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Carvedilol 12.5 mg tablets. Carvedilol 12.5 mg: Comprehensive Guide to Uses, Side Effects, and Dosage

How does Carvedilol 12.5 mg work for heart conditions. What are the potential side effects of Carvedilol. How should Carvedilol be taken for optimal effectiveness. When should you seek immediate medical attention while on Carvedilol. How does Carvedilol interact with other medications.

Содержание

Understanding Carvedilol: A Vital Medication for Heart Health

Carvedilol, available in 12.5 mg tablets, is a crucial medication used in the treatment of various heart conditions. This powerful drug belongs to a class known as alpha and beta blockers, which work by interfering with the effects of certain natural substances in the body, such as epinephrine, on the heart and blood vessels. The result is a reduction in heart rate, blood pressure, and overall strain on the heart.

Primary Uses of Carvedilol

Carvedilol is primarily prescribed for three main purposes:

  • Treatment of high blood pressure (hypertension)
  • Management of heart failure
  • Improving survival chances after a heart attack in patients with reduced heart pumping function

By effectively lowering high blood pressure, Carvedilol plays a significant role in preventing strokes, heart attacks, and kidney problems, which are common complications of untreated hypertension.

The Mechanism of Action: How Carvedilol Works in the Body

Carvedilol’s effectiveness stems from its unique dual action as both an alpha and beta blocker. This mechanism sets it apart from many other heart medications.

Alpha Blocking Action

The alpha-blocking component of Carvedilol helps to relax blood vessels, promoting better blood flow throughout the body. This action contributes to the reduction of blood pressure and eases the workload on the heart.

Beta Blocking Action

As a beta blocker, Carvedilol slows down the heart rate and reduces the force of the heart’s contractions. This dual effect not only lowers blood pressure but also decreases the oxygen demand of the heart, making it an excellent choice for patients with heart failure or those recovering from a heart attack.

How quickly does Carvedilol start working? While some effects may be noticeable within hours of taking the first dose, the full benefits of Carvedilol, especially in treating high blood pressure, may take 1 to 2 weeks to manifest. It’s crucial for patients to continue taking the medication as prescribed, even if they feel well, to maintain its therapeutic effects.

Proper Administration of Carvedilol: Dosage and Best Practices

Adhering to the correct dosage and administration guidelines is crucial for maximizing the benefits of Carvedilol while minimizing potential side effects.

Standard Dosing Regimen

Carvedilol is typically taken orally with food, usually twice daily. The 12.5 mg tablet is a common dosage, but the actual prescribed amount can vary based on individual patient needs. It’s essential to follow your doctor’s instructions precisely.

Gradual Dose Adjustment

To reduce the risk of side effects, doctors often start patients on a low dose of Carvedilol and gradually increase it over time. This approach allows the body to adjust to the medication more smoothly.

Why is it important to take Carvedilol with food? Taking Carvedilol with food helps to improve its absorption and can reduce the likelihood of experiencing side effects such as dizziness or lightheadedness. Consistently taking the medication at the same times each day with meals can help maintain steady levels of the drug in your system.

Potential Side Effects: What to Watch For

While Carvedilol is generally well-tolerated, it’s important to be aware of potential side effects that may occur.

Common Side Effects

Some of the more frequently reported side effects include:

  • Dizziness
  • Lightheadedness
  • Drowsiness
  • Diarrhea
  • Impotence
  • Fatigue

These effects are often mild and may diminish as your body adjusts to the medication. However, if they persist or worsen, it’s important to consult your healthcare provider.

Serious Side Effects Requiring Immediate Attention

While less common, some side effects warrant immediate medical attention:

  1. Very slow heartbeat
  2. Severe dizziness or fainting
  3. Unusual weakness
  4. Signs of kidney problems (such as changes in urine output)
  5. Numbness or tingling in hands or feet
  6. Blue discoloration of fingers or toes
  7. Easy bruising or bleeding
  8. Mental or mood changes (confusion, depression)
  9. Seizures

In rare cases, Carvedilol may lead to new or worsening symptoms of heart failure, particularly when starting treatment. It’s crucial to report any unusual symptoms to your doctor promptly.

Can Carvedilol cause cold hands and feet? Yes, Carvedilol may reduce blood flow to the extremities, causing cold hands and feet. This effect can be exacerbated by smoking, so patients are advised to dress warmly and avoid tobacco use.

Critical Warnings: The Importance of Proper Discontinuation

One of the most crucial aspects of Carvedilol use is understanding the risks associated with abrupt discontinuation of the medication.

Risks of Sudden Stoppage

Suddenly stopping Carvedilol can lead to severe complications, including:

  • Chest pain
  • Heart attack
  • Irregular heartbeat

These risks underscore the importance of consulting with your doctor before making any changes to your Carvedilol regimen.

Proper Discontinuation Protocol

If it becomes necessary to stop taking Carvedilol, your doctor will likely recommend a gradual reduction in dosage over 1 to 2 weeks. This tapering process allows your body to adjust and minimizes the risk of adverse effects.

During the discontinuation period, it’s advisable to limit physical activity to reduce strain on the heart. Patients should be vigilant for signs of cardiac distress, such as chest pain, unusual sweating, or difficulty breathing, and seek immediate medical attention if these occur.

Why is it dangerous to stop taking Carvedilol suddenly? Abrupt discontinuation can lead to a “rebound effect,” where the body, having adapted to the presence of the medication, suddenly experiences a surge in heart rate and blood pressure. This rapid change can overwhelm the cardiovascular system, potentially leading to serious complications.

Interactions and Precautions: Navigating Carvedilol Use Safely

Understanding potential drug interactions and necessary precautions is crucial for safe and effective use of Carvedilol.

Drug Interactions

Carvedilol may interact with various medications, including:

  • Other blood pressure medications
  • Certain antidepressants
  • Drugs that affect heart rhythm
  • Medications for diabetes

It’s essential to inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potentially harmful interactions.

Special Precautions

Certain conditions may require special consideration when using Carvedilol:

  1. Diabetes: Carvedilol may mask symptoms of low blood sugar
  2. Thyroid disorders: The drug may affect thyroid function tests
  3. Liver disease: Dosage adjustments may be necessary
  4. Upcoming surgery: Your doctor should be informed about your Carvedilol use
  5. Pregnancy and breastfeeding: Potential risks should be discussed with your healthcare provider

How does Carvedilol affect blood sugar in diabetics? Carvedilol can mask some symptoms of hypoglycemia (low blood sugar), such as increased heart rate. Diabetic patients should monitor their blood sugar levels closely and may need to adjust their diabetes medication under medical supervision.

