Prednisolone Sod Phos 15mg/5ml Sol

Manufacturer EDENBRIDGE PHARMACEUTICALS Active Ingredient Prednisolone Oral Solution(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, Glucocorticoid
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Pharmacologic Class
Adrenocortical steroid
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Pregnancy Category
Category C (first trimester), Category D (prolonged use or high doses in third trimester)
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FDA Approved
Sep 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 like natural hormones your body makes. It helps reduce inflammation (swelling and redness) and calm down an overactive immune system. It's used for 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 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 feeling well.

When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

Different brands of this medication may have specific storage requirements. Some may need to be refrigerated, while others should be stored at room temperature. If you're unsure about how to store your medication, consult with your pharmacist.

Store your medication in a dry place, away from the bathroom.
* Keep all medications in a safe location, out of the reach of children and pets.

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 a missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially after long-term use. Your doctor will provide a tapering schedule to gradually reduce the dose.
  • Avoid contact with people who are sick, especially with chickenpox or measles, as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual pain) immediately.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Discuss calcium and vitamin D supplementation with your doctor for bone health, especially with long-term use.
  • Limit sodium intake to help prevent fluid retention.
  • Regular exercise (weight-bearing) can help maintain bone density.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies widely based on condition and severity, typically 5-60 mg/day orally in single or divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

acuteAsthmaExacerbation: 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
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., bronchopulmonary dysplasia).
Infant: 0.5-2 mg/kg/day orally in single or divided doses, depending on condition. Max 60 mg/day.
Child: 0.5-2 mg/kg/day orally in single or divided doses, depending on condition. Max 60 mg/day. For acute asthma: 1-2 mg/kg/day (max 60 mg/day) for 3-5 days.
Adolescent: Similar to adult dosing, 0.5-2 mg/kg/day or 5-60 mg/day, depending on condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: May require dose reduction due to decreased metabolism and clearance; monitor for increased side effects.
Severe: May require significant dose reduction due to decreased metabolism and clearance; monitor closely for increased side effects.

Pharmacology

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Mechanism of Action

Prednisolone is an active synthetic glucocorticoid. It exerts its effects by binding to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene expression. This leads to widespread anti-inflammatory and immunosuppressive actions by inhibiting the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppressing the migration of leukocytes, and reducing the activity of the immune system (e.g., decreasing lymphocyte proliferation, inhibiting cytokine production). It also affects carbohydrate, protein, and fat metabolism, and maintains vascular tone.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90%
Tmax: 1-2 hours (for prednisolone sodium phosphate, conversion to prednisolone is rapid)
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 corticosteroid-binding globulin and albumin), decreases with increasing dose.
CnssPenetration: Limited, but sufficient to cause CNS effects (e.g., mood changes).

Elimination:

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

OnsetOfAction: Within 1-2 hours (for anti-inflammatory effects, due to rapid absorption and conversion of sodium phosphate ester)
PeakEffect: 2-4 hours
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily or alternate-day dosing for some indications)

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 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 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 gland problems: 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 bumps or patches (on the skin or in the mouth)
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
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, swelling, weight gain, or breathing difficulties

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or persist, 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 about side effects, 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 tiredness, weakness, nausea, vomiting, dizziness (signs of adrenal insufficiency if stopped too quickly)
  • Increased thirst or urination (signs of high blood sugar)
  • Changes in mood or behavior (depression, anxiety, euphoria)
  • Blurred vision or eye pain
  • Any signs of infection (fever, chills, body aches, sore throat, cough)
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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.
If you have an active infection, including bacterial, viral, or fungal infections, such as amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or 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, 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 adjust the dosage of any medication without consulting your doctor first.
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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 likely recommend regular blood tests, weight checks, and other laboratory tests to monitor your health. Additionally, you may need to have your eye pressure and bone density checked periodically.

Be aware that this medication can cause high blood pressure. Your doctor will likely monitor your blood pressure regularly while you are taking this drug. This medication may also interfere with allergy skin tests, so 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 potential risk with your doctor. Furthermore, prolonged use of this medication can lead to weak bones (osteoporosis). Talk to your doctor about your individual risk factors and any concerns you may have.

You may need to reduce your salt intake and increase your potassium consumption while taking this medication. 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, as some vaccines may not be effective or may increase your risk of infection when taken with this medication.

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

Steroid medications, including this one, can increase your risk of infection. They can cause existing infections to worsen and may mask symptoms of infection, making them more challenging to diagnose. Infections can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize your risk, wash your hands frequently, avoid contact with people who have infections, colds, or flu, and inform your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, can reactivate in individuals taking medications like this one. If you have a history of either of these infections, inform your doctor.

This medication can decrease the natural production of steroids in your body. If you experience a fever, infection, surgery, or injury, consult with your doctor, as you may require additional oral steroids to help your body cope with these stresses. It is recommended that you carry a warning card indicating that you may need extra steroids in certain situations.

