Side effects, uses, dosage, and more

1. Methylprednisolone oral tablet is available as both a generic and brand-name drug. Brand name: Medrol.
2. This drug also comes as an injectable suspension and injectable solution. These forms are only given by a healthcare professional.
3. Methylprednisolone is used to reduce inflammation in many conditions. These include endocrine diseases, severe allergies, ulcerative colitis, and multiple sclerosis. It’s also used to treat rheumatic diseases, such as rheumatoid arthritis and osteoarthritis.

Methylprednisolone oral tablet is a prescription drug that’s available as the brand-name drug Medrol. It’s also available as a generic drug.

Generic drugs usually cost less than the brand-name version. In some cases, the brand-name drug and the generic version may be available in different forms and strengths.

Methylprednisolone also comes as a suspension or solution. Those forms are given to you by a healthcare professional.

Why it’s used

This drug is used to treat many conditions. It helps to control inflammation and to modify your body’s immune response. It’s used to treat certain types of:

• endocrine disorders, such as primary or secondary adrenocortical insufficiency
• rheumatic disorders, such as rheumatoid arthritis or psoriatic arthritis
• collagen diseases, such as lupus or systemic dermatomyositis
• skin diseases, such as psoriasis or Stevens-Johnson syndrome
• severe allergies that haven’t been managed with other treatment, such as seasonal or year-round allergies or allergic reactions to medications
• eye problems, such as swelling or ulcers (sores) in your eye
• stomach or intestinal problems, such as ulcerative colitis or Crohn’s disease
• respiratory problems, such as lung damage caused by beryllium poisoning or by Loeffler’s syndrome that’s not managed by other treatments
• blood disorders, such as low levels of platelets in adults, or lack of red blood cells in children
• neoplastic diseases, such as blood cancer or cancer in the lymphatic system in adults
• multiple sclerosis flare-ups
• infections, such as trichinosis that affects the brain or heart

How it works

Methylprednisolone belongs to a class of drugs called glucocorticoids. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Methylprednisolone works by decreasing inflammation and changing your body’s immune response. This reduces the inflammation caused by your condition.

How long it lasts

After you take a dose of methylprednisolone, the drug may last up to 19 hours in your body.

After you stop taking methylprednisolone, the drug should be fully gone from your body within a day.

Note that instead of stopping treatment immediately, your doctor may recommend slowly decreasing your dose of methylprednisolone. This is because suddenly stopping the drug may cause withdrawal symptoms. (Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.)

If you have questions about how long methylprednisolone lasts in your body, ask your doctor or pharmacist.

Methylprednisolone oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects of methylprednisolone can include:

• headache
• nausea and vomiting
• weight gain
• confusion, excitement, and restlessness
• swelling of your ankles, feet, or hands
• skin problems, such as acne, thin skin, and shiny skin
• increased thirst
• infection
• high blood pressure
• muscle weakness
• depression

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 with 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 may include:
  • skin rash
  • itching or hives
  • swelling of your face, lips, or tongue
• Changes in your emotions and mood. Symptoms can include:
  • depression
  • anxiety
  • intense excitement or happiness
  • personality changes
  • psychosis
• Eye problems. Symptoms can include:
  • changes in your vision
  • eye pain
  • bulging eyes
• Trouble urinating or a change in how much you urinate.
• Diabetes. Symptoms can include:
  • increased thirst
  • urinating more often than normal
• Pain in your hips, back, ribs, shoulders, arms, or legs.
• Infection. Symptoms can include:
  • fever
  • sore throat
  • sneezing
  • coughing
• Swelling of your ankles, feet, or hands.
• Wounds that won’t heal.
• Low potassium levels in your blood. Symptoms include:
  • weakness
  • irregular heart rhythm
• Hormone changes. Symptoms can include:
  • loss of appetite
  • lack of energy
  • nausea
  • vomiting
  • headache
  • fever
  • joint or muscle pain
  • skin irritation
  • weight loss
  • low blood pressure, which may make you feel dizzy or faint

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 professional who knows your medical history.

Methylprednisolone oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. They’ll let you know if any interact with methylprednisolone and adjust your treatment if needed. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Vaccines you should not receive with methylprednisolone

You should not receive certain vaccines while taking methylprednisolone. If you get such vaccines when you’re taking methylprednisolone, dangerous side effects could result. These vaccines include:

• Live vaccines, such as the nasal flu vaccine, varicella (chickenpox) vaccine, smallpox vaccine, and measles, mumps, and rubella (MMR) vaccine: Do not receive a live vaccine while taking this drug. A live vaccine is a weakened version of the germ it protects against, such as a virus. Methylprednisolone weakens your immune system. This increases your risk of getting an infection from a live vaccine.

