What are the common and serious side effects of Coreg 6.25. How does carvedilol work for heart conditions. What precautions should be taken when using this beta-blocker. How to manage potential drug interactions with carvedilol.

Understanding Carvedilol: A Versatile Beta-Blocker for Heart Conditions

Carvedilol, available as the brand-name drug Coreg and in generic form, is a beta-blocker medication used to treat various heart conditions. This oral tablet plays a crucial role in managing high blood pressure, heart failure, and left ventricular dysfunction following a heart attack. As a member of the beta-blocker class, carvedilol works by improving heart function and widening blood vessels, ultimately reducing blood pressure and easing the workload on the heart.

Key Uses of Carvedilol

• Treatment of heart failure
• Management of left ventricular dysfunction post-heart attack
• Control of high blood pressure (hypertension)

Can carvedilol be used for other cardiovascular conditions? While primarily prescribed for the aforementioned conditions, carvedilol’s versatility in cardiovascular care may lead to off-label uses under a doctor’s guidance. However, it’s essential to use this medication strictly as prescribed and consult a healthcare professional for any changes in treatment.

Common Side Effects of Coreg 6.25: What to Expect

Like all medications, carvedilol can cause side effects. While not everyone experiences these effects, it’s important to be aware of potential reactions. Common side effects of Coreg 6.25 (carvedilol) include:

• Dizziness
• Unusual tiredness
• Low blood pressure
• Diarrhea
• High blood sugar
• Lack of energy or weakness
• Slower heart rate
• Weight gain
• Changes in sex drive or performance
• Dry eyes
• Dry, itchy skin
• Headache
• Nausea

Are these side effects a cause for concern? Generally, if these effects are mild, they may resolve within a few days to weeks as your body adjusts to the medication. However, if they persist or worsen, it’s crucial to consult your healthcare provider. They can assess whether the benefits of the medication outweigh the discomfort of side effects and may adjust your dosage or consider alternative treatments if necessary.

Serious Side Effects: Recognizing and Responding to Severe Reactions

While less common, serious side effects can occur with carvedilol use. It’s vital to be aware of these potential reactions and seek immediate medical attention if they occur. Serious side effects may include:

1. Allergic reactions (skin rash, hives, swelling of face, lips, or tongue)
2. Changes in heart rate (irregular or slow heart rate, feeling dizzy or fainting)
3. Heart problems (breathing difficulties, weight gain, swollen extremities, chest pain)
4. Liver problems (dark urine, vomiting, yellowing of skin or eyes)
5. Eye problems (changes in eyesight or contact lens comfort)
6. Urinary problems (inability to pass urine or changes in urination patterns)

How quickly should one seek medical help for serious side effects? If you experience any symptoms that feel life-threatening or severe, it’s crucial to call emergency services immediately. For other serious side effects, contact your healthcare provider right away for guidance.

Dosage and Administration: Optimizing Carvedilol Treatment

Proper dosage and administration of carvedilol are crucial for its effectiveness and safety. The typical starting dose for Coreg 6.25 may vary depending on the condition being treated and individual patient factors. Your healthcare provider will determine the most appropriate dosage for your specific needs.

Key Points on Dosage and Administration:

• Take carvedilol with food to decrease the risk of low blood pressure
• Do not stop taking the medication suddenly without consulting your doctor
• Your doctor may start with a low dose and gradually increase it
• Follow your prescription instructions carefully

Why is it important not to stop carvedilol suddenly? Abrupt discontinuation of carvedilol can lead to serious consequences, including changes in heart rhythm, worsened chest pain, or even a heart attack. If you need to stop taking the medication, your doctor will create a plan to gradually reduce your dosage over one to two weeks to minimize these risks.

Drug Interactions: Managing Potential Conflicts with Other Medications

Carvedilol can interact with various medications, herbs, and vitamins. These interactions may affect how carvedilol works or increase the risk of side effects. It’s crucial to inform your healthcare provider about all the medications and supplements you’re taking.

Common Drug Interactions to Watch For:

• Other blood pressure medications
• Diabetes medications
• Certain heart rhythm medications
• Antidepressants
• NSAIDs (non-steroidal anti-inflammatory drugs)

How can one prevent harmful drug interactions? Always provide your healthcare provider with a comprehensive list of all medications, including over-the-counter drugs, herbal supplements, and vitamins. Your doctor can then assess potential interactions and adjust your treatment plan accordingly.

Special Precautions: Navigating Carvedilol Use in Specific Populations

Certain groups of people may need to exercise extra caution when using carvedilol. Special precautions are necessary for:

Patients with Diabetes

Carvedilol can affect blood sugar levels and mask signs of hypoglycemia. If you have diabetes, your doctor will monitor you closely and may need to adjust your diabetes medication.

Individuals with Liver or Kidney Disease

These conditions may affect how your body processes carvedilol. Your doctor may need to adjust your dosage or monitor you more closely.

Pregnant or Breastfeeding Women

The safety of carvedilol during pregnancy and breastfeeding is not fully established. Discuss the potential risks and benefits with your healthcare provider.

Elderly Patients

Older adults may be more sensitive to the effects of carvedilol, particularly dizziness and low blood pressure. Careful monitoring and potential dosage adjustments may be necessary.

What should patients in these special populations do before starting carvedilol? It’s crucial to have a thorough discussion with your healthcare provider about your medical history, current health status, and any concerns you may have. This allows for personalized treatment planning and appropriate monitoring.

Monitoring and Follow-up: Ensuring Safe and Effective Carvedilol Use

Regular monitoring is essential for patients taking carvedilol to ensure the medication is working effectively and safely. Your healthcare provider will likely schedule follow-up appointments to assess your progress and make any necessary adjustments to your treatment plan.