Optimizing Carvedilol Therapy: Tips for Patients

To maximize the benefits of Carvedilol while minimizing potential side effects, consider the following tips:

Consistency is Key

Take Carvedilol at the same times each day, preferably with meals. This routine helps maintain consistent levels of the medication in your system and reduces the risk of missed doses.

Monitor Your Blood Pressure

Regularly check your blood pressure at home and keep a log to share with your doctor. This information can help in assessing the effectiveness of your treatment and making any necessary adjustments.

Stay Hydrated

Adequate hydration can help mitigate some side effects of Carvedilol, such as dizziness. However, consult your doctor about appropriate fluid intake, especially if you have heart failure.

Exercise Caution with Physical Activity

While regular exercise is beneficial, start slowly and gradually increase your activity level. Carvedilol can affect your body’s response to physical exertion.

Be Prepared for Medical Emergencies

Carry information about your Carvedilol use with you at all times. This can be crucial in emergency situations where healthcare providers need to know about your medications.

How can patients reduce the risk of dizziness when taking Carvedilol? To minimize dizziness, especially when starting Carvedilol or increasing the dose, patients should:
1. Rise slowly from sitting or lying positions
2. Stay well-hydrated (unless fluid restricted)
3. Avoid alcohol and activities requiring alertness until they know how the medication affects them
4. Take the medication with food as prescribed

Long-Term Outlook: Living Well with Carvedilol

For many patients, Carvedilol becomes a long-term part of their heart health management strategy. Understanding the long-term implications and benefits of this medication can help motivate consistent use and adherence to treatment plans.

Cardiovascular Benefits

Long-term use of Carvedilol has been associated with significant improvements in cardiovascular health, including:

  • Reduced risk of heart attacks and strokes
  • Improved survival rates in patients with heart failure
  • Better management of high blood pressure
  • Reduced progression of heart failure

Quality of Life Improvements

Many patients report an enhanced quality of life with ongoing Carvedilol therapy, experiencing:

  1. Increased energy levels
  2. Improved exercise tolerance
  3. Reduced symptoms of heart failure, such as shortness of breath
  4. Greater overall sense of well-being

What long-term effects should patients be aware of when taking Carvedilol? While Carvedilol is generally well-tolerated long-term, patients should be aware of:
1. The need for regular medical check-ups to monitor heart function and blood pressure
2. Potential changes in exercise capacity and the need to adjust physical activity accordingly
3. The importance of maintaining a healthy lifestyle to complement the medication’s effects
4. The possibility of needing dosage adjustments over time as the body’s needs change

Carvedilol 12.5 mg tablets represent a significant advancement in the treatment of various heart conditions. By understanding its uses, proper administration, potential side effects, and the importance of adherence to prescribed regimens, patients can maximize the benefits of this powerful medication. Regular communication with healthcare providers, coupled with a commitment to overall heart health, can lead to improved outcomes and a better quality of life for those managing cardiovascular conditions with Carvedilol.

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

Warnings:

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, your doctor may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Get medical help right away if you develop chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

Warnings:

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, your doctor may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Get medical help right away if you develop chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

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Uses

Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.

How to use Carvedilol

See also Warning section.

Read the Patient Information Leaflet if available from your pharmacist before you start taking carvedilol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

For the treatment of high blood pressure, it may take 1 to 2 weeks before you get the full benefit of this drug. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase, or you have worsening symptoms of heart failure like increased shortness of breath).

Side Effects

See also Warning and Precautions sections.

Dizziness, lightheadedness, drowsiness, diarrhea, impotence, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. The risk of dizziness is highest within 1 hour after you take your dose. Taking this medication with food and starting treatment with a low dose and slowly increasing your dose as directed by your doctor help to reduce the risk of dizziness.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

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 you have any serious side effects, including: very slow heartbeat, severe dizziness, fainting, unusual weakness, signs of kidney problems (such as change in the amount of urine), numbness/tingling of the hands/feet, blue fingers/toes, easy bruising/bleeding, mental/mood changes (such as confusion, depression), seizures.

Although this medication may be used to treat heart failure, some people may rarely develop new or worsening symptoms of heart failure, especially at the start of carvedilol treatment. Tell your doctor right away if you develop any of these serious side effects: shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.

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.

Precautions

Before taking carvedilol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain types of heartbeat/heart rhythm problems (such as slow/irregular heartbeat, sick sinus syndrome, second- or third-degree atrioventricular block), breathing problems (such as asthma, chronic bronchitis, emphysema), severe heart failure requiring hospitalization, liver disease, kidney disease, blood circulation problems (such as Raynaud’s disease, peripheral vascular disease), serious allergic reactions including those needing treatment with epinephrine, overactive thyroid disease (hyperthyroidism), a certain type of tumor (pheochromocytoma), other heart problems (such as Prinzmetal’s variant angina), a certain muscle disease (myasthenia gravis), certain eye problems (cataracts, glaucoma).

This drug may make you dizzy or drowsy or cause you to faint. This is most likely to occur within 1 hour after taking your dose, especially when you start carvedilol treatment or any time your doctor increases your dose. During these periods, avoid driving and doing hazardous tasks. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

People who wear contact lenses may have dry eyes while taking this medication.

Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). The risk is higher if you have diabetes, or are vomiting, fasting, or not eating regularly. Other symptoms of low blood sugar level, such as dizziness and sweating, are not affected by this drug.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Children may be at greater risk for low blood sugar (hypoglycemia) while using this drug, especially if they are vomiting or not eating regularly. To help prevent low blood sugar, make sure children eat regularly. If your child cannot eat regularly, is vomiting, or has symptoms of low blood sugar (such as sweating, shaking), tell the doctor right away.

Older adults may be more sensitive to the side effects of this drug, especially dizziness and lightheadedness.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using carvedilol. Carvedilol may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if carvedilol passes into breast milk. However, it is unlikely to pass into breast milk in large amounts. There is a low risk that it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

One product that may interact with this drug is: fingolimod.

Some products have ingredients that could raise your heart rate or blood pressure or worsen your heart failure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Does Carvedilol interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat, severe dizziness, fainting, slow/shallow breathing, seizures.

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to monitor your own blood pressure and pulse at home, and share the results with your doctor.

Lab and/or medical tests (such as kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

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This medicine is a white, round, film-coated, tablet imprinted with “ZC41”.

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This medicine is a white, round, film-coated, tablet imprinted with “ZC41”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Carvedilol: a medicine used to treat high blood pressure and prevent angina, heart disease and stroke.

1. About carvedilol

Carvedilol is a beta blocker.

It’s used to treat high blood pressure (hypertension) and helps prevent:

  • heart disease
  • heart attacks
  • strokes

It can also be given with other medicines to treat heart failure and to prevent chest pain caused by angina.

Carvedilol is only available on prescription. It comes as tablets.

