Prednisolone ODT 30mg Tablets

Manufacturer PRASCO 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, 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 helps reduce swelling and calm down your body's immune system. It's used for many conditions like asthma, allergies, arthritis, and skin problems. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth without water.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the morning if you're taking it once a day, and always take it with food. Continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well.

When taking this medication, make sure to:

Remove it from the blister pack only when you're ready to take it
Take it immediately after opening the blister pack
Do not store the removed medication for later use
Use dry hands to remove the tablet from the foil
Place the tablet on your tongue and let it dissolve; water is not needed
Do not swallow the tablet whole, chew, break, or crush it

Storing and Disposing of Your Medication

To store your medication properly:

Keep it at room temperature in a dry place
Avoid storing it in a bathroom
Keep all medications in a safe place, out of the reach of children and pets
Dispose of unused or expired medications
Do not flush them down the toilet or pour them down the drain unless instructed to do so
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs

Missing 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 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 once daily in the morning with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially after long-term use. Your doctor will provide a tapering schedule to gradually reduce the dose.
  • Avoid contact with people who have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual pain) to your doctor immediately.
  • Carry a steroid identification card or wear a medical alert bracelet if on long-term therapy, especially if you have adrenal insufficiency.
  • Limit sodium intake and ensure adequate calcium and vitamin D intake to help prevent bone loss, especially with long-term use.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose varies widely depending on the disease being treated and its severity. Typical initial doses range from 5 mg to 60 mg per day, often given once daily or in divided doses. For 30mg tablets, it might be used as a starting dose for moderate conditions or as part of a tapering regimen.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

asthma_exacerbation: 40-60 mg/day for 3-10 days, then taper
rheumatoid_arthritis: 5-10 mg/day, adjusted based on response
allergic_reactions: 20-60 mg/day, then taper over several days
multiple_sclerosis_exacerbation: 200 mg/day for 7 days, then 80 mg every other day for 1 month (oral equivalent of IV methylprednisolone)
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution if necessary (e.g., congenital adrenal hyperplasia: 0.1-0.2 mg/kg/day)
Infant: 0.5-2 mg/kg/day in 1-4 divided doses, depending on condition (e.g., asthma, nephrotic syndrome)
Child: 0.5-2 mg/kg/day in 1-4 divided doses, depending on condition (max 60 mg/day)
Adolescent: Dosing similar to adult, often 0.5-2 mg/kg/day (max 60 mg/day), then tapered
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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 post-dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Consider dose reduction in severe chronic liver disease (e.g., cirrhosis) due to impaired metabolism and increased half-life. Monitor for increased side effects.
Severe: Dose reduction may be necessary; monitor closely for adverse effects.

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., lipocortin-1) and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, adhesion molecules, prostaglandins, leukotrienes). It suppresses the immune system by inhibiting the function of lymphocytes, macrophages, and other immune cells, and by reducing the release of inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% (oral)
Tmax: 1-2 hours (for conventional tablets; ODT may have slightly faster dissolution but similar Tmax for systemic absorption)
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption. Taking with food can reduce gastrointestinal upset.

Distribution:

Vd: 0.22-0.7 L/kg
ProteinBinding: Approximately 90-95% (primarily to albumin and corticosteroid-binding globulin, transcortin), but binding is saturable at higher concentrations.
CnssPenetration: Limited (less than cortisol), but sufficient to cause CNS effects.

Elimination:

HalfLife: 2-4 hours (plasma half-life); 18-36 hours (biological half-life, reflecting duration of action)
Clearance: Not readily available as a single rate, but primarily hepatic metabolism.
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: Approximately 1-15% (renal excretion of unchanged drug)
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory/immunosuppressive effects)
PeakEffect: Varies by condition and dose; typically within 1-2 days for acute effects, longer for chronic conditions.
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily or every-other-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 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 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, 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.
Unusual burning, numbness, or tingling sensations.
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, characterized by swelling, weight gain, or breathing difficulties.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild 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:

Mild stomach upset.
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 swelling in hands, ankles, or feet (fluid retention)
  • Extreme mood changes (depression, anxiety, confusion, hallucinations)
  • Blurred vision or eye pain (glaucoma, cataracts)
  • Increased thirst or urination (high blood sugar)
  • Muscle weakness or severe fatigue
  • Signs of infection (fever, chills, body aches, persistent cough, painful urination)
  • Any new or worsening symptoms
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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 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
Nerve problems in the eye, as this may affect your treatment.
Recent or upcoming administration of the smallpox vaccine, as this may interact with the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you 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 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 is a possible side effect of this medication. Your doctor will need to monitor your blood pressure as directed.
This medication may interfere with 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 your risk of developing cataracts or glaucoma. Discuss this risk with your doctor.
Prolonged use may also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at higher risk or if you have any questions.
You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor for guidance.
If you have diabetes, it is essential to closely monitor your blood sugar levels.
Before consuming alcohol, discuss the potential risks with your doctor.
Prior to receiving any vaccinations, consult with 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 individuals taking steroid medications like this one. Avoid close contact with anyone who has these illnesses, and if you have been exposed, inform your doctor immediately.
Steroid medications, including this one, increase the risk of infection, which can be mild or severe. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu.
Inform your doctor immediately if you experience any signs of infection.