Key Aspects of Monitoring:

• Blood pressure checks
• Heart rate monitoring
• Blood tests to check liver and kidney function
• Assessment of side effects
• Evaluation of overall heart health and symptoms

How often should patients follow up with their healthcare provider while on carvedilol? The frequency of follow-up appointments may vary depending on your individual health status and how well you’re responding to the medication. Initially, you may need more frequent check-ups, which may be spaced out as your condition stabilizes. Always follow your healthcare provider’s recommendations for follow-up care.

Lifestyle Considerations: Maximizing the Benefits of Carvedilol Treatment

While carvedilol is an effective medication for various heart conditions, combining it with healthy lifestyle choices can enhance its benefits and improve overall cardiovascular health.

Lifestyle Recommendations for Patients on Carvedilol:

1. Maintain a heart-healthy diet low in saturated fats and sodium
2. Engage in regular physical activity as approved by your healthcare provider
3. Manage stress through relaxation techniques or counseling
4. Quit smoking and limit alcohol consumption
5. Monitor your blood pressure at home if recommended by your doctor
6. Stay hydrated, especially in hot weather or during exercise

How can these lifestyle changes complement carvedilol treatment? By adopting these healthy habits, you can support the medication’s effects in controlling blood pressure and improving heart function. Additionally, these changes can contribute to overall cardiovascular health, potentially reducing the risk of future heart problems.

Remember, carvedilol is a powerful medication that requires careful management and regular medical supervision. Always consult your healthcare provider before making any changes to your medication regimen or lifestyle. By staying informed about the potential side effects, interactions, and precautions associated with carvedilol, you can work closely with your healthcare team to optimize your treatment and maintain heart health.

Side effects, dosage, uses, and more

1. Carvedilol oral tablet is available as a generic drug and a brand-name drug. Brand-name: Coreg.
2. Carvedilol also comes as an oral extended-release capsule.
3. Carvedilol is a beta-blocker. It’s used to treat high blood pressure, heart failure, and heart function problems after a heart attack.

• Sudden drug stoppage warning: Don’t stop taking this drug without talking to your doctor first. Stopping carvedilol suddenly can cause changes in your heart rhythm, worsened chest pain, or a heart attack. If you will be stopping this drug, your doctor will slowly lower your dosage over one to two weeks to help prevent these effects. If your chest pain or heart problems get worse after stopping this drug, your doctor may have you start taking it again for a short time.
• Low heart rate warning: Carvedilol can decrease your heart rate. If your heart rate drops below 55 beats per minute, your doctor may decrease your dosage of this drug.
• Low blood pressure warning: Carvedilol can cause dangerously low blood pressure, which may cause you to lose consciousness. This risk is highest after your first doses and during dosing increases. To decrease the risk of this happening, take carvedilol with food. Your doctor may start you on a low dosage and slowly increase it.
• Diabetes warning: Carvedilol can cause low blood sugar levels (hypoglycemia) and delay how long it takes your blood sugar levels to return to normal. It may also mask the signs of low blood sugar levels. Use this drug with caution if you have diabetes, especially if you take insulin or other diabetes drugs that can cause low blood sugar.

Carvedilol oral tablet is a prescription drug that’s available as the brand-name drug Coreg. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, a generic drug may not be available in every strength or form as a brand-name version.

Carvedilol also comes as an extended-release oral capsule.

Why it’s used

Carvedilol oral tablet is used to treat high blood pressure. It can also improve how well your heart works if you’ve had a heart attack or if you have heart failure.

This drug is approved to treat:

• heart failure
• left ventricular dysfunction (a heart function problem) after a heart attack
• high blood pressure

How it works

Carvedilol belongs to a class of drugs called beta-blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

It isn’t fully understood how carvedilol works to treat high blood pressure or improve heart function. However, it is known that carvedilol improves the workload of your heart, exercise-induced high heart rate, and high heart rate upon standing. It also widens your blood vessels, which helps to decrease your blood pressure.

Carvedilol oral tablet can cause several types of side effects, including drowsiness. Don’t drive, use machinery, or perform activities that require alertness until you know how this drug affects you.

More common side effects

The more common side effects that can occur with carvedilol oral tablet include:

• dizziness
• unusual tiredness
• low blood pressure
• diarrhea
• high blood sugar
• lack of energy or weakness
• slower heart rate
• weight gain
• changes in sex drive or performance
• dry eyes
• dry, itchy skin
• headache
• nausea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Allergic reactions. Symptoms can include:
  • skin rash
  • hives
  • swelling of your face, lips, or tongue
• Changes in your heart rate. Symptoms can include:
  • irregular or slow heart rate
  • feeling dizzy or fainting
• Heart problems. Symptoms can include:
  • breathing problems or shortness of breath
  • weight gain
  • swollen legs, ankles, or arms
  • chest pain
• Liver problems. Symptoms can include:
  • dark-colored urine
  • vomiting
  • yellowing of your skin or the whites of your eyes
• Eye problems. Symptoms can include:
  • change in eyesight
  • changes in how contact lenses feel in your eyes
• Urinary problems. Symptoms can include:
  • being unable to pass urine
  • change in how much urine you pass

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Carvedilol oral tablet can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Examples of drugs that can cause interactions with carvedilol are listed below.

Heart rhythm drugs

Taking certain heart rhythm drugs with carvedilol can cause more severe side effects. The combination may lower your heart rate or blood pressure, or worsen a heart blockage. Your doctor may watch you closely for side effects or adjust the dosage of carvedilol or your heart rhythm drug.

Examples of these drugs include:

• amiodarone
• bretylium
• quinidine
• digoxin
• disopyramide
• encainide
• flecainide
• propafenone
• procainamide
• sotalol

Blood pressure drug

Using clonidine with carvedilol can lower your blood pressure and heart rate even further. If you’re switching to carvedilol from clonidine, your doctor will slowly take you off clonidine. You’ll start carvedilol several days after stopping clonidine. If you need both drugs, your doctor will watch you for low blood pressure and low heart rate. If you’re on both drugs and both need to be stopped, your doctor will stop your treatment with carvedilol first and clonidine a few days later.

