Prednisone 10mg** 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
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
Mar 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 by reducing inflammation and calming down the immune system. It's used to treat 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 your medication 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 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 medication suddenly, especially after long-term use. Your doctor will provide a tapering schedule to gradually 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 sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Carry a medical alert card or wear a bracelet if you are on long-term steroid therapy, indicating your need for steroids in an emergency.

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 indication and severity.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

Asthma (acute exacerbation): 40-60 mg/day for 3-10 days
Rheumatoid Arthritis: 5-10 mg/day
Multiple Sclerosis (acute exacerbation): 200 mg/day for 7 days, then taper
Allergic Reactions: 20-60 mg/day, tapered over several days
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Pediatric Dosing

Neonatal: Not established (use with caution, specific indications only)
Infant: 0.5-2 mg/kg/day orally in 1-2 divided doses (max 60 mg/day), depending on indication.
Child: 0.5-2 mg/kg/day orally in 1-2 divided doses (max 60 mg/day), depending on indication.
Adolescent: 0.5-2 mg/kg/day orally in 1-2 divided doses (max 60 mg/day), depending on indication, or adult dosing for larger adolescents.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Prednisone is a synthetic glucocorticoid. It 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 inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). It also suppresses immune responses by inhibiting leukocyte migration, reducing lymphocyte activity, and decreasing antibody production.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours (for active metabolite 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: 90-95% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited (active metabolite prednisolone does cross the blood-brain barrier)

Elimination:

HalfLife: 2-3 hours (prednisone); 18-36 hours (biological half-life of prednisolone)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Hours to days (depending on indication)
PeakEffect: Days to weeks (for chronic conditions)
DurationOfAction: 18-36 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 low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of pancreatitis (pancreas problems): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Signs of adrenal gland problems: 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, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
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.
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.
Feeling extremely tired or weak.
Changes in vision.
Confusion, difficulty concentrating, or changes in behavior.
Memory problems or loss.
Hallucinations (seeing or hearing things that are not there).
Seizures.
Abnormal sensations: burning, numbness, or tingling.
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. However, many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Nausea and vomiting.
Increased appetite.
Weight gain.
Sleep disturbances.
Restlessness.
Excessive sweating.
Dizziness or headache.

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

  • Severe stomach pain, black or tarry stools, or vomiting blood (signs of GI bleeding)
  • Swelling in your face, hands, or ankles (fluid retention)
  • Unusual weight gain
  • Extreme tiredness, weakness, nausea, vomiting, or dizziness (signs of adrenal insufficiency if stopped too quickly)
  • Blurred vision or eye pain
  • Increased thirst or urination (signs of high blood sugar)
  • New or worsening mood changes (depression, anxiety, confusion)
  • Signs of infection (fever, chills, body aches, flu symptoms, cough, painful urination)
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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

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor.

To ensure safe treatment, inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health status

Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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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 likely recommend regular blood tests, weight checks, and other laboratory tests to monitor your health. You may also need to have your eye pressure and bone density checked periodically.

Be aware that medications like this one can cause high blood pressure. Your doctor will likely advise you to have your blood pressure checked regularly. 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 drug may also lead to weak bones (osteoporosis). Your doctor can help determine if you are at a higher risk of developing osteoporosis or answer any questions you may have about this potential side effect.

This medication can interfere with allergy skin tests, so it is vital to inform your doctor and laboratory personnel that you are taking this drug. You may need to reduce your salt intake and take potassium supplements; consult with your doctor for personalized advice.

If you have diabetes, you will need to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, discuss the potential risks with your doctor. Additionally, consult with 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.

It is crucial to avoid close contact with individuals who have chickenpox or measles, as these infections can be severe or even life-threatening in people taking steroid medications like this one. If you have not had these illnesses before and are exposed to them, inform your doctor immediately. Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu. If you experience any signs of infection, notify your doctor promptly.

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 likely recommend a gradual tapering schedule. 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 promptly.

Long-term use of medications like this one 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 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; regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.

