monopril can be effective in managing hypertension and heart failure, combining medication with healthy lifestyle choices can enhance its benefits and improve overall cardiovascular health.

What lifestyle changes can support Monopril treatment?

Consider incorporating the following lifestyle modifications to complement your Monopril treatment:

1. Maintain a healthy diet low in sodium and rich in fruits, vegetables, and whole grains
2. Engage in regular physical activity as approved by your healthcare provider
3. Maintain a healthy weight
4. Limit alcohol consumption
5. Quit smoking if you currently smoke
6. Manage stress through relaxation techniques or counseling
7. Monitor your blood pressure regularly at home if recommended by your doctor

These lifestyle changes, combined with Monopril, can help improve your overall cardiovascular health and potentially reduce the need for higher medication doses.

In conclusion, Monopril (fosinopril sodium) is a valuable medication for managing hypertension and heart failure. By understanding how it works, following proper usage guidelines, being aware of potential side effects, and complementing treatment with healthy lifestyle choices, patients can maximize the benefits of this medication. Always consult with your healthcare provider for personalized advice and to address any concerns about your treatment plan.

Monopril (Fosinopril Sodium) Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Fosinopril Sodium (FOS-in-O-pril)

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking MONOPRIL.*

This leaflet answers some common questions about MONOPRIL. It does not contain all
the available information. Some of the information it contains may not apply to you.
It does not take the place of talking to your doctor or pharmacist.

Keep this leaflet.

You may need to refer to it again later.

If you have any concerns about taking MONOPRIL, ask your doctor or pharmacist.

What is MONOPRIL used for

MONOPRIL is used for treating high blood pressure (hypertension) or heart failure.
Both of these are long term (chronic) diseases so it is important that you continue
to take your MONOPRIL 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.

How MONOPRIL works

MONOPRIL contains fosinopril sodium. Fosinopril sodium belongs to a class of medicines
known as 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.

Your doctor may have prescribed MONOPRIL for another reason.

Ask your doctor if you have any questions about why MONOPRIL has been prescribed for
you.

MONOPRIL is not addictive.

MONOPRIL is available only with a doctor’s prescription.

The safety and effectiveness of MONOPRIL in children has not been established.

Before you take MONOPRIL

When you must not take it

Do not take MONOPRIL if:

you have an allergy to fosinopril sodium (the active ingredient in MONOPRIL), or to
any of the inactive ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction to MONOPRIL may include skin rash, itchiness, shortness
of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint
pain.

you have taken any other ‘ACE inhibitor’ medicine before, which caused your face,
lips, tongue, throat, hands or feet to swell up or made it hard for you to breathe.

If you have had an allergic reaction to an ACE inhibitor medicine before, you may
be allergic to MONOPRIL.

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, for no apparent reason.

Do not take MONOPRIL if you are pregnant or are trying to become pregnant.

MONOPRIL may cause serious injury to your developing baby if you take it during pregnancy.

Do not take MONOPRIL if you are breastfeeding or intend to breastfeed.

Do not take MONOPRIL after the expiry date printed on the pack.

Do not take MONOPRIL if the packaging is torn or shows signs of tampering.

If it has expired or is damaged return it to your pharmacist for disposal.

Do not take MONOPRIL if the tablets change in appearance, colour or taste.

If you are not sure whether you should start taking MONOPRIL, talk to your doctor.

Before you start to take MONOPRIL

Tell your doctor if you have allergies to:

any other medicine

any other substances, such as foods, preservatives or dyes

Tell your doctor if you have a family history of swelling of the face, lips, tongue,
throat that may cause difficulty in swallowing or breathing.

Tell your doctor if you have any medical conditions, especially the following:

diabetes

take any other medicines or drugs including any immunosuppressant medicine or trimethoprim
containing medicines

kidney problems, or have had kidney problems in the past, or are having dialysis

liver problems, or have had liver problems in the past

low blood pressure, which you may notice as dizziness or lightheadedness

are going to have surgery (including dental surgery) involving a general anaesthetic,
even if it is minor

Tell your doctor if you are pregnant or plan to become pregnant or breastfeed.