Other beta-blockers

Carvedilol shouldn’t be used with another beta-blocker. This combination may lower your heart rate and blood pressure too much. Examples of other beta-blockers include:

• acebutolol
• atenolol
• bisoprolol
• metoprolol
• propranolol

Calcium channel blockers

If you take a calcium channel blocker with carvedilol, your doctor will monitor your blood pressure and heart rhythm. Examples of these drugs include:

• diltiazem
• verapamil

Diabetes drugs

Using carvedilol with certain diabetes drugs can make these diabetes drugs lower your blood sugar levels further. If you take these diabetes drugs with carvedilol, you’ll need to check your blood sugar regularly. Examples of these drugs include:

• insulin
• oral diabetes drugs

Transplant rejection drug

Taking carvedilol with cyclosporine may increase the levels of cyclosporine in your body. Your doctor may lower your dosage of cyclosporine and monitor you closely.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal. Symptoms of an allergic reaction include:

• rash or hives
• itching
• blistering or peeling skin
• fever
• problems breathing or chest tightness
• swelling of your mouth, face, lips, tongue or throat

If you have a history of severe, life-threatening allergic reactions to different allergens, you’re at a higher risk of having the same reaction to beta-blockers. Tell your doctor about all of your allergies before starting this medication.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction warning

Talk to your doctor before using alcohol while taking this medication. If you drink alcohol while taking carvedilol, your blood pressure may decrease to levels that are lower than normal. This can be dangerous.

Warnings for people with certain health conditions

For people with asthma: If you have asthma or a related condition, you shouldn’t use this drug. A single dose of carvedilol can be fatal in people with asthma.

For people with heart problems:

• Second- or third-degree heart block: Carvedilol can make your heart block worse.
• Heart rhythm problems: If you already have a heart rhythm problem, such as sick sinus syndrome, taking carvedilol can make it worse.
• Very low heart rate: This drug can slow down your heart rate even more, possibly to dangerously low levels. Don’t take carvedilol if you have a very low heart rate unless you have a permanent pacemaker.
• Cardiogenic shock or decompensated heart failure: People with shock or decompensated failure that requires the use of certain medications (inotropic therapy that’s administered into your veins) shouldn’t use this drug. It can make the condition worse.
• Chronic heart failure: Carvedilol can worsen heart failure or fluid retention, especially during dosage increases. Carvedilol can further decrease the force of contraction of your heart and slow down your heart rate. This may make your heart failure worse if your dosage is increased too quickly. Your doctor may need to lower your dosage or temporarily stop carvedilol if this happens.

For people with severe liver problems: You shouldn’t take this medication. It’s broken down by your liver. When your liver isn’t working properly, taking this medication can result in higher amounts of it in your body. This may lead to serious side effects, such as dangerously low blood pressure or slow heart rate.

For people with low blood pressure: Carvedilol can cause dangerously low blood pressure that may cause you to lose consciousness.

For people with chronic bronchitis or emphysema: You shouldn’t take carvedilol or other beta-blockers. This drug can affect not only your heart but also your lungs. Its effects in your lungs can lead to tightened airways, making it difficult for you to breathe.

For people with diabetes: Carvedilol can cause low blood sugar (hypoglycemia) and delay how long it takes for your blood sugar to return to normal. It may also mask the signs of low blood sugar. Use this drug with caution if you have diabetes, especially if you take insulin or other diabetes drugs that can cause low blood sugar. If you have diabetes and are taking this medication for heart failure, it may increase your blood sugar levels. You’ll need to monitor your blood sugar and your doctor will adjust your medications accordingly.

For people with peripheral vascular disease (PVD): Use caution if you have PVD and take carvedilol. This drug can make your symptoms worse.

For people with kidney problems: Carvedilol can worsen your kidney function if you have heart failure. You’re at a higher risk if you have low blood pressure or heart or vascular disease. Your doctor will monitor your kidney function and may lower your dosage or stop your treatment with carvedilol.

For people with hyperactive thyroid: Carvedilol can mask the symptoms of a hyperactive thyroid (hyperthyroidism). If you stop taking carvedilol suddenly and have hyperthyroidism, your symptoms can get worse or you may develop a serious condition called thyroid storm

For people with pheochromocytoma: Take this medication with caution if you have this condition. If you have pheochromocytoma, talk with your doctor. You may need to take another medication before starting carvedilol.

For people with Prinzmetal’s variant angina (chest pain that occurs between midnight and the early morning): Carvedilol may increase your risk of chest pain if you have Prinzmetal’s variant angina. Talk with your doctor before taking carvedilol if you have this condition.

For people with intraoperative floppy iris syndrome: Before receiving any type of cataract surgery, tell your doctor that you’re taking this drug. You’re at an increased risk of getting a condition called small pupil syndrome during surgery.

Warnings for other groups

For pregnant women: Carvedilol is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Carvedilol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding: It isn’t known if carvedilol passes into breast milk. If it does, it may cause serious effects in a breastfeeding child. You and your doctor may need to decide if you’ll take carvedilol or breastfeed.

For seniors: Seniors may be more likely to experience dizziness while taking this drug.

For children: It has not been established that carvedilol is safe and effective for use in people under the age of 18 years.