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

Overdose Symptoms:

  • Acute overdose is rare and usually does not cause life-threatening problems.
  • Symptoms may include increased side effects such as fluid retention, high blood pressure, hyperglycemia, and mood disturbances.

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Major Interactions

  • Live vaccines (risk of disseminated infection)
  • Mifepristone (antagonizes corticosteroid effect)
  • Desmopressin (increased risk of hyponatremia)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) - increased risk of GI ulceration/bleeding
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Moderate Interactions

  • Antidiabetics (may increase blood glucose, requiring dose adjustment)
  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Warfarin (may alter anticoagulant effect, monitor INR)
  • Phenytoin, Phenobarbital, Rifampin (CYP3A4 inducers, may decrease prednisone levels)
  • Ketoconazole, Itraconazole (CYP3A4 inhibitors, may increase prednisone levels)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
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Minor Interactions

  • Antacids (may decrease absorption, separate administration)
  • Oral contraceptives (may increase prednisone levels)

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 worsen existing diabetes.

Timing: Prior to initiation

Electrolytes (Potassium, Sodium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: For long-term therapy (>3 months) due to risk of osteoporosis.

Timing: Prior to initiation

Ophthalmic Exam (intraocular pressure)

Rationale: For long-term therapy due to risk of glaucoma and cataracts.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

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

Target: <130/80 mmHg

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

Blood Glucose (Fasting or HbA1c)

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

Target: <100 mg/dL (fasting), <7% (HbA1c)

Action Threshold: >126 mg/dL (fasting) or significant increase from baseline

Electrolytes (Potassium)

Frequency: Periodically, especially with concomitant diuretics or high doses.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Weight and Fluid Balance

Frequency: Regularly

Target: Stable weight, no edema

Action Threshold: Significant weight gain or edema

Growth (in children)

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

Target: Normal growth velocity

Action Threshold: Growth suppression

Signs of Infection

Frequency: Ongoing clinical assessment

Target: Absence of fever, localized infection

Action Threshold: Fever, malaise, new pain, redness, swelling

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Symptom Monitoring

  • Signs of infection (fever, sore throat, unusual fatigue, non-healing wounds)
  • Mood changes (irritability, anxiety, depression, insomnia)
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes
  • Increased thirst or urination (signs of hyperglycemia)
  • Easy bruising or thinning skin
  • Signs of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, dizziness, joint/muscle pain)

Special Patient Groups

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Pregnancy

Prednisone is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects on fetal development.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts (cleft lip/palate) if used during the first trimester, though human data are conflicting and the absolute risk is low.
Second Trimester: Generally considered safer than first trimester, but still monitor for fetal growth restriction and adrenal suppression.
Third Trimester: Risk of fetal adrenal suppression, which may require monitoring of the neonate for signs of hypoadrenalism (e.g., hypoglycemia, hypotension) after birth.
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Lactation

Prednisone is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding, especially at doses up to 20 mg/day. For higher doses, waiting 4 hours after the dose before breastfeeding can minimize infant exposure.

Infant Risk: Low risk of adverse effects in breastfed infants, but monitor for signs of adrenal suppression (e.g., poor weight gain, developmental delay) with prolonged high-dose maternal therapy.
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Pediatric Use

Children are more susceptible to the adverse effects of corticosteroids, including growth suppression, adrenal suppression, and increased intracranial pressure. Use the lowest effective dose for the shortest possible duration. Monitor growth and development closely.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, hypertension, diabetes, and fluid retention. Use with caution and monitor closely for side effects.

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 impaired conversion.
  • Always taper the dose gradually after prolonged therapy to prevent adrenal insufficiency.
  • Administer in the morning with food to mimic natural cortisol rhythm and minimize GI upset and insomnia.
  • Long-term use requires monitoring for bone density, cataracts, glaucoma, and diabetes.
  • Patients on chronic prednisone should be educated on signs of infection and adrenal crisis.
  • Consider stress-dose steroids for patients on chronic therapy undergoing surgery or severe illness.
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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) for autoimmune conditions (slower onset)
  • Biologic agents for specific inflammatory/autoimmune diseases
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (10mg)
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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.