Prednisone 5mg Tablets

Manufacturer ROXANE 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
Corticosteroid, Anti-inflammatory, Immunosuppressant
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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?

Prednisone is a type of steroid medicine that helps 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Take this 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 this medication as directed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store this medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When you're finished with the medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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 close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medicine suddenly, especially if you've been on it for a long time. Your doctor will tell you how to slowly reduce the dose.
  • Avoid contact with people who are sick or have infections, as prednisone can weaken your immune system.
  • Report any signs of infection (fever, sore throat, unusual pain) to your doctor immediately.
  • Limit salt intake to help prevent fluid retention.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Carry a steroid identification card if on long-term therapy, indicating your need for steroids in an emergency.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, typically 5 mg to 60 mg orally once daily or in divided doses, depending on condition and severity. Tapering is often required for long-term use.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

asthma_exacerbation: 40-60 mg/day for 3-10 days
rheumatoid_arthritis: 5-10 mg/day (maintenance)
multiple_sclerosis_exacerbation: 200 mg/day for 7 days, then 80 mg every other day for 1 month
organ_transplant_immunosuppression: Initial doses up to 1 mg/kg/day, then tapered to maintenance
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Pediatric Dosing

Neonatal: Not established (use with caution, specific dosing for certain conditions like bronchopulmonary dysplasia)
Infant: Highly variable, often 0.5-2 mg/kg/day in divided doses, depending on condition.
Child: Highly variable, often 0.5-2 mg/kg/day in divided doses (max 60 mg/day), depending on condition. For asthma exacerbation: 1-2 mg/kg/day (max 60 mg/day) for 3-5 days.
Adolescent: Similar to adult dosing, often 0.5-2 mg/kg/day (max 60 mg/day), depending on condition.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Consider dose reduction as prednisone is a prodrug converted to active prednisolone in the liver. Monitor for increased effects.
Severe: Consider dose reduction. Monitor for increased effects.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic glucocorticoid. It binds to specific cytoplasmic glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then binds to glucocorticoid response elements (GREs) on DNA, modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) and inhibition of pro-inflammatory mediators (e.g., cytokines, prostaglandins, leukotrienes, adhesion molecules). It also suppresses immune responses by inhibiting the function of lymphocytes and macrophages.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.22-0.7 L/kg
ProteinBinding: Approximately 70-90% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited (but can cause CNS effects)

Elimination:

HalfLife: Prednisone: 2-3 hours; Prednisolone: 2-4 hours (biological half-life is longer, 18-36 hours)
Clearance: Approximately 1.5-2.5 mL/min/kg
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <5% (prednisone), <15% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Variable, typically within hours for anti-inflammatory effects, but full therapeutic effect may take days.
PeakEffect: Variable, depending on the condition being treated.
DurationOfAction: 18-36 hours (biological effect), despite shorter plasma half-life.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 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 a 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 sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
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.
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 period.
Bone or joint pain.
Feeling extremely tired or weak.
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 that are not normal.
Severe stomach pain.
Unexplained bruising or bleeding.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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

This is not a comprehensive list of all 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:

  • Signs of infection (fever, chills, body aches, flu-like symptoms, unusual pain or redness)
  • Severe stomach pain, black/tarry stools, or vomiting blood (signs of GI bleeding)
  • Swelling in your hands, ankles, or feet (fluid retention)
  • Unusual weight gain, especially in the face or upper back
  • Extreme mood changes (severe depression, euphoria, confusion, thoughts of self-harm)
  • Blurred vision, eye pain, or seeing halos around lights (signs of glaucoma/cataracts)
  • Muscle weakness or severe fatigue
  • Increased thirst or urination (signs of high blood sugar)
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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 as a result of the allergy.
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 the eye, as this may affect your treatment.

To ensure safe treatment, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to assess potential interactions between this medication and your other treatments or health conditions. 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. Additionally, you may need to undergo eye pressure and bone density checks.

Be aware that medications like this one can cause high blood pressure. Your doctor will instruct 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 weak bones and answer any questions you may have. Furthermore, 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 course of action. 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.

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. It is also important to note that chickenpox and measles can be severe or even life-threatening in individuals taking steroid medications like this one. If you have not had these illnesses before, avoid exposure to anyone with chickenpox or measles, and inform your doctor if you have been exposed.

Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. To minimize this risk, wash your hands frequently, avoid people with infections, colds, or flu, and inform your doctor if you experience any signs of infection. Some infections, such as tuberculosis and hepatitis B, may reactivate in individuals taking this medication. If you have a history of these infections, inform your doctor.

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, and you may require additional steroid doses.