This dosage information is for carvedilol oral tablets. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• the severity your condition
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Carvedilol

• Form: oral tablet
• Strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg

Brand: Coreg

• Form: oral tablet
• Strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg

Dosage for heart function problems following heart attack

Adult dosage (ages 18 years and older)

• The recommended starting dosage is 6. 25 mg taken twice per day.
• It can be increased after 3 to 10 days to 12.5 mg taken twice per day.
• It can be increased up to 25 mg taken twice per day.
• You’ll be kept on a lower dosage if you can’t tolerate higher dosages.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.
• For people with low blood pressure or heart rate or who are retaining fluid:
  • You may be started at a lower dosage of 3.125 mg taken twice per day. Or, your dosage may be increased at a slower rate.
  • You’ll be kept on a lower dosage if you can’t tolerate higher dosages.

Warnings

Your doctor will monitor you closely during dosage increases.

Dosage for high blood pressure

Adult dosage (ages 18 years and older)

• The recommended starting dose is 6.25 mg taken twice per day.
• It can be increased after 7 to 14 days based on your blood pressure level one hour after your dose.
• Your dosage can be first increased to 12.5 mg taken twice per day. It can be increased again to 25 mg taken twice per day.
• The total dosage shouldn’t go over 50 mg per day.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.

Warnings

Your doctor will monitor you closely during dosage increases.

Dosage for heart failure

Adult dosage (ages 18 years and older)

• The recommended starting dosage is 3. 125 mg taken twice per day for two weeks.
• It can be increased to 6.25 mg, 12.5 mg, and 25 mg taken twice per day over two-week intervals.
• When you first start the medication and during dosage increases, you might feel dizzy and lightheaded within the first hour of taking your dose. During this time, you shouldn’t drive or do any similar activities that require alertness.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.

Warnings

Your doctor will monitor you closely during dosage increases.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Carvedilol oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it at all: Your condition may not improve and it may get worse.

If you skip or miss doses: Your blood pressure or heart condition may not be controlled if you skip or miss doses.

If you take too much: An overdose of this drug could cause your heart to stop. Symptoms of overdose of carvedilol include:

• low blood pressure and heart rate
• vomiting
• loss of consciousness
• seizures
• trouble breathing

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you can. If it’s just a few hours before the time for your next dose, then only take one dose at that time. Never try to catch up by taking two doses at once. This could result in toxic side effects.

How to tell if the drug is working: You may be able to tell this drug is working if your blood pressure decreases or your other symptoms improve.

Keep these considerations in mind if your doctor prescribes carvedilol oral tablet for you.

General

• Take carvedilol with food. Taking it with food reduces your risk of side effects.
• You can crush carvedilol tablets.
• The generic version of this drug is usually stocked at most pharmacies. However, the brand-name version might not be stocked, so call ahead if your doctor prescribes that version.

Storage

• Store in temperatures below 86°F (30°C).
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

During treatment with carvedilol, your doctor may check your:

• blood pressure
• heart rate
• weight
• blood sugar (if you have diabetes)
• liver function
• potassium levels
• cholesterol levels

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side effects, dosage, uses, and more

1. Carvedilol oral tablet is available as a generic drug and a brand-name drug. Brand-name: Coreg.
2. Carvedilol also comes as an oral extended-release capsule.
3. Carvedilol is a beta-blocker. It’s used to treat high blood pressure, heart failure, and heart function problems after a heart attack.

• Sudden drug stoppage warning: Don’t stop taking this drug without talking to your doctor first. Stopping carvedilol suddenly can cause changes in your heart rhythm, worsened chest pain, or a heart attack. If you will be stopping this drug, your doctor will slowly lower your dosage over one to two weeks to help prevent these effects. If your chest pain or heart problems get worse after stopping this drug, your doctor may have you start taking it again for a short time.
• Low heart rate warning: Carvedilol can decrease your heart rate. If your heart rate drops below 55 beats per minute, your doctor may decrease your dosage of this drug.
• Low blood pressure warning: Carvedilol can cause dangerously low blood pressure, which may cause you to lose consciousness. This risk is highest after your first doses and during dosing increases. To decrease the risk of this happening, take carvedilol with food. Your doctor may start you on a low dosage and slowly increase it.
• Diabetes warning: Carvedilol can cause low blood sugar levels (hypoglycemia) and delay how long it takes your blood sugar levels to return to normal. It may also mask the signs of low blood sugar levels. Use this drug with caution if you have diabetes, especially if you take insulin or other diabetes drugs that can cause low blood sugar.

Carvedilol oral tablet is a prescription drug that’s available as the brand-name drug Coreg. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, a generic drug may not be available in every strength or form as a brand-name version.

Carvedilol also comes as an extended-release oral capsule.

Why it’s used

Carvedilol oral tablet is used to treat high blood pressure. It can also improve how well your heart works if you’ve had a heart attack or if you have heart failure.

This drug is approved to treat:

• heart failure
• left ventricular dysfunction (a heart function problem) after a heart attack
• high blood pressure

How it works

Carvedilol belongs to a class of drugs called beta-blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

It isn’t fully understood how carvedilol works to treat high blood pressure or improve heart function. However, it is known that carvedilol improves the workload of your heart, exercise-induced high heart rate, and high heart rate upon standing. It also widens your blood vessels, which helps to decrease your blood pressure.

Carvedilol oral tablet can cause several types of side effects, including drowsiness. Don’t drive, use machinery, or perform activities that require alertness until you know how this drug affects you.

More common side effects

The more common side effects that can occur with carvedilol oral tablet include:

• dizziness
• unusual tiredness
• low blood pressure
• diarrhea
• high blood sugar
• lack of energy or weakness
• slower heart rate
• weight gain
• changes in sex drive or performance
• dry eyes
• dry, itchy skin
• headache
• nausea

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Allergic reactions. Symptoms can include:
  • skin rash
  • hives
  • swelling of your face, lips, or tongue
• Changes in your heart rate. Symptoms can include:
  • irregular or slow heart rate
  • feeling dizzy or fainting
• Heart problems. Symptoms can include:
  • breathing problems or shortness of breath
  • weight gain
  • swollen legs, ankles, or arms
  • chest pain
• Liver problems. Symptoms can include:
  • dark-colored urine
  • vomiting
  • yellowing of your skin or the whites of your eyes
• Eye problems. Symptoms can include:
  • change in eyesight
  • changes in how contact lenses feel in your eyes
• Urinary problems. Symptoms can include:
  • being unable to pass urine
  • change in how much urine you pass

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Carvedilol oral tablet can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Examples of drugs that can cause interactions with carvedilol are listed below.

