Prednisolone Sod Phos 20mg/5ml Sol

Manufacturer PHARMACEUTICAL ASSOCIATES 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; Anti-inflammatory; Immunosuppressant
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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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 by reducing inflammation (swelling and redness) and calming down the 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 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.

Measuring Your Dose

If you are taking a liquid form of this medication, measure your dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring device.

Storing Your Medication

Different brands of this medication may have specific storage requirements. Some may need to be refrigerated, while others can be stored at room temperature. If you are 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 is 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.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially if you've been on it for more than a few days or at high doses. Your doctor will tell you how to slowly reduce the dose to prevent withdrawal symptoms.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual fatigue) to your doctor immediately.
  • Limit salt intake to help prevent fluid retention.
  • Maintain adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Carry a steroid warning card or wear medical identification if on long-term therapy, indicating you are taking a corticosteroid.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies widely based on condition and severity. Typical initial doses range from 5 mg to 60 mg daily, often given as a single dose or divided doses. Tapering is usually required for chronic use.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

asthma_acute_exacerbation: 40-60 mg/day for 3-10 days
allergic_reactions: 20-60 mg/day, tapered over several days
rheumatic_disorders: 5-60 mg/day, adjusted based on response
immunosuppression: 10-60 mg/day, adjusted based on response
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution if necessary (e.g., congenital adrenal hyperplasia: 0.1-0.25 mg/kg/day)
Infant: 0.5-2 mg/kg/day (max 60 mg/day) for acute conditions, tapered. Dosing is highly individualized.
Child: 0.5-2 mg/kg/day (max 60 mg/day) for acute conditions, tapered. Dosing is highly individualized.
Adolescent: Similar to adult dosing, 0.5-2 mg/kg/day (max 60 mg/day) for acute conditions, tapered. Dosing is highly individualized.
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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 and electrolyte disturbances.
Dialysis: Not significantly removed by dialysis; no dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in severe hepatic impairment (e.g., cirrhosis) as metabolism may be impaired, leading to increased systemic exposure.
Severe: Consider dose reduction in severe hepatic impairment (e.g., cirrhosis) as metabolism may be impaired, leading to increased systemic exposure.

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) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses the immune system by inhibiting the function of lymphocytes and macrophages.
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Pharmacokinetics

Absorption:

Bioavailability: Prednisolone sodium phosphate is rapidly and well absorbed orally, converting to prednisolone. Bioavailability of prednisolone is approximately 70-90%.
Tmax: 1-2 hours (for prednisolone after oral administration of prednisolone sodium phosphate)
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, CBG), but binding is saturable at higher concentrations.
CnssPenetration: Limited, but can cross the blood-brain barrier to some extent, especially with higher doses.

Elimination:

HalfLife: 2-4 hours (plasma half-life); 18-36 hours (biological half-life, reflecting duration of pharmacologic effect)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <1% (renal excretion of unchanged drug)
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Pharmacodynamics

OnsetOfAction: Within hours (oral)
PeakEffect: Within 1-2 days for full anti-inflammatory/immunosuppressive effect, but symptomatic relief can be quicker.
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 Attention Immediately

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 or seek medical help right away:

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 gland weakness: 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 or vomiting
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
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
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

This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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 concerns or questions, 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/tarry stools, or vomiting blood (signs of GI bleeding)
  • New or worsening swelling in your ankles or feet, or sudden weight gain (fluid retention)
  • Unusual mood changes (severe depression, anxiety, confusion, hallucinations)
  • Signs of infection (fever, chills, body aches, sore throat, cough, painful urination)
  • Extreme tiredness, weakness, dizziness, or nausea/vomiting (signs of adrenal insufficiency if stopped too quickly)
  • Blurred vision or eye pain
  • Increased thirst or urination (signs of high blood sugar)
  • 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 conditions like 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 (prescription and over-the-counter), natural products, and vitamins, as well as any health problems, with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust 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 your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

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 is a possible side effect of this medication. Your doctor will need to monitor your blood pressure regularly.
This medication may interfere with allergy skin tests, so be sure to inform your doctor and laboratory personnel that you are taking it.
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 about your individual risk factors and any questions you may have.
You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor for personalized advice.
If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication.
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 your 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 inform your doctor if you have been exposed.
Steroid medications, including this one, can increase your risk of infection and make it more challenging to recognize the signs of infection. 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 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 medications like this one. Inform your doctor if you have a history of these infections.

Adrenal Insufficiency

This medication may decrease your body's natural production of steroids. 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. Carry a warning card indicating that you may need extra steroids in certain situations.

Stopping the Medication

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you 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 promptly.

Additional Risks and Considerations

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 to your baby 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 can lead to Cushingoid features (moon face, buffalo hump, central obesity), muscle weakness, osteoporosis, and increased susceptibility to infection.

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. There is no specific antidote. Long-term effects of chronic overdose require gradual withdrawal of the drug under medical supervision.