Interactions that increase the risk of side effects from methylprednisolone

Taking methylprednisolone with certain medications raises your risk of side effects from methylprednisolone. This is because the amount of methylprednisolone in your body is increased. Examples of these drugs include:

• Cyclosporine: Methylprednisolone can cause cyclosporine (Gengraf, Neoral) to build up in your body and vice versa. If you use these drugs together, you may experience side effects such as seizures.
• Ketoconazole: Your doctor may adjust your dosage of methylprednisolone if you take ketoconazole. Your doctor may do this to avoid increased side effects from methylprednisolone.

Interactions that increase the risk of side effects from other drugs

Taking methylprednisolone with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:

• Aspirin: Your chance of side effects from aspirin increases when you stop taking methylprednisolone. If you have a blood clotting problem, ask your doctor if methylprednisolone is safe for you.
• Warfarin and heparin: When used with methylprednisolone, warfarin (Jantoven) and heparin can make your blood too thin and cause dangerous bleeding. Or they might not work as well to thin your blood. Your doctor should monitor you closely if you take either of these drugs with methylprednisolone.

Interactions that can make your drugs less effective

When methylprednisolone is used with certain drugs, it may not work as well to treat your condition. This is because the amount of methylprednisolone in your body may be decreased. Examples of these drugs include:

• Phenobarbital, phenytoin, and rifampin: Your doctor may increase your dosage of methylprednisolone if you take phenytoin (Dilantin), phenobarbital, or rifampin (Rifadin).

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 professional about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

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

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

Forms and strengths

Generic: Methylprednisolone

• Form: oral tablet
• Strengths: 4 milligrams (mg), 8 mg, 16 mg, 32 mg

Brand: Medrol

• Form: oral tablet
• Strengths: 2 mg, 4 mg, 8 mg, 16 mg, 32 mg

Dosage for multiple sclerosis

Adult dosage (ages 18 to 64 years)

• Typical starting dosage: 160 mg per day taken in one or two doses.
• Dosage changes: After taking 160 mg per day for 1 week, your doctor will reduce your dosage to 64 mg taken every other day for 1 month.

Child dosage (ages 0 to 17 years)

Your child’s doctor will decide your child’s dosage based on the condition being treated. They should give your child the lowest effective dosage.

Older adult dosage (ages 65 years and older)

If you’re an older adult, your kidneys may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for all other treated conditions

Adult dosage (ages 18 to 64 years)

• Typical starting dosage: 4 mg to 48 mg per day taken in one or more doses.
• Dosage changes: If you respond well to the drug, your doctor may decrease your dosage slowly until you reach the lowest possible effective dosage.
• Alternate day therapy: If you’re going to be taking methylprednisolone for a long time, your doctor may have you take it every other day. This may reduce side effects.

Child dosage (ages 0 to 17 years)

Your child’s doctor will decide your child’s dosage based on the condition being treated. They should give your child the lowest effective dosage.

Older adult dosage (ages 65 years and older)

If you’re an older adult, your kidneys may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

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.

As with all medications, the cost of methylprednisolone can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for methylprednisolone, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need prior authorization for methylprednisolone, contact your insurance company.

Financial and insurance assistance

Financial assistance to help you pay for methylprednisolone may be available.

Medicine Assistance Tool and NeedyMeds are two websites offering resources that may help decrease the price you pay for methylprednisolone. They also offer tools to help you find low cost healthcare, as well as educational resources. To learn more, visit their sites.

You can also refer to the coupons on this page for possible ways to save on methylprednisolone oral tablets.

Mail-order pharmacies

Methylprednisolone may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Methylprednisolone oral tablet comes with several warnings.

Hormone changes warning

This drug may cause hormone changes. It can cause your body to stop making hormones on its own. If you respond well to your dosage of this drug, your doctor may slowly reduce your dosage to reduce your risk of side effects.

Weakened immune system warning

This drug can weaken your immune system. This makes it easier for you to get infections and harder for you to fight infections. While you take this drug, you should stay away from people who are sick or who have recently been sick. This includes people who have chickenpox, measles, or the flu.

Tell your doctor if you’ve had any recent infections or if you have symptoms of an infection. These include fever, chills, or body aches.

Vaccines warning

People who receive the smallpox vaccine while taking this drug have a higher risk of serious side effects. You should wait 3 months after your last dose of methylprednisolone before you receive the smallpox vaccine.

Tell your doctor that you’re taking this drug before getting any vaccines, especially live vaccines.

Allergy warning

Methylprednisolone can cause a severe allergic reaction. Symptoms can include:

• itching
• hives
• trouble breathing
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor right away. You can also seek guidance from America’s Poison Centers at 800-222-1222 or through its online tool. If your symptoms are severe, call 911 or go to the nearest emergency room.

Food interactions warning

You should not eat grapefruit or drink grapefruit juice during your treatment with this drug. Doing so can increase the levels of methylprednisolone in your blood. This raises your risk of side effects.