Heart rhythm drugs

Taking certain heart rhythm drugs with carvedilol can cause more severe side effects. The combination may lower your heart rate or blood pressure, or worsen a heart blockage. Your doctor may watch you closely for side effects or adjust the dosage of carvedilol or your heart rhythm drug.

Examples of these drugs include:

• amiodarone
• bretylium
• quinidine
• digoxin
• disopyramide
• encainide
• flecainide
• propafenone
• procainamide
• sotalol

Blood pressure drug

Using clonidine with carvedilol can lower your blood pressure and heart rate even further. If you’re switching to carvedilol from clonidine, your doctor will slowly take you off clonidine. You’ll start carvedilol several days after stopping clonidine. If you need both drugs, your doctor will watch you for low blood pressure and low heart rate. If you’re on both drugs and both need to be stopped, your doctor will stop your treatment with carvedilol first and clonidine a few days later.

Other beta-blockers

Carvedilol shouldn’t be used with another beta-blocker. This combination may lower your heart rate and blood pressure too much. Examples of other beta-blockers include:

• acebutolol
• atenolol
• bisoprolol
• metoprolol
• propranolol

Calcium channel blockers

If you take a calcium channel blocker with carvedilol, your doctor will monitor your blood pressure and heart rhythm. Examples of these drugs include:

• diltiazem
• verapamil

Diabetes drugs

Using carvedilol with certain diabetes drugs can make these diabetes drugs lower your blood sugar levels further. If you take these diabetes drugs with carvedilol, you’ll need to check your blood sugar regularly. Examples of these drugs include:

• insulin
• oral diabetes drugs

Transplant rejection drug

Taking carvedilol with cyclosporine may increase the levels of cyclosporine in your body. Your doctor may lower your dosage of cyclosporine and monitor you closely.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal. Symptoms of an allergic reaction include:

• rash or hives
• itching
• blistering or peeling skin
• fever
• problems breathing or chest tightness
• swelling of your mouth, face, lips, tongue or throat

If you have a history of severe, life-threatening allergic reactions to different allergens, you’re at a higher risk of having the same reaction to beta-blockers. Tell your doctor about all of your allergies before starting this medication.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction warning

Talk to your doctor before using alcohol while taking this medication. If you drink alcohol while taking carvedilol, your blood pressure may decrease to levels that are lower than normal. This can be dangerous.

Warnings for people with certain health conditions

For people with asthma: If you have asthma or a related condition, you shouldn’t use this drug. A single dose of carvedilol can be fatal in people with asthma.

For people with heart problems:

• Second- or third-degree heart block: Carvedilol can make your heart block worse.
• Heart rhythm problems: If you already have a heart rhythm problem, such as sick sinus syndrome, taking carvedilol can make it worse.
• Very low heart rate: This drug can slow down your heart rate even more, possibly to dangerously low levels. Don’t take carvedilol if you have a very low heart rate unless you have a permanent pacemaker.
• Cardiogenic shock or decompensated heart failure: People with shock or decompensated failure that requires the use of certain medications (inotropic therapy that’s administered into your veins) shouldn’t use this drug. It can make the condition worse.
• Chronic heart failure: Carvedilol can worsen heart failure or fluid retention, especially during dosage increases. Carvedilol can further decrease the force of contraction of your heart and slow down your heart rate. This may make your heart failure worse if your dosage is increased too quickly. Your doctor may need to lower your dosage or temporarily stop carvedilol if this happens.

For people with severe liver problems: You shouldn’t take this medication. It’s broken down by your liver. When your liver isn’t working properly, taking this medication can result in higher amounts of it in your body. This may lead to serious side effects, such as dangerously low blood pressure or slow heart rate.

For people with low blood pressure: Carvedilol can cause dangerously low blood pressure that may cause you to lose consciousness.

For people with chronic bronchitis or emphysema: You shouldn’t take carvedilol or other beta-blockers. This drug can affect not only your heart but also your lungs. Its effects in your lungs can lead to tightened airways, making it difficult for you to breathe.

For people with diabetes: Carvedilol can cause low blood sugar (hypoglycemia) and delay how long it takes for your blood sugar to return to normal. It may also mask the signs of low blood sugar. Use this drug with caution if you have diabetes, especially if you take insulin or other diabetes drugs that can cause low blood sugar. If you have diabetes and are taking this medication for heart failure, it may increase your blood sugar levels. You’ll need to monitor your blood sugar and your doctor will adjust your medications accordingly.

For people with peripheral vascular disease (PVD): Use caution if you have PVD and take carvedilol. This drug can make your symptoms worse.

For people with kidney problems: Carvedilol can worsen your kidney function if you have heart failure. You’re at a higher risk if you have low blood pressure or heart or vascular disease. Your doctor will monitor your kidney function and may lower your dosage or stop your treatment with carvedilol.

For people with hyperactive thyroid: Carvedilol can mask the symptoms of a hyperactive thyroid (hyperthyroidism). If you stop taking carvedilol suddenly and have hyperthyroidism, your symptoms can get worse or you may develop a serious condition called thyroid storm

For people with pheochromocytoma: Take this medication with caution if you have this condition. If you have pheochromocytoma, talk with your doctor. You may need to take another medication before starting carvedilol.