If you have not told your doctor about any of the above, tell them before you start
taking MONOPRIL.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
shop.

Some medicines can affect the way MONOPRIL works. It is especially important that
you tell your doctor if you are taking any of the following:

water tablets or diuretics (for example Lasix^®, Urex^®, Natrilix^®, Moduretic^®)

lithium or lithium-containing preparations (for example Lithicarb^®, Priadel^®)

potassium tablets (for example SPAN-K^®, SLOW-K^®or MAG-K^®)

potassium-containing salt substitutes (for example PRESSOR-K^®)

antacids

if you are taking MONOPRIL 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 or pharmacist.

aspirin

anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms
of inflammation, including arthritis) and include nonsteroidal anti-inflammatory agents
– NSAIDs (for example Voltaren, Indocid) and COX-2 inhibitors (for example Celebrex). Taking
a combination of Monopril with a thiazide diuretic (fluid 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 (for example Bactrim, Septrim, Alprim) used to treat
certain types of infections

Your doctor will decide whether your treatment needs to be altered or whether you
should have check ups or blood tests more frequently

How to take MONOPRIL

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information in this leaflet. Your doctor or pharmacist will
tell you how many tablets you will need to take each day.

If you do not understand the instructions on the label on the box, ask your doctor
or pharmacist for help.

How much to take

MONOPRIL is usually taken at a dose of 10mg to 40mg once a day. Your doctor may have
prescribed a different dose for you.

When to take it

Take MONOPRIL at about the same time each day.

Taking your tablet at about the same time each day will help you to remember when
to take it. It does not matter if you take MONOPRIL before or after food.

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

How long to take it

MONOPRIL helps to control your condition but does not cure it. Therefore you must
take MONOPRIL every day. Continue taking it for as long as your doctor tells you.

If you forget to take MONOPRIL

If you forget to take one or more doses of MONOPRIL, if it is almost time for your
next dose, skip the dose you missed and take your next dose at the normal time and
in the normal amount.

Otherwise take it as soon as you remember, and then go back to taking it as you would
normally.

Do not take a double dose to make up for the dose that you missed. Do not take any
more than your doctor prescribed for you.

If you are not sure what to do, ask your doctor or pharmacist. If you have trouble
remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much MONOPRIL

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26),
or go to the Accident and Emergency Department at your nearest hospital, if you think
that you or anyone else may have taken too much MONOPRIL. Do this even if there are
no signs of discomfort or poisoning.

You may need urgent medical attention.

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are
taking MONOPRIL.

If you are about to be started on a new medicine, tell your doctor, dentist or pharmacist
that you are taking MONOPRIL. 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 MONOPRIL or if your dose is increased.

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

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

If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking MONOPRIL.

Having a general anesthetic while taking MONOPRIL may also cause your blood pressure
to drop suddenly.

If you become pregnant while taking MONOPRIL, tell your doctor immediately.

If you are about to have blood tests, tell your doctor that you are taking MONOPRIL.

MONOPRIL may interfere with the results of some tests.

Have your blood pressure checked when your doctor says, to make sure MONOPRIL is working.

Go to your doctor regularly for a check-up.

Your doctor may like to do blood tests to see how MONOPRIL is affecting you.

Things you must not do

Do not give MONOPRIL to anyone else, even if they have the same condition as you.

Do not take MONOPRIL to treat any other complaints unless your doctor or pharmacist
tells you to.

Do not stop taking MONOPRIL, or lower the dosage, without 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 MONOPRIL 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 MONOPRIL, especially if you are elderly.

Be careful driving or operating machinery until you know how MONOPRIL affects you.

As with other ACE inhibitor medicines, MONOPRIL may cause dizziness, or light-headedness
in some people. Make sure you know how you react to MONOPRIL before you drive a car,
operate machinery, or do anything else that could be dangerous if you are dizzy or
light-headed. If this occurs do not drive

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

Things that would be helpful for your blood pressure

Some self help measures suggested below may help your condition. Talk to your doctor
or pharmacist about these measures and for more information.

