Prednisolone 5mg Tablets

Manufacturer AUROBINDO PHARMA Active Ingredient Prednisolone Tablets(pred NISS oh lone) Pronunciation pred-NISS-oh-lone
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?

Prednisolone is a type of steroid medicine that works by reducing inflammation (swelling and redness) and calming down your 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 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. If you're taking this medication once a day, take it in the morning. Always take it with food to help your body absorb the medication properly. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel well.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When your medication is no longer needed or has 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. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember, with food. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing 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 to avoid withdrawal symptoms.
  • Avoid contact with people who are sick or have infections (like 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.
  • Discuss calcium and vitamin D supplementation with your doctor to protect bone health, especially with long-term use.
  • Carry a steroid warning card if on long-term therapy, indicating you are taking a corticosteroid.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication, typically 5-60 mg/day orally in single or divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

acuteExacerbationOfMS: 200 mg/day for 7 days, then 80 mg every other day for 1 month
rheumatoidArthritis: 5-7.5 mg/day
asthma: 40-60 mg/day for 3-10 days (acute exacerbation)
allergicReactions: 20-60 mg/day, tapered over several days
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often 0.05-0.2 mg/kg/day)
Infant: 0.1-2 mg/kg/day in 1-4 divided doses, depending on indication
Child: 0.1-2 mg/kg/day in 1-4 divided doses, depending on indication (max 80 mg/day)
Adolescent: 0.1-2 mg/kg/day in 1-4 divided doses, depending on indication (max 80 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 dialyzable; no supplemental dose needed

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution; monitor for increased effects
Severe: Use with caution; monitor for increased effects

Pharmacology

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Mechanism of Action

Prednisolone is a synthetic glucocorticoid that binds to specific intracellular glucocorticoid receptors. This complex translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins and the inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It also suppresses immune responses by inhibiting the function of leukocytes and fibroblasts.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90%
Tmax: 1-2 hours
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 90-95% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited (higher doses may achieve clinically relevant concentrations)

Elimination:

HalfLife: 2-4 hours (plasma); 18-36 hours (biological)
Clearance: Not available
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Within hours (anti-inflammatory effects)
PeakEffect: 1-2 hours (plasma concentration); days to weeks (maximal therapeutic effect for chronic conditions)
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily or alternate-day dosing)

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 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 high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal insufficiency: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of pancreatitis: severe abdominal pain, severe back pain, or severe nausea and vomiting.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black skin lesions or oral mucosal lesions.
Chest pain or pressure.
Abnormal heart rhythm (fast, slow, or irregular).
Swelling, warmth, numbness, discoloration, or pain in a leg or arm.
Menstrual changes.
Bone or joint pain.
Changes in vision.
New or worsening mental, mood, or behavioral changes.
Seizures.
Abnormal sensations (burning, numbness, or tingling).
Unexplained bruising or bleeding.
Abdominal swelling.
Severe abdominal pain.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.
New or worsening muscle weakness.
Fluid retention, characterized by swelling, weight gain, or breathing difficulties.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:

Upset stomach.
Increased appetite.
Weight gain.
Sleep disturbances.
Restlessness.
Excessive sweating.
Headache.
Fatigue or weakness.

This is not an exhaustive list of potential 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 (signs of GI bleeding)
  • Unusual weight gain, swelling in ankles/feet (fluid retention)
  • Extreme tiredness, weakness, dizziness, nausea, vomiting, loss of appetite (signs of adrenal insufficiency if stopped too quickly)
  • Blurred vision, eye pain (glaucoma, cataracts)
  • Increased thirst or urination (high blood sugar)
  • Mood changes (severe depression, euphoria, psychosis)
  • Signs of infection (fever, chills, persistent cough, painful urination, unexplained wounds)
  • Muscle weakness or cramps
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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 you experienced, including any symptoms that occurred.
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 affecting your eyes
If you have recently received or are scheduled to receive a smallpox vaccine

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health concerns with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information to Share with Your Healthcare Providers

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring your safety and proper care.

Regular Monitoring and Tests

If you are taking this medication long-term, your healthcare provider will need to monitor your blood work, body weight, and other laboratory tests regularly. You may also require regular checks of your eye pressure and bone density.

Potential Side Effects and Risks

High Blood Pressure: This medication can cause high blood pressure. Your healthcare provider will need to monitor your blood pressure regularly.
Allergy Skin Tests: This medication may affect the results of allergy skin tests. Be sure to inform your doctor and laboratory personnel that you are taking this medication.
Eye Problems: Long-term use of this medication may increase the risk of cataracts or glaucoma. Discuss this risk with your doctor.
Osteoporosis: Prolonged use of this medication may lead to weak bones (osteoporosis). Talk to your doctor about your risk factors and any concerns you may have.
Dietary Changes: You may need to reduce your salt intake and take potassium supplements. Consult with your doctor about any necessary dietary changes.
Blood Sugar Monitoring: If you have diabetes, you will need to closely monitor your blood sugar levels while taking this medication.
Alcohol Consumption: Discuss your alcohol consumption with your doctor before drinking.
Vaccinations: Before receiving any vaccines, inform your doctor that you are taking this medication, as some vaccines may not be effective or may increase the risk of infection.