2. Key facts

  • Carvedilol slows down your heart rate and makes it easier for your heart to pump blood around your body.
  • You’ll usually take carvedilol once or twice a day.
  • It usually starts to work after about 1 hour. But it will take days or weeks for it to reach its full effect.
  • Common side effects of carvedilol include headaches and feeling tired or dizzy.
  • Do not stop taking carvedilol suddenly. This can make your condition worse, especially if you have heart disease.

3. Who can and cannot take carvedilol

Carvedilol can be taken by most adults. It can sometimes be prescribed by a specialist for children aged 2 years and over.

Carvedilol is not suitable for some people. Tell your doctor before starting the medicine if you have:

  • ever had an allergic reaction to carvedilol or any other medicines
  • lung disease or asthma
  • heart failure that is getting worse
  • have low blood pressure (hypotension) or a slow heart rate
  • a liver problem
  • serious circulation problems in your arms and legs, such as Raynaud’s

4.

How and when to take carvedilol

When you start taking carvedilol, your doctor may advise you to take your first dose just before you go to bed. This is because it can make you feel dizzy.

After the first dose, if you do not feel dizzy, you can take your medicine in the morning. If you do feel dizzy, it’s best to keep taking your medicine at bedtime.

It’s best to take carvedilol at the same time each day.

If you take it twice a day, you’ll usually have 1 dose in the morning and 1 dose in the evening. Leave 10 to 12 hours between doses if you can.

Swallow the tablets whole with a drink of water. Do not chew or crush them.

Carvedilol does not usually upset your stomach, so you can take it with or without food. However, if you are taking carvedilol for heart failure, it’s best to take the tablets with food. This will help reduce the risk of you feeling dizzy or faint when you stand up.

If you find tablets difficult to swallow, some strengths have a score line to help you break the tablet in half. Check the information leaflet that comes with your medicine to see if you can do this.

Dosage

Carvedilol tablets come in 4 different strengths – 3.125mg, 6.25mg, 12.5mg and 25mg.

How much you take depends on why you need carvedilol.

The usual starting dose to treat:

  • high blood pressure is 12.5mg once a day for 2 days – this is increased to 25mg, taken once a day. If your blood pressure does not go down enough your doctor may increase your dose to up to 50mg a day. This can be taken as a single dose or split into 2 doses.
  • heart failure is 3.125mg, taken twice a day for 2 weeks. Your doctor will then slowly increase the dose every 2 weeks up to a maximum of 25mg to 50mg (depending on your weight).
  • angina is 12.5mg, taken twice a day for 2 days – this is increased to 25mg, taken twice a day.

If your child is prescribed carvedilol, the doctor will use their weight to work out the right dose.

What if I forget to take it?

If you miss a dose of carvedilol, take it as soon as you remember, unless it’s nearly time for your next dose. In this case, just leave out the missed dose and take your next dose as normal.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

The amount of carvedilol that can lead to an overdose varies from person to person.

Taking too much carvedilol can lower your blood pressure, slow your heart rate, and make it difficult to breathe.

Urgent advice: Contact 111 for advice now if:

  • you take too much carvedilol

Call 111 or go to 111.nhs.uk

If you need advice for a child under the age of 5 years, call 111.

5. Side effects

Like all medicines, carvedilol can cause side effects in some people, but many people have no side effects or only minor ones.

Side effects usually improve as your body gets used to the medicine.

Common side effects

These common side effects may happen in more than 1 in 100 people. They’re usually mild and last a few days after starting the medicine or increasing your dose.

Talk to your doctor or pharmacist if these side effects bother you or do not go away:

  • feeling dizzy
  • headaches
  • feeling tired
  • feeling or being sick (nausea or vomiting)
  • cold fingers or toes

Serious side effects

It happens rarely, but some people have serious side effects when taking carvedilol.

Tell a doctor straight away if you have:

  • nose bleeds that last for more than 10 minutes, unexplained bruising, or you bruise more easily than usual – these can be signs of low numbers of platelets in your blood (thrombocytopenia)
  • high temperature, sore throat, mouth sores, toothache, flu-like symptoms – these can be signs of a low number of white blood cells (leukopenia)
  • shortness of breath with a cough that gets worse when you exercise (like walking up the stairs), swollen ankles or legs, chest pain, or an irregular heartbeat – these may be signs of other heart problems
  • shortness of breath, wheezing and tightening of your chest – these can be signs of lung problems
  • yellow skin or the whites of your eyes turn yellow – these can be signs of liver problems
Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to carvedilol.

Immediate action required: Call 999 or go to A&E now if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you’re wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of carvedilol. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

6. How to cope with side effects of carvedilol

What to do about:

  • feeling dizzy – as your body gets used to carvedilol this side effect should wear off. If carvedilol makes you feel dizzy, stop what you’re doing and sit or lie down until you feel better. Do not drive or operate machinery until you feel OK again. Try to avoid alcohol as it’ll make you feel worse.
  • headaches – make sure you rest and drink plenty of fluids. Ask your pharmacist to recommend a painkiller. Do not drink too much alcohol. Headaches usually go away after the first week of taking carvedilol. Talk to your doctor if the headaches last more than a week or are severe.
  • feeling tired – do not drive, ride a bike, or use tools or machinery if you’re feeling tired. Do not drink any alcohol as this will make you feel more tired.
  • feeling sick or being sick – stick to simple meals and do not eat rich or spicy food. It might help to take your carvedilol after a meal or snack. If you’re being sick, try drinking small, frequent sips of water to avoid dehydration.
  • cold fingers or toes – put your hands or feet under warm running water, massage them, and wiggle your fingers and toes. Do not smoke or have drinks with caffeine, as this can make your blood vessels narrower and restrict your blood flow. It’s best not to wear tight watches or bracelets as well. Try wearing mittens (they’re warmer than gloves) and warm socks. Speak to your doctor if this side effect bothers you.

7. Pregnancy and breastfeeding

Carvedilol and pregnancy

Carvedilol is not usually recommended if you’re pregnant.

If you’re trying to get pregnant or you’re already pregnant, talk to your doctor about taking carvedilol. It may be possible to change to other medicines that are more suitable when you’re pregnant, such as labetalol or nifedipine.

Carvedilol and breastfeeding

If your doctor or health visitor says that your baby is healthy, it’s OK to take carvedilol while breastfeeding.

There is no information about whether carvedilol passes into breast milk, but it would only be expected to pass through in small amounts. It’s unlikely to cause any side effects in your baby.

If you notice that your baby isn’t feeding as well as usual, or seems unusually sleepy, or if you have any other concerns about your baby, then talk to your health visitor, midwife or doctor as soon as possible.

Non-urgent advice: Tell your doctor if you’re:

  • trying to get pregnant
  • pregnant
  • breastfeeding

Find out more about high blood pressure and pregnancy.

