Prednisolone ODT 10mg Tablets

Manufacturer PRASCO LABORATORIES Active Ingredient Prednisolone Orally Disintegrating 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
Anti-inflammatory agent, Immunosuppressant
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Pharmacologic Class
Corticosteroid, 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 irritation) and calming down your body's immune system. It's used for many conditions like asthma, allergies, arthritis, and certain skin conditions. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth, making it easier to take.
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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 to you and follow the instructions closely.

If you take this medication once a day, take it in the morning.
Take your medication with food to help your body absorb it properly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

Handling and Taking Your Medication

Do not remove your medication from the blister pack until you are ready to take it.
Take your medication immediately after opening the blister pack. Do not store the removed medication for future use.
When opening the blister pack, do not push the tablet through the foil. Instead, use dry hands to carefully remove the tablet from the foil.
Place the tablet on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the tablet whole, and do not chew, break, or crush it.

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 place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them 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, with food.
If it is 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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually with food or milk to reduce stomach upset.
  • Do not stop taking suddenly, especially after long-term use, as this can cause withdrawal symptoms. Your doctor will provide a tapering schedule.
  • Avoid exposure to people with infections (especially chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat) immediately.
  • Limit sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake, and discuss bone health with your doctor, especially for long-term use.
  • Monitor blood sugar if you have diabetes or are at risk.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on condition and severity. Typical initial doses range from 5 mg to 60 mg orally once daily or in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

asthmaExacerbation: 40-60 mg/day for 3-10 days
allergicReactions: 20-60 mg/day, tapered over several days
inflammatoryConditions: 5-60 mg/day, adjusted based on response and tolerability
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution if necessary.
Infant: 0.1-2 mg/kg/day, typically once daily or divided doses, depending on condition. Max 60 mg/day.
Child: 0.1-2 mg/kg/day, typically once daily or divided doses, depending on condition. Max 60 mg/day.
Adolescent: 0.1-2 mg/kg/day, typically once daily or divided doses, depending on condition. Max 60 mg/day, or adult dosing if weight/age appropriate.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment recommended, monitor for increased effects.
Moderate: Consider dose reduction or extended dosing interval; monitor closely.
Severe: Significant dose reduction may be necessary; monitor closely for adverse effects due to decreased metabolism.

Pharmacology

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Mechanism of Action

Prednisolone is a synthetic glucocorticoid that exerts its effects by binding to specific intracellular glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It suppresses immune responses by inhibiting leukocyte migration, reducing capillary permeability, and stabilizing lysosomal membranes.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90%
Tmax: 1-2 hours (oral tablet); ODT may have slightly faster absorption onset but similar Tmax for peak systemic levels.
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.7-1.5 L/kg
ProteinBinding: Approximately 90-95% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 2-4 hours (plasma half-life); 18-36 hours (biological half-life)
Clearance: Not readily available as a single rate, varies with metabolism.
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Within hours (anti-inflammatory effects)
PeakEffect: Variable, depends on condition and duration of therapy.
DurationOfAction: 18-36 hours (biological effects)

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 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, extreme 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 mouth sores.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Changes in menstrual periods.
Bone or joint pain.
Vision changes.
New or worsening mental, mood, or behavioral changes.
Seizures.
Abnormal sensations (burning, numbness, or tingling).
Unexplained bruising or bleeding.
Abdominal swelling.
Severe stomach pain.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.
New or worsening muscle weakness.
Fluid retention, leading to swelling, weight gain, or breathing difficulties.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, some may be more bothersome. If you experience any of the following side effects or any others that concern you, contact your doctor:

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

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

  • Severe stomach pain or black/tarry stools (signs of GI bleeding)
  • Swelling in your face, hands, or ankles (fluid retention)
  • Unusual weight gain
  • Extreme mood changes (depression, anxiety, euphoria)
  • Blurred vision or eye pain
  • Increased thirst or urination (signs of high blood sugar)
  • Muscle weakness or cramps
  • Signs of infection (fever, chills, persistent sore throat, body aches)
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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 conditions to ensure safe treatment:

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.
The presence of any 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
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
Nerve problems affecting the eye
Recent or upcoming administration of the 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 issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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

Regular Monitoring

If you are taking this medication long-term, your healthcare provider will need to monitor your blood work, body weight, and other laboratory tests as directed. Additionally, you may need to have your eye pressure and bone density checked regularly.

Potential Side Effects

High blood pressure is a possible side effect of this medication. Your healthcare provider will need to check your blood pressure as directed.
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.
Long-term use of this medication may increase the risk of cataracts or glaucoma. Discuss this risk with your doctor.
Prolonged use of this medication may also lead to weak bones (osteoporosis). Talk to your doctor about your individual risk and any questions you may have.

Dietary Considerations

You may need to reduce your salt intake and take potassium supplements. Consult with your doctor about any necessary dietary changes.

Managing Other Health Conditions

If you have diabetes, you will need to closely monitor your blood sugar levels.
Before consuming alcohol, discuss the potential risks with your doctor.
Before receiving any vaccines, talk to your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Infection Risks

Chickenpox and measles can be severe or even life-threatening in people taking steroid medications like this one. Avoid exposure to anyone with these illnesses if you have not had them before. If you have been exposed, contact your doctor immediately.
Steroid medications, including this one, increase the risk of infection. They can cause existing infections to worsen and may mask signs of infection. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, wash your hands frequently, avoid people with infections, colds, or flu, and notify your doctor if you experience any signs of infection.