Warnings for people with certain health conditions

For people with heart disease: This drug can increase your blood pressure. It can also cause your body to retain salt and water. Tell your doctor about your history of heart disease.

For people with diabetes: This drug may affect your body’s ability to manage your blood sugar level. You might need to test your blood sugar level more often. Tell your doctor about your history of diabetes.

For people with ulcers: This drug may cause stomach bleeding. Tell your doctor if you have an ulcer or have had an ulcer in the past.

For people with glaucoma: This drug can increase the pressure in your eyes if you take it for a long time. Tell your doctor if you have glaucoma or any other eye-related illness before you start taking this drug.

For people with infections: This drug may make it harder for your body to fight off your infection. Ask your doctor if this drug is safe for you.

For people with liver problems: If you have cirrhosis, you may not be able to process this drug as well as you might otherwise. This may increase the levels of methylprednisolone in your body and cause more side effects. Your doctor may start you on a lower dosage depending on your liver function.

For people with hypothyroidism: You have a higher risk of side effects from this drug. Tell your doctor about your history of thyroid disease. You may need a lower dosage of this drug.

For people with herpes of the eye: Ask your doctor if this drug is safe for you. You may have a higher risk of side effects.

For people with systemic sclerosis: Corticosteroids, including this drug, increase your risk of scleroderma renal crisis. Your doctor will monitor you carefully if you have systemic sclerosis and you take methylprednisolone.

Warnings for other groups

For pregnant people: There haven’t been enough studies done to be certain how methylprednisolone might affect a pregnancy. Talk with your doctor if you’re pregnant or plan to become pregnant. Methylprednisolone should only be used during pregnancy if the benefits outweigh potential risks to the pregnancy.

Contact your doctor right away if you become pregnant while taking this drug.

For people who are breastfeeding: Methylprednisolone may pass into breast milk and cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child. They may recommend that you stop breastfeeding or suggest a different medication for your condition.

For older adults: The kidneys of older adults may not work as well as they used to. This can cause the body to process drugs more slowly. As a result, more of a drug stays in the body for a longer time. This raises the risk of side effects. If you’re an older adult, you may need a lower dosage or you may need a different dosing schedule.

For children: This drug may slow your child’s growth. Your child’s doctor should monitor your child’s height and growth regularly. Children should use the lowest effective dosage of this drug to decrease the risks of slowed growth.

Methylprednisolone oral tablet is used for long-term or short-term treatment. Your length of treatment depends on your condition and how your body responds to treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your symptoms, such as inflammation and pain, may not get better. You may have more flare-ups of your disease and your disease won’t be managed.

Do not stop taking this drug without speaking to your doctor first. This drug can disrupt how your body controls hormones. Stopping it suddenly can cause side effects. If you need to stop taking this drug, your doctor will slowly lower your dosage. This will reduce your risk of side effects.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Signs and symptoms of an overdose of this drug can include:

• high blood pressure
• salt and water retention, which may cause swelling of your arms, legs, or feet
• low potassium levels in your blood, which may cause weakness, tiredness, and muscle cramps

If you think you’ve taken too much of this drug, call your doctor right away. You can also seek guidance from America’s Poison Centers at 800-222-1222 or through its online tool. However, 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 almost time for your next dose, talk with your healthcare professional. You may need to miss a dose or take an extra dose. Do not take double or extra doses without talking with your healthcare professional first.

How to tell if the drug is working: The inflammation caused by your condition should decrease.

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

General

• Take this drug with food or milk. This may help to reduce upset stomach.
• If you take this drug once per day, take it in the morning. You can cut or crush the tablet.

Storage

• Store this drug at room temperature. Keep it between 68°F and 77°F (20°C and 25°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 container 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 your treatment with this drug, your doctor will monitor you for signs of side effects. Your doctor may also monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include:

• Height and weight. This drug can slow growth in children. Your child’s doctor will monitor their growth.
• Eye pressure. This drug can cause eye problems. Your doctor may do tests to check your eye pressure.
• Potassium levels. This drug can lower your potassium levels. Your doctor will do blood tests to check your potassium levels.
• Blood sugar levels. This drug may raise your blood sugar levels. Your doctor will check your blood sugar during treatment.
• Blood pressure. This drug can raise your blood pressure. Your doctor will check your blood pressure during treatment.

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk with 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 another 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.

Read the article in Spanish.

Medrol Dose Pack Side Effects

December 11, 2022December 11, 2022

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

Physicians may prescribe the corticosteroid medication generically called methylprednisolone for many different problems 1. These may include lupus, allergies, breathing disorders, psoriasis, different forms of arthritis and a bowel disease called ulcerative colitis, among others. Corticosteroids, such as the brand-name Medrol Dosepak, function by blocking chemicals from being released by the body that can induce inflammation 4. Patients take a course of the medicine laid out in the Medrol Dosepak over several days, with the doses generally decreasing 4.