8. Cautions with other medicines

There are some medicines that can affect the way carvedilol works.

Tell your doctor if you’re taking:

  • other medicines for high blood pressure – when taken together with carvedilol, they can sometimes lower your blood pressure too much
  • other medicines that can lower your blood pressure – these include some antidepressants, nitrates (for chest pain), baclofen (a muscle relaxant), medicines for an enlarged prostate gland like tamsulosin, or levodopa (for Parkinson’s disease)
  • medicines for an irregular heartbeat such as amiodarone or flecainide
  • medicines for asthma or chronic obstructive pulmonary disease (COPD)
  • medicines for diabetes, particularly insulin – carvedilol may make it more difficult to recognise the warning signs of low blood sugar. Speak to your doctor if you have low blood sugar levels without getting any warning signs. You should check your blood sugar after exercise, and follow usual advice about checking it before driving, or operating machinery.
  • medicines that treat nose or sinus congestion, or other cold remedies (including those you can buy in the pharmacy)
  • medicines for allergies, such as ephedrine, noradrenaline or adrenaline
  • non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, diclofenac and naproxen – these medicines may increase your blood pressure

Mixing carvedilol with herbal remedies and supplements

There’s very little information about taking herbal remedies and supplements with carvedilol. However, some herbal products, such as cod liver oil, hawthorn and garlic tablets may cause low blood pressure (hypotension).

Important:
Medicine safety

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal medicines, vitamins or supplements.

9. Common questions about carvedilol

How does carvedilol work?

Carvedilol is a type of medicine called a beta blocker.

Like other beta blockers, carvedilol works by slowing down your heart rate and making it easier for your heart to pump blood around your body.

It also works like an alpha blocker to widen some of your blood vessels. This helps lower your blood pressure.

For angina, carvedilol works by improving the blood supply to your heart. Angina is chest pain that comes on when not enough blood gets to the muscles of the heart. It usually happens because the arteries to the heart become hardened and narrowed.

Carvedilol widens the arteries so more oxygen gets to the heart and chest pain is prevented. It also slows your heart down and makes it beat more effectively. This reduces the amount of oxygen needed by your heart muscle and prevents angina.

How long does it take to work?

Carvedilol usually starts to work after about 1 hour. But it will take days or weeks to reach its full effect.

You may not feel any different when you take carvedilol for high blood pressure, but this does not mean it’s not working. It’s important to keep taking your medicine.

How long will I take it for?

Usually, treatment with carvedilol is long term. It may be for the rest of your life.

Can I take carvedilol for a long time?

Most people take carvedilol for a long time with no problems. In fact, it works best when you take it long term.

What will happen if I stop taking it?

Talk to your doctor if you want to stop taking carvedilol. If you’re bothered by side effects, your doctor may be able to prescribe a different medicine instead.

How does it compare with other medicines for high blood pressure?

Carvedilol works as well as other beta blockers to reduce blood pressure, but it’s mainly used to prevent angina or heart failure because it also widens the blood vessels.

The main difference with carvedilol is that it can affect other parts of your body too, such as your lungs.

Other medicines used to lower blood pressure work in different ways to beta blockers. These include:

  • ACE inhibitors such as ramipril and lisinopril
  • angiotensin receptor blockers like losartan
  • calcium channel blockers like amlodipine
  • medicines that make you pee more (diuretics) like indapamide

The medicine your doctor prescribes first depends on your age and ethnicity. If you’re under 55 years old, you’ll usually be offered an ACE inhibitor or an angiotensin receptor blocker. If you’re 55 years old or over, or of African Caribbean or black African origin, you’ll usually be offered a calcium channel blocker.

If you are bothered by side effects, you may have to try a different blood pressure medicine. Many people need to take a combination.

How does it compare with other medicines for chest pain and angina?

There are lots of other medicines to prevent angina attacks.

They include:

  • calcium channel blockers such as diltiazem and amlodipine
  • nitrates like isosorbide mononitrate
  • medicines such as ranolazine, nicorandil or ivabradine

If carvedilol does not work for you, or you cannot take carvedilol or other beta blockers because of side effects, you may be able to switch to another medicine.

Your doctor will be able to decide which medicine is best for you. Some people may need to take a combination of medicines to control their angina symptoms.

How does it compare with other medicines that treat heart failure?

Carvedilol is used with other medicines to treat heart failure and prevent complications, These can include ACE inhibitors (like ramipril and lisinopril) or angiotensin receptor blockers (like losartan).

Other beta blockers like bisoprolol and nebivolol can be used instead of carvedilol in a similar way.

Will I need to stop carvedilol before surgery?

Tell your doctor you’re taking carvedilol if you’re going to be put to sleep (using general anaesthetic) or have any kind of major operation.

Your doctor may advise you to stop taking carvedilol before surgery.

This is because carvedilol can lower your blood pressure too much when it’s combined with some general anaesthetics.

Can I drink alcohol?

Drinking alcohol can increase the blood pressure-lowering effect of carvedilol. This can make you feel dizzy or lightheaded.

During the first few days of taking carvedilol, or after an increase in your dose, it is best to stop drinking alcohol until you see how the medicine affects you.

If you find carvedilol makes you feel dizzy it’s best to stop drinking alcohol.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking carvedilol.

Eating a healthy, balanced diet can help your heart condition.

Will it affect my contraception?

Carvedilol will not stop your contraception working.

But some types of combined hormonal methods of contraception, such as the combined pill and contraceptive patch, are not usually recommended for women with high blood pressure.

Talk to your doctor if you’re taking a combined hormonal contraceptive.

If carvedilol makes you vomit, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do.

Read more about what to do if you’re on the pill and you’re being sick.

Will it affect my fertility?

There’s no clear evidence to suggest that taking carvedilol will reduce fertility in either men or women.

If you’re trying for a baby or having problems getting pregnant while on carvedilol, speak to your doctor.

Will it affect my sex life?

Some people on carvedilol say their sex drive goes down and some men say they cannot get an erection.

There’s not enough evidence to say that carvedilol causes this.

If you’re having problems with your sex life, talk to your doctor.

Do I need to avoid playing sports?

You do not need to stop playing sports if you take carvedilol. But it’s a good idea not to push yourself too much.

Regular exercise is good for you because it lowers blood pressure by keeping your heart and blood vessels in good condition.

However, in some sports carvedilol may not be allowed if you’re competing at a very high level.

Can I drive or ride a bike?

Carvedilol can make you feel tired or dizzy, especially when you first start taking it or after increasing your dose.

If this happens to you, do not drive a car, ride a bike, or use tools or machinery until you feel OK again.

Can lifestyle changes help heart problems?

If you have heart problems, you can boost the health of your heart by making some lifestyle changes.