For people with Prinzmetal’s variant angina (chest pain that occurs between midnight and the early morning): Carvedilol may increase your risk of chest pain if you have Prinzmetal’s variant angina. Talk with your doctor before taking carvedilol if you have this condition.

For people with intraoperative floppy iris syndrome: Before receiving any type of cataract surgery, tell your doctor that you’re taking this drug. You’re at an increased risk of getting a condition called small pupil syndrome during surgery.

Warnings for other groups

For pregnant women: Carvedilol is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Carvedilol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding: It isn’t known if carvedilol passes into breast milk. If it does, it may cause serious effects in a breastfeeding child. You and your doctor may need to decide if you’ll take carvedilol or breastfeed.

For seniors: Seniors may be more likely to experience dizziness while taking this drug.

For children: It has not been established that carvedilol is safe and effective for use in people under the age of 18 years.

This dosage information is for carvedilol oral tablets. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• the severity your condition
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Carvedilol

• Form: oral tablet
• Strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg

Brand: Coreg

• Form: oral tablet
• Strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg

Dosage for heart function problems following heart attack

Adult dosage (ages 18 years and older)

• The recommended starting dosage is 6.25 mg taken twice per day.
• It can be increased after 3 to 10 days to 12.5 mg taken twice per day.
• It can be increased up to 25 mg taken twice per day.
• You’ll be kept on a lower dosage if you can’t tolerate higher dosages.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.
• For people with low blood pressure or heart rate or who are retaining fluid:
  • You may be started at a lower dosage of 3.125 mg taken twice per day. Or, your dosage may be increased at a slower rate.
  • You’ll be kept on a lower dosage if you can’t tolerate higher dosages.

Warnings

Your doctor will monitor you closely during dosage increases.

Dosage for high blood pressure

Adult dosage (ages 18 years and older)

• The recommended starting dose is 6.25 mg taken twice per day.
• It can be increased after 7 to 14 days based on your blood pressure level one hour after your dose.
• Your dosage can be first increased to 12.5 mg taken twice per day. It can be increased again to 25 mg taken twice per day.
• The total dosage shouldn’t go over 50 mg per day.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.

Warnings

Your doctor will monitor you closely during dosage increases.

Dosage for heart failure

Adult dosage (ages 18 years and older)

• The recommended starting dosage is 3.125 mg taken twice per day for two weeks.
• It can be increased to 6. 25 mg, 12.5 mg, and 25 mg taken twice per day over two-week intervals.
• When you first start the medication and during dosage increases, you might feel dizzy and lightheaded within the first hour of taking your dose. During this time, you shouldn’t drive or do any similar activities that require alertness.

Child dosage (ages 0 to 17 years)

A safe and effective dosage hasn’t been established for this age group.

Special considerations

• For people with kidney problems: If you have kidney problems, your doctor will closely monitor you during treatment. They may lower your dose or stop treatment if your kidney function gets worse.

Warnings

Your doctor will monitor you closely during dosage increases.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Carvedilol oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you don’t take it at all: Your condition may not improve and it may get worse.

If you skip or miss doses: Your blood pressure or heart condition may not be controlled if you skip or miss doses.

If you take too much: An overdose of this drug could cause your heart to stop. Symptoms of overdose of carvedilol include:

• low blood pressure and heart rate
• vomiting
• loss of consciousness
• seizures
• trouble breathing

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you can. If it’s just a few hours before the time for your next dose, then only take one dose at that time. Never try to catch up by taking two doses at once. This could result in toxic side effects.

How to tell if the drug is working: You may be able to tell this drug is working if your blood pressure decreases or your other symptoms improve.

Keep these considerations in mind if your doctor prescribes carvedilol oral tablet for you.

General

• Take carvedilol with food. Taking it with food reduces your risk of side effects.
• You can crush carvedilol tablets.
• The generic version of this drug is usually stocked at most pharmacies. However, the brand-name version might not be stocked, so call ahead if your doctor prescribes that version.

Storage

• Store in temperatures below 86°F (30°C).
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

During treatment with carvedilol, your doctor may check your:

• blood pressure
• heart rate
• weight
• blood sugar (if you have diabetes)
• liver function
• potassium levels
• cholesterol levels

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

tablets, 25 mg

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

• I10 Essential (primary) hypertension
• I15 Secondary hypertension
• I20 Angina pectoris [angina pectoris]

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 OPSS, 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. With _max in plasma is reached 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, marked bradycardia, sick sinus syndrome, II and III degree AV block (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.

Arterial 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 daily, after 7-14 days under medical supervision the dose may be increased to 25 mg twice daily. 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 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 activity of 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 limbs, 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, coronary artery 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.

The information provided on drug prices 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.

Cardiloc 1.

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

See also:
What are the possible side effects of Cardiloc 1.25?

Clinical Trial Experience

Cardiloc 1.25 has been evaluated for safety in patients with heart failure (mild, moderate and severe), in patients with left ventricular dysfunction after myocardial infarction and in patients with arterial hypertension. The observed profile of adverse events was consistent with the pharmacology of the drug and health status of subjects in clinical trials. Adverse events reported for each of these populations reflecting the use of either Cardiloc 1.25 or Cardiloc 1.25 immediate release are listed below. Excluded are adverse events considered too general to be informative and those not reasonably related to the use of the drug because they were associated with the disease being treated or very common in the treated population. Rates of adverse events were generally similar across demographic subgroups ( men and women, old and old, black and non-black). Cardiloc 1.25 was evaluated for safety in a 4-week (2-week Cardiloc 1.25 immediate-release and 2-week Cardiloc 1.25 immediate-release) clinical trial (n = 187) that included 157 patients with stable mild, moderate, or severe chronic heart failure and 30 patients with left ventricular dysfunction. ventricle after acute myocardial infarction. The adverse event profile observed with Cardiloc 1.25 in this small, short-term trial was broadly similar to that observed with Cardiloc 1.25 immediate release. Differences in safety not expected based on similarity in plasma levels for Cardiloc 1.25 and immediate release of Cardiloc 1.25

Heart failure

The following information describes the safety experience in heart failure with immediate release Cardiloc 1.25.