Alcohol –

your doctor may advise you to limit your alcohol intake.

Weight –

your doctor may suggest losing some weight to help lower your blood pressure and help
lessen the amount of work your heart has to do. Some people may need a dietician’s
help to lose weight.

Diet –

eat a healthy low-fat diet which includes plenty of fresh vegetables, fruit, bread,
cereals and fish. Also eat less fat and sugar.

Salt –

your doctor may advise you to watch the amount of salt in your diet. To reduce your
salt intake you should avoid using salt in cooking or at the table.

Exercise –

regular exercise helps to reduce blood pressure and helps to get the heart fitter,
but it is important not to overdo it. Walking is good exercise, but try to find a
route that is reasonably flat. Before starting any exercise, ask your doctor about
the best kind of programme for you.

Smoking –

your doctor may advise you to stop smoking or at least cut down.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking MONOPRIL.

MONOPRIL helps most people with high blood pressure, but it may have unwanted side
effects in a few people. All medicines can have side effects. Sometimes they are
serious, most of the time they are not. You may need medical treatment if you get
some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Following is a list of possible side effects. Do not be alarmed by this list. You
may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

feeling lightheaded, 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

These are the more common side effects of MONOPRIL. (Mostly these are mild and short
lived).

Tell your doctor as soon as possible if you notice any of the following:

changes to your heart rhythm

infections of your urinary tract or upper respiratory tract (URTI, or 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.)

These are serious side effects. You may need medical attention. Serious side effects
are rare.

If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital.

Swollen face, swollen lips, swollen mouth, swollen throat, swollen hands or feet

if you faint or if your skin turns yellow

sore throat and fever

chest pain

difficulty breathing

itchy skin and/or rash

not urinating (passing water) as much as usual

stomach pain with or without nausea

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

Other side effects not listed above may occur in some patients. Tell your doctor
or pharmacist if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects.

You may not experience any of them

After using MONOPRIL

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the pack they will not keep well.

Keep MONOPRIL tablets in a cool dry place, in the dark, where the temperature stays
below 25°C.

Do not store MONOPRIL or any other medicine in the bathroom or near a sink. Do not
leave it in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep it 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 MONOPRIL or the tablets have passed their
expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like:-

MONOPRIL 10mg tablets –

White biconvex, diamond shaped tablet and marked on one side and with a star design
and on the other side ‘158’ (AUST R 46475). Each carton contains 30 tablets.

Ingredients

Active ingredient

MONOPRIL 10mg tablets – 10mg fosinopril sodium per tablet

Other ingredients

MONOPRIL tablets also contain lactose, microcrystalline cellulose, crospovidone, povidone
and sodium stearyl fumarate.

Sponsored by

Bristol-Myers Squibb Australia Pty Ltd,

4 Nexus Court, Mulgrave,

Victoria 3170, Australia

Date of Preparation: September 2019

* Monopril is a registered trademark of Bristol-Myers Squibb

AU_CMI_Monopril_V19.0_6 September 2019

Monopril: Uses, Dosage & Side Effects

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

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 7, 2023.

The Monopril brand name has been discontinued in the U. S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

What is Monopril?

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

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

Monopril belongs to a class of medications called angiotensin-converting enzyme (ACE) inhibitors.

Monopril works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.

Warnings

Do not use Monopril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use Monopril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

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

Before taking this medicine

You should not use Monopril if you are allergic to fosinopril 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 Monopril together with any medication that contains aliskiren (a blood pressure medicine).

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

To make sure this medicine is safe for you, 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 Monopril 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 Monopril?

Take Monopril exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Monopril 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 Monopril. 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.

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

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.

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 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 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.

Monopril side effects

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

Monopril 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 Monopril side effects 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.

What other drugs will affect Monopril?

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 Monopril.

