Prednisone 10mg Tabs Pack 21s

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 (Older classification; newer labels provide risk summary)
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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 works like a natural hormone your body makes. It's used to reduce inflammation (swelling and redness) and calm down an overactive immune system. This helps treat 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 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, ask your pharmacist. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next 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 the missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Take in the morning if prescribed once daily to mimic the body's natural cortisol rhythm and reduce insomnia.
  • Do not stop taking this medicine suddenly, especially if you've been on it for more than a few days or at high doses. Your body needs time to adjust, and stopping too quickly can cause serious withdrawal symptoms. Your doctor will tell you how to slowly reduce the dose.
  • Avoid close contact with people who are sick, especially with chickenpox or measles, as your immune system may be weakened.
  • Report any signs of infection immediately.
  • Limit salt intake to help reduce fluid retention.
  • Discuss calcium and vitamin D supplementation with your doctor, especially for long-term use, to protect bone health.
  • Avoid alcohol, as it can increase the risk of stomach upset.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication, typically 5-60 mg orally once daily or in divided doses. Tapering is essential for prolonged therapy.
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 (maintenance)
multiple_sclerosis_acute_exacerbation: 200 mg/day for 7 days, then 80 mg every other day for 1 month
allergic_reactions: 20-60 mg/day, tapered over several days
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, specific indications only)
Infant: Dosing highly individualized based on weight and condition (e.g., 0.5-2 mg/kg/day)
Child: Dosing highly individualized based on weight and condition (e.g., 0.5-2 mg/kg/day, max 60 mg/day)
Adolescent: Dosing highly individualized based on weight and condition, often similar to adult dosing for specific indications.
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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 supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Caution advised; Prednisone is converted to active prednisolone in the liver. Monitor for increased effects.
Severe: Caution advised; Prednisone is converted to active prednisolone in the liver. Monitor for increased effects, consider using prednisolone directly.

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 widespread effects, including potent anti-inflammatory and immunosuppressive actions (e.g., inhibition of prostaglandin and leukotriene synthesis, reduction of leukocyte migration, suppression of humoral immunity). It also affects carbohydrate, protein, and fat metabolism, and maintains vascular tone.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.7-1.5 L/kg
ProteinBinding: Approximately 70-90% (to albumin and transcortin)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: Prednisone: 2-3 hours; Prednisolone: 2-4 hours (plasma half-life); Biological half-life: 18-36 hours
Clearance: Approximately 1.5-2.5 mL/min/kg
ExcretionRoute: Renal (primarily as inactive metabolites and conjugated forms)
Unchanged: <5% (prednisone); <10% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Within hours (for anti-inflammatory effects), but full therapeutic effect may take days depending on condition.
PeakEffect: Variable, often within 1-2 days for acute effects, longer for chronic conditions.
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily or alternate-day dosing)
Confidence: High

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 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 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 problems): 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 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, increased 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 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. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Nausea and vomiting
Increased appetite
Weight gain
Difficulty 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, 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:

  • Fever, chills, body aches, or other signs of infection
  • Severe stomach pain, black or tarry stools, or vomiting blood
  • Unusual swelling in your hands, ankles, or feet
  • Sudden weight gain
  • Shortness of breath
  • Severe mood changes (depression, anxiety, confusion, euphoria)
  • Blurred vision or eye pain
  • Increased thirst or urination
  • Muscle weakness or severe fatigue (especially if stopping the medication)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or other medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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, cerebral malaria, threadworm infestation, or any other type of infection.
* If you have any pre-existing nerve problems in the eye.

It is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This information will help them assess potential interactions between this medication and your other health conditions or medications. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

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

Be aware that medications like this one can cause high blood pressure. Your doctor will need to monitor your blood pressure as directed. 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 have a higher risk of developing osteoporosis or answer any questions you may have. Furthermore, this medication may 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 increase your potassium consumption. Consult with your doctor to determine the best course of action. If you have diabetes, it is crucial 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 vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

It is essential to exercise caution when interacting 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 infections before, avoid close contact with anyone who has them. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications, including this one, can increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and inform your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, may reactivate in patients taking medications like this one. If you have a history of these infections, inform your doctor. This medication can suppress the production of natural steroids in your body. 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 may increase the risk of side effects. If you need to discontinue this medication, your doctor will provide guidance on how to gradually taper off the dose. 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 medications like this one 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, and they may require regular growth checks. Consult with your doctor to discuss the potential risks and benefits.

This medication may harm the 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, 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, high blood sugar, and mood changes.

