Prednisone 10mg Tabs Pack 48s

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 Receptor Agonist
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Pregnancy Category
C (first trimester), D (long-term or high dose in third trimester)
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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 by reducing inflammation (swelling and redness) and calming down your immune system. It's used for many conditions like allergies, asthma, arthritis, and certain skin problems.
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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, consult your pharmacist. You may also want to check if there are any 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 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 immediately.
  • Limit salt intake to help prevent fluid retention.
  • Discuss calcium and vitamin D supplementation with your doctor for bone health, especially with long-term use.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Carry a steroid 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 depending on indication; typically 5-60 mg/day orally, often in divided doses or once daily.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

antiInflammatory: 5-30 mg/day
immunosuppressive: 30-60 mg/day or higher for acute conditions
multipleSclerosisExacerbation: 200 mg/day for 7 days, then taper
asthmaExacerbation: 40-60 mg/day for 3-10 days
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Pediatric Dosing

Neonatal: Not established (use with caution, specific dosing for certain conditions like bronchopulmonary dysplasia)
Infant: 0.5-2 mg/kg/day, depending on indication (e.g., asthma, inflammatory conditions)
Child: 0.5-2 mg/kg/day, depending on indication (max 60-80 mg/day)
Adolescent: Similar to adult dosing, or 0.5-2 mg/kg/day
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not significantly dialyzable; no supplemental dose needed

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects due to impaired conversion to prednisolone
Moderate: Consider dose reduction or use prednisolone directly, as conversion to active prednisolone may be impaired
Severe: Consider dose reduction or use prednisolone directly, as conversion to active prednisolone may be significantly impaired

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 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) by inhibiting phospholipase A2. It also suppresses the immune system by inhibiting lymphocyte proliferation and function, reducing antibody production, and decreasing the activity of phagocytic cells.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90% (oral)
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: 0.7-1.5 L/kg (prednisolone)
ProteinBinding: Approximately 90% (prednisolone), primarily to albumin and corticosteroid-binding globulin (CBG)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 2-4 hours (prednisolone, plasma half-life); 18-36 hours (biological half-life)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <5% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Within hours (oral)
PeakEffect: 1-2 hours (anti-inflammatory effects may take longer to manifest)
DurationOfAction: 18-36 hours (biological effect, allowing for once-daily dosing for some indications)

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 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 abnormal 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 adrenal insufficiency (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, 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. Many people may not experience any side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:

Upset stomach or 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain or black, tarry stools (signs of GI bleeding)
  • Swelling in your face, hands, or ankles
  • Unusual weight gain
  • Blurred vision or eye pain
  • Extreme mood changes (depression, anxiety, confusion)
  • Signs of infection (fever, chills, sore throat, body aches)
  • Severe muscle weakness
  • Persistent high blood sugar symptoms (increased thirst, urination, hunger)
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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 your 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 need to monitor your blood work, body weight, and other laboratory tests regularly. You may also require regular checks for 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. Discuss this potential risk with your doctor.

Prolonged use of this drug may also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions about this potential side effect.

This medication may interfere with allergy skin tests. Ensure that your doctor and laboratory personnel are aware 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 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 vaccinations. Certain vaccines may not be effective when taken with this medication, or they may increase the risk of infection.

It is vital to be aware that chickenpox and measles can be severe or even life-threatening in individuals taking steroid medications like this one. Avoid exposure to anyone with these illnesses if you have not previously had them. If you have been exposed, notify your doctor immediately.

Steroid medications, including this one, can increase the risk of infection. They can cause existing infections to worsen and may mask symptoms of infection, making them harder to detect. Infections associated with steroid use can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with increased doses of steroids. To minimize this risk, wash your hands frequently, avoid people with infections, colds, or flu, and notify your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, may 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, notify 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 abruptly stop taking this medication without consulting your doctor, as this may 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, notify 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 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 may 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 may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks and benefits with your doctor.