Cardiloc 1.25 has been evaluated for safety in heart failure in more than 4,500 patients worldwide, of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total number of treated patients in placebo-controlled clinical trials received Cardiloc 1. 25 for at least 6 months and 30% received Cardiloc 1.25 for at least 12 months. In the COMET study, 1511 patients with mild to moderate heart failure were treated with Cardiloc 1.25 for up to 5 years.9years (average: 4.8 years). Both in the US clinical trials in mild to moderate heart failure that compared Cardiloc 1.25 at daily doses up to 100 mg (n = 765) with placebo (n = 437) and in the Multinational Clinical Trial in Severe Heart Failure (COPERNICUS) , which compared Cardiloc 1.25 at daily doses up to 50 mg (n = 1.156) with placebo (n = 1.133), discontinuation rates of adverse experiences were similar in Cardiloc 1.25 and placebo subjects. In placebo-controlled clinical trials, the only reason for discontinuation of the drug exceeded 1% and was more common on Cardiloc 1.25 was dizziness (1.3% on Cardiloc 1.25, 0.6% on placebo in the COPERNICK study)

Table 2 lists adverse events reported in patients with mild to moderate heart failure enrolled in US placebo-controlled clinical trials and those with severe heart failure enrolled in the COPERNICUS study. Side effects are shown that occurred more often in patients treated with medication than in patients treated with placebo, with a frequency of more than 3% in patients treated with Cardiloc 1..25, regardless of causality. Median exposure to the test drug was 6.3 months for Cardiloc 1.25 and placebo in the mild to moderate heart failure trials and 10.4 months in the severe heart failure trial. The adverse event profile of Cardiloc 1.25 observed in the long-term COMET trial was broadly similar to that observed in the US heart failure trials.11

Table 2: Adverse Events (%) More Common with Cardiloc 1.25 Immediate Release than with Placebo in Patients with Mild to Moderate Heart Failure (HF) Enrolled in the American Heart Failure Study or in Patients with Severe Heart Failure failure in the Copernicus study (Frequency > 3% in patients treated with Cardiloc 1.25, regardless of causation)

900 96 Cardiovascular

9 0096 7

900 96 1

9 0095

Body System/Adverse Event	Mild to moderate HF	Severe HF
Cardiloc 1. 25 (n = 765)	Placebo (n = 437)	Cardiloc 1.25 (N = 1.156)	Placebo (H = 1.133)
Whole body
Asthenia 9009 7	7	7	11	9
Fatigue	24	22	—	—
Increased digoxin level	5	4	2	1
Generalized edema	5	3	6	5
Edema dependence	4	2	—	—
Bradycardia		1	10	3
9	14
Syncopal states	3	3	8	5
Angina Central Nervous System
Dizziness	32	19	24	17
8	5
Gastrointestinal
diarrhea	12	6	5	3
Nausea 96 4	3
Vomiting	6	4	1	2
Metabolism
Hyperglycemia	12	8	5	3
Weight gain	10	12	11
Gingerbread man increased	6	5	—	—
NPN increased	6	5	–	–
Hypercholesterolemia	4	3	1
Peripheral edema	Musculoskeletal system
Arthralgia	6	5	1	1
Respiratory 9	8	9	5	4
Wheezing	4	4	4	2
97	5	2	–	–

Heart failure and dyspnoea were also reported in these studies, but rates were equal or higher in patients treated with placebo.

The following adverse events have been reported at rates greater than 1% but less than or equal to 3% or more frequently with Cardiloc 1.25 in either US placebo-controlled trials in patients with mild to moderate heart failure or in patients with severe heart failure in the COPERNICUS study.

Incidence From More Than 1% To Less Than Or Equal To 3%

Body as a Whole: Allergy, malaise, hypovolemia, fever, swelling of legs.

Cardiovascular: Fluid overload, postural hypotension, exacerbation of angina pectoris, AV block, palpitations, arterial hypertension.

Central and peripheral nervous system: Hypoesthesia, dizziness, paresthesia.

Gastrointestinal: Melena, periodontitis.

Liver and biliary system: Laboratory tests include: * increased, erythrocytes indicated the presence of the process increases.

Metabolism and nutrition: Hyperuricemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, glycosuria, hypervolemia, diabetes mellitus, increased GGT, weight loss, hyperkalemia, increased creatinine.

Musculoskeletal system: Muscle cramps.

Platelets, Bleeding and blood clotting: Decreased prothrombin, purpura, thrombocytopenia.

Psychiatric: Drowsiness.

Reproductive male: Impotence.

Special Senses: Blurred vision.

Urinary system: Renal failure, albuminuria, hematuria.

Left ventricular dysfunction after myocardial infarction

The following information describes the safety experience in left ventricular dysfunction after acute myocardial infarction with Cardiloc 1.25 immediate release.

Cardiloc 1.25 was evaluated for safety in survivors of acute myocardial infarction with left ventricular dysfunction in the CAPRICORN study, which included 969 people who received Cardiloc 1.25 and 980 people who received placebo. Approximately 75% of subjects received Cardiloc 1.25 for at least 6 months, and 53% received Cardiloc 1.25 for at least 12 months. Subjects received an average of 12. 9 months and 12.8 months of Cardiloc 1.25 and placebo, respectively.