It’s a good idea to:

  • quit smoking – not smoking will bring down your blood pressure and relieve heart failure symptoms.
  • cut down on alcohol – drinking too much alcohol raises blood pressure over time and makes heart failure worse. Drinking alcohol while you’re taking carvedilol can make you feel dizzy or lightheaded.
  • exercise – regular exercise lowers blood pressure by keeping your heart and blood vessels in good condition. Even walking every day will help.
  • eat well and lower the salt in your diet – aim to eat plenty of fruit and veg, wholegrains, fat-free or low-fat dairy products and lean proteins. Eating too much salt is the biggest cause of high blood pressure – the more salt you eat, the higher your blood pressure will be.
  • deal with stress – when you’re anxious or upset, your heart beats faster, you breathe more heavily and your blood pressure often goes up. This can make heart failure worse too. Finding ways to cope with stress will help to keep your blood pressure down.

Carvedilol – instructions for use, doses, side effects, reviews of the drug: tablets, 25 mg

Description of the drug Carvedilol (tablets, 12.5 mg) is based on official instructions, approved by the manufacturer in 2005

Approval date: 07/01/2005

Contents

  • Active substance
  • ATX
  • Pharmacological group
  • Nosological classification (ICD-10)
  • Composition and form of release
  • pharmachologic effect
  • pharmachologic effect
  • Pharmacodynamics
  • Pharmacokinetics
  • Indications
  • Contraindications
  • Use during pregnancy and lactation
  • Dosage and administration
  • Side effects
  • Interaction
  • Overdose
  • Precautionary measures
  • special instructions
  • Manufacturer
  • Storage conditions
  • Best before date
  • Order in Moscow pharmacies
  • Reviews

Active ingredient

Carvedilol* (Carvedilol*)

ATX

C07AG02 Carvedilol

Pharmacological group

Alpha and beta blockers

Nosological classification (ICD-10)

ICD-10 code list

Composition and formulation

Tablets 1 tab.
carvedilol 12.5 mg
25 mg
excipients: milk sugar; sucrose; polyvidone K25; crospovidone; methylcellulose; croscarmellose sodium


in a blister pack of 10 pcs., in a carton box of 3 packs.

Pharmacological action

Pharmacological action

vasodilator , antianginal , antiarrhythmic .

Blocks alpha 1 -, beta 1 – and beta 2 -adrenergic receptors. It does not have its own sympathomimetic activity, it has membrane-stabilizing properties. It has an antioxidant effect, eliminating free oxygen radicals.

Blocks alpha 1 -, beta 1 – and beta 2 -adrenergic receptors. It does not have its own sympathomimetic activity, it has membrane-stabilizing properties. It has an antioxidant effect, eliminating free oxygen radicals.

Pharmacodynamics

Reduces peripheral vascular resistance, reduces pre- and afterload on the heart. It does not have a pronounced effect on lipid metabolism and the content of potassium, sodium and magnesium in blood plasma.

Pharmacokinetics

Rapidly and almost completely absorbed from the gastrointestinal tract. Binds to plasma proteins by 98-99%. Bioavailability is about 25% due to the high degree of metabolism in the liver. Metabolites have beta-blocking properties. Food slows absorption but does not affect bioavailability. Plasma concentration is proportional to the dose taken. From max in plasma is achieved after 1 hour. T 1/2 – 6-10 hours. Excreted mainly with bile.

In elderly patients, plasma concentrations are approximately 50% higher than in younger patients. In case of impaired liver function, bioavailability can increase up to 80%. Passes through the placental barrier, excreted in breast milk.

Indications

Arterial hypertension (monotherapy or in combination with other antihypertensive drugs), stable angina pectoris.

Contraindications

Hypersensitivity, chronic obstructive pulmonary disease, severe liver failure, severe bradycardia, sick sinus syndrome, AV block II and III degree (except in patients with a pacemaker), decompensated heart failure, pulmonary hypertension or cardiogenic shock, arterial hypotension, pregnancy, breast-feeding, age under 18 years (safety and efficacy in persons under 18 years of age have not been established).

Use during pregnancy and lactation

Contraindicated. At the time of treatment should stop breastfeeding.

Dosage and administration

Information for healthcare professionals only.
Are you a healthcare professional?

By mouth, after meals, with a little liquid. The dose is selected individually.

Hypertension: The recommended dose for the first 7-14 days is 12.5 mg/day in the morning after breakfast or divided into 2 doses of 6.25 mg, then 25 mg/day once in the morning or divided into 2 doses of 12. 5 mg. After 14 days, the dose may be increased again.

Stable angina: starting dose is 12.5 mg twice a day, after 7-14 days under the supervision of a physician, the dose can be increased to 25 mg twice a day. After 14 days, with insufficient efficacy and good tolerability of the drug, the dose can be further increased. The total daily dose should not exceed 100 mg (50 mg 2 times a day), over the age of 70 – 50 mg / day (25 mg 2 times a day).

If the next dose is missed, the drug should be taken as soon as possible, however, if the time for the next dose is approaching, then take only it, without doubling it. If it is necessary to cancel the drug, the dose should be reduced gradually over 1-2 weeks.

Side effects

From the side of the nervous system and sensory organs: headache, dizziness, syncope, muscle weakness (more often at the beginning of treatment), sleep disturbances, depression, paresthesia, decreased secretion of lacrimal fluid.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): bradycardia, AV blockade, orthostatic hypotension, rarely – “intermittent” claudication, impaired peripheral circulation, progression of heart failure, thrombocytopenia, leukopenia.

From the respiratory system: sneezing, nasal congestion, bronchospasm, shortness of breath (in predisposed patients).

From the digestive tract: dry mouth, nausea, vomiting, abdominal pain, diarrhea or constipation, increased liver transaminases.

From the urinary system: severe renal dysfunction, edema.

On the part of the skin: exacerbation of psoriatic rashes.

Allergic reactions: exanthema, urticaria, itching, rash.

Other: influenza-like syndrome, pain in the extremities, weight gain.

Interactions

Information for healthcare professionals only.
Are you a healthcare professional?

Enhances the effect of hypoglycemic agents, increases the concentration of digoxin in the blood. Some antiarrhythmic drugs, anesthetics, antihypertensives, antianginal drugs, other beta-blockers (including in the form of eye drops), MAO inhibitors, sympatholytics (reserpine), cardiac glycosides may enhance the effect. Cimetidine increases the concentration of carvedilol in the blood; rifampicin, phenobarbital – reduce. Simultaneous use with ergot alkaloids impairs peripheral circulation. Incompatible with the / in the introduction of verapamil and diltiazem (possibly pronounced slowing of the heart rate and a pronounced decrease in blood pressure).

Overdose

Symptoms: pronounced decrease in blood pressure, bradycardia, impaired respiratory function (including bronchospasm), heart failure, cardiogenic shock, cardiac arrest.

