Hydrocortisone 20mg Tablets

Manufacturer STRIDES 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
Adrenal corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone is a type of steroid medicine that is similar to a natural hormone your body makes. It is used to treat many conditions, including hormone deficiencies (like adrenal insufficiency), inflammation, and certain autoimmune diseases. It works by reducing inflammation and suppressing the immune system.
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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 feeling well.

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 medications, 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 scheduled dose, skip the missed dose and resume 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; do not stop abruptly without consulting your doctor, as this can lead to serious withdrawal symptoms.
  • Take with food or milk to reduce stomach upset.
  • If taking once daily, take in the morning to mimic your body's natural hormone rhythm.
  • Carry identification (e.g., medical alert card/bracelet) stating you are on steroid therapy, especially if for adrenal insufficiency.
  • Avoid exposure to infections (e.g., sick people) as your immune system may be weakened.
  • Report any signs of infection immediately.
  • Discuss 'stress dosing' with your doctor for times of illness, surgery, or severe injury.
  • Maintain a balanced diet, potentially low in sodium and high in potassium, and ensure adequate calcium and vitamin D intake for bone health.
  • Regular exercise can help maintain muscle strength and bone density.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. For adrenal insufficiency: 20-30 mg daily, usually divided (e.g., 2/3 in AM, 1/3 in PM). For anti-inflammatory/immunosuppressive: 20-240 mg daily or more, tapered as needed.
Dose Range: 20 - 240 mg

Condition-Specific Dosing:

adrenal_insufficiency: 20-30 mg/day in divided doses
anti_inflammatory_immunosuppressive: 20-240 mg/day, adjusted based on response and tapered
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Pediatric Dosing

Neonatal: Not established for general use; specific protocols for congenital adrenal hyperplasia (CAH) or other conditions.
Infant: For adrenal insufficiency (CAH): 0.5-0.75 mg/kg/day or 20-25 mg/m2/day in divided doses. For other conditions, highly variable.
Child: For adrenal insufficiency (CAH): 0.5-0.75 mg/kg/day or 20-25 mg/m2/day in divided doses. For other conditions, highly variable.
Adolescent: Dosing similar to adult for anti-inflammatory/immunosuppressive effects, or weight-based for adrenal insufficiency.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment typically required.
Moderate: May require dose reduction in severe impairment due to decreased metabolism; monitor for increased side effects.
Severe: May require dose reduction due to decreased metabolism; monitor closely for increased side effects.

Pharmacology

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Mechanism of Action

Hydrocortisone is a naturally occurring glucocorticoid. It binds to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene expression. This leads to widespread effects including potent anti-inflammatory and immunosuppressive actions, metabolic effects (gluconeogenesis, protein catabolism, fat redistribution), and mineralocorticoid effects (sodium retention, potassium excretion).
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.5-1.5 L/kg
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin [transcortin] and albumin)
CnssPenetration: Limited, but sufficient to exert central effects.

Elimination:

HalfLife: Plasma half-life: 1.5-2 hours; Biological half-life: 8-12 hours
Clearance: Approximately 0.5-1 L/hr/kg
ExcretionRoute: Primarily renal (urine)
Unchanged: <1%
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent 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 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 abdominal 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 gland problems: 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 periods.
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 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 unusual symptoms, contact your doctor for advice:

Nausea or vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Increased appetite.
* Weight gain.

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling of ankles or feet, significant weight gain (fluid retention)
  • Increased thirst, increased urination, increased hunger (signs of high blood sugar)
  • Signs of infection (fever, chills, sore throat, body aches, unusual fatigue)
  • Severe mood changes, depression, anxiety, insomnia
  • Muscle weakness, severe fatigue, dizziness, nausea, vomiting (signs of adrenal crisis if dose is too low or stopped abruptly)
  • Blurred vision or eye pain
  • Easy bruising or thinning skin
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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 conditions like amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other type of infection.
* If you have any nerve problems affecting your eyes.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will likely recommend regular blood tests to monitor your condition. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

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 the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Your doctor can help determine if you are at a higher risk of developing osteoporosis or if you have any questions about this potential side effect. You may need to reduce your salt intake and take potassium supplements, so consult with your doctor about this.

If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, discuss the potential risks with your doctor. Additionally, if you regularly drink grapefruit juice or eat grapefruit, inform your doctor, as this may interact with the medication.

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

If you have not had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even deadly in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor immediately.

Steroid medications, including this one, can increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. If you have a history of these infections, inform your doctor. This medication can also lower the levels of natural steroids in your body. If you experience a fever, infection, surgery, or injury, consult with your doctor, as you may require additional oral steroids to help your body cope with these stresses. Carry a warning card indicating that you may need extra steroids in certain situations.

If you have been taking this medication for an extended period, do not stop taking it without consulting your doctor, as you may need to gradually taper off the medication. If you have missed a dose or recently stopped taking this medication and experience symptoms such as 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 a type of cancer called Kaposi's sarcoma. Discuss this potential risk with your doctor. If you have or may have a condition called pheochromocytoma, inform your doctor, as this medication can have severe and potentially life-threatening effects in people with this condition.

