Prednisone 5mg Pak 48

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
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Pharmacologic Class
Glucocorticoid Receptor Agonist; Anti-inflammatory; Immunosuppressant
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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 like a natural hormone your body makes. It's used to reduce inflammation (swelling and pain) and calm down an overactive immune system. It can treat many conditions like asthma, allergies, arthritis, and certain skin conditions.
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How to Use This Medicine

Taking Your Medication Correctly

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 cupboard, 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 consider participating in a drug take-back program 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 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.
  • Do not stop taking this medication suddenly, especially if you've been on it for more than a few days or at high doses. Your doctor will tell you how to slowly reduce the dose to prevent withdrawal symptoms.
  • 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 (fever, sore throat, body aches) to your doctor immediately.
  • Limit salt intake to help prevent fluid retention and high blood pressure.
  • Monitor blood sugar if you have diabetes, as prednisone can raise blood sugar levels.
  • Consider calcium and vitamin D supplementation for long-term use to protect bone health.
  • Wear a medical alert tag or carry an ID card stating you are taking corticosteroids, especially if on long-term therapy, in case of emergency.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, depends on condition. For Prednisone 5mg Pak 48, it's typically a tapering dose regimen, e.g., 20mg daily for 6 days, then tapering down.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

acuteExacerbationOfCOPD: 30-40 mg/day for 5-7 days, then taper
asthmaExacerbation: 40-60 mg/day for 3-10 days
rheumatoidArthritis: 5-10 mg/day (maintenance), higher for flares
allergicReactions: 20-60 mg/day, tapered over 5-10 days
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., 0.5-2 mg/kg/day)
Infant: 0.5-2 mg/kg/day, depending on condition and severity, often tapered
Child: 0.5-2 mg/kg/day, depending on condition and severity, often tapered (max 60 mg/day)
Adolescent: 0.5-2 mg/kg/day, depending on condition and severity, often tapered (max 60 mg/day)
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution; monitor for increased effects due to impaired conversion to prednisolone or reduced clearance.
Severe: Use with caution; monitor for increased effects due to impaired conversion to prednisolone or reduced clearance. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic corticosteroid and a prodrug that is 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 modulates gene expression, leading to widespread effects including inhibition of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines), suppression of immune cell function (e.g., lymphocytes, macrophages), and stabilization of lysosomal membranes. It also affects carbohydrate, protein, and fat metabolism, and maintains vascular tone.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90%
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: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: Prednisone: 2-4 hours; Prednisolone: 18-36 hours (biological half-life, reflecting duration of action)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites and some unchanged prednisolone)
Unchanged: Less than 5% (prednisone); 10-25% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Hours to days (depending on condition and dose)
PeakEffect: Days to weeks (for full therapeutic effect)
DurationOfAction: 18-36 hours (biological half-life of prednisolone)

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 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, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or belly, 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
Menstrual changes
Bone or joint pain
Extreme fatigue or weakness
Changes in vision
Confusion, difficulty concentrating, 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'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 mood changes (depression, euphoria, psychosis)
  • Swelling in the face, hands, or ankles
  • Unusual weight gain
  • Extreme fatigue or weakness
  • Vision problems (blurred vision, eye pain)
  • Black, tarry stools or severe stomach pain (signs of GI bleeding)
  • Persistent high blood sugar symptoms (increased thirst, frequent urination)
  • Signs of infection (fever, chills, persistent cough, unusual 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 allergic reaction and its symptoms.
If you have an active infection, including bacterial, viral, or fungal infections, such as amoeba infections (e.g., traveler's diarrhea), herpes infections of the eye, cerebral malaria, threadworm infestations, or any other type of infection.
* If you have nerve problems affecting your eyes.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this medication for an extended period, your doctor 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 regularly.

Be aware that medications like this one can cause high blood pressure. Your doctor will likely monitor your blood pressure regularly.

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing weak bones or if you have any questions or concerns.

This medication may interfere with allergy skin tests. Be sure 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 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 your risk of infection when taken with this medication.

It is essential to be aware that chickenpox and measles can be severe or even life-threatening in individuals taking steroid medications like this one. Avoid close contact with anyone who has chickenpox or measles if you have not had these illnesses before. If you have been exposed to chickenpox or measles, inform your doctor immediately.

Steroid medications, including this one, can increase your risk of infection. They can cause existing infections to worsen and may mask some signs of infection, making them harder to detect. Infections can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize your risk, wash your hands frequently, avoid close contact with individuals 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, can reactivate in individuals taking medications like this one. 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. 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 your risk of side effects. If you need to discontinue this medication, your doctor will likely recommend a gradual tapering schedule.

If you miss 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 immediately.

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, and they may require regular growth checks. 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, inform your baby's doctor.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor to discuss the potential risks and benefits of taking this medication. If you are breastfeeding, consult with your doctor to determine the best approach for your specific situation. 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 not life-threatening.
  • Symptoms may include: nausea, vomiting, stomach upset, fluid retention, hypertension, and electrolyte imbalances.
  • Chronic overdose can lead to Cushingoid features (moon face, buffalo hump, central obesity), muscle weakness, osteoporosis, skin thinning, and adrenal suppression.

