Prednisolone 15mg/5ml Solution

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
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
FDA Approved
Jan 1970
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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 a natural hormone 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 to feel well.

When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually with food or milk to reduce stomach upset.
  • Do not stop taking suddenly, especially after long-term use, as this can cause serious withdrawal symptoms. Your doctor will tell you how to slowly reduce the dose.
  • 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) immediately.
  • Monitor blood sugar if you have diabetes, as this medication can raise it.
  • Maintain a diet rich in calcium and vitamin D, and consider supplements, especially with long-term use, to protect bone health.
  • Limit sodium intake to help prevent fluid retention and high blood pressure.
  • Regular exercise, if appropriate, can help maintain muscle strength and bone density.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies widely based on indication and severity. Typical initial doses range from 5 mg to 60 mg orally per day, often given as a single dose or in divided doses. Dosing is then tapered based on clinical response.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

antiInflammatory: 5-60 mg/day orally, tapered as needed
immunosuppressive: 30-60 mg/day orally, tapered as needed
acuteExacerbations: Higher initial doses (e.g., 40-60 mg/day) for short courses (3-10 days)
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and specific indication (e.g., bronchopulmonary dysplasia). Dosing is highly individualized.
Infant: 0.1-2 mg/kg/day orally in 1-4 divided doses, or 30-60 mg/m²/day. Dosing is highly individualized based on indication and response.
Child: 0.1-2 mg/kg/day orally in 1-4 divided doses, or 30-60 mg/m²/day. Max 80 mg/day. Dosing is highly individualized based on indication and response.
Adolescent: Similar to adult dosing, 0.1-2 mg/kg/day orally in 1-4 divided doses, or 30-60 mg/m²/day. Max 80 mg/day. Dosing is highly individualized based on indication and response.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Prednisolone is not significantly removed by hemodialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required, but monitor for increased systemic effects due to reduced metabolism.
Severe: Consider dose reduction and monitor closely for increased systemic effects due to significantly reduced metabolism.

Pharmacology

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Mechanism of Action

Prednisolone is a synthetic glucocorticoid that exerts its effects by binding to intracellular glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression, leading to widespread effects on metabolism, inflammation, and immune responses. It inhibits the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppresses immune cell function (e.g., lymphocytes, macrophages), and stabilizes lysosomal membranes.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.22-0.7 L/kg
ProteinBinding: 70-90% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited (crosses blood-brain barrier to some extent)

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 hours (anti-inflammatory effects)
PeakEffect: 4-8 hours (anti-inflammatory effects)
DurationOfAction: 18-36 hours (biological half-life, allowing for once-daily dosing for some indications)

Safety & Warnings

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Side Effects

Urgent 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 or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal 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.
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 many people may not experience any or may only have mild symptoms. If you're concerned about any of the following side effects or if they 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 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, or vomiting blood (signs of GI bleeding)
  • Unusual swelling of the face, ankles, or hands (fluid retention)
  • Extreme fatigue, weakness, dizziness, nausea, vomiting, or loss of appetite (signs of adrenal insufficiency, especially if stopping suddenly)
  • Blurred vision, eye pain, or seeing halos around lights (signs of glaucoma or cataracts)
  • Increased thirst or urination (signs of high blood sugar)
  • Any signs of infection (fever, chills, body aches, sore throat, cough, painful urination)
  • Severe mood changes, depression, or thoughts of self-harm
  • 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, vitamins, and health issues 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 Warnings and 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 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.

Be aware that medications like this one can cause high blood pressure. Your doctor will need to monitor your blood pressure as directed.

This medication may interfere with allergy skin tests, so it is crucial to inform your doctor and laboratory personnel that you are taking it.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at higher risk or have any questions.

You may need to reduce your salt intake and take potassium supplements. Consult with your doctor to determine the best course of action.

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 the risk of infection when taken with this medication.

If you are taking this medication, it is crucial to avoid exposure to chickenpox or measles, as these infections can be severe or even fatal. If you have not had these infections before, avoid contact with anyone who has them. If you have been exposed, inform your doctor immediately.

Medications like this one can 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, 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.

In some cases, medications like this one can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections.

This medication can lower the levels of natural steroids in your body. If you experience a fever, infection, surgery, or injury, inform 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 can increase the 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 miss 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.

Long-term use of medications like this one 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.

In some cases, this medication can affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this potential risk with your doctor.

This medication may lower sperm counts. If you have concerns, discuss them with your doctor.

If you are pregnant or become pregnant while taking this medication, 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 to ensure the best possible care for your child.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare and usually not life-threatening. Symptoms may include: fluid retention, hypertension, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity), muscle weakness, osteoporosis, and increased susceptibility to infection.

