Solu-Medrol 1gm Inj, 1 Vial

Methylprednisolone is a synthetic glucocorticoid that binds to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex modulates gene expression, leading to diverse effects including inhibition of inflammatory mediators (prostaglandins, leukotrienes), suppression of immune cell migration and function (lymphocytes, macrophages), and reduction of capillary permeability. It also has metabolic effects (gluconeogenesis, protein catabolism, fat redistribution).

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of pancreatitis: severe abdominal pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Changes in menstrual periods
Bone or joint pain
Changes in vision
New or worsening mental, mood, or behavioral changes
Seizures
Unusual burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Severe abdominal pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
New or worsening muscle weakness
Fluid retention, swelling, weight gain, or difficulty breathing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Nausea or vomiting
Difficulty sleeping
Restlessness
Excessive sweating
* Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

To ensure safe treatment, inform your doctor of the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
The presence of any infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Other types of infections
If you have nerve problems affecting the eye.

Additional Considerations for Injection (Muscle Administration):

If you have idiopathic thrombocytopenic purpura (ITP), inform your doctor.

It is essential to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this medication for an extended period, your healthcare provider will monitor your blood work, body weight, and other laboratory tests regularly. You may also need to undergo eye pressure and bone density checks.

Be aware that this medication can cause high blood pressure. Your doctor will monitor your blood pressure as directed.

This medication may interfere with allergy skin tests, so it is crucial to inform your doctor and laboratory personnel that you are taking this medication.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions.

You may need to reduce your salt intake and take potassium supplements. Consult with your doctor to determine the best course of action.

If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication.

Before consuming alcohol, discuss the potential risks with your doctor.

Before receiving any vaccines, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you are exposed to chickenpox or measles, and you have not had these illnesses before, avoid close contact with anyone who has these conditions. If you have been exposed, inform your doctor immediately. Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. Wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and inform your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, can reactivate in patients taking this medication. Inform your doctor if you have a history of these infections.

This medication can suppress your body's natural production of steroids. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stresses may be affected. You may require additional steroid doses.

Do not stop taking this medication abruptly without consulting your doctor, as this can increase the risk of side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually taper off the dose.

Using this medication epidurally (in the spine) has been associated with severe health problems, including paralysis, loss of vision, stroke, and death. This use is not approved, and you should discuss the potential risks with your doctor.

Some formulations of this medication contain benzyl alcohol, which can cause serious side effects in newborns and infants. If possible, avoid products containing benzyl alcohol in these age groups, and consult with your doctor to determine if this product contains benzyl alcohol.

If you miss a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor.

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this potential risk with your doctor. Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

This medication may affect growth in children and adolescents. Regular growth checks may be necessary, and you should discuss this potential risk with your doctor.

This medication may lower sperm counts, and you should discuss this potential risk with your doctor if you have any questions.

If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as this medication can harm the unborn baby.

If you are breastfeeding, discuss the potential risks to your baby with your doctor.

If you took this medication during pregnancy, inform your baby's doctor, as this information is essential for their care.

• Systemic fungal infections (unless used as a life-saving measure)
• Live or live-attenuated vaccines (during immunosuppressive doses)

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit juice): May significantly increase methylprednisolone levels, leading to increased adverse effects.
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May significantly decrease methylprednisolone levels, reducing efficacy.
• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effects (increase or decrease INR); monitor INR closely.
• Diuretics (loop and thiazide): Increased risk of hypokalemia.
• Digoxin: Increased risk of digoxin toxicity due to hypokalemia.

• Antidiabetic agents (e.g., insulin, oral hypoglycemics): Methylprednisolone can increase blood glucose, requiring dose adjustments of antidiabetics.
• Cyclosporine: Mutual inhibition of metabolism, leading to increased levels of both drugs and increased risk of seizures.
• Neuromuscular blocking agents (e.g., pancuronium, vecuronium): Prolonged neuromuscular blockade, especially with high-dose corticosteroids.
• Cholestyramine: May decrease absorption of methylprednisolone.
• Anticholinesterases (e.g., neostigmine, pyridostigmine): May cause severe weakness in patients with myasthenia gravis.

• Not typically categorized as minor for systemic corticosteroids; interactions are generally significant due to the drug's potency and broad effects.

• Signs of infection (fever, chills, sore throat, cough, painful urination, unexplained fatigue)
• Gastrointestinal upset (stomach pain, black/tarry stools, vomiting blood)
• Muscle weakness or pain
• Mood changes (anxiety, depression, irritability, insomnia, psychosis)
• Fluid retention (swelling in ankles, feet, hands, rapid weight gain)
• Vision changes (blurred vision, eye pain)
• Unusual bruising or bleeding
• Slow wound healing
• Increased thirst or urination (signs of hyperglycemia)

Methylprednisolone is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animals. Human data are limited, but prolonged or repeated use during pregnancy may lead to fetal growth restriction or adrenal suppression in the neonate.

Methylprednisolone is excreted into breast milk. The American Academy of Pediatrics considers corticosteroids compatible with breastfeeding, but caution is advised. Monitor the infant for signs of adverse effects.

Children are more susceptible to the adverse effects of corticosteroids, including growth suppression, adrenal suppression, and increased intracranial pressure. Growth and development should be carefully monitored. Alternate day therapy may minimize growth retardation. Immunosuppression increases susceptibility to infections.

Elderly patients may be at increased risk for common corticosteroid adverse effects, including osteoporosis, diabetes, hypertension, fluid retention, and psychiatric disturbances. Lower doses or more careful monitoring may be appropriate.

• Methylprednisolone IV should be administered slowly, especially high doses (e.g., 1gm over at least 30-60 minutes) to avoid adverse reactions like bradycardia or arrhythmias.
• Never abruptly discontinue high-dose or long-term corticosteroid therapy due to the risk of adrenal crisis. Always taper the dose gradually under medical supervision.
• Patients on corticosteroids are at increased risk of infection; advise them to report any signs of illness immediately.
• Monitor blood glucose levels closely, even in non-diabetic patients, as corticosteroids can induce hyperglycemia.
• Be aware of potential psychiatric disturbances (e.g., mood swings, insomnia, psychosis), especially with high doses.
• Consider gastroprotective agents (e.g., PPIs) for patients at high risk of GI ulceration, especially if co-administered with NSAIDs.
• Long-term use requires monitoring for bone density, cataracts, and glaucoma.

• Other systemic corticosteroids (e.g., Dexamethasone, Prednisone, Hydrocortisone)
• For inflammation: NSAIDs (e.g., ibuprofen, naproxen), COX-2 inhibitors (e.g., celecoxib)
• For immunosuppression: Specific immunosuppressants (e.g., methotrexate, azathioprine, biologics) depending on the autoimmune condition.
• For asthma/COPD: Bronchodilators (e.g., albuterol, ipratropium), inhaled corticosteroids (e.g., fluticasone, budesonide).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, do not share your prescription medications with others, and never take someone else's medications. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.