Cortisone Acetate 25mg Tablets

Manufacturer CHARTWELL RX Active Ingredient Cortisone(KOR ti sone) Pronunciation 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
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cortisone is a type of steroid medication that works like a natural hormone your body makes. It helps reduce inflammation (swelling and redness) and calm down an overactive immune system. It's often used to treat conditions like arthritis, allergies, asthma, and certain skin conditions, or to replace hormones if your body isn't making enough.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

If you take this medication once a day, it's best to take it in the morning.
Take your medication with food to help your body absorb it properly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. This will help ensure that you get the full benefit of the treatment.
If you've been taking this medication for several weeks and want to stop, talk to your doctor first. They may recommend gradually reducing your dosage to minimize potential side effects.

Storing and Disposing of Your Medication

To keep your medication effective and safe:
Store it at room temperature, away from direct light.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in the bathroom, as the moisture can affect its potency.
Keep all medications out of the reach of children and pets to avoid accidents.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However:
If it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing 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, usually with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially if you've been on it for more than a few days, as it can lead to serious withdrawal symptoms. Your doctor will tell you how to slowly reduce the dose.
  • Carry a medical alert card or wear a bracelet stating you are taking corticosteroids, especially if on long-term therapy, in case of emergency.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual tiredness) immediately.
  • Limit salt intake to help prevent fluid retention and high blood pressure.
  • Ensure adequate calcium and vitamin D intake to protect bone health, especially with long-term use.
  • Regular exercise can help maintain muscle strength and bone density.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly based on indication. For adrenal insufficiency: 25-37.5 mg daily in divided doses. For anti-inflammatory/immunosuppressive: 25-300 mg daily in divided doses.
Dose Range: 25 - 300 mg

Condition-Specific Dosing:

adrenalInsufficiency: 25-37.5 mg daily in divided doses (e.g., 2/3 in morning, 1/3 in evening)
antiInflammatoryImmunosuppressive: 25-300 mg daily in divided doses, adjusted based on disease severity and patient response
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Pediatric Dosing

Neonatal: Not established (use hydrocortisone if needed)
Infant: Dosing is highly individualized based on weight/surface area and indication (e.g., 0.7 mg/kg/day or 20-25 mg/m2/day for replacement therapy, divided doses)
Child: Dosing is highly individualized based on weight/surface area and indication (e.g., 0.7 mg/kg/day or 20-25 mg/m2/day for replacement therapy, divided doses)
Adolescent: Dosing is highly individualized based on weight/surface area and indication, often similar to adult dosing for anti-inflammatory uses, or weight-based for replacement.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Caution advised; monitor for efficacy and side effects as conversion to hydrocortisone may be impaired.
Moderate: Dose reduction may be necessary; monitor closely for efficacy and signs of adrenal insufficiency or corticosteroid excess.
Severe: Significant dose reduction likely required; consider using hydrocortisone directly as conversion of cortisone to hydrocortisone is impaired.

Pharmacology

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Mechanism of Action

Cortisone is a prodrug that is converted in the liver to its active metabolite, hydrocortisone (cortisol). Hydrocortisone binds to specific cytoplasmic glucocorticoid receptors in target tissues. This complex then translocates to the nucleus, where it modulates gene expression, leading to diverse effects. These include potent anti-inflammatory and immunosuppressive actions by inhibiting the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppressing immune cell function (e.g., lymphocytes, macrophages), and stabilizing lysosomal membranes. It also has mineralocorticoid activity, affecting electrolyte and water balance.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25-50% (oral, due to first-pass metabolism and conversion to hydrocortisone)
Tmax: 1-2 hours (for cortisone itself); peak plasma levels of hydrocortisone occur within 1-2 hours after oral cortisone administration.
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 0.5-1.5 L/kg (for hydrocortisone)
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin (CBG) and albumin)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: Approximately 0.5-1 hour (for cortisone itself); biological half-life of hydrocortisone is 8-12 hours.
Clearance: Not available (highly variable)
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (of cortisone)
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Pharmacodynamics

