Prednisone 20mg Tablets

Manufacturer ACTAVIS Active Ingredient Prednisone Tablets(PRED ni sone) Pronunciation PRED-ni-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; Anti-inflammatory Agent; Immunosuppressant
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Sep 1955
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Prednisone is a type of steroid medicine that works like a natural hormone your body makes. It helps to reduce inflammation (swelling and redness) and calm down an overactive immune system. It's used for many conditions like asthma, allergies, arthritis, and certain skin conditions.
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How to Use This Medicine

Taking Your Medication

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. Take your medication with food or milk to help your body absorb it. If you're taking it once a day, take it in the morning. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or cabinet, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets to ensure their safety. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.

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 return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medicine suddenly, especially if you've been on it for more than a few days. Your doctor will tell you how to slowly reduce the dose to prevent serious withdrawal symptoms.
  • Avoid close contact with people who are sick, especially with chickenpox or measles, as your immune system will be weaker.
  • Report any signs of infection (fever, chills, sore throat) to your doctor immediately.
  • Limit salt intake to help prevent fluid retention and high blood pressure.
  • Eat a diet rich in calcium and vitamin D, and consider supplements, especially for long-term use, to protect bone health.
  • Exercise regularly to maintain muscle strength and bone density.
  • Monitor your blood sugar if you have diabetes, as prednisone can raise blood sugar levels.
  • Carry a medical alert card or wear a bracelet if you are on long-term prednisone, indicating your steroid use.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, typically 5-60 mg orally once daily or in divided doses, depending on condition. Tapering is essential for doses >7-10 days.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

acute exacerbations of multiple sclerosis: 200 mg/day for 7 days, then 80 mg every other day for 1 month
rheumatoid arthritis: 5-10 mg/day
asthma: 40-60 mg/day for 3-10 days (acute exacerbation)
organ transplant (immunosuppression): Initial doses may be higher, then tapered to maintenance
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, risk of adrenal suppression)
Infant: 0.5-2 mg/kg/day orally in divided doses (max 60 mg/day), highly individualized based on condition.
Child: 0.5-2 mg/kg/day orally in divided doses (max 60 mg/day), highly individualized based on condition.
Adolescent: 0.5-2 mg/kg/day orally in divided doses (max 60 mg/day), highly individualized based on condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Prednisone is not significantly removed by hemodialysis. No dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Monitor for increased effects due to impaired conversion of prednisone to prednisolone (active metabolite) or impaired prednisolone clearance. Dose reduction may be necessary in severe cases.
Severe: Monitor closely for increased effects. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic glucocorticoid. It acts as a prodrug, being converted in the liver to its active metabolite, prednisolone. Prednisolone exerts its effects by binding to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) and the inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses the immune system by inhibiting the function of lymphocytes and macrophages.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours (for prednisone), 1-3 hours (for prednisolone)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.7-1.5 L/kg
ProteinBinding: Approximately 90% (to albumin and transcortin)
CnssPenetration: Limited

Elimination:

HalfLife: 2-4 hours (prednisone), 18-36 hours (biological half-life of prednisolone)
Clearance: Not readily available as a single rate, but primarily hepatic metabolism and renal excretion.
ExcretionRoute: Renal (as metabolites)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Hours (for anti-inflammatory effects), days to weeks for full immunosuppressive effects.
PeakEffect: Variable, depending on the condition being treated and the specific effect (e.g., anti-inflammatory vs. immunosuppressive).
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily or alternate-day dosing for some conditions).