Treatment: gastric lavage, administration of adrenergic agonists; symptomatic therapy.

Precautions

Use with caution in bronchospastic syndrome, chronic bronchitis, pulmonary emphysema, Prinzmetal’s angina (possibly worsening), diabetes mellitus or hypoglycemia (regular monitoring of blood glucose levels is necessary), hyperthyroidism, peripheral vascular disease (possibly worsening course), pheochromocytoma (the appointment of beta-blockers is possible only after prior therapy with alpha-blockers), depression, myasthenia gravis, psoriasis, renal failure, severe metabolic acidosis, in patients using contact lenses.

At the beginning of treatment and with increasing doses, orthostatic hypotension, dizziness, syncope may occur (especially in elderly patients with heart failure or while using other antihypertensive drugs or diuretics). It is recommended to monitor renal function in patients with renal insufficiency, ischemic heart disease, diffuse peripheral vascular disease, heart failure (with a deterioration in renal function, drug withdrawal is necessary). It is possible to reduce the sensitivity of allergic tests. Before extensive surgical interventions, a gradual withdrawal of the drug is recommended. If concomitant therapy with carvedilol and clonidine is discontinued, treatment with carvedilol should be discontinued initially, and clonidine should be discontinued only a few days later.

It is not recommended to drink alcoholic beverages during the treatment period.

Special instructions

Do not stop taking the drug or change its dosage without first consulting a doctor. If treatment is interrupted for 2 weeks or more, treatment should be resumed with the lowest doses. If there is no therapeutic effect or if the condition worsens, you should consult your doctor.

Should not be used during work by drivers of vehicles and people whose profession is associated with increased concentration of attention.

Producer

Makiz-Pharma, Russia.

Storage conditions

In a dry, dark place, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Expiry date

3 years.

Do not use after the expiry date which is stated on the package.

Update date: 06/07/2023

The information provided about the prices of drugs is not an offer to sell or buy goods.

The information is intended solely for comparing prices in stationary pharmacies operating in
in accordance with Article 55 of the Federal Law “On the Circulation of Medicines” dated April 12, 2010 No. 61-FZ.

Carvedilol tablets 12.5 mg No. 30

Composition

1 tablet contains:

active substance : carvedilol – 12.5 mg or 25 mg,

excipients : lactose monohydrate 89.51 mg/77, 06 mg, microcrystalline cellulose 63 mg/63 mg, povidone 5.4 mg/12.5 mg tablets), povidone (KZO) (5.4 mg for 25 mg tablet), crospovidone 7.2 mg/7.2 mg, colloidal silicon dioxide 0.72 mg / 0.72 mg, magnesium stearate 1.62 mg / 1.62 mg, quinoline yellow (0.05 mg for a 12.5 mg tablet).

Dosage form

tablets

Description

Tablets with a dosage of 12.5 m g: round, slightly biconvex, scored on one side, yellowish in color.

25 mg tablets: round, slightly biconvex, scored on one side, white or off-white.

Pharmacodynamics

Carvedilol is an alpha1-, beta1- and beta2-adrenergic blocker. It has a vasodilatory, antianginal and antiarrhythmic effect. Carvedilol is a racemic mixture of R(+) and S(-) stereoisomers, each of which has the same α-adrenergic blocking and antioxidant properties. The beta-adrenergic blocking effect of carvedilol is non-selective and is due to the levorotatory S (-) stereoisomer.

Carvedilol does not have its own sympathomimetic activity, it has membrane stabilizing properties.

The vasodilatory effect is associated mainly with the blockade of alpha1-adrenergic receptors. Due to vasodilation, the total peripheral vascular resistance (OPVR) decreases. The combination of vasodilation and blockade of beta-adrenergic receptors leads to the following effects: in patients with arterial hypertension, a decrease in blood pressure (BP) is not accompanied by an increase in TPVR, peripheral blood flow does not decrease (unlike beta-blockers). Heart rate (HR) decreases slightly. In patients with ischemic heart disease, it has an antianginal effect. Reduces pre- and afterload on the heart. It does not have a pronounced effect on lipid metabolism and the content of potassium, sodium and magnesium ions in blood plasma.

In patients with impaired left ventricular function and / or heart failure, it has a beneficial effect on hemodynamic parameters and improves the ejection fraction and size of the left ventricle. It has an antioxidant effect, eliminating free oxygen radicals.

Carvedilol reduces mortality and hospitalizations, improves symptoms and improves left ventricular function in patients with ischemic and non-ischemic chronic heart failure. The effects of carvedilol are dose dependent.

Pharmacokinetics

Carvedilol is rapidly absorbed from the gastrointestinal tract when taken orally. It has a high lipophilicity. The maximum concentration in the blood is reached after 1 hour.

The elimination half-life is 6-10 hours. It binds to plasma proteins by 95-99%. The bioavailability of the drug is 24-28%. The absolute bioavailability of carvedilol is about 25%: 30% for the R-form and 15% for the S-form. Eating does not affect bioavailability.

Carvedilol is metabolized primarily in the liver by oxidation and conjugation to form a number of metabolites. It is metabolized during the primary passage through the liver. The metabolism of carvedilol by oxidation is stereoselective. The R(+) isomer is metabolized mainly by CYP2D6 and CYP1A2 isoenzymes, and the S(-) isomer is mainly metabolized by CYP2D9 isoenzymeand, to a lesser extent, with the help of the CYP2D6 isoenzyme. Other isoenzymes of cytochrome P450 involved in the metabolism of carvedilol include isoenzymes CYP3A4, CYP2E1, CYP2C19. As a result of demethylation and hydroxylation of the phenol ring, 3 metabolites are formed, which have less pronounced vasodilating properties than carvedilol.

The half-life is 6-10 hours. Metabolites have a pronounced antioxidant and adrenoblocking effect. Carvedilol is excreted mainly with bile through the intestines and partially by the kidneys in the form of metabolites.

In case of impaired renal function, the pharmacokinetic parameters of carvedilol do not change significantly.

The age of the patient does not have a statistically significant effect on the pharmacokinetics of carvedilol.

In patients with cirrhosis of the liver, the bioavailability of carvedilol is increased by 80% due to a decrease in the severity of metabolism during the primary passage through the liver. In severe hepatic impairment, carvedilol is contraindicated.

Carvedilol crosses the placental barrier and is excreted in breast milk.

Carvedilol is almost not removed from plasma during hemodialysis.

Indications for use

– Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs, such as calcium channel blockers or diuretics),

– chronic heart failure (as part of combination therapy),

– ischemic heart disease (including in patients with unstable angina and painless myocardial ischemia).