Reactivation of Infections

Some infections, such as tuberculosis and hepatitis B, may reactivate in patients taking this medication. Inform your doctor if you have a history of these infections.

Adrenal Insufficiency

This medication may lower the levels of natural steroids in your body. If you experience a fever, infection, surgery, or injury, consult with your doctor, as you may need additional oral steroids to help your body respond to these stresses. Carry a warning card indicating that you may require extra steroids in certain situations.

Stopping the Medication

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 taper off the medication gradually.

Missed Doses or Recently Stopped Medication

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, contact your doctor immediately.

Rare but Serious Side Effects

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.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Special Considerations

This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Consult with your doctor.
This medication may lower sperm counts. If you have concerns, discuss them with your doctor.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as this medication may harm the unborn baby. If you are breastfeeding, discuss the potential risks with your 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 but may include: nausea, vomiting, stomach upset, fluid retention, high blood pressure, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

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

  • Barbiturates (e.g., phenobarbital)
  • Carbamazepine
  • Phenytoin
  • Rifampin
  • Ketoconazole
  • Itraconazole
  • Macrolide antibiotics (e.g., erythromycin)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
  • Warfarin
  • Antidiabetic agents (insulin, oral hypoglycemics)
  • Diuretics (thiazide, loop)
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Moderate Interactions

  • Cyclosporine
  • Digoxin
  • Oral contraceptives
  • Fluoroquinolones (increased risk of tendon rupture)
  • Neuromuscular blockers
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Minor Interactions

  • Grapefruit juice (potential minor increase in levels)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: Risk of hypertension

Timing: Prior to initiation

Blood Glucose

Rationale: Risk of hyperglycemia/diabetes

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia

Timing: Prior to initiation

Complete Blood Count (CBC)

Rationale: Baseline assessment, can cause leukocytosis

Timing: Prior to initiation

Bone Mineral Density (BMD)

Rationale: Risk of osteoporosis with long-term use

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

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose adjustments and long-term therapy

Target: Normal range for age

Action Threshold: Sustained elevation requiring intervention

Blood Glucose

Frequency: Regularly, especially in diabetics or those at risk

Target: Fasting <100 mg/dL, Postprandial <140 mg/dL

Action Threshold: Persistent hyperglycemia requiring intervention

Serum Electrolytes (especially Potassium)

Frequency: Periodically, especially with concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia requiring supplementation

Growth (Pediatric Patients)

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

Target: Normal growth velocity for age

Action Threshold: Growth suppression

Ophthalmic Exam (intraocular pressure, cataracts)

Frequency: Annually (for long-term therapy >6 weeks)

Target: Normal

Action Threshold: Elevated IOP, cataract formation

Signs of Infection

Frequency: Ongoing clinical assessment

Target: Absence of fever, localized infection

Action Threshold: Fever, malaise, localized pain/redness

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Symptom Monitoring

  • Signs of infection (fever, sore throat, unusual fatigue)
  • Mood changes (irritability, depression, euphoria)
  • Sleep disturbances
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Gastrointestinal upset (stomach pain, heartburn)
  • Muscle weakness or pain
  • Vision changes
  • Increased thirst or urination (signs of hyperglycemia)
  • Easy bruising or skin thinning

Special Patient Groups

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Pregnancy

Prednisolone is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placenta.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible association with oral clefts, though overall risk is low and controversial.
Second Trimester: Risk of fetal growth restriction and adrenal suppression with prolonged high-dose use.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Prednisolone is excreted into breast milk. However, the amount is generally considered low, and short-term use or low doses are usually compatible with breastfeeding. Monitor infant for adverse effects.

Infant Risk: Low risk. Consider waiting 4 hours after a dose before breastfeeding to minimize infant exposure, especially with higher doses.
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Pediatric Use

Children are more susceptible to growth suppression and adrenal suppression with long-term corticosteroid use. Monitor growth velocity and consider alternate-day therapy if possible. Increased risk of intracranial hypertension.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, hypertension, diabetes, fluid retention, and cataracts. Use the lowest effective dose for the shortest duration possible. Monitor closely.

Clinical Information

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Clinical Pearls

  • Prednisolone ODT is beneficial for patients who have difficulty swallowing tablets or for rapid administration.
  • Always advise patients not to stop prednisolone abruptly, especially after prolonged use, due to the risk of adrenal insufficiency.
  • Administer with food or milk to minimize gastrointestinal irritation.
  • Consider alternate-day therapy for long-term use to reduce adrenal suppression and other side effects.
  • Educate patients on signs of infection and to report them immediately, as corticosteroids can mask symptoms.
  • For patients on long-term therapy, consider bone protection strategies (calcium, vitamin D, bisphosphonates) and regular eye exams.
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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 diseases (long-term management)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) for severe autoimmune/inflammatory conditions
  • Specific therapies for underlying conditions (e.g., bronchodilators for asthma, antihistamines for allergies)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.