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Major Interactions

  • Live vaccines (risk of disseminated infection)
  • Mifepristone (antagonizes corticosteroid effects)
  • Desmopressin (increased risk of hyponatremia)
  • Non-depolarizing neuromuscular blockers (prolonged blockade with high-dose corticosteroids)
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates - may decrease prednisolone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - may increase prednisolone levels)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • Warfarin (may alter anticoagulant effect, monitor INR)
  • Antidiabetic agents (may increase blood glucose, requiring dose adjustment of antidiabetics)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Fluoroquinolones (increased risk of tendon rupture)
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Minor Interactions

  • Oral contraceptives (may increase prednisolone levels)
  • Antacids (may decrease absorption, separate administration)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: Long-term use increases risk of osteoporosis.

Timing: Prior to initiation for anticipated long-term therapy

Ophthalmologic Exam (intraocular pressure)

Rationale: Long-term use increases risk of glaucoma and cataracts.

Timing: Prior to initiation for anticipated long-term therapy

Tuberculosis (TB) screening

Rationale: Immunosuppression can reactivate latent TB.

Timing: Prior to initiation for anticipated long-term therapy in at-risk patients

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during dose adjustments or long-term therapy (e.g., weekly to monthly)

Target: <130/80 mmHg (or patient-specific target)

Action Threshold: Sustained elevation requiring intervention

Blood Glucose (Fasting or HbA1c)

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

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

Action Threshold: Persistent hyperglycemia requiring antidiabetic therapy

Serum Electrolytes (Na, K)

Frequency: Periodically, especially during initial therapy or with concomitant diuretics (e.g., monthly to quarterly)

Target: Na: 135-145 mEq/L, K: 3.5-5.0 mEq/L

Action Threshold: Significant deviations (e.g., K <3.0 mEq/L)

Growth (in pediatric patients)

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

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Signs of Infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection, especially opportunistic infections

Bone Mineral Density (DEXA scan)

Frequency: Every 1-2 years for long-term therapy

Target: T-score >-2.5

Action Threshold: Significant bone loss or fracture

Ophthalmologic Exam

Frequency: Annually for long-term therapy

Target: Normal intraocular pressure, absence of cataracts

Action Threshold: Elevated IOP or cataract formation

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue, non-healing wounds)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria, insomnia)
  • Muscle weakness or pain
  • Stomach pain, black/tarry stools (GI bleeding)
  • Vision changes (blurred vision, eye pain)
  • Increased thirst or urination (hyperglycemia)
  • Easy bruising or thinning skin
  • Slow wound healing
  • Facial puffiness (moon face)
  • Development of new or worsening psychiatric symptoms
  • Symptoms of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, dizziness, joint pain)

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. It crosses the placenta.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations. Some studies suggest a slightly increased risk of oral clefts, but data are inconsistent.
Second Trimester: Risk of fetal growth restriction, premature delivery, and adrenal suppression in the neonate with prolonged high-dose use.
Third Trimester: Increased risk of fetal growth restriction, premature delivery, and neonatal adrenal insufficiency (which may require temporary corticosteroid replacement in the neonate).
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Lactation

Prednisolone is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding, especially at doses up to 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, especially with typical doses. Monitor for signs of adrenal suppression (e.g., poor weight gain, irritability) with prolonged high-dose maternal therapy.
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Pediatric Use

Children are more susceptible to the adverse effects of corticosteroids, including growth suppression, adrenal suppression, and increased intracranial pressure. Long-term use should be carefully monitored for growth and development. Alternate-day therapy may reduce some side effects.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always taper prednisolone doses gradually after prolonged therapy (typically >10-14 days) to prevent adrenal insufficiency.
  • Administer prednisolone with food or milk to minimize gastrointestinal upset.
  • Consider alternate-day dosing for long-term therapy to reduce adrenal suppression and other side effects, if clinically appropriate.
  • Patients on long-term corticosteroids should carry a steroid card or wear medical alert identification.
  • Be vigilant for signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Monitor blood glucose closely, especially in diabetic patients or those at risk for diabetes.
  • Counsel patients on lifestyle modifications (calcium/vitamin D intake, exercise, sodium restriction) to mitigate common side effects.
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Alternative Therapies

  • Dexamethasone (longer-acting, more potent)
  • Methylprednisolone (similar potency to prednisolone, often used intravenously)
  • Hydrocortisone (shorter-acting, less potent, often used for adrenal insufficiency)
  • Betamethasone (similar to dexamethasone)
  • Triamcinolone (intermediate-acting)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 120ml of 15mg/5ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.