Contraindications

Symptoms : pronounced decrease in blood pressure, bradycardia, heart failure, cardiogenic shock, cardiac arrest, possible respiratory failure, bronchospasm, vomiting, confusion and generalized convulsions.

Treatment : Monitor and correct vital signs, if necessary in intensive care unit.

The following measures can be used:

a) lay the patient on his back (with legs raised),

b) with severe bradycardia – atropine 0. 5-2 mg intravenously,

c) to maintain cardiovascular activity – glucagon 1-10 mg intravenously by stream, then 2-5 mg per hour as a long-term infusion ,

d) sympathomimetics (dobutamine, epinephrine (adrenaline)) in various doses, depending on body weight and response to therapy.

If arterial hypotension predominates in the clinical picture of overdose, norepinephrine (norepinephrine) is administered, it is prescribed under conditions of continuous monitoring of blood circulation parameters.

In treatment-resistant bradycardia, an artificial pacemaker is indicated.

In case of bronchospasm, beta-adrenergic agonists are administered in the form of an aerosol (if ineffective – intravenously) or aminophylline intravenously.

Diazepam is given slowly intravenously for convulsions.

Since severe overdose with symptoms of shock may prolong the half-life of carvedilol and remove the drug from the depot, it is necessary to continue maintenance therapy for a sufficiently long time.

Use in pregnancy and lactation

There are limited data on the use of carvedilol during pregnancy. Beta-blockers reduce placental blood flow, have an adverse effect on the development of the embryo, can cause arterial hypotension, bradycardia and hypoglycemia in the fetus. There is no sufficient experience with the use of Carvedilol in pregnant women. Carvedilol is contraindicated for use during pregnancy, unless absolutely necessary, if the potential benefit to the mother justifies the risk to the fetus.

In animals, carvedilol and its metabolites pass into breast milk. Data on the release of carvedilol into human breast milk are not available, therefore, if the drug is necessary during lactation, breastfeeding should be discontinued.

Side effects

The frequency of occurrence of adverse reactions is estimated as follows: very often (>, 1/10), often (>.1/100, <.1/10), infrequently (>.1/1000, <.1 /100), rarely (>.1/10,000, <.1/1000), very rarely (<. 1/10,000).

Adverse reactions in patients with chronic heart failure

From the side of the central nervous system : very often – dizziness, headache (usually not severe and occurring at the beginning of treatment), asthenia, fatigue, depression .

From the side of the cardiovascular system : often – bradycardia, orthostatic hypotension, marked decrease in blood pressure, edema (including generalized, peripheral, depending on body position, perineal edema, edema of the lower extremities, hypervolemia, fluid retention), infrequently – syncope (including presyncope), atrioventricular block and heart failure during the dose increase.

From the digestive tract : often – nausea, diarrhea, vomiting.

From the side of the hematopoietic system: rarely – thrombocytopenia, very rarely – leukopenia.

From the side of metabolism : often – weight gain, hypercholesterolemia, in patients with pre-existing diabetes – hyperglycemia or hypoglycemia, impaired glycemic control.

Other : often – visual disturbances, rarely – renal failure and impaired renal function in patients with diffuse vasculitis and / or impaired renal function.

Adverse reactions in patients with arterial hypertension and coronary heart disease , infrequently – mood lability, sleep disturbances, paresthesia.

From the side of the cardiovascular system : often – bradycardia, orthostatic hypotension, syncope (infrequently), especially at the beginning of therapy, infrequently – peripheral circulatory disorders (cold extremities, exacerbation of intermittent claudication and Raynaud’s syndrome), atrioventricular blockade, angina pectoris, development or progression of symptoms of heart failure and peripheral edema.

From the respiratory system : often – bronchospasm and shortness of breath in predisposed patients, rarely – nasal congestion.

From the digestive tract : often – nausea, diarrhea, abdominal pain, infrequently – constipation, vomiting.

Laboratory indicators : very rarely – increased activity of hepatic transaminases – alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and gamma-glutamyl transferase.

From the side of the hematopoietic system : very rarely – platelet singing, leukopenia.

From the side of metabolism : weight gain, impaired carbohydrate metabolism.

On the part of the skin: infrequently – skin reactions (skin rash, dermatitis, urticaria and pruritus).

Other: often – pain in the extremities, decreased tearing and eye irritation, infrequently – decreased potency, visual disturbances, rarely – dryness of the oral mucosa and urination disorders, very rarely – exacerbation of psoriasis, sneezing, flu-like syndrome, isolated cases of allergic reactions.

Also, the presence of beta-adrenergic blocking properties in the drug does not exclude the possibility of manifestation of latent diabetes mellitus, decompensation of existing diabetes mellitus or suppression of the contra-insular system, alopecia, rare cases of urinary incontinence in women, reversible after discontinuation of the drug, have been reported.

Interactions

Carvedilol may potentiate the effect of other concomitantly taken antihypertensive drugs or drugs that have an antihypertensive effect (nitrates).

Co-administration of carvedilol and diltiazem, amiodarone and other antiarrhythmic drugs may lead to cardiac conduction disturbances and hemodynamic disturbances.

While taking carvedilol and digoxin , the concentration of the latter increases and the time of atrioventricular conduction may increase.

Carvedilol may potentiate the action of insulin and hypoglycemic agents for oral administration, while the symptoms of hypoglycemia (especially tachycardia) may be masked, therefore, in patients with diabetes, regular monitoring of blood glucose concentration is recommended.

Inhibitors of microsomal oxidation (cimetidine) increase, and inducers (phenobarbital, rifampicin) weaken the antihypertensive effect of carvedilol.

Drugs that reduce the content of catecholamines (reserpine, monoamine oxidase inhibitors), increase the risk of arterial hypotension and severe bradycardia.

With the simultaneous use of cyclosporine , the concentration of the latter increases (adjustment of the daily dose of cyclosporine is recommended).

Co-administration of clonidine may potentiate the antihypertensive and heart rate-lowering effects of carvedilol.

General anesthetics enhance the negative inotropic and antihypertensive effects of carvedilol.

Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and beta-blockers can lead to an increase in blood pressure and a decrease in blood pressure control.

Bronchodilators (beta-adrenergic agonists) – since non-cardioselective beta-blockers interfere with the bronchodilator effect of bronchodilators, which are beta-adrenergic stimulants, regular monitoring of patients receiving these drugs is necessary.

Dosage and administration

Inside, regardless of food intake.

Arterial hypertension

The recommended starting dose is 6. 25 – 12.5 mg (1/2 tablet of 12.5 mg – 1 tablet) 1 time per day for the first two days of treatment, then 25 mg 1 time per day. In case of insufficiency of the antihypertensive effect after 2 weeks of therapy, the dose can be increased by 2 times. The maximum recommended daily dose of the drug is 50 mg once a day (possibly divided into 2 doses).

