Solu-Medrol 2gm Inj , 1 Vial

Manufacturer PFIZER U.S. Active Ingredient Methylprednisolone Injection(meth il pred NIS oh lone) Pronunciation METH-il-PRED-nis-oh-lone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Glucocorticoid, Anti-inflammatory, Immunosuppressant
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Pharmacologic Class
Corticosteroid
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Pregnancy Category
Category C
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FDA Approved
Jan 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Methylprednisolone is a powerful medicine that belongs to a group called corticosteroids. It works by reducing inflammation (swelling and redness) and calming down the body's immune system. It's often used for severe allergic reactions, asthma attacks, arthritis, and other conditions where the body's immune system is overactive or there's a lot of inflammation.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered via injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Do not stop taking this medication suddenly, especially after prolonged use, as it can lead to serious withdrawal symptoms. Your doctor will provide a tapering schedule.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection immediately (fever, chills, sore throat, unusual pain).
  • Follow a diet low in sodium and high in potassium to help manage fluid retention and electrolyte balance.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Limit alcohol intake.
  • Regular exercise, if appropriate, can help maintain muscle strength and bone density.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. For severe conditions (e.g., acute spinal cord injury, organ transplant rejection, severe acute exacerbations), pulse doses of 250 mg to 2 gm IV per day may be used.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

acuteSpinalCordInjury: 30 mg/kg IV bolus over 15 minutes, followed by 5.4 mg/kg/hr continuous infusion for 23-47 hours (within 8 hours of injury).
organTransplantRejection: 500 mg to 1 gm IV daily for 3-5 days.
severeAsthmaExacerbation: Typically 40-80 mg/day, but in very severe, life-threatening cases, higher doses up to 1 gm/day may be considered for short pulse therapy.
multipleSclerosisExacerbation: 500 mg to 1 gm IV daily for 3-7 days.
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under expert guidance (e.g., congenital adrenal hyperplasia, severe inflammation).
Infant: Dosing is highly individualized based on weight and severity of condition (e.g., 0.5-1.7 mg/kg/day in divided doses for anti-inflammatory/immunosuppressive effects; higher doses for acute severe conditions).
Child: Dosing is highly individualized based on weight and severity of condition (e.g., 0.5-1.7 mg/kg/day in divided doses for anti-inflammatory/immunosuppressive effects; higher doses for acute severe conditions).
Adolescent: Dosing similar to adult, but may be weight-based for some indications.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.
Dialysis: Methylprednisolone is not significantly removed by hemodialysis. No dose adjustment needed.

Hepatic Impairment:

Mild: No specific dose adjustment generally required, but monitor for increased effects.
Moderate: Reduced clearance may occur; consider lower doses or extended intervals, monitor for adverse effects.
Severe: Reduced clearance may occur; consider lower doses or extended intervals, monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylprednisolone is a synthetic glucocorticoid that exerts potent anti-inflammatory and immunosuppressive effects. It binds to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then modulates gene expression by either activating or repressing the transcription of specific genes. This leads to decreased synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), inhibition of leukocyte migration, stabilization of lysosomal membranes, and suppression of the immune response.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Immediate (IV)
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: 0.7-1.5 L/kg
ProteinBinding: Approximately 77% (primarily to albumin and transcortin)
CnssPenetration: Yes, readily crosses the blood-brain barrier

Elimination:

HalfLife: Elimination half-life: 2-3 hours; Biological half-life: 18-36 hours
Clearance: Approximately 0.4-0.8 L/hr/kg
ExcretionRoute: Renal (as metabolites)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes to hours for anti-inflammatory effects)
PeakEffect: Variable, depending on the specific effect being measured (e.g., anti-inflammatory effects may peak within hours, but full therapeutic effect may take days)
DurationOfAction: 18-36 hours (biological half-life, influencing duration of effect)
Confidence: Medium