As a person begins the course of corticosteroids in the Medrol Dosepak, certain common side effects not classified as serious can occur 4. For example, the person may experience facial flushing during the first few doses of the medication. Flushing causes the skin to become hot and the face will turn red. Facial flushing typically decreases and ends without medical aid, but speak to your patients should consult their doctor if the problem persists.

• As a person begins the course of corticosteroids in the Medrol Dosepak, certain common side effects not classified as serious can occur 4.
• For example, the person may experience facial flushing during the first few doses of the medication.

Nausea, vomiting, heartburn, headache, dizziness, trouble sleeping, appetite changes, increased sweating, or acne may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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

This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough, white patches in the mouth).

Tell your doctor right away if you have any serious side effects, including: unusual weight gain, menstrual period changes, bone/joint pain, easy bruising/bleeding, mental/mood changes (such as mood swings, depression, agitation), muscle weakness/pain, puffy face, slow wound healing, swelling of the ankles/feet/hands, thinning skin, unusual hair/skin growth, vision problems, fast/slow/irregular heartbeat, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).

Get medical help right away if you have any very serious side effects, including: seizures.

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.

Sources:

https://healthfully.com/side-effects-of-the-medrol-dosepak-4189034.html
https://www.webmd.com/drugs/2/drug-11321/medrol-pak-oral/details

What helps, analogues, dosage, side effects

THERE ARE CONTRAINDICATIONS. POSSIBLE SIDE EFFECTS. A SPECIALIST’S CONSULTATION IS NECESSARY.AllergyPain in joints and musclesBronchial asthmaInflammation of jointsPillsInjections for allergies 24 3510722 reg. number 31917

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Contents of the article

• Prednisolone: ​​from what
• Prednisolone for allergies
• Prednisolone for covid
• Prednisolone: ​​dosage
• Consequences of treatment with Prednisolone
• Prednisolone: ​​side effects
• Prednisolone and alcohol
• Before nisolone: ​​analogues
• Ask an expert on the topic of the article

Prednisolone is successfully used for treatment of inflammatory and autoimmune diseases since 1955. This is a proven drug. Prednisolone has thousands of clinical studies in its “baggage”, is included in the list of vital and essential drugs in Russia and WHO.

We tell you when Prednisolone helps, what side effects it has and how to use the drug correctly.

All products Prednisolone 4 reviews

Prednisolone: ​​what

Prednisolone is a synthetic hormone glucocorticoid. In the human body, glucocorticoids are produced by the adrenal glands. They regulate carbohydrate, protein and mineral metabolism.

Prednisolone has the following actions:

• anti-inflammatory
• decongestant
• antiallergic
• anti-shock
• immunosuppressive

The drug has a wide range of indications, it is used for:

• shock states
• allergic diseases, including anaphylactic shock
• cerebral edema
• bronchial asthma
• systemic lupus erythematosus and rheumatoid arthritis
• inflammatory diseases of the joints
• acute adrenal insufficiency
• thyrotoxic crisis, thyroiditis
• hepatitis and hepatic coma
• diseases of the skin and eyes
• diseases of the hematopoietic organs
• lung diseases (including tuberculosis and cancer)
• in organ transplantation

Hormone treatment seriously affects the organs and systems of the human body. There are a lot of contraindications for Prednisolone, a complete list is indicated in the instructions for the drug and in the Register of Medicines of Russia (RLS). The drug is contraindicated in pregnancy and breastfeeding.

For life-saving use, the only contraindication is hypersensitivity to prednisolone or any of the drug’s components.

You may be interested in: Bronchial asthma clinical guidelines for treatment and prevention

Prednisolone for allergies

The antiallergic effect of Prednisolone is due to the fact that the drug changes the body’s immune response to allergens. The hormone inhibits the synthesis of biologically active substances – allergy mediators. Reduces the number of cells responsible for immunity. Inhibits the formation of antibodies.

In case of anaphylactic shock and bronchial status, prednisolone is administered intravenously, in other cases, for allergies, the doctor prescribes intramuscular injections or tablets.

Prednisolone for covid

Glucocorticoids, including Prednisolone, are indicated for the complicated course of coronavirus infection. They are prescribed when pneumonia develops with respiratory failure.

World Health Organization (WHO) Interim Guidelines published based on clinical trial data:

• Recommendation #1: WHO strongly recommends oral or intramuscular corticosteroids (dexamethasone, hydrocortisone, or prednisolone) for the treatment of patients with severe and critical COVID-19.
• Recommendation #2: WHO does not recommend the use of corticosteroids in the treatment of patients with non-severe COVID-19 unless the patient is already taking the drug for another condition.