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) - decreased prednisolone effect
  • Phenytoin - decreased prednisolone effect
  • Rifampin - decreased prednisolone effect
  • Ketoconazole - increased prednisolone effect
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin) - increased prednisolone effect
  • NSAIDs (e.g., ibuprofen, naproxen) - increased risk of GI ulceration/bleeding
  • Warfarin - altered anticoagulant effect (monitor INR closely)
  • Diuretics (thiazide and loop) - increased risk of hypokalemia
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment of antidiabetics
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Moderate Interactions

  • Digoxin - increased risk of digitalis toxicity due to hypokalemia
  • Cyclosporine - increased levels of both drugs, increased risk of seizures
  • Oral contraceptives - increased prednisolone effect
  • Fluoroquinolones - increased risk of tendon rupture (especially in elderly)
  • Cholestyramine - decreased prednisolone absorption
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Minor Interactions

  • Antacids - may decrease prednisolone absorption (separate administration times)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Before initiation of therapy

Blood glucose

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Before initiation of therapy

Serum electrolytes (especially potassium)

Rationale: Corticosteroids can cause hypokalemia and fluid retention.

Timing: Before initiation of therapy

Bone mineral density (DEXA scan)

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

Timing: Before initiation of long-term therapy

Ophthalmic exam (intraocular pressure)

Rationale: For patients anticipated to be on long-term therapy due to risk of glaucoma/cataracts.

Timing: Before initiation of long-term therapy

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during initial therapy and dose changes; at least monthly for chronic therapy.

Target: Normal range for age

Action Threshold: Sustained elevation above target; consider antihypertensive therapy or dose adjustment.

Blood glucose (fasting or HbA1c)

Frequency: Weekly/bi-weekly initially, then monthly for chronic therapy; more frequently in diabetics.

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

Action Threshold: Persistent hyperglycemia; consider antidiabetic therapy or dose adjustment.

Serum electrolytes (especially potassium)

Frequency: Periodically, especially during initial therapy or with concomitant diuretics.

Target: Potassium 3.5-5.0 mEq/L

Action Threshold: Hypokalemia; consider potassium supplementation or dose adjustment.

Weight and fluid balance

Frequency: Regularly

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain or edema; consider fluid restriction, diuretics, or dose adjustment.

Signs of infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection; prompt evaluation and treatment.

Growth (pediatric patients)

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

Target: Normal growth velocity for age

Action Threshold: Growth retardation; consider alternate-day therapy or dose reduction.

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Symptom Monitoring

  • Signs of infection (fever, sore throat, cough, painful urination, unexplained fatigue)
  • Mood changes (irritability, anxiety, depression, euphoria, insomnia)
  • Gastrointestinal upset (stomach pain, black/tarry stools, vomiting blood)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Increased thirst or urination
  • Easy bruising or thinning skin
  • Delayed wound healing

Special Patient Groups

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Pregnancy

Prednisolone is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown teratogenic effects. Human data are limited but suggest a possible association with increased risk of oral clefts when used in the first trimester, though this risk is small and controversial. Neonates exposed to corticosteroids in utero should be observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of oral clefts (controversial, data are mixed).
Second Trimester: Generally considered safer than first trimester, but still monitor for fetal growth restriction.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism (e.g., hypoglycemia, hypotension).
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Lactation

Prednisolone is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding, especially at lower doses (<20 mg/day). For higher doses, consider waiting 4 hours after the dose before breastfeeding to minimize infant exposure.

Infant Risk: Low risk of adverse effects in breastfed infants, but monitor for signs of adrenal suppression (e.g., poor weight gain, developmental delay) with prolonged high-dose maternal therapy. The L2 lactation risk rating suggests it is generally safe.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Growth should be carefully monitored. Long-term use should be avoided if possible, or alternate-day therapy considered to minimize growth suppression and adrenal suppression. Increased susceptibility to infections, especially chickenpox and measles, is a concern.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, hypertension, diabetes, fluid retention, and cataracts. Lower initial doses and careful monitoring are often recommended.

Clinical Information

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Clinical Pearls

  • Always taper prednisolone doses gradually after prolonged therapy (typically >7-10 days or high doses) to prevent adrenal insufficiency.
  • Administer with food or milk to minimize gastrointestinal irritation.
  • Consider alternate-day therapy for chronic conditions to reduce side effects, especially adrenal suppression and growth retardation in children.
  • Patients on long-term corticosteroids should be advised about the risk of infection and to report any signs promptly.
  • Monitor blood glucose closely, especially in diabetic patients, as corticosteroids can significantly elevate blood sugar.
  • Educate patients about the importance of not abruptly stopping the medication and the signs of adrenal insufficiency.
  • For patients undergoing surgery or experiencing severe stress while on or recently off corticosteroids, supplemental stress-dose steroids may be required.
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Alternative Therapies

  • NSAIDs (for inflammatory conditions, less potent)
  • Disease-modifying antirheumatic drugs (DMARDs) for autoimmune diseases
  • Biologic agents (for specific inflammatory/autoimmune conditions)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine for severe autoimmune/inflammatory conditions)
  • Bronchodilators (for asthma, symptomatic relief)
  • Antihistamines (for allergic reactions, less potent)
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Cost & Coverage

Average Cost: Varies widely, typically low per 120 mL of 20mg/5ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred 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.