Cortef 5mg Tablets

Manufacturer PFIZER Active Ingredient Hydrocortisone Tablets(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Glucocorticoid; Anti-inflammatory; Immunosuppressant
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Pharmacologic Class
Adrenocortical steroid
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Pregnancy Category
Category C
FDA Approved
Mar 1952
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone is a type of steroid medicine that is similar to a natural hormone your body makes. It's used to replace this hormone when your body doesn't make enough (like in adrenal insufficiency) or to reduce inflammation and suppress the immune system in various conditions like allergies, arthritis, or skin problems.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the tablet with food as directed. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed; do not stop taking it suddenly, especially if on long-term therapy, as this can lead to serious withdrawal symptoms.
  • Take with food or milk to reduce stomach upset.
  • Carry a medical alert card or wear a bracelet if taking for adrenal insufficiency, indicating your need for hydrocortisone.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection immediately.
  • Limit sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake, and discuss bone health with your doctor, especially for long-term use.
  • Avoid alcohol and NSAIDs if you have a history of stomach ulcers.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: For adrenal insufficiency: 20-30 mg daily in divided doses (e.g., 2/3 in morning, 1/3 in late afternoon). For anti-inflammatory/immunosuppressive: 20-240 mg daily in divided doses.
Dose Range: 5 - 240 mg

Condition-Specific Dosing:

adrenal_insufficiency: 20-30 mg/day, divided
anti_inflammatory: 20-240 mg/day, divided
allergic_reactions: 20-240 mg/day, divided
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., congenital adrenal hyperplasia: 0.5-0.7 mg/kg/day divided every 8 hours).
Infant: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., congenital adrenal hyperplasia: 0.5-0.7 mg/kg/day divided every 8 hours).
Child: Adrenal insufficiency: 0.5-0.7 mg/kg/day or 20-25 mg/m²/day orally in 3 divided doses. Anti-inflammatory/immunosuppressive: 0.5-4 mg/kg/day or 15-120 mg/m²/day orally in 3-4 divided doses.
Adolescent: Similar to adult dosing, adjusted for weight and surface area, or specific indication.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not significantly removed by dialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor for increased effects.
Moderate: Consider dose reduction and monitor for increased effects due to reduced metabolism.
Severe: Dose reduction likely necessary; monitor closely for increased effects and adverse reactions.

Pharmacology

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Mechanism of Action

Hydrocortisone is a naturally occurring glucocorticoid. It binds to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and interacts with DNA (glucocorticoid response elements). This interaction modulates gene transcription, leading to altered protein synthesis. Its actions include potent anti-inflammatory and immunosuppressive effects, metabolic effects (gluconeogenesis, protein catabolism, fat redistribution), and mineralocorticoid activity (sodium retention, potassium excretion).
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Pharmacokinetics

Absorption:

Bioavailability: 90-100% (oral)
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.2-0.6 L/kg
ProteinBinding: 90% (primarily to corticosteroid-binding globulin [transcortin] and albumin)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: 1.5-2 hours (plasma half-life); 8-12 hours (biological half-life)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within hours (oral)
PeakEffect: 1-2 hours (oral)
DurationOfAction: 8-12 hours (biological effects)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

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

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 low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
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 (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Shortness of breath, significant weight gain, or swelling in the arms or legs
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
Bone or joint pain
Changes in menstrual period
Chest pain or pressure
Changes in vision, eye pain, or severe eye irritation
Changes in behavior or mood
Depression or other mood changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Unexplained bruising or bleeding
Severe stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

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 unusual symptoms, contact your doctor or seek medical attention:

Upset stomach or vomiting
Trouble sleeping
Restlessness
Excessive sweating
Increased appetite
* Weight gain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe fatigue, weakness, dizziness, nausea, vomiting, abdominal pain (signs of adrenal crisis, especially if dose is missed or stopped suddenly)
  • Fever, chills, sore throat, body aches (signs of infection)
  • Unusual bruising or bleeding
  • Swelling in ankles or feet, rapid weight gain
  • Blurred vision or eye pain
  • Severe mood changes (depression, anxiety, euphoria)
  • Black, tarry stools or severe stomach pain
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have an active infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
If you have nerve problems in your eye, as this may affect your treatment.