The most common adverse events reported with Cardiloc 1.25 in the CAPRICORN trial were consistent with the drug profile in the American Heart Failure Trials and the COPERNICAUS Trial. The only additional adverse events noted in CAPRICORN in more than 3% of subjects and most commonly on Cardiloc 1.25 were shortness of breath, anemia and pulmonary edema. The following adverse events have been reported with a frequency of more than 1%, but less than or equal to 3% and more often when using Cardiloc 1.25: influenza syndrome, cerebrovascular accident, peripheral vascular disorder, hypotension, depression, gastrointestinal pain, arthritis and gout. The overall rates of treatment discontinuation due to adverse events were similar in both treatment groups. In this database, the only reason for drug discontinuation exceeding 1% and occurring more frequently on Cardiloc 1.25 was hypotension (1.5% on Cardiloc 1.25, 0.2% on placebo)

Hypertension

Cardiloc 1. 25 was evaluated for safety in an 8-week double-blind study in 337 patients with essential hypertension. The side effect profile observed with Cardiloc 1.25 was generally similar to the side effect profile observed with Cardiloc 1.25 immediate release. The overall discontinuation rate due to adverse events was similar between Cardiloc 1.25 and placebo.

Table 3: Adverse events (%) more common with Cardiloc 1.25 than with placebo in patients with arterial hypertension (Frequency ≥ 1% in patients treated with Cardiloc 1.25, regardless of causal relationship )

The following information describes the safety experience in hypertension with immediate release Cardiloc 1. 25.

Cardiloc 1.25 has been evaluated for safety in hypertension in more than 2193 patients in US clinical trials and 2976 patients in international clinical trials. Approximately 36% of the total number of patients received Cardiloc 1.25 for at least 6 months. In general, Cardiloc 1.25 is well tolerated at doses up to 50 mg per day. The majority of adverse events reported during Cardiloc 1.25 cases of therapy were mild to moderate in severity. In our controlled clinical trials directly comparing Cardiloc 1.25 monotherapy at doses up to 50 mg (n=1142) with placebo (n=462), 4.9% of Cardiloc 1.25 patients were discontinued due to adverse events compared to 5.2% of subjects receiving placebo. Although there was no overall difference in the frequency of interruptions, interruptions were more common in the Cardiloc 1.25 group for postural hypotension (1% vs 0). It was found that the overall incidence of adverse events in American placebo-controlled studies increases with increasing dose of Cardiloc 1. 25. For individual adverse events, this could only be distinguished from dizziness, the frequency of which increased from 2% to 5% as the total daily dose increased from 6.25 mg to 50 mg in single or divided doses

Table 4 shows adverse events in US placebo-controlled clinical trials of hypertension that occurred at a rate greater than or equal to 1% regardless of causation and were more common in patients treated with drugs than in patients treated with receiving a placebo.

Table 4: Adverse Events (% Occurrence) in American Placebo-Controlled Hypertension Trials with Cardiloc 1.25 Immediate Release (Incidence ≥ 1% in patients treated with Cardiloc 1.25, regardless of causality)*

Adverse event	Cardiloc 1.25 (N = 1.142)	Placebo (n = 462) 900 97
Cardiovascular
Bradycardia	2	–
Postural hypotension	2	–
Peripheral edema	1	–
Central Nervous System
Dizziness	6	5
Insomnia
Gastrointestinal
Diarrhea logical Hyper triglyceridemia	1	—
* Events > 1% shown rounded to the nearest whole number.

Shortness of breath and fatigue were also reported in these studies, but the rates were equal or greater in patients receiving placebo.

The following adverse events not described above have been reported as possibly or likely related to Cardiloc 1.25 in international open-label or controlled studies with Cardiloc 1.25 in patients with hypertension or heart failure.

Incidence More than 0.1% to Less than or Equal to 1%

Cardiovascular: Peripheral ischemia, tachycardia.

Central and peripheral nervous system: Hypokinesia.

Gastrointestinal: Bilirubinemia, increased liver enzymes (0.2% of patients with arterial hypertension and 0.4% of patients with heart failure were discontinued from therapy due to elevated liver enzymes).

Psychiatric: Nervousness, sleep disturbance, acute depression, impaired concentration, abnormal thinking, paronyria, emotional lability.

Respiratory system: Asthma.

Reproductive, male: Decreased libido.

Skin and appendages: Itching, rash erythematous, rash maculopapular, rash psoriatic, photosensitivity reaction.

Special feelings: Tinnitus.

Urinary system: The frequency of urination has increased.

Autonomic Nervous System: Dry mouth, increased sweating.

Metabolism and nutrition: Hypokalemia, hypertriglyceridemia.

Hematological: Anemia, leukopenia.

The following events were reported in less than 0.1% of subjects and are potentially important: complete AV block, bundle branch block, myocardial ischemia, cerebrovascular accident, convulsions, migraine, neuralgia, paresis, anaphylactoid reaction, alopecia, exfoliative dermatitis , amnesia, gastrointestinal hemorrhage, bronchospasm, pulmonary edema, hearing loss, respiratory alkalosis, increased BUN, decreased HDL, pancytopenia, and atypical lymphocytes.

Laboratory Abnormalities

A reversible increase in serum transaminases (ALT or AST) has been observed during treatment with Cardiloc 1. 25. Transaminase elevations (2-3 times the upper limit of normal) observed in controlled clinical trials were generally similar in patients treated with Cardiloc 1.25 and those treated with placebo. However, an increase in the level of transaminases, confirmed by repeated analysis, was observed with the use of Cardiloc 1.25. In a long-term placebo-controlled study in severe heart failure, subjects receiving Cardiloc 1.25 had lower hepatic transaminase values ​​than placebo-treated subjects, possibly because Cardiloc 1.25-induced improvement in cardiac function resulted in less hepatic congestion and/or improved hepatic function. blood flow

Therapy with Cardiloc 1.25 was not associated with clinically significant changes in serum potassium, total triglyceride, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine. There were no clinically significant changes in fasting serum glucose in patients with arterial hypertension, and fasting serum glucose was not assessed in clinical studies of heart failure.