Do not stop taking this medication abruptly without consulting your doctor, as this can increase your risk of side effects. If you need to discontinue this medication, your doctor will likely recommend a gradual tapering schedule. If you have missed a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor immediately.

Long-term use of this medication has been associated with an increased risk of a type of cancer called Kaposi's sarcoma. Discuss this potential risk with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can affect growth in children and adolescents, so regular growth checks may be necessary. Additionally, this medication can lower sperm counts in some individuals. If you have concerns, discuss them with your doctor.

This medication can harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, inform your doctor immediately. If you are breastfeeding, discuss the potential risks and benefits 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: fluid retention, hypertension, hyperglycemia, and electrolyte imbalance. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

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

  • Barbiturates (e.g., phenobarbital)
  • Carbamazepine
  • Phenytoin
  • Rifampin
  • Ketoconazole
  • Itraconazole
  • Non-steroidal anti-inflammatory drugs (NSAIDs) - increased risk of GI ulceration/bleeding
  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Warfarin (may alter anticoagulant effect)
  • Antidiabetic agents (insulin, oral hypoglycemics) - may increase blood glucose
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Moderate Interactions

  • Cyclosporine (increased levels of both drugs)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Oral contraceptives/Estrogens (may increase prednisolone levels)
  • Fluoroquinolones (increased risk of tendon rupture)
  • Cholestyramine (may decrease prednisolone absorption)
  • Antacids (may decrease prednisolone absorption)
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Minor Interactions

  • Grapefruit juice (potential minor increase in prednisolone levels)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Risk of hypertension

Timing: Prior to initiation

Blood glucose (fasting)

Rationale: Risk of hyperglycemia/diabetes

Timing: Prior to initiation

Serum electrolytes (Na, K, Ca)

Rationale: Risk of fluid retention, hypokalemia, hypocalcemia

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: Risk of osteoporosis with long-term use

Timing: Prior to initiation for anticipated long-term therapy

Ophthalmologic exam (intraocular pressure)

Rationale: Risk of glaucoma/cataracts with long-term use

Timing: Prior to initiation for anticipated long-term therapy

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during initiation and dose changes

Target: Individualized, typically <130/80 mmHg

Action Threshold: Sustained elevation requiring intervention

Blood glucose

Frequency: Periodically, more frequently in diabetics or those at risk

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

Action Threshold: Persistent hyperglycemia requiring intervention

Serum potassium

Frequency: Periodically, especially with concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Growth (pediatric patients)

Frequency: Regularly (height, weight)

Target: Normal growth velocity for age

Action Threshold: Growth suppression

Signs of infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, unusual pain)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Hyperglycemia (increased thirst, urination, hunger)
  • Gastrointestinal upset (stomach pain, black/tarry stools)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Muscle weakness or pain
  • Vision changes
  • Difficulty sleeping
  • Adrenal insufficiency symptoms upon withdrawal (fatigue, weakness, nausea, vomiting, dizziness)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Prednisolone crosses the placenta. Category C for general use, Category D for prolonged use or high doses in the third trimester due to potential for fetal adrenal suppression.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts (though data are conflicting and overall risk is low).
Second Trimester: Generally considered safer than first or third trimester, but still monitor for fetal growth.
Third Trimester: Risk of fetal adrenal suppression, which may require monitoring of the neonate for signs of hypoadrenalism (e.g., hypoglycemia, hypotension) and temporary corticosteroid replacement therapy.
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Lactation

Prednisolone is excreted into breast milk. While generally considered compatible with breastfeeding at typical doses, monitor the infant for adverse effects such as growth suppression or signs of adrenal suppression. For high doses, consider waiting 4 hours after dose before breastfeeding to minimize infant exposure.

Infant Risk: Low to moderate risk. Potential for growth suppression, adrenal suppression, or other adverse effects in the infant, especially with high maternal doses or long-term use. Monitor infant for signs of adverse effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity closely. Long-term use can also lead to adrenal suppression, osteoporosis, and increased susceptibility to infections. 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 psychiatric disturbances. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Prednisolone sodium phosphate oral solution is particularly useful for pediatric patients or those with difficulty swallowing tablets, as it is rapidly absorbed and has a pleasant taste.
  • Always advise patients not to abruptly discontinue prednisolone, especially after prolonged therapy, due to the risk of adrenal insufficiency. A gradual tapering schedule is crucial.
  • Administer with food or milk to minimize gastrointestinal irritation.
  • Patients on long-term corticosteroid therapy should carry a steroid card or wear medical alert identification.
  • Immunosuppression is a significant concern; advise patients to avoid exposure to infections and report any signs of illness promptly.
  • Monitor for signs of Cushing's syndrome with prolonged high-dose therapy.
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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 chronic autoimmune conditions (steroid-sparing)
  • Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) for severe autoimmune or inflammatory conditions
  • Specific therapies for underlying conditions (e.g., bronchodilators for asthma, antihistamines for allergies)
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Cost & Coverage

Average Cost: $20 - $100 per 120 mL of 15mg/5mL solution
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 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 taken, the amount, and the time it happened.