Additionally, to ensure safe use of this medication, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Share information about your health problems, as this may impact the safety and effectiveness of this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Your doctor will need to monitor your blood work regularly. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Allergy Testing and Long-Term Use

This medication may interfere with allergy skin tests, so be sure to notify your doctor and laboratory personnel that you are taking it. Long-term use of this medication may increase your risk of developing cataracts or glaucoma; discuss this with your doctor. Additionally, long-term use may cause weak bones (osteoporosis); talk to your doctor about your risk factors and any concerns you may have.

Dietary Considerations and Health Conditions

You may need to reduce your salt intake and take potassium supplements; consult with your doctor about this. If you have diabetes, you will need to closely monitor your blood sugar levels. Before consuming alcohol, discuss it with your doctor. If you regularly drink grapefruit juice or eat grapefruit, inform your doctor.

Medication Dosage and Interactions

Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase your risk of severe side effects. Before receiving any vaccines, consult with your doctor, as some vaccines may not be effective or may increase your risk of infection when taken with this medication.

Infection Risks and Precautions

Chickenpox and measles can be severe or even fatal in individuals taking steroid medications like this one. Avoid exposure to these diseases if you have not had them before, and if you have been exposed, notify your doctor immediately. Steroid medications increase the risk of infection, which can be mild or severe. The risk is higher with higher doses. To minimize your risk, wash your hands frequently, avoid people with infections, colds, or flu, and notify your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, may reactivate in patients taking this medication. If you have a history of these infections, inform your doctor. This medication may decrease your body's natural steroid production. If you experience a fever, infection, undergo surgery, or are injured, consult with your doctor, as you may need additional oral steroids to help your body cope with stress. Carry a warning card indicating that you may require extra steroids in certain situations.

Stopping the Medication and Special Considerations

If you have been taking this medication for an extended period, consult with your doctor before stopping, as you may need to taper off the medication gradually. If you miss a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, notify your doctor.

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this with your doctor. If you have or may have pheochromocytoma, inform your doctor, as this medication can have severe and potentially fatal effects in individuals with this condition.

Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this with your doctor. 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; they may require regular growth checks. If the patient is a premature infant, discuss the potential risks with your doctor, as a specific heart problem has been reported in this population.

Pregnancy, Breastfeeding, and Adrenal Function

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you used this medication during pregnancy, inform your baby's doctor.

For individuals with poor adrenal function, stopping this medication, taking too low of a dose, or switching between different forms of this medication can lead to severe and potentially life-threatening adrenal gland problems. If you have questions or concerns, consult with your doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: fluid retention, hypertension, hypokalemia, hyperglycemia, and psychiatric disturbances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in immunosuppressed patients)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine): May decrease hydrocortisone levels, requiring dose increase.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase hydrocortisone levels, requiring dose reduction.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease), requiring INR monitoring.
  • Diuretics (thiazide or loop): Increased risk of hypokalemia.
  • Digoxin: Increased risk of digoxin toxicity due to hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetic agents.
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Moderate Interactions

  • Cholestyramine, colestipol: May decrease hydrocortisone absorption.
  • Oral contraceptives/estrogens: May increase hydrocortisone levels due to increased transcortin.
  • Cyclosporine: Increased levels of both hydrocortisone and cyclosporine.
  • Vaccines (inactivated): Reduced immune response to vaccines.
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Minor Interactions

  • Grapefruit juice: May slightly increase hydrocortisone levels (CYP3A4 inhibition).

Monitoring

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Baseline Monitoring

Adrenal function (e.g., cortisol levels, ACTH stimulation test)

Rationale: To confirm diagnosis of adrenal insufficiency or assess baseline adrenal axis function.