Infection Risks

Chickenpox and Measles: If you have not had chickenpox or measles before, avoid close contact with anyone who has these infections. If you are exposed, inform your doctor immediately.
General Infection Risk: This medication can increase the risk of infection, which can be severe or even life-threatening. Wash your hands frequently, avoid close contact with people who have infections, and inform your doctor if you experience any signs of infection.
Reactivation of Infections: If you have a history of tuberculosis or hepatitis B, inform your doctor, as this medication may reactivate these infections.

Steroid-Related Risks

Adrenal Insufficiency: This medication may lower your body's natural steroid production. If you experience stress, such as a fever, infection, surgery, or injury, inform your doctor, as you may need additional steroid medication.
Warning Card: Carry a warning card indicating that you may require extra steroids during times of stress.
Gradual Dose Reduction: Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually reduce the dose.

Additional Risks and Precautions

Kaposi's Sarcoma: Long-term use of this medication may increase the risk of a type of cancer called Kaposi's sarcoma. Discuss this risk with your doctor.
Age-Related Risks: If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Growth Effects in Children and Teens: This medication may affect growth in children and teens. Regular growth checks may be necessary.
Effects on Sperm Count: This medication may lower sperm counts. If you have concerns, discuss them with your doctor.
Pregnancy and Breastfeeding: If you are pregnant or breastfeeding, inform your doctor, as this medication may harm the unborn baby or affect milk production. If you become pregnant while taking this medication, contact your doctor immediately.
Informing Your Baby's Doctor: 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: nausea, vomiting, stomach upset, fluid retention, high blood pressure, and temporary mood changes.

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately. Treatment is generally supportive; no specific antidote exists. Long-term overdose may lead to Cushingoid features and adrenal suppression.

Drug Interactions

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Contraindicated Interactions

  • Live or live-attenuated vaccines (during immunosuppressive doses of corticosteroids)
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Major Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Anticoagulants (warfarin - altered anticoagulant effect, monitor INR)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine - decreased prednisolone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased prednisolone levels)
  • Antidiabetic agents (insulin, oral hypoglycemics - increased blood glucose, requiring dose adjustment)
  • Cardiac glycosides (e.g., digoxin - increased risk of toxicity with hypokalemia)
  • Neuromuscular blockers (prolonged weakness/myopathy with long-term high-dose corticosteroids)
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Moderate Interactions

  • Cholestyramine, colestipol (decreased prednisolone absorption)
  • Antacids (may decrease prednisolone absorption, separate administration)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Oral contraceptives (estrogens - increased prednisolone levels)
  • Isoniazid (decreased isoniazid levels)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia.

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

Target: <130/80 mmHg

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

Blood Glucose (fasting or HbA1c)

Frequency: Weekly to monthly (depending on duration/dose), or more frequently if diabetic

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

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

Serum Electrolytes (Potassium)

Frequency: Periodically (e.g., monthly for long-term therapy)

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant weight gain (e.g., >2 kg/week)

Signs of Infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Presence of signs/symptoms of infection

Growth (pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Adrenal Function (ACTH stimulation test)

Frequency: Consider if concerns about adrenal suppression after prolonged therapy

Target: Normal cortisol response

Action Threshold: Subnormal cortisol response

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Fluid retention (edema, weight gain)
  • Muscle weakness or pain
  • Increased thirst or urination (signs of hyperglycemia)
  • Increased appetite
  • Easy bruising or thinning skin
  • Vision changes (blurred vision, halos around lights)
  • Signs of infection (fever, chills, sore throat, cough, painful urination)
  • Stomach pain or black/tarry stools (GI bleeding)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Prednisolone is classified as Pregnancy Category C.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies show teratogenicity (e.g., cleft palate). Risk of congenital malformations is generally low in humans, but careful consideration is warranted.
Second Trimester: Generally considered safer than first trimester, but still used with caution.
Third Trimester: May increase risk of fetal growth restriction, premature delivery, and transient neonatal adrenal suppression. Monitor neonates for signs of hypoadrenalism.
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Lactation

Prednisolone is excreted into breast milk. Low doses (e.g., <20 mg/day) are generally considered compatible with breastfeeding. For higher doses, consider waiting 4 hours after dose before breastfeeding to minimize infant exposure.

Infant Risk: Low risk for typical doses. Potential for growth suppression or adrenal suppression in the infant with high maternal doses or prolonged use. Monitor infant for adverse effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity carefully. Long-term use can also lead to adrenal suppression, osteoporosis, and cataracts. Use the lowest effective dose for the shortest possible duration.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Use the lowest effective dose and monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Always taper the dose of prednisolone gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
  • Take prednisolone with food or milk to minimize gastrointestinal upset.
  • Administer the daily dose in the morning to align with the body's natural cortisol rhythm and minimize sleep disturbances.
  • Patients on long-term therapy should be monitored for bone density, blood glucose, blood pressure, and ophthalmic changes.
  • Immunosuppressive doses of corticosteroids can mask signs of infection; patients should be advised to report any fever or signs of illness immediately.
  • Consider alternate-day therapy for chronic conditions to reduce side effects, if clinically appropriate.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, 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 autoimmune/inflammatory conditions)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (5mg)
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, including the amount taken and the time it happened, to ensure you receive the best possible care.