Prednisolone: ​​dosage

The dose of Prednisolone and the duration of therapy is determined by the doctor individually, depending on the indications and severity of the disease.

At the beginning of the course, the drug is prescribed in a higher dose. When a therapeutic effect is achieved, it is reduced to maintenance.

The daily dose is best taken once in the morning. This corresponds to the biological rhythm of the adrenal glands. The high dose can be divided into 2-4 doses, and the largest dose taken between 6 and 8 am.

Withdrawal of the drug is carried out gradually. A smooth dose reduction is due to the “withdrawal” syndrome. When treated with Prednisolone, the adrenal glands stop producing their own glucocorticoids. With a sharp cessation of the intake of Prednisolone, the body remains without hormones.

A serious life-threatening condition occurs. It is necessary to gradually reduce the intake of the hormone from the outside in order to restore the function of the adrenal glands. The doctor should draw up a scheme on how to reduce the dose of Prednisolone. For each case, it is individual and depends on the duration of treatment and the dose that the patient took during treatment.

If Prednisolone is used urgently and not more than 3 days, then gradual withdrawal is not required

Effects of treatment with Prednisolone

Hormone treatment should be taken very seriously. Long-term therapy with large doses of Prednisolone is accompanied by numerous adverse reactions.

One of the most noticeable is weight gain. It is better from the first days of therapy to choose a diet with a lot of vegetables, exclude sugar, limit carbohydrates, fatty and fried foods. Arrange fasting days, drink plenty of water and give yourself physical activity.

Still needed:

• take medicines to protect the digestive tract, heart and bones
• monitor blood pressure
• see an ophthalmologist
• monitor glucose levels
• stop taking the drug gradually under the supervision of the attending physician

Prednisolone: ​​side effects

The frequency and severity of side effects depends on the duration of treatment, the level of doses taken and compliance with the rules for taking the drug. We indicate the most severe negative effects:

• development of diabetes
• adrenal suppression
• bleeding and gastrointestinal ulcers
• increased blood pressure, cardiac arrhythmias up to cardiac arrest, heart failure
• thrombosis
• osteoporosis
• mental disorders
• development and exacerbation of infections

Antacids and potassium preparations are prescribed to reduce side effects.

Prednisolone and alcohol

Do not drink alcohol during treatment with Prednisolone. Alcohol increases the risk of erosions, ulcers and bleeding in the gastrointestinal tract.

Prednisolone analogues

Hormone therapy is a complex and responsible process. Only the attending physician can choose an analogue to replace Prednisolone. For information, we indicate drugs that also belong to glucocorticoids:

• Dexazon
• Dexamethasone
• Kenalog
• Cortef
• Medrol
• Methylprednisolone
• Metipred
• Polcortolone
• Triamcinolone

All goods Metipred 25 reviews

All products Medrol 20 reviews

All products Kenalog 6 reviews

All products Dexamethasone 12 reviews

Let’s summarize the information.

Prednisolone is a powerful analogue of natural glucocorticoids. It suppresses the immune system and has an anti-inflammatory effect. In emergency and severe cases, the drug saves lives.

Treatment with Prednisolone is carried out only according to strict indications and under the supervision of doctors. Against the background of hormone therapy, improper treatment and abrupt withdrawal, serious side effects appear.

The drug has a pronounced “withdrawal” syndrome, so the correct termination of treatment is as important as the therapy itself.

Prednisone is available from pharmacies by prescription. Only a doctor can replace the drug with an analogue.

Ask an expert about the topic of the article

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Zotina Natalia Igorevna,

Expert pharmacist

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Technology for constructing the function of prednisolone efficiency on a clinical model for the treatment of inflammatory bowel diseases.

Clinical pharmacology and therapy

Original articles

Alekseeva A.A.

Federal State Budgetary Educational Institution of Higher Education “Privolzhsky Research Medical University” of the Ministry of Health of Russia, Nizhny Novgorod

GBUZ “Nizhny Novgorod Regional Clinical Hospital. ON THE. Semashko, Nizhny Novgorod

,

Krishtopenko S.V.

GBUZ “Nizhny Novgorod Regional Clinical Hospital. ON THE. Semashko, Nizhny Novgorod

DOI

10.32756/0869-5490-2022-2-32-36

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911

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Target

Determining the optimal dose of systemic glucocorticosteroids (prednisolone) to induce remission in patients with peptic ulcer
colitis (UC) and Crohn’s disease (CD) based on the efficiency function construction technology.