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive. In chronic overdose, gradual withdrawal of the drug is necessary to prevent adrenal insufficiency.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)
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Major Interactions

  • Barbiturates (e.g., phenobarbital)
  • Carbamazepine
  • Phenytoin
  • Rifampin
  • Ketoconazole
  • Itraconazole
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased risk of GI ulceration/bleeding
  • Warfarin (effects can be increased or decreased)
  • Antidiabetic agents (insulin, oral hypoglycemics) - may require dose adjustment
  • Diuretics (thiazide, loop) - increased risk of hypokalemia
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs)
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Moderate Interactions

  • Oral contraceptives (estrogens) - may increase corticosteroid effects
  • Cholestyramine
  • Antacids (aluminum/magnesium hydroxide) - may decrease absorption
  • Fluoroquinolones (increased risk of tendon rupture)
  • Aprepitant
  • Diltiazem
  • Verapamil
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin)
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Minor Interactions

  • Grapefruit juice (potential for minor increase in levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause fluid retention and hypertension.

Timing: Prior to initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia.

Timing: Prior to initiation

Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects.

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 (if long-term therapy anticipated)

Ophthalmic Exam (intraocular pressure)

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

Timing: Prior to initiation (if long-term therapy anticipated)

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during initial therapy and dose changes

Target: Individualized, typically <130/80 mmHg

Action Threshold: Persistent elevation requiring intervention

Blood Glucose (Fasting or HbA1c)

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

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

Action Threshold: Persistent hyperglycemia requiring intervention (e.g., diet, oral agents, insulin)

Electrolytes (Potassium)

Frequency: Periodically, especially with concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L) requiring supplementation

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant weight gain (fluid retention)

Signs of Infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection (corticosteroids can mask symptoms)

Adrenal Function (e.g., ACTH stimulation test)

Frequency: Considered if abrupt discontinuation after prolonged high-dose therapy

Target: Normal adrenal response

Action Threshold: Evidence of adrenal suppression requiring slow taper or stress-dose steroids

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Fluid retention (swelling in ankles, hands, face)
  • Increased appetite/weight gain
  • Muscle weakness
  • Easy bruising/thinning skin
  • Vision changes
  • Increased thirst/urination (signs of hyperglycemia)
  • Signs of infection (fever, sore throat, cough, unusual pain)

Special Patient Groups

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Pregnancy

Prednisone is 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 teratogenic effects. Human data are limited but suggest a possible increased risk of oral clefts with first-trimester exposure, though this is debated. Neonates exposed to corticosteroids in utero should be observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Possible increased risk of oral clefts (controversial, data inconsistent).
Second Trimester: Potential for fetal growth restriction, but generally considered safer than first trimester.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for hypoadrenalism.
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Lactation

Prednisone (and its active metabolite prednisolone) is excreted into breast milk. The amount is generally considered low, especially with doses up to 20 mg/day. However, high doses or prolonged use may lead to adverse effects in the infant (e.g., growth suppression, adrenal suppression). The American Academy of Pediatrics considers corticosteroids compatible with breastfeeding.

Infant Risk: L3 (Moderate risk). Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) with higher maternal doses or prolonged use. Consider waiting 4 hours after a dose before breastfeeding to minimize infant exposure.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Growth should be carefully monitored. Long-term use should be avoided if possible. Children are also more susceptible to some adverse effects, including adrenal suppression and increased intracranial pressure. Lowest effective dose for the shortest duration is recommended.

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Geriatric Use

Elderly patients may be more susceptible to the adverse effects of corticosteroids, including osteoporosis, fluid retention, hypertension, diabetes, and skin thinning. Close monitoring for these effects is warranted. Lower initial doses or slower titration may be appropriate.

Clinical Information

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Clinical Pearls

  • Prednisone is a prodrug; its conversion to active prednisolone occurs in the liver. Patients with severe hepatic impairment may have reduced conversion.
  • Always emphasize the importance of not stopping prednisone abruptly, especially after prolonged use, due to the risk of adrenal insufficiency.
  • Administering prednisone in the morning (single daily dose) can help minimize adrenal suppression and mimic the body's natural cortisol rhythm.
  • For short-term use (e.g., <10-14 days), tapering may not be necessary, but always follow prescriber's instructions.
  • Patients on long-term prednisone should be advised about bone health (calcium, vitamin D, bisphosphonates if indicated) and regular eye exams.
  • Prednisone can mask signs of infection, so patients should be vigilant about any new symptoms of illness.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent)
  • Immunosuppressants (e.g., methotrexate, azathioprine, biologics) for chronic autoimmune diseases (often used as steroid-sparing agents)
  • Specific disease-modifying agents depending on the condition (e.g., bronchodilators for asthma, antihistamines for allergies)
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Cost & Coverage

Average Cost: $10 - $50 per 48 tablets (5mg Pak)
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 details. If you have any questions or concerns about your 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 information about the medication taken, the amount, and the time it happened.