What to Do:

Call your doctor or poison control center (1-800-222-1222) immediately. Treatment is generally supportive; no specific antidote exists.

Drug Interactions

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Contraindicated Interactions

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

  • Barbiturates (e.g., phenobarbital) - decreased corticosteroid effect
  • Carbamazepine - decreased corticosteroid effect
  • Phenytoin - decreased corticosteroid effect
  • Rifampin - decreased corticosteroid effect
  • Ketoconazole - increased corticosteroid effect
  • Macrolide antibiotics (e.g., erythromycin) - increased corticosteroid effect
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased risk of GI ulceration/bleeding
  • Warfarin - variable effect on anticoagulant activity (monitor INR closely)
  • Diuretics (thiazide, loop) - increased risk of hypokalemia
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment
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Moderate Interactions

  • Cyclosporine - increased levels of both drugs, increased risk of seizures
  • Digoxin - increased risk of digitalis toxicity with hypokalemia
  • Oral contraceptives - increased corticosteroid effect
  • Fluoroquinolones - increased risk of tendon rupture (especially in elderly)
  • Cholestyramine - decreased prednisone absorption
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Minor Interactions

  • Antacids - may decrease prednisone absorption (separate administration)

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 patients anticipated to be on long-term therapy (>3 months) due to risk of osteoporosis.

Timing: Prior to initiation

Ophthalmic Exam (intraocular pressure)

Rationale: Risk of glaucoma and cataracts with long-term use.

Timing: Prior to initiation (for long-term therapy)

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during dose adjustments and long-term therapy (e.g., weekly initially, then monthly)

Target: <130/80 mmHg (individualized)

Action Threshold: Sustained elevation requiring intervention

Blood Glucose (Fasting or HbA1c)

Frequency: Regularly (e.g., weekly initially, then monthly/quarterly for long-term)

Target: Fasting <100 mg/dL, HbA1c <7%

Action Threshold: Persistent hyperglycemia requiring antidiabetic therapy

Electrolytes (Potassium)

Frequency: Periodically, especially with concomitant diuretics or high doses (e.g., monthly)

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia requiring supplementation

Weight and Fluid Balance

Frequency: Regularly

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain or edema

Growth (Pediatric Patients)

Frequency: Regularly (e.g., 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)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Gastrointestinal upset (heartburn, abdominal pain, black stools)
  • Fluid retention (swelling in ankles, feet, hands)
  • Muscle weakness or pain
  • Vision changes
  • Increased thirst or urination

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Prednisone crosses the placenta. Prolonged or high-dose use may lead to fetal adrenal suppression, requiring monitoring of the neonate.

Trimester-Specific Risks:

First Trimester: Possible increased risk of oral clefts (though data are conflicting and overall risk is low).
Second Trimester: Risk of fetal growth restriction and adrenal suppression.
Third Trimester: Increased risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Prednisone is excreted into breast milk in small amounts. Low-dose prednisone (e.g., <20 mg/day) is generally considered compatible with breastfeeding. For higher doses, waiting 4 hours after the dose before breastfeeding can minimize infant exposure.

Infant Risk: Low risk of adverse effects in the infant with typical therapeutic doses. Monitor for signs of adrenal suppression (e.g., poor weight gain, irritability) with prolonged high-dose maternal therapy.
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Pediatric Use

Corticosteroids can cause growth retardation in children. The lowest effective dose for the shortest duration should be used. Monitor growth velocity closely. Increased risk of adverse effects such as cataracts, glaucoma, and osteoporosis with long-term use.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Use the lowest effective dose for the shortest duration. Close monitoring is recommended.

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of not stopping prednisone abruptly due to the risk of adrenal crisis.
  • For long-term therapy, consider alternate-day dosing to minimize adrenal suppression and other side effects.
  • Administering prednisone in the morning (before 9 AM) can help mimic the body's natural diurnal cortisol rhythm and reduce insomnia.
  • Patients on long-term prednisone should be advised about calcium and vitamin D supplementation and regular bone density monitoring to prevent osteoporosis.
  • Educate patients about increased susceptibility to infections and to report any signs of illness promptly.
  • Monitor for psychiatric side effects, which can range from mood swings to severe psychosis, especially at higher doses.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., methylprednisolone, dexamethasone, hydrocortisone)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for inflammatory conditions (less potent)
  • Disease-Modifying Antirheumatic Drugs (DMARDs) for autoimmune diseases (e.g., methotrexate, biologics)
  • Immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
  • Specific targeted therapies depending on the underlying condition (e.g., bronchodilators for asthma, antihistamines for allergies)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 21 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 promptly. 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 details. 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.