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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of pancreatitis (pancreas problems), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness or fainting
+ Changes in vision
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow wound healing
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ Excessive hair growth
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Abnormal heartbeat (fast, slow, or irregular)
Chest pain or pressure
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Changes in menstrual periods
Bone or joint pain
Fatigue or weakness
Changes in vision
Confusion, difficulty focusing, or changes in behavior
Memory problems or loss
Hallucinations (seeing or hearing things that are not there)
Seizures
Burning, numbness, or tingling sensations
Severe stomach pain
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

Other Possible Side Effects

Most people do not experience serious side effects, and some may only have mild or minor side effects. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

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 stomach pain or black, tarry stools (signs of stomach ulcer/bleeding)
  • Swelling in your hands, ankles, or feet (fluid retention)
  • Unusual weight gain, especially in the face (moon face) or upper back (buffalo hump)
  • Extreme mood changes (severe depression, euphoria, anxiety, confusion)
  • Blurred vision or eye pain
  • Increased thirst or urination (signs of high blood sugar)
  • Muscle weakness or severe fatigue
  • Signs of infection (fever, chills, persistent cough, unusual pain)
  • Shortness of breath or chest 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 symptoms you experienced.
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

Additionally, to ensure safe treatment, 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 medication may interact with other conditions or substances.
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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your healthcare provider will monitor your blood work, body weight, and other laboratory tests regularly. You may also need to undergo eye pressure and bone density checks.

Be aware that medications like this one can cause high blood pressure. Your doctor will advise you on how often to check your blood pressure. Long-term use of this drug may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

Prolonged use of this medication may also lead to weak bones (osteoporosis). Your doctor can help determine if you are at a higher risk of developing osteoporosis and answer any questions you may have. Additionally, this drug may interfere with allergy skin tests, so it is vital to inform your doctor and laboratory personnel that you are taking this medication.

You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor to determine the best approach for your specific situation. If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication.

Before consuming alcohol, discuss the potential risks with your doctor. It is also important to talk to your doctor before receiving any vaccinations, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you are taking this drug, it is crucial to avoid close contact with individuals who have chickenpox or measles, especially if you have not had these illnesses before. If you are exposed to chickenpox or measles, inform your doctor immediately. Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. To minimize this 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, can reactivate in patients taking medications like this one. Inform your doctor if you have a history of these infections.

This medication can suppress your body's natural production of steroids. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stresses may be affected. You may require additional doses of steroids in these situations.

Do not stop taking this medication abruptly without consulting your doctor, as this can increase the risk of side effects. If you need to discontinue this medication, your doctor will advise you on how to gradually taper off the dosage. 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, inform 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 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 also affect growth in children and adolescents, so regular growth checks may be necessary. Consult with your doctor to determine the best approach for your specific situation.

This medication can harm an unborn baby if taken during pregnancy. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication with your doctor. If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare and usually does not cause life-threatening symptoms.
  • Symptoms may include: nausea, vomiting, stomach upset, fluid retention, electrolyte imbalances (e.g., hypokalemia), hypertension, hyperglycemia, and psychiatric disturbances (e.g., agitation, psychosis).

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. There is no specific antidote. Long-term overdose may lead to Cushingoid features and adrenal suppression, requiring gradual withdrawal.

Drug Interactions

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Contraindicated Interactions

  • Live or live-attenuated vaccines (when receiving immunosuppressive doses of corticosteroids)
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Major Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Antidiabetic agents (insulin, oral hypoglycemics) - corticosteroids can increase blood glucose, requiring dose adjustments of antidiabetics
  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine) - may decrease prednisone/prednisolone levels, reducing efficacy
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may increase prednisone/prednisolone levels, increasing risk of side effects
  • Warfarin - corticosteroids can either potentiate or inhibit anticoagulant effects; monitor INR closely
  • Digoxin - hypokalemia induced by corticosteroids can potentiate digoxin toxicity
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Moderate Interactions

  • Cyclosporine - increased risk of seizures and other CNS effects with concomitant use
  • Oral contraceptives/estrogens - may increase corticosteroid levels
  • Anticholinesterase agents (e.g., neostigmine, pyridostigmine) - severe weakness in patients with myasthenia gravis
  • Fluoroquinolones - increased risk of tendon rupture
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose (Fasting)

Rationale: Corticosteroids can induce hyperglycemia or exacerbate diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: Long-term use increases risk of osteoporosis.

