Prednisolone Sod Phos 5mg/5ml Sol

Manufacturer SETON 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.
đŸˇī¸
Drug Class
Adrenal corticosteroid; Anti-inflammatory agent; Immunosuppressant
đŸ§Ŧ
Pharmacologic Class
Glucocorticoid
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

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.
📋

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 to feel better.

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 can 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 dose.
💡

Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Take your dose in the morning if taking once daily, to mimic your body's natural hormone release and reduce sleep disturbances.
  • Do not stop taking this medicine suddenly, especially if you've been on it for more than a few days or at high doses. Your body needs time to adjust, and stopping abruptly can cause serious withdrawal symptoms. Your doctor will provide a tapering schedule.
  • Avoid close contact with people who are sick or have infections (like chickenpox or measles) as this medicine can weaken your immune system.
  • Report any signs of infection (fever, sore throat, unusual tiredness) immediately.
  • Limit sodium intake to help prevent fluid retention and high blood pressure.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Monitor blood sugar if you have diabetes or are at risk.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Highly variable, typically 5-60 mg/day, often tapered. Administer as a single dose or in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

Asthma (acute exacerbation): 40-60 mg/day for 3-10 days
Rheumatic disorders: 5-60 mg/day, adjusted based on response
Allergic reactions: 5-60 mg/day, often tapered over 5-10 days
Multiple Sclerosis (acute exacerbation): 200 mg/day for 7 days, then 80 mg every other day for 1 month
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use with extreme caution, specific dosing for certain conditions only)
Infant: 0.1-2 mg/kg/day, depending on condition and severity, often divided or once daily
Child: 0.1-2 mg/kg/day (max 80 mg/day), depending on condition and severity, often divided or once daily
Adolescent: 0.1-2 mg/kg/day (max 80 mg/day), depending on condition and severity, often divided or once daily
âš•ī¸

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 supplemental dose needed post-dialysis. Monitor fluid/electrolytes.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Consider dose reduction in severe chronic liver disease (e.g., cirrhosis) due to impaired metabolism
Severe: Consider dose reduction due to impaired metabolism and increased systemic exposure. Monitor closely for adverse effects.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Prednisolone is an intermediate-acting synthetic glucocorticoid. It exerts its effects by binding to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then binds to glucocorticoid response elements (GREs) on DNA, modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). It also suppresses immune responses by inhibiting leukocyte migration and function.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90%
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 0.2-1 L/kg
ProteinBinding: Approximately 90% (primarily to albumin and transcortin)
CnssPenetration: Yes, but limited; higher concentrations achieved with inflammation.

Elimination:

HalfLife: 2-4 hours (plasma half-life); 18-36 hours (biological half-life)
Clearance: Approximately 1.5-2.5 mL/min/kg
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <5%
âąī¸

Pharmacodynamics

OnsetOfAction: Hours (for anti-inflammatory effects)
PeakEffect: Days to weeks (for full therapeutic effect in chronic conditions)
DurationOfAction: 18-36 hours (biological effect)

Safety & Warnings

âš ī¸

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 and vomiting.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black skin bumps or patches, or oral lesions.
Chest pain or pressure.
Abnormal heartbeat (fast, slow, or irregular).
Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Menstrual changes.
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 possible 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of infection (fever, chills, body aches, sore throat, cough, painful urination, skin sores)
  • Severe stomach pain, black/tarry stools, or vomiting blood (signs of GI bleeding)
  • Swelling in your hands, ankles, or feet; rapid weight gain (fluid retention)
  • Unusual bruising or bleeding
  • Muscle weakness or severe fatigue
  • Blurred vision or eye pain
  • Mood changes (severe depression, anxiety, agitation, insomnia, hallucinations)
  • Increased thirst or urination (signs of high blood sugar)
  • Any new or worsening symptoms after stopping the medication (e.g., severe fatigue, weakness, nausea, vomiting, dizziness, joint/muscle pain)
📋

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 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 concerns with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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 monitor your blood work, body weight, and other laboratory tests regularly. You may also need to undergo eye pressure and bone density checks.

Be aware that high blood pressure is a potential side effect of this medication. Your doctor will advise you on how often to check your blood pressure. Additionally, this drug may interfere with allergy skin tests, so it is crucial to inform your doctor and laboratory personnel that you are taking this medication.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor. Furthermore, prolonged use may lead to weak bones (osteoporosis). Your doctor can help determine if you are at a higher risk of developing osteoporosis and answer any questions you may have.

You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor to determine the best course of action. If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication.

Before consuming alcohol, discuss the potential risks with your doctor. Similarly, consult with your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you have not had chickenpox or measles before, avoid exposure to these diseases, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications, including this one, increase the risk of infection, which can be mild or severe. To minimize this risk, wash your hands frequently, avoid people with infections, colds, or flu, and notify your doctor if you experience any signs of infection.

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.

This medication may decrease the natural steroid levels 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. 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 may increase the risk of side effects. If you need to discontinue this medication, your doctor will advise you on how to gradually stop taking it. 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.

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 may affect growth in children and adolescents, and they may require regular growth checks. Additionally, this medication may lower sperm counts, so 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.