Timing: Prior to initiation for adrenal insufficiency; as clinically indicated for other uses.

Electrolytes (Na, K)

Rationale: To establish baseline and monitor for mineralocorticoid effects (sodium retention, potassium loss).

Timing: Prior to initiation.

Blood glucose

Rationale: To establish baseline and monitor for glucocorticoid-induced hyperglycemia.

Timing: Prior to initiation.

Blood pressure

Rationale: To establish baseline and monitor for hypertension.

Timing: Prior to initiation.

Bone mineral density (BMD)

Rationale: For patients on long-term therapy to assess osteoporosis risk.

Timing: Prior to initiation for anticipated long-term use.

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Routine Monitoring

Electrolytes (Na, K)

Frequency: Periodically, especially during dose changes or intercurrent illness.

Target: Within normal limits

Action Threshold: Significant deviations (e.g., hypokalemia, hypernatremia) require intervention.

Blood glucose

Frequency: Periodically, more frequently in diabetic patients or those at risk.

Target: Individualized, typically non-diabetic ranges

Action Threshold: Persistent hyperglycemia requires intervention (e.g., diet, antidiabetic medication adjustment).

Blood pressure

Frequency: Regularly, especially during initial therapy and dose adjustments.

Target: Individualized, typically <130/80 mmHg

Action Threshold: Sustained hypertension requires intervention.

Growth (pediatric patients)

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

Target: Normal growth velocity for age

Action Threshold: Growth retardation may necessitate dose reduction or alternative therapy.

Ophthalmologic exam (intraocular pressure)

Frequency: Annually for long-term therapy.

Target: Normal intraocular pressure

Action Threshold: Elevated pressure may indicate glaucoma.

Bone mineral density (BMD)

Frequency: Every 1-2 years for long-term therapy.

Target: Stable or improving BMD

Action Threshold: Significant bone loss may require osteoporosis treatment.

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise)
  • Gastrointestinal upset (abdominal pain, black/tarry stools)
  • Mood changes (irritability, depression, euphoria)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes
  • Skin changes (thinning, bruising)
  • Signs of adrenal crisis (severe fatigue, weakness, dizziness, nausea, vomiting, low blood pressure) if abruptly discontinued

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hydrocortisone crosses the placenta. High doses or prolonged use may lead to fetal adrenal suppression, requiring monitoring of the neonate.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts, though data are conflicting and overall risk is low.
Second Trimester: Risk of fetal adrenal suppression increases with prolonged use.
Third Trimester: Risk of fetal adrenal suppression increases with prolonged use; neonates should be monitored for signs of hypoadrenalism.
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Lactation

Considered compatible with breastfeeding at typical therapeutic doses. Hydrocortisone is excreted into breast milk in small amounts. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) with high maternal doses or prolonged use.

Infant Risk: Low risk at typical doses; potential for adrenal suppression at very high doses.
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Pediatric Use

Children are more susceptible to growth retardation and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Monitor growth and development closely. Alternate day therapy may be considered to minimize HPA axis suppression. Increased risk of intracranial hypertension in children.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always advise patients not to abruptly discontinue hydrocortisone, especially after prolonged use, due to the risk of adrenal crisis.
  • For adrenal insufficiency, emphasize the importance of stress dosing (increasing dose during illness, surgery, or severe stress).
  • Educate patients on signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Recommend taking hydrocortisone in the morning or divided doses (e.g., 2/3 AM, 1/3 PM) to mimic natural cortisol secretion and minimize sleep disturbances.
  • Long-term use requires monitoring for bone density, blood glucose, blood pressure, and ophthalmologic changes.
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Alternative Therapies

  • Other glucocorticoids (e.g., prednisone, methylprednisolone, dexamethasone) for anti-inflammatory/immunosuppressive indications.
  • Fludrocortisone (for mineralocorticoid replacement in adrenal insufficiency).
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent).
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for autoimmune diseases (long-term management).
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic hydrocortisone)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.