Hydrocortisone 10mg Tablets

Manufacturer STRIDES PHARMA 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 Cortical Steroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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's used to treat many conditions, including hormone deficiencies (like adrenal insufficiency), inflammation, and certain immune system disorders. It helps reduce swelling, redness, itching, and allergic reactions.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take the tablet with food to help your body absorb the medication properly.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure 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 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 local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
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, usually with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially if you've been on it for a long time or at high doses. Your body needs time to adjust, and stopping abruptly can cause serious withdrawal symptoms (adrenal crisis). Your doctor will provide a tapering schedule.
  • Carry a 'steroid card' or medical alert identification if you are taking this medication for adrenal insufficiency or long-term.
  • Avoid exposure to people with infections (especially chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat) immediately.
  • Limit sodium intake to reduce fluid retention.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect 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: 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: 10 - 240 mg

Condition-Specific Dosing:

adrenal_insufficiency: 20-30 mg/day, divided
anti_inflammatory: 20-240 mg/day, divided
stress_dosing: Increased doses during stress (e.g., surgery, severe illness)
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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).
Infant: For adrenal insufficiency: 0.5-0.75 mg/kg/day or 20-25 mg/m²/day orally in 2-3 divided doses. For other conditions, dose varies widely.
Child: For adrenal insufficiency: 0.5-0.75 mg/kg/day or 20-25 mg/m²/day orally in 2-3 divided doses. For other conditions, dose varies widely.
Adolescent: Similar to adult dosing for adrenal insufficiency; for other conditions, dose varies widely based on weight/surface area or adult doses.
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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 dose adjustment based on dialysis status.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in severe hepatic impairment due to reduced metabolism and clearance.
Severe: Consider dose reduction due to reduced metabolism and clearance; monitor for increased side effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Hydrocortisone is a naturally occurring glucocorticoid. It binds to specific intracellular glucocorticoid receptors in target tissues, forming a steroid-receptor complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements), modulating the transcription of specific genes. This leads to a wide range of physiological effects, including anti-inflammatory, immunosuppressive, metabolic, and electrolyte-balancing actions. It inhibits the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppresses immune cell function, and affects carbohydrate, protein, and fat metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
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: Approximately 90% (primarily to corticosteroid-binding globulin [transcortin] and albumin), saturable at higher concentrations.
CnssPenetration: Limited, but sufficient to exert central effects.

Elimination:

HalfLife: Biological half-life: 8-12 hours (reflects duration of action); Plasma half-life: 1.5-2 hours.
Clearance: Approximately 0.5-1 L/hr/kg
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within hours (oral)
PeakEffect: 4-8 hours (anti-inflammatory effects)
DurationOfAction: 8-12 hours (physiological effects); up to 36 hours (anti-inflammatory effects)
Confidence: Medium

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, sudden 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 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 symptoms that bother you or don't go away, contact your doctor:

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

This is not a complete 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 medication is stopped suddenly)
  • Unexplained weight gain, swelling in face/neck/abdomen (Cushing's syndrome symptoms)
  • Increased thirst or urination (high blood sugar)
  • Black, tarry stools or severe stomach pain (GI bleeding)
  • Blurred vision or eye pain
  • Mood changes (severe depression, anxiety, agitation)
  • Signs of infection (fever, chills, persistent 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 have any active infections, 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

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and 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. Do not start, stop, or adjust the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor. 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; discuss this with your doctor.

Prolonged use of this medication may also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions. You may need to reduce your salt intake and take extra potassium; consult with your doctor.

If you have diabetes, it is crucial to monitor your blood sugar levels closely. Before consuming alcohol, discuss it with your doctor. If you regularly drink grapefruit juice or eat grapefruit, inform your doctor.

Do not exceed the prescribed dose, as taking more than directed may increase the risk of severe side effects. Before receiving any vaccines, 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 diseases, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, notify your doctor immediately.

Steroid medications, including this one, increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is higher with higher doses of steroids. To minimize the 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. Inform your doctor if you have a history of these infections.

This medication may decrease the natural production of 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, consult with your doctor before stopping, as you may need to gradually taper off the medication. If you have missed 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, a specific condition, inform your doctor, as this medication can cause severe and potentially fatal effects in patients 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; regular growth checks may be necessary. Consult with your doctor.

If you are a premature infant, inform your doctor, as this medication has been associated with a specific heart problem in this population.

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.

Poor Adrenal Function

Stopping this medication, taking too low a dose, or switching between dose forms can lead to severe adrenal gland problems, which can be life-threatening or fatal. 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, hyperglycemia, hypokalemia, and increased risk of infection. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity, skin thinning, muscle wasting).