Materials and methods

The study included 86 patients aged 18 to 65 years with active moderate to severe inflammatory bowel disease (61 with UC, 25 with CD). For remission induction
patients were first prescribed prednisolone at an initial dose of 30 to 60 mg/day with subsequent reduction. The effect of therapy was evaluated
two weeks later and at the time of complete withdrawal of prednisolone using generally accepted criteria. The construction of the efficacy function (dose-effect relationship) of prednisolone was carried out according to the original method, the meaning of which is the statistical transformation of the initial clinical data obtained in the form of a quantitative expression of the actually used set of doses and registered alternative responses established according to the criteria of the end point, into a visual graph . The mean value at each point was determined using the regression kernel method.

results

The “dose-effect” dependence was built at the end of the course
treatment with prednisolone in the form of a graph, which traces the initial point of the output of the efficiency function to a plateau. This point (the optimal clinically effective dose – OCED) statistically reflects the level of saturation of the trait, and clinically – the value
the maximum possible effect of the drug. OKED of prednisolone was 50.70±0.65 mg (95% confidence interval [CI] 49.41-
51.98), and the maximum probabilistic effect (remission rate) with this dose was 82.21±8.23% (95% CI 66.08-
98.33).

Conclusion

In patients with UC and CD of moderate and severe degree, during induction therapy, the OKED of prednisolone was determined, which amounted to 50. 70 mg/day and provided a remission rate of 82%.

Article tags

Determination of the “dose-response” relationship is a fundamental factor in the selection of adequate doses of drugs. Previously, in clinical practice, such assessments were not carried out due to the lack of an appropriate technology for constructing an efficiency function. With the substantiation and development of a set of modern methods for statistical evaluation of initial experimental and clinical indicators, combined into the technology of constructing an efficiency function (dose-effect dependence), it became possible to determine effective (optimal) doses of drugs for solving specific problems in medical practice [1 ].

Systemic glucocorticosteroids (GCS), including prednisolone and methylprednisolone, remain the basic drugs in the treatment of moderate and severe inflammatory bowel disease (IBD) [2,3]. Rapid clinical response and low cost make them essential for remission induction. The positive effect of corticosteroids has been proven both in ulcerative colitis (UC) [4–8] and in Crohn’s disease (CD) [8–11].

However, data on the optimal doses of corticosteroids are very contradictory and ambiguous. Clinical guidelines indicate oral doses of prednisolone from 40 to 60 mg or 0.5–1 mg/kg of the patient’s body weight [12–16]. In severe UC and CD, the dose of prednisolone can be increased to 75 mg/day intravenously, followed by a transition to the same doses orally [7,12-14,16]. These starting doses have been recommended based on a small number of randomized clinical trials [4-5, 9–10], as well as their meta-analyses and systematic reviews [6–8,11,18]. Most clinical guidelines state that the dose of prednisone should not exceed 60 mg/day.

Despite the vast experience in the use of systemic corticosteroids in the treatment of IBD, many issues remain unresolved: effective doses for the first and subsequent courses of treatment, optimal doses for oral and intravenous administration, the incidence of steroid resistance, steroid dependence and toxic effects, an objective quantitative distribution of doses to low or high.

At present, a universal technology has been created for constructing and analyzing drug efficacy functions to determine optimal clinically effective doses (OCED) of drugs [1]. The aim of the study was to determine the optimal dose of systemic corticosteroids (prednisolone) to induce remission in patients with UC and CD using the efficiency function construction technology.

Material and methods

The prospective study included patients aged 18 to 65 years with UC and CD who were first prescribed prednisone at various doses to induce remission of the disease. All patients gave written informed consent to participate in the study. Patients were examined and treated in a gastroenterological hospital and outpatient clinic of the regional clinical hospital named after. N.A. Semashko, Nizhny Novgorod in the period from 2017 to 2019gg. The diagnosis of UC or CD was established in accordance with international and Russian recommendations, taking into account the clinical picture, the results of laboratory, endoscopic and morphological examination, with the exclusion of intestinal infections [12–14].

All patients underwent ileocolonoscopy to assess the extent and severity of damage to the intestinal mucosa and targeted biopsy (from 3 to 10 biopsies) using the OLYMPUS-CF h285L device (Japan). The severity of exacerbation of UC was assessed according to the Truelove-Witts criteria and the quantitative index of clinical activity (Mayo index), the severity of exacerbation of CD was assessed using the Crohn’s disease activity index (CADI) [4,19,20]. The response to treatment was assessed after 2 weeks and after the end of the course of therapy.

Oral prednisolone was administered at doses of 30 to 60 mg/day as the first course of therapy. The dose was chosen by the attending physicians in accordance with their clinical practice. In patients with severe IBD, treatment with prednisolone was started with intravenous administration and switched to oral administration at the same dose. In the presence of a clinical response after 2 weeks, the dose of prednisolone was gradually reduced by 5 mg per week. The total duration of therapy did not exceed 16 weeks. In CD, prednisolone was prescribed in combination with azathioprine at a dose of 2 mg/kg. After achieving clinical remission, patients with UC were prescribed mesalazine at a dose of 2 g/day, and patients with CD continued to receive azathioprine at a dose of 2 mg/kg. Patients who did not achieve clinical remission were transferred to treatment with genetically engineered biological preparations.