Safety & Warnings

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Side Effects

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 emergency 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 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 insufficiency: 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 skin lesions or oral mucosal changes
Chest pain or pressure
Abnormal heart rhythm
Changes in menstrual cycle
Bone or joint pain
Vision changes
New or worsening mental, mood, or behavioral changes
Seizures
Abnormal sensations (burning, numbness, or tingling)
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, contact your doctor if they bother you or persist:

Nausea or vomiting
Insomnia
Restlessness
Excessive sweating
* Headache

This is not an exhaustive list of potential 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling of the face, hands, or ankles
  • Extreme mood changes, depression, anxiety, or confusion
  • Blurred vision or eye pain
  • Increased thirst or frequent urination (signs of high blood sugar)
  • Muscle weakness or cramps
  • Any signs of infection (fever, chills, body aches, sore throat, cough, painful urination)
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Before Using This Medicine

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.
If you have any type of infection, including bacterial, viral, or fungal infections, as well as conditions like amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other infectious disease.
If you have nerve problems affecting your eyes.

Additional Considerations for Injection (Intramuscular Administration):

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 if it is safe to take this medication with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

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 long-term, your healthcare provider will need to monitor your blood work, body weight, and other laboratory tests regularly. You may also require regular checks of your eye pressure and bone density.

Be aware that medications like this one can cause high blood pressure. Your doctor will need to monitor your blood pressure regularly.

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

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this 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 higher risk or 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, you will need to closely monitor your blood sugar levels.

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, you are at risk of developing a severe or even life-threatening infection. Avoid contact with individuals who have these infections, and inform your doctor if you have been exposed.

Medications like this one can increase your risk of infection, which can be mild or severe. Wash your hands frequently, avoid close contact with individuals who have infections, and inform your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. 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 stress may be affected. You may require additional steroid doses.

Do not stop taking this medication abruptly without consulting your doctor, as this can increase your 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 medications like this one 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 risks with your doctor.

Some products containing this medication may have benzyl alcohol, which can cause serious side effects in newborns and infants. Consult with your doctor to determine if this product contains benzyl alcohol and to discuss alternative options.

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 medications like this one has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor.

Patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Inform your doctor if you have cancer.

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 with your doctor.

This medication may lower sperm counts, and you should discuss any concerns with your doctor.

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

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

If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: hypertension, fluid retention, hypokalemia, hyperglycemia, and psychiatric disturbances (e.g., psychosis, agitation).
  • Chronic overdose can lead to Cushingoid features (moon face, buffalo hump), muscle weakness, osteoporosis, and adrenal suppression.

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (during immunosuppressive doses of corticosteroids)
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Major Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May significantly increase methylprednisolone levels, leading to increased adverse effects.
  • CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May significantly decrease methylprednisolone levels, reducing efficacy.
  • Anticoagulants (e.g., warfarin): May potentiate or inhibit anticoagulant effects; monitor INR closely.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose levels, requiring dose adjustment of antidiabetic agents.
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Moderate Interactions

  • Cardiac glycosides (e.g., digoxin): Increased risk of digitalis toxicity due to hypokalemia.
  • Neuromuscular blocking agents (e.g., pancuronium, vecuronium): Prolonged neuromuscular blockade may occur, especially with high-dose corticosteroids.
  • Cholestyramine, colestipol: May decrease absorption of oral corticosteroids (less relevant for IV).
  • Cyclosporine: Mutual inhibition of metabolism may occur, leading to increased levels of both drugs and increased risk of seizures.
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Minor Interactions

  • Oral contraceptives/estrogens: May decrease clearance of corticosteroids, increasing effects.
  • Aspirin (high dose): Increased salicylate clearance; withdrawal of corticosteroids may lead to salicylate toxicity.

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Serum Glucose

Rationale: Corticosteroids can induce hyperglycemia or exacerbate diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects.

Timing: Prior to initiation

Complete Blood Count (CBC)

Rationale: To assess baseline infection risk and potential for leukocytosis.

Timing: Prior to initiation

Bone Mineral Density (BMD)

Rationale: For patients anticipated to be on long-term therapy (>3 months) due to osteoporosis risk.