Timing: Prior to initiation for anticipated long-term therapy

Ophthalmologic Exam (intraocular pressure)

Rationale: Long-term use increases risk of glaucoma and cataracts.

Timing: Prior to initiation for anticipated long-term therapy

Infection Screening (e.g., TB, fungal)

Rationale: Immunosuppression increases risk of opportunistic infections.

Timing: Prior to initiation for anticipated long-term or high-dose therapy

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Routine Monitoring

Blood Pressure

Frequency: Regularly, e.g., weekly to monthly depending on dose/duration

Target: <130/80 mmHg

Action Threshold: >140/90 mmHg or significant increase from baseline

Blood Glucose (Fasting or HbA1c)

Frequency: Weekly to monthly, then every 3-6 months for long-term use

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

Action Threshold: Fasting >126 mg/dL, HbA1c >7% (consider antidiabetic therapy)

Serum Electrolytes (especially Potassium)

Frequency: Periodically, especially during initiation or dose changes

Target: K: 3.5-5.0 mEq/L

Action Threshold: K <3.0 mEq/L

Weight

Frequency: Monthly

Target: Stable

Action Threshold: Significant weight gain (fluid retention)

Growth (Pediatric Patients)

Frequency: Every 3-6 months

Target: Normal growth velocity

Action Threshold: Growth retardation

Bone Mineral Density (DEXA scan)

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

Target: Stable or improving T-score

Action Threshold: Significant bone loss or fracture

Ophthalmologic Exam

Frequency: Annually for long-term therapy

Target: Normal intraocular pressure, no cataracts

Action Threshold: Elevated intraocular pressure, cataract formation

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Stomach pain or black/tarry stools (GI bleeding)
  • Vision changes
  • Increased thirst or urination (hyperglycemia)
  • Slow wound healing
  • Easy bruising or thinning skin

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Prednisone crosses the placenta. Studies in animals have shown teratogenic effects. Human data are limited but suggest a possible association with increased risk of oral clefts if used during the first trimester, though this risk is debated and likely small. Neonates exposed to corticosteroids in utero should be observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of oral clefts (controversial).
Second Trimester: Generally considered safer than first trimester, but still risk of fetal growth restriction and adrenal suppression.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism (e.g., hypoglycemia, hypotension).
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Lactation

Prednisone is excreted into breast milk. However, the amount is generally considered low, especially with doses up to 20 mg/day. For higher doses, waiting 4 hours after the dose before breastfeeding can minimize infant exposure. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, developmental delay) or other adverse effects.

Infant Risk: Low to moderate risk (L3). Monitor for adverse effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Long-term use requires careful monitoring of growth and development. Adrenal suppression is a significant risk, especially with prolonged or high-dose therapy. Alternate-day therapy may reduce some side effects.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, 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

  • Prednisone is a prodrug; its conversion to active prednisolone occurs in the liver. Patients with severe liver dysfunction may have reduced efficacy.
  • Always emphasize the importance of not stopping prednisone abruptly, especially after prolonged use, due to the risk of adrenal crisis.
  • Administer prednisone with food or milk to minimize gastrointestinal irritation.
  • For long-term therapy, consider alternate-day dosing to reduce adrenal suppression and other side effects, if clinically appropriate.
  • Patients on chronic prednisone should be advised about bone health (calcium, vitamin D, bisphosphonates if indicated) and regular eye exams.
  • Immunosuppressive effects mean patients are at higher risk for infections; advise prompt reporting of fever or other signs of illness.
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Alternative Therapies

  • NSAIDs (for inflammatory conditions, less potent)
  • DMARDs (Disease-Modifying Antirheumatic Drugs, for autoimmune conditions)
  • Biologic agents (for autoimmune/inflammatory conditions)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine)
  • Bronchodilators (for asthma)
  • Antihistamines (for allergies)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (20mg)
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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the medication taken, the amount, and the time it occurred.