It is essential to follow your doctor's instructions and attend all scheduled appointments to minimize the risks associated with this medication.
🆘

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

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Live or live-attenuated vaccines (in immunosuppressed patients)
  • Systemic fungal infections (unless used to control life-threatening reactions)
🔴

Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May decrease prednisolone levels, reducing efficacy.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, macrolide antibiotics like erythromycin, clarithromycin): May increase prednisolone levels, increasing risk of adverse effects.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (either increase or decrease INR), requiring close monitoring.
  • Diuretics (thiazide or loop): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics): Prednisolone can increase blood glucose, requiring dose adjustments of antidiabetics.
  • Digoxin: Increased risk of digitalis toxicity due to hypokalemia.
🟡

Moderate Interactions

  • Cholestyramine, colestipol: May decrease prednisolone absorption.
  • Oral contraceptives/estrogens: May increase prednisolone levels.
  • Cyclosporine: Increased risk of seizures and other CNS effects with concomitant use.
  • Vaccines (inactivated): Reduced immune response to vaccines.
  • Fluoroquinolones: Increased risk of tendon rupture.
đŸŸĸ

Minor Interactions

  • Antacids: May slightly decrease prednisolone absorption (separate administration by 2 hours).

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Before initiation

Weight

Rationale: Corticosteroids can cause fluid retention and weight gain.

Timing: Before initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia.

Timing: Before initiation

Blood Glucose

Rationale: Risk of hyperglycemia, especially in predisposed individuals.

Timing: Before initiation

Complete Blood Count (CBC)

Rationale: Assess baseline immune status and potential for leukocytosis.

Timing: Before initiation

Bone Mineral Density (BMD)

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

Timing: Before initiation (if long-term therapy anticipated)

Ophthalmic Exam (intraocular pressure)

Rationale: For long-term therapy due to risk of glaucoma and cataracts.

Timing: Before initiation (if long-term therapy anticipated)

📊

Routine Monitoring

Blood Pressure

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

Target: Individualized, aim for normal range

Action Threshold: Persistent elevation requiring intervention

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant, unexplained weight gain

Blood Glucose

Frequency: Regularly (e.g., weekly to monthly, more frequently in diabetics)

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

Action Threshold: Persistent hyperglycemia requiring intervention

Serum Electrolytes (especially Potassium)

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

Target: K: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia requiring supplementation

Signs of Infection

Frequency: Continuously

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

Action Threshold: New onset of fever, malaise, or localized signs of infection

Mood/Behavioral Changes

Frequency: Continuously

Target: Stable mood

Action Threshold: Significant mood swings, insomnia, anxiety, depression, psychosis

đŸ‘ī¸

Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, localized pain/redness)
  • Fluid retention (swelling in ankles/feet, shortness of breath, rapid weight gain)
  • Hyperglycemia (increased thirst, increased urination, fatigue)
  • Gastrointestinal upset (stomach pain, black/tarry stools, vomiting blood)
  • Mood changes (irritability, anxiety, depression, insomnia, euphoria)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Adrenal insufficiency symptoms upon withdrawal (fatigue, weakness, nausea, vomiting, dizziness, joint/muscle pain)

Special Patient Groups

🤰

Pregnancy

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, though data are inconsistent. Fetal growth restriction and adrenal suppression in the neonate are potential risks with prolonged or high-dose use.

Trimester-Specific Risks:

First Trimester: Possible increased risk of oral clefts (controversial, data inconsistent).
Second Trimester: Potential for fetal growth restriction with prolonged use.
Third Trimester: Risk of adrenal suppression in the neonate, requiring monitoring and potentially temporary corticosteroid replacement therapy after birth.
🤱

Lactation

Prednisolone is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, especially at low to moderate doses. Monitor the infant for adverse effects such as growth suppression or signs of adrenal suppression (e.g., poor feeding, lethargy). Administering the dose immediately after a feeding or waiting 3-4 hours may minimize infant exposure.

Infant Risk: Low (L3 - Moderately safe)
đŸ‘ļ

Pediatric Use

Corticosteroids can cause growth retardation in children. Growth should be carefully monitored. Children are also more susceptible to adrenal suppression and increased intracranial pressure. Use the lowest effective dose for the shortest possible duration. Monitor for signs of infection and bone health.

👴

Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, diabetes, hypertension, fluid retention, and psychiatric disturbances. Use with caution and monitor closely. Lower doses or longer intervals may be appropriate.

Clinical Information

💎

Clinical Pearls

  • Always taper the dose gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
  • Administer the daily dose in the morning to minimize disruption of the hypothalamic-pituitary-adrenal (HPA) axis and reduce insomnia.
  • Patients on long-term therapy should carry a steroid card or wear medical alert identification.
  • Monitor for signs of infection, as corticosteroids can mask symptoms.
  • Consider prophylactic measures for bone health (calcium, vitamin D, bisphosphonates) in patients on long-term therapy.
  • Educate patients on potential mood changes and to report them to their healthcare provider.
🔄

Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone, hydrocortisone)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent)
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for autoimmune diseases (long-term management)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) for severe autoimmune or inflammatory conditions
  • Antihistamines for allergic reactions (less potent)
💰

Cost & Coverage

Average Cost: Typically $10-$50 per 120ml bottle (5mg/5ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

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.