If you took this medication during pregnancy, inform your baby's doctor, as they may need to monitor your child's health.
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Overdose Information

Overdose Symptoms:

  • Severe nausea or vomiting
  • Stomach pain
  • Weakness
  • Drowsiness
  • Confusion
  • Fluid retention (swelling)
  • High blood pressure
  • High blood sugar

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Overdose is rarely life-threatening but may require supportive care and monitoring of electrolytes and glucose.

Drug Interactions

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Major Interactions

  • Live vaccines (increased risk of infection)
  • Mifepristone (antagonizes corticosteroid effects)
  • Desmopressin (increased risk of hyponatremia)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (increased risk of GI ulceration/bleeding)
  • Antidiabetic agents (may require increased dose of antidiabetic agent due to hyperglycemia)
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Moderate Interactions

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

  • Antacids (may decrease absorption, separate administration)
  • Oral contraceptives (may increase corticosteroid effects)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Before initiation

Blood Glucose (Fasting)

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Before initiation

Electrolytes (Potassium, Sodium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Before initiation

Bone Mineral Density (DEXA scan)

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

Timing: Before initiation

Ophthalmologic Exam (intraocular pressure)

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

Timing: Before initiation (for long-term use)

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Routine Monitoring

Blood Pressure

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

Target: <140/90 mmHg

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

Blood Glucose (Fasting or HbA1c)

Frequency: Regularly (e.g., weekly to monthly, more frequently if diabetic)

Target: Fasting <100 mg/dL (non-diabetic); individualized for diabetic patients

Action Threshold: Persistent hyperglycemia, new onset diabetes

Electrolytes (Potassium)

Frequency: Periodically (e.g., monthly, more frequently if on diuretics)

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Weight and Fluid Balance

Frequency: Regularly

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain, edema

Signs of Infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection (fever, malaise, localized symptoms)

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Gastrointestinal upset (heartburn, indigestion, abdominal pain)
  • Muscle weakness or pain
  • Swelling in ankles or feet
  • Increased thirst or urination
  • Blurred vision
  • Easy bruising or thinning skin
  • Signs of infection (fever, chills, sore throat, cough)

Special Patient Groups

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Pregnancy

Use during pregnancy should be carefully considered, weighing potential benefits against risks. Prednisone crosses the placenta. Category C for first trimester (animal studies show adverse effects, no adequate human studies), Category D for long-term or high dose in third trimester (risk of fetal growth restriction, adrenal suppression in neonate).

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity (e.g., cleft palate) observed in animal studies, but human data are inconclusive. Generally avoided if possible, but may be used if benefits outweigh risks.
Second Trimester: Generally considered safer than first or third trimester, but still used with caution.
Third Trimester: Risk of fetal growth restriction, premature delivery, and transient adrenal suppression in the neonate, especially with prolonged or high-dose use. Monitor neonate for signs of adrenal insufficiency.
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Lactation

Prednisone is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, especially at doses up to 20 mg/day. For higher doses, consider waiting 4 hours after dose before breastfeeding to minimize infant exposure. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, delayed development).

Infant Risk: Low risk, but monitor for potential adrenal suppression with high doses or prolonged use.
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid use. Monitor growth and development closely. 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 more susceptible to adverse effects such as osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Prednisone is a prodrug; hepatic impairment can affect its conversion to active prednisolone.
  • Always taper prednisone doses gradually to prevent adrenal crisis, especially after prolonged therapy.
  • Administering prednisone in the morning (before 9 AM) can help mimic the body's natural cortisol rhythm and minimize adrenal suppression.
  • Patients on long-term prednisone should be screened for osteoporosis and may require calcium/vitamin D supplementation and/or bisphosphonates.
  • Increased susceptibility to infections, especially fungal and viral; advise patients to report any signs of infection promptly.
  • Can cause significant mood changes, including euphoria, anxiety, and depression; counsel patients and caregivers about this possibility.
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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 (long-term management)
  • Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) for severe autoimmune or transplant indications
  • Inhaled corticosteroids for asthma/COPD (local action, fewer systemic side effects)
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Cost & Coverage

Average Cost: $10 - $30 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 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.