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 instruct you on how to gradually taper off the dosage. If you have missed a dose or recently stopped taking this medication and experience 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 may affect growth in children and adolescents, so regular growth checks may be necessary. Discuss this with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as this medication may harm the unborn baby. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy. If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Severe nausea or vomiting
  • Stomach pain
  • Weakness
  • Drowsiness
  • Confusion
  • Agitation
  • Seizures

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Overdose is rare but can lead to acute adrenal crisis or severe electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

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

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine): May decrease prednisone levels, reducing efficacy.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase prednisone levels, increasing toxicity.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI ulceration and bleeding.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (either increase or decrease), requiring close INR monitoring.
  • Diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, metformin): May increase blood glucose, requiring dose adjustments of antidiabetics.
  • Cholestyramine, colestipol: May decrease prednisone absorption.
  • Cyclosporine: Increased risk of seizures and other CNS effects for both drugs.
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Moderate Interactions

  • Digoxin: Increased risk of digoxin toxicity due to hypokalemia.
  • Oral contraceptives/estrogens: May increase prednisone levels.
  • Vaccines (inactivated): Reduced immune response to vaccines.
  • Fluoroquinolones: Increased risk of tendon rupture (rare, but reported with corticosteroids).
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Minor Interactions

  • Antacids: May slightly decrease absorption (separate administration by 2 hours).

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Risk of hypertension

Timing: Before initiation

Blood glucose (fasting)

Rationale: Risk of hyperglycemia/diabetes

Timing: Before initiation

Serum electrolytes (Na, K)

Rationale: Risk of fluid retention, hypokalemia

Timing: Before initiation

Bone mineral density (DEXA scan)

Rationale: Risk of osteoporosis with long-term use

Timing: Before initiation (for anticipated long-term therapy)

Ophthalmic exam (intraocular pressure)

Rationale: Risk of glaucoma/cataracts with long-term use

Timing: Before initiation (for anticipated long-term therapy)

Weight

Rationale: Risk of fluid retention/weight gain

Timing: Before initiation

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Routine Monitoring

Blood pressure

Frequency: Regularly (e.g., weekly to monthly, depending on duration)

Target: <130/80 mmHg

Action Threshold: >140/90 mmHg or significant increase

Blood glucose (fasting or HbA1c)

Frequency: Weekly to monthly (fasting), every 3-6 months (HbA1c) for long-term use

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

Action Threshold: Fasting >126 mg/dL, HbA1c >7%

Serum electrolytes (K)

Frequency: Periodically (e.g., monthly for long-term use or with diuretics)

Target: 3.5-5.0 mEq/L

Action Threshold: <3.0 mEq/L

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant or rapid weight gain

Signs of infection

Frequency: Ongoing clinical assessment

Target: Absence of fever, localized pain, redness, swelling

Action Threshold: Presence of signs/symptoms of infection

Growth (pediatric patients)

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

Target: Normal growth velocity

Action Threshold: Growth retardation

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Symptom Monitoring

  • Signs of infection (fever, sore throat, cough, painful urination, non-healing wounds)
  • Mood changes (irritability, anxiety, depression, euphoria, psychosis)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Gastrointestinal upset (stomach pain, black/tarry stools, vomiting blood)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Increased thirst or urination (signs of hyperglycemia)
  • Difficulty sleeping
  • Easy bruising or thinning skin

Special Patient Groups

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Pregnancy

Prednisone is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts (though data is conflicting and overall risk is low).
Second Trimester: Generally considered safer than first trimester, but still used with caution.
Third Trimester: Risk of fetal adrenal suppression if used in high doses or for prolonged periods, potentially requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Prednisone is excreted into breast milk. The amount is generally low, and adverse effects in breastfed infants are unlikely with typical doses. However, high doses or prolonged use may lead to infant adrenal suppression or growth retardation.

Infant Risk: Low risk with typical doses. Monitor infant for signs of adrenal suppression (e.g., poor feeding, lethargy, weight gain issues) or growth retardation. Consider administering the dose immediately after breastfeeding or waiting 4 hours after a dose before breastfeeding to minimize infant exposure.
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid use. Close monitoring of growth and development is essential. Alternate-day therapy may reduce some side effects. Increased risk of intracranial hypertension in children.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, hypertension, diabetes, fluid retention, and cataracts. Lower initial doses and careful monitoring are often recommended.

Clinical Information

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Clinical Pearls

  • Always taper prednisone doses gradually after prolonged therapy (typically >7-10 days) to prevent adrenal insufficiency. The rate of tapering depends on the dose, duration, and individual patient response.
  • Take prednisone with food or milk to minimize gastrointestinal irritation.
  • Administer the daily dose in the morning to mimic the body's natural cortisol rhythm and minimize sleep disturbances.
  • Patients on long-term prednisone therapy should carry a steroid identification card.
  • Monitor for signs of infection, as corticosteroids can mask symptoms of inflammation and suppress the immune response.
  • Educate patients on potential mood changes and encourage them to report any significant psychological disturbances.
  • Consider bone protection strategies (calcium, vitamin D, bisphosphonates) for patients on long-term prednisone therapy.
  • Prednisone is a prodrug; its conversion to active prednisolone may be impaired in severe liver disease.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., methylprednisolone, dexamethasone, 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)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) for severe autoimmune or inflammatory conditions
  • Topical corticosteroids (for localized skin conditions)
  • Inhaled corticosteroids (for asthma/COPD)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.