Ischemic heart disease

The recommended starting dose is 12.5 mg twice daily for the first two days of treatment. Then 25 mg 2 times a day. If the antianginal effect is insufficient, after 2 weeks of therapy, the dose can be increased by 2 times. The maximum recommended daily dose of the drug is 100 mg per day, divided into 2 doses.

Chronic heart failure

The dose is selected individually, under close medical supervision. In patients receiving cardiac glycosides, diuretics and ACE inhibitors, their doses should be adjusted before starting treatment with Carvedilol.

The recommended starting dose is 3. 125 mg (another dosage form of carvedilol may be used: 6.25 mg scored tablets) twice a day for 2 weeks. With good tolerance, the dose is increased at intervals of at least 2 weeks to 6.25 mg (1/2 tablet of 12.5 mg) 2 times a day, then up to 12.5 mg 2 times a day, then up to 25 mg 2 times per day. The recommended maximum dose is 25 mg twice daily for all patients with severe chronic heart failure and for patients with mild to moderate chronic heart failure weighing less than 85 kg. In patients with mild to moderate chronic heart failure and weighing more than 85 kg – 50 mg 2 times a day.

Before each increase in dose, a medical examination is necessary to identify a possible increase in symptoms of chronic heart failure or vasodilation. With a transient increase in symptoms of chronic heart failure or fluid retention in the body, the dose of diuretics should be increased, although sometimes it is necessary to reduce the dose of Carvedilol or temporarily cancel it.

Symptoms of vasodilation can be relieved by reducing the dose of diuretics. If symptoms persist, the dose of the ACE inhibitor can be reduced (if the patient is taking one) and then, if necessary, the dose of Carvedilol. In such a situation, the dose of Carvedilol should not be increased until the symptoms of worsening chronic heart failure or hypotension improve.

If drug therapy is interrupted for more than 1 week, then its use is resumed at a lower dose and then increased in accordance with the above recommendations. If treatment with Carvedilol is interrupted for more than 2 weeks, then its administration should be resumed at a dose of 3.125 mg (carvedilol may be used in another dosage form: 6.25 mg scored tablets) 2 times a day, then the dose is selected in accordance with above recommendations,

In patients with moderate to severe renal insufficiency, dose adjustment of carvedilol is not required.

Carvedilol is contraindicated in patients with clinical signs of hepatic impairment.

Overdose

Symptoms of : pronounced decrease in blood pressure, bradycardia, heart failure, cardiogenic shock, cardiac arrest, respiratory failure, bronchospasm, vomiting, confusion and generalized convulsions are possible.

Treatment : Vital signs should be monitored and corrected, if necessary in the intensive care unit.

The following measures can be used:

a) lay the patient on his back (with legs raised),

b) with severe bradycardia – atropine 0.5-2 mg intravenously,

c) to maintain cardiovascular activity – glucagon 1-10 mg intravenously by stream, then 2-5 mg per hour as a long-term infusion,

d) sympathomimetics (dobutamine, epinephrine (adrenaline)) in various doses, depending on body weight and response to therapy.

If arterial hypotension predominates in the clinical picture of overdose, norepinephrine (norepinephrine) is administered, it is prescribed under conditions of continuous monitoring of blood circulation parameters.

In treatment-resistant bradycardia, an artificial pacemaker is indicated.

In case of bronchospasm, beta-adrenergic agonists are administered in the form of an aerosol (if ineffective – intravenously) or aminophylline intravenously.

Diazepam is given slowly intravenously for convulsions.

Since severe overdose with symptoms of shock may prolong the half-life of carvedilol and remove the drug from the depot, it is necessary to continue maintenance therapy for a sufficiently long time.

Special instructions

Therapy should be long-term and should not be stopped abruptly, especially in patients with ischemic heart disease, as this may lead to a worsening of the underlying disease. If necessary, reducing the dose of the drug should be gradual, over 1-2 weeks.

At the beginning of therapy with Carvedilol or with an increase in the dose of the drug in patients, especially the elderly, there may be an excessive decrease in blood pressure, mainly when moving from a supine position to a standing position. Dose adjustment is required. In patients with chronic heart failure, when choosing a dose, an increase in the symptoms of chronic heart failure and the appearance of edema are possible. In this case, the dose of carvedilol should not be increased, it is recommended to prescribe large doses of diuretics until the patient’s condition stabilizes.

Sometimes it may be necessary to reduce the dose of Carvedilol or, in rare cases, stop the drug temporarily. Such episodes do not prevent further correct selection of the dose of the drug Carvedilol.

Carvedilol should be used with caution concomitantly with cardiac glycosides (risk of atrioventricular conduction delay).

Continuous monitoring of electrocardiogram and blood pressure is recommended with the simultaneous administration of carvedilol and slow calcium channel blockers, phenylalkylamine derivatives (verapamil) and benzodiazepine (diltiazem), as well as with antiarrhythmic drugs.

Non-selective beta-blockers may cause pain in patients with Prinzmetal’s angina and should be used with caution.

In patients with COPD (including bronchospastic syndrome) who are not receiving oral or inhaled anti-asthma drugs, carvedilol should only be given if the possible benefits outweigh the potential risks.

If there is an underlying predisposition to bronchospastic syndrome when taking Carvedilol, dyspnea may develop as a result of increased airway resistance. At the beginning of therapy and with an increase in the dose of Carvedilol, such patients should be observed, reducing the dose of the drug at the onset of initial signs of bronchospasm.

It is recommended to monitor renal function in patients with chronic renal failure, arterial hypotension and chronic heart failure. In the case of a surgical intervention using general anesthesia, it is necessary to warn the anesthesiologist about previous therapy with Carvedilol.

Use with caution in diabetic patients as it may mask or relieve symptoms of hypoglycemia (especially tachycardia). In patients with CHF and diabetes mellitus, the use of Carvedilol may be accompanied by impaired glycemic control.

Caution is required when using Carvedilol in patients with peripheral vascular disease (including Raynaud’s syndrome), since beta-blockers may exacerbate symptoms of arterial insufficiency.

Like other beta-blockers, carvedilol may reduce the symptoms of thyrotoxicosis.

Care must be taken when prescribing Carvedilol to patients with a history of severe hypersensitivity reactions or undergoing desensitization, as beta-blockers may increase sensitivity to allergens and the severity of anaphylactic reactions. Avoid drinking alcohol during treatment.

Patients with pheochromocytoma should be treated with alpha-blockers before starting therapy.

Patients with a history of development or exacerbation of the course of psoriasis in the use of beta-blockers, carvedilol should be prescribed only after a thorough analysis of the possible benefits and risks.

Patients wearing contact lenses should be aware that the drug may cause a decrease in lacrimation.

Influence on the ability to drive vehicles and control mechanisms

Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the fact that dizziness may develop.