Solu-Medrol 125mg 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
Adrenal cortical steroid, anti-inflammatory agent, immunosuppressant
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Methylprednisolone is a type of steroid medicine that works by reducing inflammation (swelling and redness) and calming down your body's immune system. It's used to treat many conditions like severe allergies, asthma, arthritis, and certain autoimmune diseases.
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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 follow all instructions provided. This drug is administered via injection.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid sudden discontinuation; always taper the dose as directed by your doctor to prevent withdrawal symptoms.
  • Report any signs of infection (fever, sore throat, unusual fatigue) immediately, as this medicine can mask them.
  • Limit salt intake to help prevent fluid retention and high blood pressure.
  • Monitor blood sugar if you have diabetes, as this medicine can increase it.
  • Consider calcium and vitamin D supplementation for long-term use to protect bone health.
  • Avoid close contact with people who are sick, especially with chickenpox or measles, if you are on high doses or long-term therapy.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. For Solu-Medrol 125mg Inj, common uses include acute exacerbations of multiple sclerosis (e.g., 125mg-1000mg IV daily for 3-7 days), severe allergic reactions, or as part of a pulse therapy regimen. Dosing must be individualized.
Dose Range: 40 - 1000 mg

Condition-Specific Dosing:

acute_ms_exacerbation: 125mg to 1000mg IV daily for 3-7 days
severe_allergic_reactions: 40mg to 125mg IV, then tapered
anti-inflammatory_immunosuppressive: 10mg to 250mg IV daily, depending on severity and condition
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution if necessary (e.g., 0.5-1.6 mg/kg/day IV divided every 6-12 hours for anti-inflammatory/immunosuppressive effects)
Infant: 0.5-1.6 mg/kg/day IV divided every 6-12 hours for anti-inflammatory/immunosuppressive effects
Child: 0.5-1.6 mg/kg/day IV divided every 6-12 hours for anti-inflammatory/immunosuppressive effects; for acute severe asthma: 1-2 mg/kg/day IV divided every 6-12 hours (max 60mg/day)
Adolescent: Dosing similar to adult, often weight-based initially then adjusted to clinical response
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required.
Dialysis: Methylprednisolone is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Methylprednisolone is a synthetic glucocorticoid that exerts its effects by binding to specific intracellular glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses immune responses by inhibiting the proliferation and function of lymphocytes and other immune cells.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.7 to 1.5 L/kg
ProteinBinding: Approximately 77% (concentration-dependent, primarily to albumin and transcortin)
CnssPenetration: Limited (less than some other corticosteroids like dexamethasone)

Elimination:

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

OnsetOfAction: Rapid (within minutes to hours for anti-inflammatory effects after IV administration)
PeakEffect: Variable, depending on the specific effect being measured (e.g., anti-inflammatory, immunosuppressive)
DurationOfAction: 18-36 hours (biological half-life, reflecting duration of pharmacologic effect)
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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

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, trouble 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 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 bumps or patches on the skin or in the mouth
Chest pain or pressure
Abnormal heartbeat: fast, slow, or irregular
Changes in menstrual period
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

Mild stomach upset or nausea
Trouble sleeping
Restlessness
Excessive sweating
* Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:

  • Signs of infection (fever, chills, severe sore throat, body aches)
  • Severe stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling in hands, ankles, or feet
  • Significant mood changes (severe depression, anxiety, confusion, hallucinations)
  • Blurred vision or eye pain
  • Extreme fatigue, weakness, nausea, vomiting, dizziness (signs of adrenal insufficiency if abruptly stopped)
  • Increased thirst and urination (signs of high blood sugar)
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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 about 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.
If you have any type of infection, including bacterial, viral, or fungal infections, as well as conditions like traveler's diarrhea, herpes infection of the eye, cerebral malaria, threadworm infestation, or other infections.
If you have nerve problems affecting your eyes.

Additional Considerations for Injection Administration (Intramuscular):
If you have idiopathic thrombocytopenic purpura (ITP), a bleeding disorder characterized by low platelet count.

It is essential 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 and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 for an extended period, your doctor will likely recommend regular blood tests, weight checks, and other laboratory tests to monitor your health. You may also need to have your eye pressure and bone density checked.

Be aware that medications like this one can cause high blood pressure. Your doctor will likely 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 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 vaccinations, 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 have not had chickenpox or measles before, avoid exposure to these diseases, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, inform your doctor immediately.

Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. Wash your hands frequently, avoid people with infections, and inform your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, can reactivate in people taking medications like this one. 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 stop taking this medication, your doctor will likely recommend a gradual tapering schedule.

Using medications like this one via epidural injection (into the spine) has been associated with severe health problems, including paralysis, loss of vision, stroke, and death. This medication is not approved for epidural use, and you should discuss the potential risks with your doctor.