Timing: Prior to initiation (if long-term use expected)

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Routine Monitoring

Blood Pressure

Frequency: Daily during acute high-dose therapy, then weekly/monthly for chronic therapy.

Target: Individualized, aim for normotensive.

Action Threshold: Sustained elevation requiring intervention.

Serum Glucose

Frequency: Daily during acute high-dose therapy, then weekly/monthly for chronic therapy.

Target: Fasting <126 mg/dL, postprandial <200 mg/dL.

Action Threshold: Persistent hyperglycemia requiring antidiabetic therapy or adjustment.

Serum Electrolytes (especially Potassium)

Frequency: Daily during acute high-dose therapy, then weekly/monthly for chronic therapy.

Target: Potassium 3.5-5.0 mEq/L.

Action Threshold: Hypokalemia requiring supplementation or dose adjustment.

Signs/Symptoms of Infection

Frequency: Daily during therapy.

Target: Absence of fever, localized pain, redness, swelling.

Action Threshold: Any signs of infection; prompt evaluation and treatment.

Growth and Development (Pediatric Patients)

Frequency: Regularly (e.g., every 3-6 months) for chronic therapy.

Target: Normal growth velocity for age.

Action Threshold: Growth retardation; consider alternative therapy or lowest effective dose.

Ophthalmic Exam

Frequency: Annually for chronic therapy (>6 months).

Target: Absence of cataracts or glaucoma.

Action Threshold: Development of cataracts or increased intraocular pressure.

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual pain)
  • Increased thirst or urination (hyperglycemia)
  • Swelling of ankles/feet, weight gain (fluid retention)
  • Mood changes, irritability, depression, insomnia
  • Muscle weakness, fatigue
  • Stomach pain, black/tarry stools (GI ulceration)
  • Blurred vision, eye pain
  • Easy bruising, thin skin
  • Delayed wound healing

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids cross the placenta. Prolonged or repeated use during pregnancy may lead to fetal growth restriction or adrenal suppression in the neonate.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for malformations at therapeutic doses. Animal studies show teratogenicity.
Second Trimester: Risk of fetal growth restriction and adrenal suppression increases with prolonged use.
Third Trimester: Increased risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Methylprednisolone is excreted into breast milk. While generally considered compatible with breastfeeding at typical 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.

Infant Risk: Low to Moderate. Consider delaying breastfeeding for 3-4 hours after a high dose to minimize infant exposure.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Long-term use requires careful monitoring of growth and development. Adrenal suppression is a significant risk, especially with prolonged or high-dose therapy. Use the lowest effective dose for the shortest possible duration.

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Geriatric Use

Elderly patients may be more susceptible to the adverse effects of corticosteroids, including osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Close monitoring is warranted.

Clinical Information

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Clinical Pearls

  • Methylprednisolone 2gm is a very high dose, typically reserved for acute, severe, life-threatening conditions or pulse therapy for autoimmune diseases/transplant rejection.
  • Always taper corticosteroids gradually after prolonged use to prevent adrenal insufficiency.
  • Patients on high-dose corticosteroids are at increased risk of infection; monitor closely for subtle signs.
  • Monitor blood glucose levels closely, even in non-diabetic patients, as corticosteroids can induce hyperglycemia.
  • Consider gastroprotection (e.g., PPI) in patients at high risk for GI ulceration, especially when co-administered with NSAIDs.
  • Educate patients on the importance of not discontinuing the medication abruptly and reporting any unusual symptoms.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., Dexamethasone, Prednisone, Hydrocortisone)
  • Immunosuppressants (e.g., Cyclosporine, Azathioprine, Methotrexate, Biologics) for chronic inflammatory/autoimmune conditions
  • NSAIDs (for less severe inflammatory conditions)
  • Specific disease-modifying agents depending on the underlying condition.
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Cost & Coverage

Average Cost: Highly variable, typically several hundred to over a thousand USD for a 2gm vial. per 2gm vial
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often covered for acute, severe conditions)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.