The effectiveness of GCS treatment was assessed on the basis of generally accepted criteria [21]. The clinical response in UC was understood as a decrease compared to the baseline indices of the frequency of bowel movements and the amount of blood in the stool by more than 30%, in CD – a decrease in IABC by more than 70 points. Criteria for clinical remission of UC (endpoint) were stool frequency index 0-1, bleeding index 0, good general condition, normalization of laboratory parameters (C-reactive protein and albumin, platelet count), and criteria for clinical remission of CD (endpoint) – IABC value ≤150 and normalization of laboratory parameters (contents of C-reactive protein and albumin, platelet count).

The plotting of the “dose-effect” dependence in patients with IBD was carried out according to the technology developed by S.V. Krishtopenko et al. [17]. The average value at each point of the efficiency function is determined using the method of kernel regression estimation as a weighted average of the response variables in a fixed neighborhood of the point according to the principle of k-nearest neighbors, based on the Epanechkov kernel known in nonparametric statistics [22]. 95% confidence intervals (CI) were calculated for the mean values ​​[23]. The meaning of constructing an efficacy function lies in the adequate statistical transformation of the initial clinical data in the form of a quantitative expression of the actually used set of doses and registered alternative responses, established according to the endpoint criteria in the studied sample of patients, into a visual plot of the efficacy function. An important feature of this technology is the quantitative assessment of the final error of the study, which is based on two leading factors: the individual sensitivity of the organism to the drug and adequate dose selection, followed by an assessment of the endpoint parameters. The technology for constructing the efficiency function has been tested in experimental and clinical studies [1,24].

Results

The study included 86 patients aged 18 to 65 years, including 61 with UC and 25 with CD (Table 1). The duration of the disease was less than 1 year in 55 (64.0%) patients, from 1 to 2 years in 21 (24.4%), from 2 to 5 years in 10 (11.6%) patients. The majority of patients with UC had a total lesion of the colon (78.7%), and terminal ileitis was more common in patients with CD (40.0%). In both groups, the acute course of the disease was more often observed (39.3% and 76.0%, respectively). Among patients with UC, patients with severe form of IBD prevailed (75.4%), and among patients with CD – with moderate (84.0%).

TABLE 1. Classification of idiopathic interstitial pneumonia (IIP) ATS/ERS (2013) [1]

Indicator	YaK, n=61	BC, n=25
-12 points. The severity of CD was assessed using IABC: medium – 331-450 points, severe – more than 450 points
Current, n (%)
Acute	24 (39.3)	19 (76.0)
Chronic relapsing	21 (34.4)	3 (12.0)
Chronic continuous	16 (26.3)	3 (12.0)
Disease duration, n (%)
Up to 1 year	39 (64.0)	16 (64.0)
2 to 5 years	15 (24.6)	9 (36.0)
Over 5 years	7 (11.4)	–
UC localization, n (%)
Total	48 (78.7)	–
Left hand	13 (21.3)	–
BC localization, n (%)
Ileum	–	10 (40. 0)
Large intestine	–	8 (32.0)
Large and small intestine	–	7 (28.0)
Disease severity, n (%)*
Medium	15 (24.5)	21 (84.0)
Heavy	46 (75.5)	4 (16.0)

Based on the initial doses of prednisolone and the clinical response (0 or 1), a dose-response relationship was plotted at the end of the first course of GCS therapy (Fig. 1). The graph clearly shows the starting point of the efficiency function reaching a plateau, which statistically reflects the level of saturation of the trait, and clinically – the magnitude of the maximum possible effect of the drug. This point corresponds to the optimal clinically effective dose (OCED), which was 50.70±0.65 mg (95% CI 49.41-51.98). The maximum probabilistic effect (frequency of achieving remission) at this dose should be expected in the range of 82. 21±8.23% (95% CI 66.08-98.33). The appointment of higher doses of prednisolone does not lead to a significant increase in the expected clinical effect, but is accompanied by an increase in the risk of adverse events. The average value of the maximum effect was 82%, and, accordingly, in 18% of cases, the appointment of GCS in doses of more than 50 mg / day was ineffective (primary steroid resistance). The lack of response to the treatment of corticosteroids in 18-20% of cases was also registered in other clinical studies [3,25]. It should be noted that it is incorrect to interpret the lack of effect when using doses of prednisolone less than 50 mg / day as steroid resistance, since the area of ​​​​the efficiency function up to the point of OKED reflects an insufficient dose of corticosteroids.