Some formulations of this medication contain benzyl alcohol, which can be harmful to 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 medications like this one has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this potential risk with your doctor. Additionally, 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, and regular growth checks may be necessary. Discuss this potential risk 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 this medication 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, as this may be relevant to their health.
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Overdose Information

Overdose Symptoms:

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

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. Hemodialysis is not effective. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

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

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit juice) - may increase methylprednisolone levels and effects
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may decrease methylprednisolone levels and effects
  • Warfarin - may alter anticoagulant effects (monitor INR closely)
  • NSAIDs - increased risk of GI ulceration and bleeding
  • Antidiabetic agents (insulin, oral hypoglycemics) - corticosteroids can increase blood glucose, requiring dose adjustments of antidiabetics
  • Digoxin - increased risk of digitalis toxicity due to hypokalemia
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Moderate Interactions

  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Amphotericin B - increased risk of hypokalemia
  • Cyclosporine - increased levels of both drugs, increased risk of seizures
  • Neuromuscular blockers - may prolong or antagonize blockade
  • Cholestyramine - may decrease absorption of methylprednisolone
  • Oral contraceptives/estrogens - may increase methylprednisolone levels
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Minor Interactions

  • Antacids - may decrease absorption (if oral formulation)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Serum electrolytes (Na, K)

Rationale: Risk of fluid retention and hypokalemia.

Timing: Prior to initiation

Blood glucose

Rationale: Risk of hyperglycemia, especially in predisposed individuals.

Timing: Prior to initiation

Weight

Rationale: Fluid retention and metabolic changes.

Timing: Prior to initiation

Signs/symptoms of infection

Rationale: Corticosteroids can mask signs of infection.

Timing: Prior to initiation

Ophthalmic exam (if long-term use anticipated)

Rationale: Risk of cataracts and glaucoma.

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Daily to weekly, depending on duration and dose

Target: Individualized

Action Threshold: Significant increase from baseline or above target range

Blood glucose

Frequency: Daily (especially in diabetics) to weekly

Target: Individualized, typically <180 mg/dL postprandial

Action Threshold: Persistent hyperglycemia requiring intervention

Serum electrolytes (K)

Frequency: Weekly to bi-weekly, especially with concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: < 3.5 mEq/L

Weight

Frequency: Weekly

Target: Stable or as desired

Action Threshold: Significant, unexplained weight gain

Signs/symptoms of infection

Frequency: Continuously

Target: Absence of infection

Action Threshold: Fever, localized pain, redness, swelling, malaise

Growth (pediatric patients)

Frequency: Every 3-6 months for long-term therapy

Target: Normal growth velocity

Action Threshold: Growth suppression

Bone mineral density (if long-term use >3 months)

Frequency: Baseline and annually

Target: Stable or improving

Action Threshold: Significant bone loss

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue)
  • Hyperglycemia (increased thirst, urination, hunger)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Skin changes (thinning, bruising, acne)
  • Adrenal insufficiency symptoms upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)

Special Patient Groups

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Pregnancy

Methylprednisolone is classified as Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects (e.g., cleft palate). Human data are less clear but suggest a potential for fetal growth restriction and other adverse outcomes with prolonged use.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate (based on animal data and some human observational studies, though overall human risk is low).
Second Trimester: Risk of fetal growth restriction, premature delivery, and adrenal suppression in the neonate with prolonged use.
Third Trimester: Risk of fetal growth restriction, premature delivery, and adrenal suppression in the neonate with prolonged use. Monitor neonate for signs of hypoadrenalism.
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Lactation

Methylprednisolone is excreted into breast milk. The American Academy of Pediatrics considers corticosteroids compatible with breastfeeding. However, monitor the infant for potential adverse effects such as growth suppression, adrenal suppression, or other signs of corticosteroid exposure. Use the lowest effective dose for the shortest duration possible. Consider administering the dose immediately after a feeding or delaying feeding for 3-4 hours after a dose to minimize infant exposure.

Infant Risk: L3 (Moderately Safe) - Potential for low-level exposure; monitor infant for adverse effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity closely. Long-term use can also lead to adrenal suppression, osteoporosis, and increased susceptibility to infections. Use the lowest effective dose for the shortest duration possible.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, diabetes, hypertension, and fluid retention. Use with caution and monitor closely for these complications.

Clinical Information

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Clinical Pearls

  • Always taper systemic corticosteroids gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
  • Patients on immunosuppressive doses should avoid live vaccines.
  • Monitor for signs of infection, as corticosteroids can mask inflammatory responses.
  • Administer IV methylprednisolone slowly (over at least 5 minutes for 125mg dose) to avoid adverse effects like perineal tingling or flushing.
  • Consider gastroprotective agents (e.g., PPIs) for patients at high risk of GI ulceration, especially with concomitant NSAID use.
  • Educate patients about potential psychiatric effects (mood swings, insomnia, anxiety, depression) and to report severe changes.
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Alternative Therapies

  • Prednisone (oral)
  • Dexamethasone (oral, IV)
  • Hydrocortisone (oral, IV)
  • Betamethasone (oral, IV)
  • Other immunosuppressants or anti-inflammatory agents depending on the specific condition being treated (e.g., NSAIDs, DMARDs, biologics)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 125mg vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic) / Tier 3 (brand) for most commercial and government plans
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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, never share your medication with others, and do not take medication prescribed for someone else. 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional 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 it occurred.