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Gradual withdrawal of the drug may be necessary if chronic overdose has occurred.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection)
  • Mifepristone (antagonizes glucocorticoid effect)
  • Desmopressin (risk of hyponatremia with high doses of hydrocortisone)
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine): May decrease hydrocortisone levels, requiring dose increase.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice): May increase hydrocortisone levels, requiring dose decrease.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI ulceration/bleeding.
  • Diuretics (thiazide, loop): Increased risk of hypokalemia.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (monitor INR).
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetics.
  • Cardiac glycosides (e.g., digoxin): Increased risk of toxicity with hypokalemia.
  • Cholestyramine, colestipol: May decrease hydrocortisone absorption.
  • Cyclosporine: Increased blood levels of both drugs, increased risk of seizures.
  • Oral contraceptives/estrogens: May increase hydrocortisone levels.
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Minor Interactions

  • Antacids: May reduce absorption if taken concurrently (separate administration).

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Glucocorticoids can cause hypertension.

Timing: Before initiation and periodically.

Serum electrolytes (Na, K)

Rationale: Risk of fluid retention, hypokalemia.

Timing: Before initiation and periodically.

Blood glucose

Rationale: Risk of hyperglycemia, especially in predisposed individuals.

Timing: Before initiation and periodically.

Bone mineral density (DEXA scan)

Rationale: For patients anticipated to be on long-term therapy (e.g., >3 months) due to risk of osteoporosis.

Timing: Before initiation.

Ophthalmic exam (intraocular pressure)

Rationale: For patients anticipated to be on long-term therapy due to risk of glaucoma/cataracts.

Timing: Before initiation.

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Routine Monitoring

Blood pressure

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

Target: Individualized, typically <130/80 mmHg

Action Threshold: Sustained elevation requiring intervention.

Serum electrolytes (Na, K)

Frequency: Periodically (e.g., monthly for first few months, then every 3-6 months)

Target: Na: 135-145 mEq/L, K: 3.5-5.0 mEq/L

Action Threshold: Significant deviations (e.g., K <3.0 mEq/L or Na <130 mEq/L).

Blood glucose (fasting or HbA1c)

Frequency: Periodically (e.g., monthly for first few months, then every 3-6 months)

Target: Fasting: <100 mg/dL, HbA1c: <5.7% (non-diabetic)

Action Threshold: Persistent hyperglycemia (e.g., fasting >126 mg/dL).

Weight

Frequency: Monthly

Target: Stable

Action Threshold: Significant unexplained gain.

Growth (pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth velocity for age

Action Threshold: Growth retardation.

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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)
  • Muscle weakness or pain
  • Swelling in ankles/feet
  • Unusual bruising or skin thinning
  • Vision changes
  • Increased thirst or urination
  • Symptoms of adrenal insufficiency if tapering (fatigue, weakness, nausea, dizziness)

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. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate in animal studies, but human data are inconclusive and generally do not show a consistent pattern of major malformations.
Second Trimester: Risk of fetal growth restriction and adrenal suppression.
Third Trimester: Risk of fetal growth restriction and adrenal suppression; monitor neonate for signs of hypoadrenalism.
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Lactation

Hydrocortisone is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding when used at physiological replacement doses. For higher doses, monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) or other adverse effects.

Infant Risk: Low risk at typical doses; monitor for potential effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity carefully. Long-term use can lead to adrenal suppression, requiring careful tapering. Increased susceptibility to infections.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Hydrocortisone is the physiological replacement for cortisol in adrenal insufficiency; dosing should mimic the natural diurnal rhythm (e.g., 2/3 in AM, 1/3 in PM).
  • Patients on chronic hydrocortisone therapy for adrenal insufficiency require 'stress dosing' (increased doses) during illness, surgery, or severe physical/emotional stress to prevent adrenal crisis.
  • Never abruptly discontinue hydrocortisone, especially after prolonged use, due to the risk of iatrogenic adrenal insufficiency.
  • Educate patients on the signs and symptoms of adrenal insufficiency and the importance of carrying medical identification.
  • Long-term use requires monitoring for bone density, blood glucose, blood pressure, and ophthalmic changes.
  • Consider prophylactic measures for osteoporosis (calcium, vitamin D, bisphosphonates) in patients on long-term therapy.
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Alternative Therapies

  • Prednisone (for anti-inflammatory/immunosuppressive effects)
  • Methylprednisolone (for anti-inflammatory/immunosuppressive effects)
  • Dexamethasone (for anti-inflammatory/immunosuppressive effects, longer duration)
  • Fludrocortisone (for mineralocorticoid replacement in adrenal insufficiency, often used in combination with hydrocortisone)
  • Other anti-inflammatory agents (e.g., NSAIDs, DMARDs, biologics, depending on condition)
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Cost & Coverage

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.