OnsetOfAction: Within hours (for anti-inflammatory effects)
PeakEffect: Within 1-2 hours (for plasma levels of hydrocortisone); clinical effects may take longer.
DurationOfAction: 8-12 hours (due to biological half-life of hydrocortisone)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of pancreatitis (pancreas problem): severe abdominal pain, severe back pain, or severe nausea and vomiting
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
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Chest pain or pressure
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Changes in menstrual period
Bone or joint pain
Changes in vision
Depression or mood changes
Changes in behavior
Seizures
Unexplained bruising or bleeding
Severe abdominal 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Nausea and vomiting
Difficulty sleeping
Restlessness
Excessive sweating
Headache
Weight gain
Increased appetite
* Fatigue or weakness

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

  • Severe stomach pain, black or tarry stools, vomiting blood (signs of GI bleeding)
  • Swelling in ankles or feet, unusual weight gain (fluid retention)
  • Extreme fatigue, weakness, dizziness, nausea, vomiting, loss of appetite (signs of adrenal insufficiency)
  • Increased thirst or urination (signs of high blood sugar)
  • Blurred vision, eye pain (signs of glaucoma or cataracts)
  • Mood changes (severe depression, anxiety, confusion)
  • Signs of infection (fever, chills, body aches, sore throat, cough, painful urination)
  • Muscle weakness or cramps
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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 symptoms you experienced.
If you currently have a fungal infection.

This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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

Your doctor will monitor your blood work and bone density as directed. Be aware that this medication may affect certain laboratory tests, so it's crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

While taking this medication, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

If you have not previously had chickenpox or measles, it's vital to avoid exposure to these illnesses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult your doctor promptly.

This medication may decrease the natural production of steroids in your body. If you experience a fever, infection, undergo surgery, or are injured, discuss this with your doctor, as you may require additional doses of oral steroids to help your body cope with these stresses. It's recommended that you carry a warning card indicating that you may need extra steroids in certain situations.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor about this potential risk and schedule regular eye exams, including eye pressure checks, if you are taking this medication for an extended period.

Prolonged use of this medication may also lead to weak bones (osteoporosis). Discuss your individual risk factors with your doctor and ask about any concerns you may have.

Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Monitor your blood sugar levels closely, especially if you have diabetes, and be aware of the signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath. If you experience any of these symptoms, notify your doctor. Additionally, consult your doctor before consuming alcohol, as it may affect your blood sugar levels.

You may need to reduce your salt intake and increase your potassium consumption while taking this medication. Discuss this with your doctor to determine the best approach for your individual needs.

If you miss a dose or recently stopped taking this medication and experience extreme fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor promptly.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor to discuss this potential risk.

This medication may also lower sperm counts in some individuals. If you have concerns, discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, it's essential to discuss the benefits and risks of this medication with your doctor. Additionally, if you took this medication during pregnancy, inform your baby's doctor.

Remember to follow your doctor's instructions and attend all scheduled appointments to ensure safe and effective use of this medication.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare and usually does not cause life-threatening problems.
  • Symptoms may include: fluid retention, hypertension, hyperglycemia, hypokalemia, and possibly psychiatric disturbances (e.g., agitation, psychosis).

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately. Treatment is generally supportive and symptomatic. Chronic overdose can lead to Cushingoid features and adrenal suppression.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)
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Major Interactions

  • Barbiturates (e.g., phenobarbital) - decreased corticosteroid effect
  • Phenytoin - decreased corticosteroid effect
  • Rifampin - decreased corticosteroid effect
  • Ketoconazole - increased corticosteroid effect
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased risk of GI ulceration/bleeding
  • Warfarin - altered anticoagulant effect (monitor INR)
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment of antidiabetics
  • Diuretics (thiazide, loop) - enhanced potassium depletion, increased risk of hypokalemia
  • Cardiac glycosides (e.g., digoxin) - increased risk of digitalis toxicity with hypokalemia
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Moderate Interactions

  • Oral contraceptives - increased corticosteroid effect
  • Cyclosporine - increased levels of both drugs, increased risk of seizures
  • Aspirin (high dose) - decreased salicylate levels, increased risk of GI side effects
  • Cholestyramine - decreased corticosteroid absorption
  • Antacids - decreased corticosteroid absorption
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Minor Interactions

  • Grapefruit juice - theoretical increase in corticosteroid levels (minor effect)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Serum electrolytes (Na, K, Cl)

Rationale: Risk of fluid retention, hypokalemia.

Timing: Prior to initiation

Blood glucose

Rationale: Risk of hyperglycemia, especially in predisposed individuals.