Patients with cancer may be at a higher risk of developing a potentially life-threatening condition called tumor lysis syndrome (TLS). Discuss this risk 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 can affect growth in children and adolescents, so they may require regular growth checks. If you are a premature infant, inform your doctor, as this medication can increase the risk of a certain heart problem.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you took 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 any 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, hyperglycemia, hypokalemia, and increased risk of infection. Chronic overdose leads to Cushing's syndrome symptoms.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Live or live-attenuated vaccines (during immunosuppressive doses of hydrocortisone)
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Major Interactions

  • CYP3A4 inducers (e.g., Phenytoin, Rifampin, Barbiturates, Carbamazepine): May decrease hydrocortisone levels, reducing efficacy.
  • CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin): May increase hydrocortisone levels, increasing risk of side effects.
  • NSAIDs (e.g., Ibuprofen, Naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., Warfarin): Effects can be variable (increased or decreased), requiring close INR monitoring.
  • Diuretics (e.g., Thiazide, Loop diuretics): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., Insulin, Metformin): Hydrocortisone can increase blood glucose, requiring dose adjustment of antidiabetics.
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Moderate Interactions

  • Cardiac glycosides (e.g., Digoxin): Increased risk of digitalis toxicity if hypokalemia occurs.
  • Cholestyramine, Colestipol: May decrease absorption of hydrocortisone.
  • Oral contraceptives/Estrogens: May increase hydrocortisone levels by altering protein binding and metabolism.
  • Immunosuppressants (e.g., Cyclosporine): Increased risk of seizures and other CNS effects with concomitant use.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Risk of hypertension

Timing: Prior to initiation

Serum electrolytes (especially potassium)

Rationale: Risk of hypokalemia and fluid retention

Timing: Prior to initiation

Blood glucose

Rationale: Risk of hyperglycemia/diabetes

Timing: Prior to initiation

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

Rationale: If treating adrenal insufficiency or assessing suppression

Timing: Prior to initiation (if applicable)

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during dose adjustments or long-term therapy

Target: Individualized, aim for normal

Action Threshold: Sustained elevation requiring intervention

Serum electrolytes (especially potassium)

Frequency: Periodically, especially with concomitant diuretics or high doses

Target: K+ 3.5-5.0 mEq/L

Action Threshold: K+ < 3.5 mEq/L

Blood glucose (fasting or HbA1c)

Frequency: Periodically, more frequently in diabetics or those at risk

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

Action Threshold: Sustained hyperglycemia

Weight and fluid balance

Frequency: Regularly

Target: Stable weight, no edema

Action Threshold: Significant weight gain or edema

Growth in pediatric patients

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

Target: Normal growth velocity

Action Threshold: Growth retardation

Bone mineral density (DEXA scan)

Frequency: Baseline and periodically (e.g., every 1-2 years) for long-term therapy

Target: Stable bone density

Action Threshold: Significant bone loss or fracture

Ophthalmologic exam (for cataracts/glaucoma)

Frequency: Annually for long-term therapy

Target: Normal vision, intraocular pressure

Action Threshold: Development of cataracts or glaucoma

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise)
  • Signs of adrenal insufficiency (fatigue, weakness, dizziness, nausea, vomiting, hypotension) upon withdrawal or stress
  • Signs of hyperglycemia (increased thirst, urination, hunger)
  • Signs of fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes, insomnia, anxiety, depression
  • Gastrointestinal upset, abdominal pain, black/tarry stools
  • Muscle weakness, cramps
  • Skin changes (thinning, bruising, acne)

Special Patient Groups

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Pregnancy

Hydrocortisone crosses the placenta. While generally considered safe for short-term use, prolonged or high-dose use may be associated with fetal adrenal suppression and, rarely, other adverse effects. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible, though small, increased risk of oral clefts with first-trimester exposure to systemic corticosteroids. Data are conflicting.
Second Trimester: Risk of fetal adrenal suppression with prolonged high-dose use.
Third Trimester: Risk of fetal adrenal suppression with prolonged high-dose use, potentially requiring monitoring of the neonate.
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Lactation

Hydrocortisone is excreted into breast milk in small amounts. Low doses are generally considered compatible with breastfeeding. High doses or prolonged use may lead to potential adverse effects in the infant (e.g., adrenal suppression, growth retardation). Monitor the infant for signs of adverse effects.

Infant Risk: Low risk with typical doses; moderate risk with high or prolonged doses.
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid therapy. Close monitoring of growth, blood pressure, and intraocular pressure is essential. Alternate-day therapy may be considered to minimize growth suppression.

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Geriatric Use

Elderly patients may be more susceptible to the adverse effects of corticosteroids, including osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Lower doses or careful monitoring may be required.

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of not abruptly discontinuing hydrocortisone, especially after prolonged use, due to the risk of adrenal insufficiency.
  • Educate patients on 'stress dosing' for periods of illness, surgery, or trauma to prevent adrenal crisis.
  • Advise patients to take hydrocortisone in the morning to mimic the body's natural cortisol rhythm and minimize sleep disturbances.
  • Monitor for signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Long-term use requires monitoring for osteoporosis, cataracts, glaucoma, and diabetes.
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Alternative Therapies

  • Other glucocorticoids (e.g., Prednisone, Methylprednisolone, Dexamethasone, Betamethasone) for anti-inflammatory/immunosuppressive effects.
  • Mineralocorticoids (e.g., Fludrocortisone) for adrenal insufficiency (often used in combination with hydrocortisone).
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent).
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for autoimmune conditions (often used as steroid-sparing agents).
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Cost & Coverage

Average Cost: Varies, typically low per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 this medication, don't hesitate to discuss them with 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.