HomeNDC LookupIngredientsMethylprednisolone › 00009-0056-04
Medrol methylprednisolone 4 mg Tablet, 21-count — NDC 00009-0056-04 package photo

Medrol methylprednisolone 4 mg Tablet, 21-count

by Pharmacia & Upjohn Company LLC · 1 DOSE PACK in 1 CARTON (0009-0056-04) / 21 TABLET in 1 DOSE PACK
NDC 00009-0056-04
🏷️ FDA NDC (as labeled) 0009-0056-04 billing pads the labeler segment with a zero
This package
Contains21-count Cost per ea$0.2908 NADAC Per package$6.11 / 21 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $4.69/unit · Part D plans $0.3001/unit — full pricing hub ↓
Also comes in: 100 tablets 00009-0056-02
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Methylprednisolone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 15, 2026 — Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. (Greenstone Llc) · FDA recall D-0299-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0009-0056-04
Product NDC 0009-0056
11-digit billing NDC 00009005604
NCPDP billing unit EA — each (per item)
UNII X4W7ZR7023
UPC 0300090056025, 0300090022013, 0300090073015, 0300090020019
Application # NDA011153
SPL Set ID 39d5270b-d957-4821-93d6-501b7b9f02d4
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1957-10-24
Route ORAL
Dosage form TABLET
Substance METHYLPREDNISOLONE
GPI-14 22100030000310
GPI class Medrol
GCN Seq No 045311
GCN 37499
HICL code 002877
Ingredient (HICL) Methylprednisolone
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name MEDROL 4 MG DOSEPAK
FDB brand name Medrol
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0009-0056-04 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00009-0056-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, weak (group I), Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPharmacia & Upjohn Company LLC
Application holderPFIZER INC
FDA applicationNDA011153 (NDA)
Labeler code00009
First marketedOct 1957
Product typeHuman Prescription Drug
Portfolio106 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MEDROL 4 MG DOSEPAK Ingredient Methylprednisolone
📗 Our plain-language guide HelloPharmacist
  • Methylprednisolone is used for a very wide range of conditions — basically anything where your immune system or inflammation is causing the problem. That includes severe allergic r...
  • What conditions does methylprednisolone actually treat?
  • It really depends on what you're being treated for. Some people take a short course for an acute flare and then stop. Others need longer-term treatment for chronic conditions. The...
  • How long will I need to take this medication?
📖 Read our full Methylprednisolone guide →
9
Nutrient depletion considerations