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: For long-term therapy, risk of osteoporosis.

Timing: Prior to initiation (if long-term therapy anticipated)

Ophthalmic exam (intraocular pressure)

Rationale: Risk of glaucoma and cataracts with long-term use.

Timing: Prior to initiation (if long-term therapy anticipated)

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Routine Monitoring

Blood pressure

Frequency: Regularly (e.g., weekly to monthly, then every 3-6 months for chronic use)

Target: Normal range for age

Action Threshold: Sustained elevation requiring intervention

Serum electrolytes (Na, K)

Frequency: Periodically (e.g., monthly for initial therapy, then every 3-6 months for chronic use)

Target: Normal range

Action Threshold: Significant deviations (e.g., K < 3.5 mEq/L)

Blood glucose (fasting or HbA1c)

Frequency: Periodically (e.g., monthly for initial therapy, then every 3-6 months for chronic use)

Target: Fasting glucose < 100 mg/dL, HbA1c < 6.5%

Action Threshold: Sustained hyperglycemia requiring intervention

Weight

Frequency: Monthly

Target: Stable

Action Threshold: Significant gain (fluid retention) or loss

Growth (in children)

Frequency: Every 3-6 months

Target: Normal growth curve

Action Threshold: Growth retardation

Signs of infection

Frequency: Ongoing clinical assessment

Target: Absence of infection

Action Threshold: Fever, malaise, localized signs of infection

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Symptom Monitoring

  • Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, dizziness, hypotension) upon withdrawal or dose reduction
  • Signs of Cushing's syndrome (moon face, buffalo hump, central obesity, striae, easy bruising, muscle weakness) with chronic high doses
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Gastrointestinal upset (heartburn, indigestion, abdominal pain)
  • Sleep disturbances
  • Fluid retention (edema, weight gain)
  • Muscle weakness or pain
  • Vision changes
  • Increased thirst or urination

Special Patient Groups

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Pregnancy

Category C. Cortisone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects. Human data are limited but suggest a possible association with oral clefts, though the overall risk is low.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of oral clefts (e.g., cleft lip/palate), though data are inconsistent and overall risk is low.
Second Trimester: Generally considered safer than first trimester, but continued monitoring for fetal growth and adrenal suppression is advised.
Third Trimester: Risk of fetal adrenal suppression, especially with prolonged or high-dose use. Neonates should be monitored for signs of hypoadrenalism.
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Lactation

Cortisone (and its active metabolite hydrocortisone) is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding when used at typical therapeutic doses, but monitor the infant for adverse effects.

Infant Risk: Low risk. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, delayed development) or other adverse effects, though unlikely with typical doses. Consider administering the dose immediately after a feeding to minimize infant exposure.
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Pediatric Use

Children are more susceptible to the adverse effects of corticosteroids, including growth retardation, adrenal suppression, and increased intracranial pressure. Dosing must be carefully individualized and monitored. Long-term therapy requires regular monitoring of growth, bone density, and ophthalmic exams.

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Geriatric Use

Elderly patients may be at increased risk for adverse reactions, including osteoporosis, hypertension, diabetes, fluid retention, and psychiatric disturbances. Use with caution and the lowest effective dose. Close monitoring is essential.

Clinical Information

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Clinical Pearls

  • Cortisone is a prodrug that requires hepatic conversion to hydrocortisone for activity. This is important in patients with liver dysfunction.
  • Always taper the dose gradually when discontinuing long-term corticosteroid therapy to prevent adrenal insufficiency.
  • Administer daily doses in the morning or in divided doses (e.g., 2/3 in AM, 1/3 in PM) to mimic the body's natural cortisol rhythm and minimize adrenal suppression.
  • Patients on chronic corticosteroid therapy should be advised to carry identification indicating their steroid use.
  • Increased susceptibility to infection, especially opportunistic infections, is a significant concern with immunosuppressive doses.
  • Monitor for signs of Cushing's syndrome with chronic high-dose therapy and adrenal insufficiency upon withdrawal.
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Alternative Therapies

  • NSAIDs (for inflammatory conditions, less potent)
  • Disease-modifying antirheumatic drugs (DMARDs) for autoimmune diseases
  • Biologic agents (for autoimmune/inflammatory conditions)
  • Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.