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 interact with 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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Further information

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

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

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instructions for use and features of the drug

Contents

• 1 Monopril (monopril) instructions for use
  • 1.4 Q&A:
    • • 1.4.0.1 What are the benefits of Monopril?
      • 1.4.0.2 How does Monopril work?
      • 1.4.0.3 How to take Monopril?
      • 1.4.0.4 What side effects can occur when taking Monopril?
      • 1.4.0.5 What are the contraindications for Monopril?
      • 1.4.0.6 Can Monopril be taken during pregnancy and breastfeeding?
      • 1.4.0.7 What features of Monopril should be taken into account when using it?
      • 1.4.0.8 How to take Monopril?
  • 1.5 Contraindications
  • 1.6 Side effects
  • 1.7 Interactions with other drugs
  • 1. 8 Pregnancy and nursing women
  • 1.9 Features of use in children
  • 1.10 Shelf life and storage conditions of the drug

Monopril (Monopril) – instructions for use, indications, dosage, side effects, analogues and patient reviews. Learn how to properly take Monopril to treat hypertension and other cardiovascular conditions.

Monopril is a drug that belongs to the group of ACE (Angiotensin Converting Enzyme) inhibitors. It is used to treat hypertension and heart failure. Monopril helps to lower blood pressure, improve blood circulation and reduce the load on the heart.

A feature of the drug Monopril is its long-term effect. It has a high degree of selectivity for ACE, which reduces the risk of side effects. The drug is well tolerated by patients and is an effective means for controlling blood pressure.

Monopril is available as tablets for oral administration. The dosage and duration of taking the drug depend on the individual characteristics of the patient and the recommendations of the doctor. Before starting treatment, you should carefully study the instructions for use and consult with your doctor.

Dosage and route of administration

Monopril is an oral tablet to be taken whole with plenty of water.

The dosage of Monopril (monopril) depends on the indication, age and condition of the patient. The doctor must determine the optimal dose individually for each patient.

The generally recommended starting dose for adults is 10 mg once daily. In case of insufficient effect, the dose can be increased to 20 mg once a day.

For patients with impaired renal function, it is recommended to start at a lower dose and gradually increase it.

The duration of treatment is determined by the doctor, based on the individual characteristics of the patient and the nature of the disease.

Before using Monopril, it is recommended that you read the instructions for use and consult your doctor.

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Indications for use

Monopril is used to treat the following conditions:

• Arterial hypertension (high blood pressure).
• Heart failure (weakening of heart function).
• After myocardial infarction (condition after a heart attack has passed).

Monopril belongs to the class of angiotensin converting enzyme inhibitors (ACE inhibitors). It helps lower blood pressure, improves heart function, and prevents recurrent myocardial infarctions.

The drug is effective both in monotherapy (use of one drug) and in combination with other antihypertensive agents.

Before you start using Monopril, you should consult your doctor and get detailed information about contraindications and possible side effects.

ConditionIndications for use

Monopril is an effective drug for the treatment of these conditions, but its use should be under the supervision of a physician and in strict accordance with his recommendations.

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Q&A:

What are the benefits of Monopril?

The advantages of Monopril include its high efficacy in the treatment of hypertension, the ability to improve cardiac function in patients with heart failure, and no effect on lipid and carbohydrate metabolism.

How does Monopril work?

Monopril belongs to the group of angiotensin-converting enzyme (ACE) inhibitors. It blocks the action of this enzyme, which leads to vasodilation, a decrease in peripheral resistance and a decrease in blood pressure.

How should I take Monopril?

Monopril should be taken by mouth with or without food. The dosage and mode of administration are determined by the doctor depending on the patient’s condition. It is usually recommended to start with a dose of 10 mg per day, then the dose can be increased to 20-40 mg per day.

What side effects can occur when taking Monopril?

When taking Monopril, side effects such as headache, fatigue, dizziness, drowsiness, sleep disturbance, nausea, diarrhea, dry mouth, cough, decreased potency may occur. If these effects are severe or do not go away, you should consult a doctor.

What are the contraindications for Monopril?

Contraindications to the use of Monopril include allergic reactions to the drug, pregnancy, lactation, renal artery stenosis, severe renal impairment, arterial hypotension, hyperkalemia and other conditions.

Can Monopril be taken during pregnancy and breastfeeding?

Monopril is contraindicated during pregnancy and lactation. If a woman becomes pregnant while taking the drug, stop using it and consult a doctor.

