HomeNDC LookupIngredientsHydrocortisone › 00009-0012-01
CORTEF hydrocortisone 5 mg Tablet, 50-count — NDC 00009-0012-01 package photo

CORTEF hydrocortisone 5 mg Tablet, 50-count

by Pharmacia & Upjohn Company LLC · 50 TABLET in 1 BOTTLE (0009-0012-01)
NDC 00009-0012-01
🏷️ FDA NDC (as labeled) 0009-0012-01 billing pads the labeler segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0009-0012-01
Product NDC 0009-0012
11-digit billing NDC 00009001201
NCPDP billing unit EA — each (per item)
UNII WI4X0X7BPJ
UPC 0300090044015, 0300090031015, 0300090012014
Application # NDA008697
SPL Set ID 9ce19944-dd88-4a7b-84ca-b07f4ec23bad
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 1952-12-15
Route ORAL
Dosage form TABLET
Substance HYDROCORTISONE
GPI-14 22100025000303
GPI class Cortef
GCN Seq No 006705
GCN 26783
HICL code 002867
Ingredient (HICL) Hydrocortisone
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 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name CORTEF 5 MG TABLET
FDB brand name Cortef
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 0009-0012-01 — 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 → 00009-0012-01. 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, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
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 holderPHARMACIA AND UPJOHN CO
FDA applicationNDA008697 (NDA)
Labeler code00009
First marketedDec 1952
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 CORTEF 5 MG TABLET Ingredient Hydrocortisone
📖 What it is MedlinePlus · NLM

Hydrocortisone is used to replace cortisol (a steroid normally produced by the body) when your body doesn't make enough of it. Hydrocortisone is also used to treat lupus (a disease in which immune system attacks body attacks many of its own organs); certain types of arthritis; certain lung, skin, eye, kidney, blood, thyroid, stomach, and intestinal disorders; severe allergies; and certain types of cancer.I Hydrocortisone is in a class of medications called corticosteroids. It works by replacing steroids that are normally produced naturally by the body. It also works to reduce swelling and r...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 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 White
ShapeRound
ImprintCORTEF;20
Size1 mm
ScoringScored — splits in 2
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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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.

6 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 $0.978 $48.91 / 50 tablets
Medicaid paysCMS SDUD · 12 mo $0.9325 $46.63 / 50 tablets
Medicare drug plans payPart D · Q2 2026 $0.9810 $49.05 / 50 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.978 $0.967
▲ Up 1% over the last 9 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 5 mg 00115-1696-06 Amneal 50 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 50268-0405-15 AvPAK 50 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 59651-0413-50 Aurobindo 50 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 59762-0073-01 Mylan 50 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 60687-0844-21 American 30 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 62135-0551-60 Chartwell 60 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 64380-0970-25 Strides 50 tablets $0.137 AB Availability likely save 86%
Hydrocortisone 5 mg 70954-0052-10 ANI 50 tablets $0.137 AB Availability likely save 86%
hydrocortisone 5 mg 71930-0078-50 Eywa 50 tablets $0.137 AB Availability likely save 86%
Cortef 5 mgthis 00009-0012-01 Pharmacia 50 tablets $0.978 AB Availability likely
Hydrocortisone 5 mg 42543-0970-25 Strides 50 tablets AB FDA listed
Hydrocortisone 5 mg 68788-8455-03 Preferred 30 tablets AB FDA listed
Hydrocortisone 5 mg 71335-1989-01 Bryant 30 tablets AB FDA listed
Hydrocortisone 5 mg 71335-2770-01 Bryant 30 tablets AB FDA listed
Hydrocortisone 5 mg 72789-0227-50 PD-Rx 50 tablets AB FDA listed
Hydrocortisone 5 mg 76420-0028-50 Asclemed 50 tablets AB FDA listed
Hydrocortisone 5 mg 76420-0110-50 Asclemed 50 tablets AB FDA listed
Hydrocortisone 5 mg 43547-0892-05 Solco 50 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

🏛️
1952
On the market since
Dec 1952
📍
2026
Currently FDA-listed
74 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 00009-0012-01, 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
624
Units reimbursed last 4 qtrs
96.6K
Gross reimbursed last 4 qtrs
$90.1K
Avg / prescription
$144.39
Avg / unit
$0.9325
Latest quarter Q4 2025
138Rx
Medicaid pays / ea
$0.9325
gross reimbursed
vs
NADAC / ea
$0.9781
acquisition cost
=
Spread
−$0.0456
-5% 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
62% FFS 38% MCO
Fee-for-service · 389 Rx Managed care · 235 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: 4,024 units · 40.1 per 100k residents MI New York: 9,832 units · 50.2 per 100k residents 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: no data reported SD Iowa: 1,700 units · 53.0 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 23,567 units · 182 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 48,639 units · 125 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported 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: 8,857 units · 29.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
29.0182
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 Pennsylvania 182 /100k
2 California 125 /100k
3 Iowa 53.0 /100k
4 New York 50.2 /100k
5 Michigan 40.1 /100k
6 Texas 29.0 /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.

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

Medicare Part D (outpatient prescription) spending for Cortef — 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 Cortef. 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
$127.7K
Claims incl. refills
617
Beneficiaries
373
Spend / beneficiary
$342.23
Spend / claim
$206.89
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 CORTEF (this brand).

Top reported reactions

Fatigue6,293
Condition Aggravated5,512
Nausea5,244
Rash4,969
Headache4,657
Diarrhoea4,636
Pain4,606

Age at onset

Neonate332
Infant314
Child1,050
Adolescent695
Adult8,092
Elderly3,492

Reporter sex

69,214 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization29,315
Death9,969
Life-threatening8,743
Disabling5,675
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,564 0
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 Marketing startStatus
00009-0012-01 You're viewing this 50 TABLET in 1 BOTTLE (0009-0012-01) 1952-12-15 Active

📄 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 CORTEF 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 Non suppurative 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: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 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 Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7.

Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis 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.

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 ~1 min read

DOSAGE AND ADMINISTRATION The initial dosage of CORTEF Tablets may vary from 20 mg to 240 mg of hydrocortisone 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, CORTEF 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 CORTEF 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.

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 CORTEF, 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 CORTEF withdrawal or dosage reduction as needed. Tuberculosis If CORTEF 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 CORTEF 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 CORTEF.

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 CORTEF-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 CORTEF-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 CORTEF.

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

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating CORTEF in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including CORTEF, 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 CORTEF, 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 209 words

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass 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 Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Neurological Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Convulsions Vertigo Headache Epidural lipomatosis 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 for insulin or oral hypoglycemic agents in diabetics Ophthalmic Central serous chorioretinopathy Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism Blood and lymphatic system disorders Leukocytosis

🔄 Drug Interactions 150 words

Drug Interactions The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance.

Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids 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 corticosteroid is withdrawn.

Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids.

Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

📦 How Supplied / Storage and Handling 65 words

HOW SUPPLIED CORTEF Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, imprinted CORTEF 5) Bottles of 50 NDC 0009-0012-01 10 mg (white, round, scored, imprinted CORTEF 10) Bottles of 100 NDC 0009-0031-01 20 mg (white, round, scored, imprinted CORTEF 20) Bottles of 100 NDC 0009-0044-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

📋 Description 123 words

DESCRIPTION CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C.

It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below.

CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose. Chemical Structure

💬 Information for Patients 40 words

Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox 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.