Rice. Fig. 1. Dependence “dose-effect” of prednisolone in patients with IBD at the end of the first course of therapy (maximum dose error 20%)

Side effects of prednisolone at a dose of 40 mg/day were observed in 4 patients (headache, sleep disturbance – in 3, urticaria – in 1). When using the drug at a dose of 60 mg / day, weakness, headache, palpitations, increased blood pressure were registered in 12 patients, impaired glucose tolerance in 2, local herpes infection in 2, acute psychosis in 1).

Talk

In experimental studies of the dose-response dependence, linear models based on probit analysis are considered standard [26]. However, in many experimental and in most clinical situations, the complex pharmacokinetic and pharmacodynamic components of the process of forming the final effect at different doses of the drug are reflected in nonlinear dependencies, which greatly complicates the objectification of the selection of adequate doses of drugs. In clinical studies of drugs, dose selection is carried out preliminary at 2-4 points, followed by an assessment of the frequency of effect, as a rule, at one empirically selected point.

Systemic corticosteroids remain the mainstay of treatment for moderate-to-severe UC and CD, although the optimal doses of these drugs have not been clearly defined. In the first placebo-controlled study of corticosteroids in 210 patients with UC of various lengths and severity, cortisone was studied at an initial dose of 100 mg. Treatment continued for 6 weeks. The frequency of remission in the main group significantly exceeded that in the placebo group (41.3% and 15.8%, respectively) [4]. In the only comparative study of various daily doses of oral prednisolone in patients with mild to moderate UC, conducted in 1962 g, doses of 20, 40 and 60 mg/day were used. The effectiveness of the drug was insufficient at a dose of 20 mg/day and comparable at a dose of 40 and 60 mg/day. For the treatment of moderate UC, the authors recommended oral prednisolone at a dose of 40 mg/day for 7 days, followed by a decrease of 5 mg per week for 8 weeks [5]. Almost the same course of treatment is recommended in European and American guidelines [12,15-16]. The guidelines of the Russian Gastroenterological Association and the Russian Association of Coloproctologists recommend using prednisolone at a daily dose of 1 mg/kg or 60 mg orally in moderate attacks of UC and CD [13,14].

Treatment of a severe attack of UC and CD involves intravenous administration of corticosteroids. A systematic review of clinical studies in patients with severe UC showed the effectiveness of methylprednisolone at a dose of 60 mg/day or hydrocortisone at a dose of 100 mg/day for no more than 7-10 days [7]. The response to therapy was registered in 67% of patients. Increasing the doses of corticosteroids did not lead to a further increase in the effectiveness of treatment, while when prescribing lower doses, it was lower [27]. When prescribing high doses of corticosteroids, as well as their use in combination with immunosuppressive drugs, an increase in the frequency of side effects was noted [28]. In Russian hospitals, in particular, in the National Research Center for Coloproctology named after A.N. Ryzhyzhy, for the relief of a severe attack of IBD, prednisolone is used at a dose of 2 mg/kg/day. At this dosage, a satisfactory clinical response was obtained in 67 (48. 2%) of 139 patients.patients [29].

Two fairly large clinical studies have been conducted, which studied the effectiveness of induction therapy with corticosteroids in patients with CD. In one of them, 162 patients were randomized to receive prednisolone at doses of 0.5–0.75 mg/kg/day (no more than 60 mg/day) or placebo. The dose of prednisolone was reduced by 5 mg per week. The remission rate in the main group was 2 times higher than in the placebo group (60% and 30%, respectively) [9]. Another 18-week European cooperative study included 105 patients. Clinical remission was achieved in 83% of patients treated with oral methylprednisolone at a dose of 48 mg/day, and in 38% of patients in the placebo group [10].

Russian recommendations for severe UC and CD of any localization allow the use of prednisolone at a dose of 75 mg/day or methylprednisolone at a dose of 60 mg/day intravenously for 7–10 days, followed by switching to oral administration at the same dose. Simultaneously with GCS, it is recommended to prescribe azathioprine at a dose of 2 mg/kg or 6-mercatopurine at a dose of 1.5 mg/kg [14].

The study of the “dose-effect” of corticosteroids with the construction of an efficiency function to assess the results of IBD treatment has never been carried out. The method used is a promising technology for studying the effect of any drugs on pathological processes in the body and allows you to determine their OKED. With a given marginal error of 20%, efficiency functions monotonous in structure were obtained, which proves the adequacy of the study as a whole. The maximum error in the study of processes with a normal distribution of a feature, which includes drug research, cannot exceed 33% in accordance with the laws of statistics.

Conclusion

The application of the technology for constructing and evaluating the “dose-effect” dependence of prednisolone on the model of the first (induction) course of treatment of patients with IBD made it possible to determine the drug’s OKED, which amounted to 50. 70±0.65 mg/day (95% CI 49.41-51.98 ). The maximum effect at this dose should be expected in the range of 82.21±8.23 (95% CI 66.08-98.33).

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