What features of the drug Monopril should be considered when using it?

Monopril is a drug that belongs to the group of ACE (Angiotensin Converting Enzyme) inhibitors. It is used to treat hypertension and heart failure. Monopril helps reduce pressure in blood vessels and improve heart function.

How to take Monopril?

Monopril should be taken by mouth with a full glass of water. The dosage of the drug depends on the individual characteristics of the patient and is recommended to be determined by the doctor. The usual starting dose is 10 mg per day. Further, depending on the effectiveness and tolerability of the drug, the dosage may be increased or decreased. It is important to observe the regularity of taking Monopril and not to skip doses.

Contraindications

Monopril is not recommended for use in the following cases:

• Known individual intolerance to the active substance fosinopril or other ingredients of the preparation.
• History of angioedema or allergic reactions after the use of ACE (angiotensin converting enzyme) inhibitors.
• Condition after kidney transplantation.
• Heart failure requiring treatment with ACE inhibitors.
• Pregnancy and breastfeeding.
• Children’s age (up to 18 years).

Before you start taking Monopril, you should consult your doctor and notify him of any existing diseases, as well as the medications and nutritional supplements you are taking.

Side effects

The use of Monopril may cause various side effects. Some of these may be serious and require immediate medical attention, while others may be mild and temporary.

The following side effects should be noted:

• Dizziness or weakness;
• Drowsiness or tiredness;
• Loss of appetite or nausea;
• Stomach pain or diarrhoea;
• Insomnia or restlessness;
• Dry mouth;
• Redness or tingling of the skin;
• palpitations or low blood pressure;
• Swelling in the legs or legs;
• Loss of sex drive or erection problems;

If you experience any of these side effects, it is important to see your doctor for advice and to determine what to do next.

It is important to remember that this is not a complete list of side effects. If you find any other unusual symptoms or sensations, be sure to tell your doctor or pharmacist.

Interaction with other drugs

When monopril is used concomitantly with certain drugs, interactions may occur that may lead to a change in the efficacy and safety of therapy. Therefore, before starting treatment, it is necessary to inform the doctor about all the medicines taken.

The interaction of Monopril with some drugs can lead to the following effects:

• Diuretics: when Monopril is used simultaneously with diuretics, a synergistic effect may occur, leading to an increase in the diuretic effect. This may lead to an increased risk of hypotensive effects.
• Drugs that increase the level of potassium in the blood: Concomitant use of Monopril with drugs such as potassium-containing salts or potassium-sparing diuretics may lead to hyperkalemia (increased levels of potassium in the blood).
• Potassium-lowering drugs: Concomitant use of Monopril with drugs such as thiazide diuretics may lead to hypokalemia (low potassium levels in the blood).
• Drugs that increase the level of lithium in the blood: Concomitant use of Monopril with drugs containing lithium may lead to an increase in the concentration of lithium in the blood, which may cause toxic effects.
• Lithium-lowering drugs: The simultaneous use of Monopril with drugs that reduce the level of lithium in the blood may lead to a decrease in the effectiveness of lithium therapy.

If Monopril is prescribed in combination with other drugs, the patient’s condition should be carefully monitored and the level of potassium and lithium in the blood should be checked regularly.

This information is not exhaustive. Before starting treatment with Monopril, you should consult with your doctor and read the full information about the interaction of the drug with other drugs.

Pregnant and lactating women

Use of the drug Monopril (monopril) in pregnant and lactating women requires special care and consultation with the doctor. It is important to consider the potential risks to mother and child, as well as the possible benefits and necessity of using this drug.

During pregnancy, the use of Monopril may adversely affect the development of the fetus and cause congenital anomalies. Therefore, the physician should carefully evaluate the benefits and risks of using the drug before prescribing it to a pregnant patient. If it is necessary to use Monopril during pregnancy, it is recommended to use the lowest effective dose and monitor the condition of the fetus using ultrasound.