Methylprednisolone may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / White
ShapeOval
ImprintMedrol;2
Size8 mm
ScoringScored — splits in 4
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.291 $6.11 / 21 tablets
Medicaid paysCMS SDUD · 12 mo $4.69 $98.45 / 21 tablets
Medicare drug plans payPart D · Q2 2026 $0.3001 $6.30 / 21 tablets
Medicare Part B allowsASP · J7509 $0.160 / J7509 unit
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Feb 2026 May 2026 Aug 2026 $0.292 $0.291
▼ Down 1% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0009-0056-04
11-digit billing NDC00009-0056-04
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7509
DescriptorMETHYLPREDNISOLONE ORAL, PER 4 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
methylprednisolone 4 mg 00904-6914-61 Major 100 tablets $0.124 AB Availability likely save 57%
Methylprednisolone 4 mg 42806-0400-01 Epic 100 tablets $0.124 AB Availability likely save 57%
Methylprednisolone 4 mg 62135-0760-01 Chartwell 100 tablets $0.124 Availability likely save 57%
Methylprednisolone 4 mg 68084-0149-01 American 100 tablets $0.124 AB Availability likely save 57%
methylprednisolone 4 mg 68382-0916-01 Zydus 100 tablets $0.124 AB Availability likely save 57%
MethylPREDNISolone 4 mg 00603-4593-15 Par 21 tablets $0.126 AB Availability likely save 57%
Methylprednisolone 4 mg 59762-4440-02 Mylan 21 tablets $0.126 AB Availability likely save 57%
methylprednisolone 4 mg 68001-0624-01 BluePoint 21 tablets $0.126 AB Availability likely save 57%
Medrol 4 mgthis 00009-0056-04 Pharmacia 21 tablets $0.291 AB Availability likely
MethylPREDNISolone 4 mg 55289-0649-30 PD-Rx 30 tablets AB FDA listed
Methylprednisolone 4 mg 57582-0101-01 Tianjin 100 tablets AB FDA listed
MethylPREDNISolone 4 mg 63629-2218-01 Bryant 100 tablets AB FDA listed
Methylprednisolone 4 mg 68071-2370-01 NuCare 21 tablets AB FDA listed
Methylprednisolone 4 mg 68071-5221-01 NuCare 21 tablets AB FDA listed
Methylprednisolone 4 mg 69306-0400-21 Doc 21 tablets AB FDA listed
methylprednisolone 4 mg 70771-1348-01 Zydus 100 tablets AB FDA listed
MethylPREDNISolone 4 mg 72162-1161-01 Bryant 100 tablets AB FDA listed
methylprednisolone 4 mg 82804-0007-21 Proficient 21 tablets AB FDA listed
Methylprednisolone 4 mg 85509-1400-02 PHOENIX 21 tablets AB FDA listed
Methylprednisolone 4 mg 85766-0037-01 Sportpharm 100 tablets AB FDA listed
Methylprednisolone 4 mg 71205-0453-21 Proficient 21 tablets AB FDA listed
Methylprednisolone 4 mg 76420-0041-21 Asclemed 21 tablets AB FDA listed
Methylprednisolone 4 mg 76420-0193-21 Asclemed 21 tablets AB FDA listed
Methylprednisolone 4 mg 63187-0160-21 Proficient 21 tablets AB FDA listed
MethylPREDNISolone 4 mg 63629-2226-01 Bryant 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0230-01 Advanced 21 tablets AB FDA listed
methylprednisolone 4 mg 50090-3811-00 A-S 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0231-01 Advanced 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0255-01 Advanced 21 tablets AB FDA listed
Methylprednisolone 4 mg 50090-3094-00 A-S 21 tablets AB FDA listed
Methylprednisolone 4 mg 72189-0264-21 Direct_Rx 21 tablets AB FDA listed
Methylprednisolone 4 mg 68788-7833-02 Preferred 21 tablets AB FDA listed
Methylprednisolone 4 mg 70518-2864-00 REMEDYREPACK 21 tablets AB FDA listed
Methylprednisolone 4 mg 60760-0961-21 St. 21 tablets AB FDA listed
Methylprednisolone 4 mg 70518-4213-00 REMEDYREPACK 21 tablets AB FDA listed
Methylprednisolone 4 mg 85534-0035-00 HAWAII 21 tablets AB FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1957
On the market since
Oct 1957
📍
2026
Currently FDA-listed
69 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00009-0056-04, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
151
Units reimbursed last 4 qtrs
3.2K
Gross reimbursed last 4 qtrs
$14.9K
Avg / prescription
$98.45
Avg / unit
$4.6881
Latest quarter Q4 2025
27Rx
Medicaid pays / ea
$4.6881
gross reimbursed
vs
NADAC / ea
$0.2908
acquisition cost
=
Spread
+$4.3973
+1512% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
48% FFS 52% MCO
Fee-for-service · 72 Rx Managed care · 79 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,386 units · 13.8 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 357 units · 38.8 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 882 units · 2.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 273 units · 4.4 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 273 units · 0.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.938.8
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 South Dakota 38.8 /100k
2 Michigan 13.8 /100k
3 Missouri 4.4 /100k
4 California 2.3 /100k
5 Texas 0.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets00009-0056-02 No Medicaid data
Drug total (last 4 qtrs): 151 Rx · 3,171 units · $14,866 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Medrol — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Medrol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.4K
Claims incl. refills
449
Beneficiaries
419
Spend / beneficiary
$19.97
Spend / claim
$18.64
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Medrol (this brand).

Top reported reactions

Fatigue6,303
Nausea5,947
Pain5,846
Headache5,688
Pyrexia5,639
Pneumonia5,630
Dyspnoea5,374

Age at onset

Neonate465
Infant401
Child1,240
Adolescent773
Adult13,301
Elderly5,596

Reporter sex

121,836 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization50,154
Death19,031
Life-threatening11,102
Disabling3,149
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 10,694 4,449
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00009-0056-02 100 TABLET in 1 BOTTLE (0009-0056-02) $0.2454 / ea $24.54 1957-10-24 Active
00009-0056-04 You're viewing this 1 DOSE PACK in 1 CARTON (0009-0056-04) / 21 TABLET in 1 DOSE PACK $0.2908 / ea $6.11 1957-10-24 Active

Per ea, this pack runs about 19% above the cheapest pack (100-count, $0.2454 vs $0.2908 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00009-0056-04?
NDC 00009-0056-04 is a 21-count package — 1 dose pack in 1 carton / 21 tablet in 1 dose pack.
What is the difference between NDC 00009-0056-04 and NDC 00009-0056-02?
Both are Medrol methylprednisolone 4 mg Tablet — the drug itself is identical. NDC 00009-0056-04 is the 21-count package, while NDC 00009-0056-02 is the 100 tablets package. Per-ea NADAC also differs: $0.2908 here vs $0.2454 for the 100 tablets pack.
What NDC number is used to bill for this package of Medrol methylprednisolone 4 mg Tablet?
Bill NDC 00009-0056-04 — the 11-digit billing format is 00009005604. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4.

Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7.

Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler's syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.

Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.

Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION The initial dosage of MEDROL Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted.

If after a reasonable period of time there is a lack of satisfactory clinical response, MEDROL should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT . After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of MEDROL for a period of time consistent with the patient's condition.

If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone). ADT ® (Alternate Day Therapy): Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.

The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm.

Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity.

There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadren…

Contraindications 9 words

CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.

⚠️ Warnings ~2 min read

WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including MEDROL, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider MEDROL withdrawal or dosage reduction as needed. Tuberculosis If MEDROL is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation. During prolonged MEDROL therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including MEDROL.

In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: • If a MEDROL-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. • If a MEDROL-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including MEDROL.

Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with MEDROL. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections Corticosteroids, including MEDROL, may exacerbate systemic fungal infections; therefore, avoid MEDROL use in the presence of such infections unless MEDROL is needed to control drug reactions. For patients on chronic MEDROL therapy who develop systemic fungal infections, MEDROL withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including MEDROL, may activate latent amebiasis.

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating MEDROL in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including MEDROL, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria Avoid corticosteroids, including MEDROL, in patients with cerebral malaria. Ophthalmic Effects Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corti…

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Fluid and Electrolyte Disturbances • Sodium retention • Congestive heart failure in susceptible patients • Hypertension • Fluid retention • Potassium loss • Hypokalemic alkalosis Musculoskeletal • Muscle weakness • Loss of muscle mass • Steroid myopathy • Osteoporosis • Tendon rupture, particularly of the Achilles tendon • Vertebral compression fractures • Aseptic necrosis of femoral and humeral heads • Pathologic fracture of long bones Gastrointestinal • Peptic ulcer with possible perforation and hemorrhage • Pancreatitis • Abdominal distention • Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment.

These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic • Impaired wound healing • Petechiae and ecchymoses • May suppress reactions to skin tests • Thin fragile skin • Facial erythema • Increased sweating Neurological • Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment • Convulsions • Vertigo • Headache Endocrine • Development of Cushingoid state • Suppression of growth in children • Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness • Menstrual irregularities • Decreased carbohydrate tolerance • Manifestations of latent diabetes mellitus • Increased requirements of insulin or oral hypoglycemic agents in diabetics Ophthalmic • Posterior subcapsular cataracts • Increased intraocular pressure • Glaucoma • Exophthalmos Metabolic • Negative nitrogen balance due to protein catabolism Vascular • Flushing The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

🔄 Drug Interactions 194 words

DRUG INTERACTIONS The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin.

Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

🤰 Pregnancy 70 words

Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

📦 How Supplied / Storage and Handling 100 words

HOW SUPPLIED MEDROL Tablets are available in the following strengths and package sizes: 2 mg (white, elliptical, scored, imprinted MEDROL 2) Bottles of 100 NDC 0009-0020-01 4 mg (white, elliptical, scored, imprinted MEDROL 4) Bottles of 100 NDC 0009-0056-02 DOSEPAK ™ Unit of Use (21 tablets) NDC 0009-0056-04 8 mg (white, elliptical, scored, imprinted MEDROL 8) Bottles of 25 NDC 0009-0022-01 16 mg (white, elliptical, scored, imprinted MEDROL 16) Bottles of 50 NDC 0009-0073-01 32 mg (white, elliptical, scored, imprinted MEDROL 32) Bottles of 25 NDC 0009-0176-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

📦 Storage and Handling 13 words

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

📋 Description 203 words

DESCRIPTION MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder.

It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48.

The structural formula is represented below: Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. Inactive ingredients: 2 mg 4 mg and 8 mg Calcium Stearate Calcium Stearate Corn Starch Corn Starch Lactose Lactose Mineral Oil Sucrose Sorbic Acid Sucrose 16 mg and 32 mg Calcium Stearate Corn Starch Lactose Mineral Oil Sucrose ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Chemical Structure

💬 Information for Patients 39 words

Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.