Solu-Medrol 500mg Inj, 1vial

Methylprednisolone is a synthetic glucocorticoid that binds to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). It suppresses immune responses by inhibiting leukocyte migration, reducing capillary permeability, and stabilizing lysosomal membranes.

Urgent 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 emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 discolored sputum, 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, 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 breathing difficulties

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Mild stomach upset or nausea
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, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you've experienced.
The presence of any infections, 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
+ Any other type of infection
If you have nerve problems affecting your eyes

Additional Considerations for Injection Administration (Intramuscular):

If you have idiopathic thrombocytopenic purpura (ITP), a condition affecting platelet count

It is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, to your doctor and pharmacist. This information will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.Have your blood work, body weight, and other lab tests checked as you have been told if you take this drug for a long time. You may also need to have your eye pressure and bone density checked.High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.This drug may affect allergy skin tests. Be sure your doctor and lab workers know you take this drug.Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.This drug may cause weak bones (osteoporosis) with long- term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.Talk with your doctor before you drink alcohol.Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor. Steroid drugs, including this one, raise the risk of infection. They can cause an active infection to get worse. They can also make some signs of infection harder to notice. Infections that happen with steroids can be mild, but they can also be severe and even deadly. The risk of problems from these infections is usually raised with higher doses of steroids. Wash hands often. Stay away from people with infections, colds, or flu. Tell your doctor if you have any signs of an infection.Some infections may become active again in patients taking drugs like this one. This includes tuberculosis and hepatitis B. Tell your doctor if you have ever had one of these infections.This drug lowers how much natural steroid your body makes. Tell your doctor if you have fever, infection, surgery, or injury. Your body's normal response to these stresses may be affected. You may need extra doses of steroid.Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.Very bad health problems have happened when drugs like this one have been given into the spine (epidural). These include paralysis, loss of eyesight, stroke, and sometimes death. It is not known if drugs like this one are safe and effective when given into the spine. These drugs are not approved for this use. Talk with the doctor.Some products have benzyl alcohol. If possible, avoid products with benzyl alcohol in newborns or infants. Serious side effects can happen in these children with some doses of benzyl alcohol, including if given with other drugs that have benzyl alcohol. Talk with the doctor to see if this product has benzyl alcohol in it.Tell your doctor if you have missed a dose or recently stopped this drug and you feel very tired, weak, or shaky, or have a fast heartbeat, confusion, sweating, or dizziness.A type of cancer (Kaposi's sarcoma) has happened in people taking drugs like this one for a long time. Talk with the doctor. Patients with cancer may be at greater risk of getting a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Talk with the doctor.If you are 65 or older, use this drug with care. You could have more side effects.This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.This drug may lower sperm counts. If you have questions, talk with the doctor.This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.If you used this drug when you were pregnant, tell your baby's doctor.

• Live or live attenuated vaccines (risk of severe infection)
• CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates) - decreased methylprednisolone efficacy
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - increased methylprednisolone effects/toxicity
• Anticoagulants (e.g., warfarin) - altered anticoagulant effect (increased or decreased)
• NSAIDs (e.g., ibuprofen, naproxen) - increased risk of GI ulceration/bleeding
• Diuretics (loop and thiazide) - enhanced potassium depletion, increased risk of hypokalemia
• Digoxin - increased risk of digitalis toxicity due to hypokalemia
• Antidiabetic agents (e.g., insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment of antidiabetic agents

• Cholestyramine - decreased absorption of methylprednisolone
• Cyclosporine - increased plasma concentrations of both drugs, increased risk of seizures
• Neuromuscular blocking agents (e.g., pancuronium, vecuronium) - prolonged neuromuscular blockade
• Oral contraceptives/estrogens - increased methylprednisolone effects
• Aspirin (high dose) - decreased salicylate levels, increased risk of GI side effects

• Antacids - may decrease absorption (if oral form used)

• Signs of infection (fever, chills, sore throat, cough, painful urination)
• Unusual bruising or bleeding
• Swelling in ankles or feet
• Increased thirst or urination
• Muscle weakness or pain
• Mood changes (irritability, depression, euphoria)
• Sleep disturbances
• Stomach pain, black/tarry stools (GI bleeding)
• Vision changes
• Delayed wound healing

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects. Human data are limited but suggest a possible association with oral clefts when used in the first trimester, though this risk is low and not consistently proven.

Methylprednisolone is excreted into breast milk. While generally considered compatible with breastfeeding at low to moderate doses, high doses or prolonged use may pose a risk to the infant (e.g., growth suppression, adrenal suppression). Monitor the infant for adverse effects.

Corticosteroids can cause growth retardation in children. Monitor growth and development carefully. Long-term use should be avoided if possible. Children are also more susceptible to some adverse effects like intracranial hypertension.

Elderly patients may be at increased risk for adverse effects such as osteoporosis, fluid retention, hypertension, and diabetes. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

• Methylprednisolone sodium succinate (Solu-Medrol) is suitable for IV and IM administration, offering rapid onset of action.
• For acute, severe conditions, pulse therapy (e.g., 1000 mg IV daily for 3-5 days) is often used, but requires careful monitoring.
• Always taper corticosteroids gradually after prolonged therapy to prevent adrenal insufficiency.
• Patients on long-term corticosteroids should be advised about bone health (calcium, vitamin D, bisphosphonates if indicated) and ophthalmologic exams.
• Corticosteroids can mask signs of infection; maintain a high index of suspicion for new infections.
• Administering doses in the morning may help minimize sleep disturbances due to the drug's stimulating effects.

• Prednisone (oral)
• Dexamethasone (oral, IV)
• Hydrocortisone (oral, IV)
• Betamethasone (oral, IM)
• Triamcinolone (oral, IM)

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, never share your medication with others, and do not take medication prescribed to someone else. 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 can be a safe and convenient way to dispose of unwanted medications. 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 help healthcare providers deliver appropriate care.