Reactivation of Infections

Certain infections, such as tuberculosis and hepatitis B, may reactivate in individuals taking this medication. If you have a history of these infections, inform your doctor.

Steroid Replacement

This medication may decrease the natural production of steroids in your body. If you experience a fever, infection, undergo surgery, or are injured, consult with your doctor, as you may require additional oral steroids to help your body cope with 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 discontinue the medication, your doctor will provide guidance on how to gradually taper off the dosage.
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, inform your doctor immediately.

Additional Risks and Precautions

Long-term use of this medication has been associated with an increased risk of a type of cancer called Kaposi's sarcoma. Discuss this risk with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Consult with your doctor.
This medication may decrease sperm count. If you have concerns, discuss them with your doctor.
If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as it 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 and usually does not cause life-threatening effects.
  • Symptoms may include: increased blood pressure, fluid retention, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. Long-term high doses require gradual tapering.

Drug Interactions

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Major Interactions

  • Live or live-attenuated vaccines (risk of disseminated infection in immunosuppressed patients)
  • Mifepristone (antagonizes glucocorticoid effects)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine) - may decrease prednisolone levels and efficacy
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase prednisolone levels and toxicity
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Anticoagulants (e.g., warfarin) - may alter anticoagulant effect (increase or decrease)
  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Digoxin - increased risk of digoxin toxicity due to hypokalemia
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Moderate Interactions

  • Antidiabetic agents (insulin, oral hypoglycemics) - prednisolone may increase blood glucose, requiring dose adjustment of antidiabetics
  • Cholestyramine, colestipol - may decrease prednisolone absorption
  • Cyclosporine - increased risk of seizures and other CNS effects with concurrent use
  • Neuromuscular blockers - prolonged neuromuscular blockade
  • Oral contraceptives/estrogens - may increase prednisolone levels
  • Fluoroquinolones - increased risk of tendon rupture
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Minor Interactions

  • Antacids - may reduce absorption if taken concurrently (separate administration by 2 hours)
  • Grapefruit juice - may slightly increase prednisolone levels (CYP3A4 inhibition)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose (Fasting)

Rationale: Corticosteroids can induce hyperglycemia or exacerbate diabetes.

Timing: Prior to initiation

Electrolytes (Potassium, Sodium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

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

Timing: Prior to initiation

Ophthalmic Exam (intraocular pressure)

Rationale: For patients anticipated to be on long-term therapy (>6 weeks) due to risk of glaucoma and cataracts.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

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

Target: <130/80 mmHg (individualized)

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

Blood Glucose (Fasting or HbA1c)

Frequency: Weekly initially, then monthly for long-term therapy; HbA1c every 3-6 months

Target: <100 mg/dL (fasting); <7% (HbA1c)

Action Threshold: >126 mg/dL (fasting) or significant increase from baseline

Electrolytes (Potassium)

Frequency: Periodically, especially with concomitant diuretics or high doses

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 or edema

Growth (Pediatric Patients)

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

Target: Normal growth velocity

Action Threshold: Growth retardation

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, unusual pain)
  • Hyperglycemia (increased thirst, urination, fatigue)
  • Fluid retention/edema (swelling in ankles, feet, hands)
  • Mood changes (irritability, anxiety, depression, euphoria, psychosis)
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Muscle weakness or pain
  • Vision changes (blurred vision, halos around lights)
  • Skin changes (thinning, easy bruising, acne)
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prednisolone crosses the placenta. Observational studies suggest a possible increased risk of oral clefts with first-trimester use, but data are inconsistent. Adrenal suppression in the neonate is a potential risk with prolonged or high-dose use near term.

Trimester-Specific Risks:

First Trimester: Possible, but inconsistent, association with oral clefts. Risk appears low.
Second Trimester: Generally considered safer than first or third trimester, but still use with caution.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

L3 (Moderately Safe). Prednisolone is excreted into breast milk in small amounts. Low doses (e.g., <20 mg/day) are generally considered compatible with breastfeeding. For higher doses, consider waiting 4 hours after the dose before breastfeeding to minimize infant exposure.

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

Corticosteroids can cause growth retardation in children. Monitor growth velocity closely. Use the lowest effective dose for the shortest possible duration. Risk of adrenal suppression is higher with prolonged use. Increased susceptibility to infections.

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Geriatric Use

Increased risk of adverse effects, including osteoporosis, hyperglycemia, hypertension, fluid retention, and cataracts. Use the lowest effective dose and monitor closely for side effects. Consider bone protection strategies.

Clinical Information

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Clinical Pearls

  • Always taper prednisolone doses gradually after prolonged therapy (typically >7-10 days) to prevent adrenal insufficiency. The rate of tapering depends on the dose, duration, and individual patient response.
  • Take prednisolone in the morning with food to mimic the body's natural cortisol rhythm and minimize gastrointestinal upset and sleep disturbances.
  • Patients on long-term prednisolone should be advised on strategies to prevent osteoporosis, including adequate calcium and vitamin D intake, weight-bearing exercise, and potentially bisphosphonate therapy.
  • Monitor for signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Prednisolone ODT is beneficial for patients who have difficulty swallowing pills or require rapid dissolution without water.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone)
  • 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 or inflammatory conditions
  • Specific therapies tailored to the underlying condition (e.g., bronchodilators for asthma, antihistamines for allergies)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (30mg strength)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 overdose, including the medication taken, the amount, and the time it occurred.