During lactation, Monopril may pass into breast milk. There is insufficient data on the safety of its use during this period. Therefore, it is recommended to stop breastfeeding or stop taking the drug, based on the benefits and risks for the child and mother. It is necessary to consult with the doctor and make a joint decision on further treatment.

It is important to remember that this information is not a guide to action and does not replace the advice of a doctor. Only a qualified medical professional can evaluate the benefits and risks of using the drug Monopril in pregnant and lactating women at an individual level and decide on its use.

Pediatric considerations

Monopril is a drug commonly used in adults to treat hypertension and heart failure. However, its use in children may be justified in certain cases. The following are the features of the use of Monopril in children.

1. Age limit: Monopril is not recommended for use in children under 18 years of age.
2. Pediatric: Monopril is available in tablet form that is not intended to be divided or crushed. The tablet size may not be suitable for children, so administration in children may be difficult.
3. Dosage: The dosage of Monopril for children should be determined by the doctor on an individual basis, based on the age, weight and condition of the patient. The usual starting dose is 5 mg per day.
4. Surveillance: Children taking Monopril should be under constant medical supervision to monitor the effectiveness of treatment and possible side effects.

It is important to note that the use of Monopril in children should be carried out only as prescribed by a doctor and under his supervision. Self-medication and changing the dosage without consulting a doctor can be dangerous for the health of the child.

Shelf life and storage conditions of the drug

Monopril is a drug that must be stored under certain conditions in order to remain effective and safe. Below are recommendations on the shelf life and storage conditions of this drug:

• Monopril expiration date is indicated on the package. It is necessary to pay attention to the expiration date and do not use the drug after this date.
• Keep Monopril out of the reach of children. Children should not have access to the drug to avoid accidental use.
• The drug should be stored in its original packaging to protect from light and moisture.
• Store Monopril at room temperature not exceeding 25 degrees Celsius.
• Do not store Monopril in the bathroom or in places where there is high humidity to avoid damage to the drug.
• Do not freeze Monopril. The drug should be stored at normal temperature.
• If you have unused or expired Monopril tablets, do not throw them away with your regular trash. Contact your pharmacy or local drug disposal authority for information on the correct way to dispose of your drugs.

Following these Monopril expiration and storage recommendations will help you keep your product in optimal conditions and ensure its effectiveness when used.

MONOPRYL indications for use, instructions for use in Russian

MONOPRIL

Indications for use

Arterial hypertension (as monotherapy or as part of combination therapy).

Chronic heart failure (as part of combination therapy).

See Use in children

See Use in pregnancy and lactation

Use in the elderly

No special adjustment of the dosing regimen of fosinopril is required in elderly patients.

Special instructions

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

It is recommended that prior diuretic therapy be discontinued 2-3 days prior to initiation of fosinopril treatment, except in patients with malignant or difficult-to-treat hypertension. In such cases, fosinopril therapy should be initiated immediately, at a reduced dose, under close medical supervision and cautious dose escalation.

Symptomatic arterial hypotension with ACE inhibitors most often develops in patients after intensive treatment with diuretics, a diet that restricts salt intake, 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 cause an excessive antihypertensive effect, which may 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 diuretic.

ACE inhibitors rarely cause swelling of the intestinal mucosa. At the same time, patients experience 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 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 high-permeability 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.

Agranulocytosis and bone marrow suppression may occur 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).

If marked jaundice develops and a pronounced increase in liver enzyme activity occurs, fosinopril treatment should be discontinued and appropriate treatment instituted.

With arterial hypertension in patients with bilateral renal artery stenosis or stenosis of the artery of a single 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 disappear after treatment is stopped. 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, acute renal failure and possible death.

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

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

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

Influence on the ability to drive vehicles and control mechanisms

dizziness is possible, especially after the initial dose of fosinopril.

Analogs 9

MONOPRIL®, FOSICARD tablets, FOSICARD N tablets, FOZINAP® tablets, FOSINOPRIL tablets, FOSINOPRIL-OBL tablets, FOSINOPRIL-TEVA tablets, FOSINOTECH tablets, FOSINOTECH N tablets, tablets

website you will find detailed information about the drug MONOPRYL (tablets) and its instructions for use in Russian.