Prednisone Soln 5mg/5ml (1mg/1ml)

Manufacturer ROXANE Active Ingredient Prednisone Oral Solution(PRED ni sone) Pronunciation PRED-ni-sone
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 Receptor Agonist
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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?

Prednisone is a type of steroid medicine that works like natural hormones your body makes. It's used to reduce inflammation (swelling and redness) and suppress the immune system. This helps treat many conditions like asthma, allergies, arthritis, and certain skin or blood disorders.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food or milk to help your body absorb it.
If you take your medication once a day, take it in the morning.
When taking a liquid dose, measure it carefully using the measuring device that comes with your medication. If you don't have one, ask your pharmacist for a device to measure your medication accurately.

It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To keep your medication effective and safe:

Store your medication at room temperature, protected from light.
Keep it in a dry place, away from the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take it as soon as you remember.
However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Take your dose in the morning if taking once daily, to mimic the body's natural cortisol rhythm and reduce sleep disturbances.
  • 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 exposure to people with infections (especially chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection immediately.
  • 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 manage fluid retention and blood pressure.
  • Regular exercise, including weight-bearing activities, can help maintain bone and muscle strength.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable, dependent on indication. Typical initial doses range from 5 mg to 60 mg orally once daily or in divided doses.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

acuteAsthmaExacerbation: 40-60 mg/day for 3-10 days
rheumatoidArthritis: 5-10 mg/day, adjusted based on response
multipleSclerosisExacerbation: 200 mg/day for 7 days, then 80 mg every other day for 1 month
organTransplantRejection: Higher doses, e.g., 1-2 mg/kg/day, then tapered
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., congenital adrenal hyperplasia).
Infant: 0.5-2 mg/kg/day orally in single or divided doses, depending on indication. Max 60 mg/day.
Child: 0.5-2 mg/kg/day orally in single or divided doses, depending on indication. Max 60 mg/day.
Adolescent: Dosing similar to adult, 0.5-2 mg/kg/day or adult dose, depending on indication and weight.
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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; monitor for fluid retention.
Dialysis: Prednisone is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: Use with caution; monitor for increased effects due to impaired conversion to prednisolone or reduced clearance. Dose reduction may be necessary in severe cases.
Severe: Use with caution; monitor for increased effects due to impaired conversion to prednisolone or reduced clearance. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic glucocorticoid. It is a prodrug that is converted in the liver to its active metabolite, prednisolone. Prednisolone exerts its effects by binding to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to widespread effects including potent anti-inflammatory and immunosuppressive actions. It inhibits the synthesis of prostaglandins and leukotrienes, suppresses the migration of polymorphonuclear leukocytes, and reverses increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: 70-90%
Tmax: 1-2 hours (for prednisone), 1-3 hours (for active prednisolone)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.7-1.5 L/kg
ProteinBinding: Approximately 90% (to albumin and corticosteroid-binding globulin)
CnssPenetration: Yes (limited, but sufficient to cause CNS effects)

Elimination:

HalfLife: 2-4 hours (prednisone), 18-36 hours (biological half-life of prednisolone)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <1% (prednisone), 10-25% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Hours (for anti-inflammatory effects), days to weeks for full therapeutic effect in chronic conditions.
PeakEffect: Variable, depending on condition and dose. Acute effects within hours, chronic effects over days to weeks.
DurationOfAction: 18-36 hours (biological half-life of prednisolone, allowing for once-daily or alternate-day dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you 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 sputum production or change in sputum color, painful urination, mouth sores, or a wound that won't heal
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an abnormal heartbeat
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of adrenal insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Shortness of breath, significant weight gain, or swelling in the arms or legs
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
Abnormal heartbeat (fast, slow, or irregular)
Chest pain or pressure
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Menstrual changes
Bone or joint pain
Fatigue or weakness
Changes in vision
Confusion, difficulty focusing, or changes in behavior
Memory problems or loss
Hallucinations (seeing or hearing things that are not there)
Seizures
Burning, numbness, or tingling sensations that are not normal
Severe stomach pain
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

Other 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 any other symptoms that bother you or don't go away, contact your doctor:

Nausea or vomiting
Increased appetite
Weight gain
Sleep disturbances
Restlessness
Excessive sweating
Dizziness or headache

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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:

  • Signs of infection (fever, chills, sore throat, body aches, unusual tiredness)
  • Severe stomach pain, black or tarry stools, or vomiting blood
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • Blurred vision or eye pain
  • Severe mood changes (depression, anxiety, euphoria, confusion)
  • Muscle weakness or severe fatigue
  • Increased thirst or urination (signs of high blood sugar)
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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 symptoms you experienced as a result of the allergy.
If you have an active 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
* If you have nerve problems in your eye, as this may affect your treatment.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 undergo eye pressure and bone density tests.

Be aware that medications like this one can cause high blood pressure. Your doctor will likely advise you to have your blood pressure checked regularly.

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

Prolonged use of this drug may also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any concerns.

This medication may interfere with allergy skin tests. Ensure that your doctor and laboratory personnel are aware that you are taking this drug.

You may need to reduce your salt intake and increase your potassium consumption. 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.

It is also important to talk to 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.

If you are taking this medication, it is essential to avoid close contact with individuals who have chickenpox or measles, especially if you have not had these illnesses before. If you are exposed to chickenpox or measles, inform your doctor immediately. Steroid medications like this one can increase your risk of infection, which can be severe or even life-threatening. To minimize your 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 medications like this one. Inform your doctor if you have a history of these infections.

This medication can suppress your body's natural production of steroids. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stresses may be affected. You may require additional doses of steroids in these situations.

Do not abruptly stop taking this medication 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 miss 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 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. This medication may also affect growth in children and adolescents, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.

This medication may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks and benefits with your doctor. If you took this medication during pregnancy, inform your baby's doctor.

It is essential to weigh the benefits and risks of this medication, especially if you are pregnant or breastfeeding. Your doctor will help you make an informed decision about using this medication.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: nausea, vomiting, stomach upset, weakness, fluid retention, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive; no specific antidote. Chronic overdose requires gradual withdrawal of the drug under medical supervision.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)
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Major Interactions

  • Barbiturates (e.g., phenobarbital) - decreased prednisone effect
  • Carbamazepine - decreased prednisone effect
  • Phenytoin - decreased prednisone effect
  • Rifampin - decreased prednisone effect
  • Ketoconazole - increased prednisone effect
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin) - increased prednisone effect
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - increased risk of GI ulceration/bleeding
  • Warfarin - altered anticoagulant effect (monitor INR closely)
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment of antidiabetics
  • Digoxin - increased risk of digitalis toxicity due to hypokalemia
  • Loop and Thiazide Diuretics - increased risk of hypokalemia
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Moderate Interactions

  • Oral Contraceptives - increased prednisone effect
  • Cyclosporine - increased levels of both drugs, increased risk of seizures
  • Isoniazid - decreased isoniazid levels
  • Cholestyramine - decreased prednisone absorption
  • Antacids - decreased prednisone absorption (separate administration)
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Minor Interactions

  • Grapefruit juice - may slightly increase prednisone levels (minor clinical significance)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose (Fasting)

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia, especially with concomitant diuretics.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: Long-term corticosteroid use increases osteoporosis risk.

Timing: Prior to initiation for anticipated long-term therapy (>3 months)

Ophthalmologic Exam (intraocular pressure)

Rationale: Risk of glaucoma and cataracts with long-term use.

Timing: Prior to initiation for anticipated long-term therapy

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Routine Monitoring

Blood Pressure

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

Target: <130/80 mmHg (or individualized)

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

Blood Glucose (Fasting or HbA1c)

Frequency: Weekly to monthly, or more frequently in diabetics

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

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

Serum Electrolytes (Potassium)

Frequency: Periodically, e.g., monthly, or more frequently if on diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant weight gain (e.g., >2 kg/week)

Growth (Pediatric Patients)

Frequency: Every 3-6 months

Target: Normal growth velocity for age

Action Threshold: Growth retardation

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise)
  • Mood changes (irritability, depression, euphoria)
  • Sleep disturbances
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes
  • Gastrointestinal upset (stomach pain, black/tarry stools)
  • Easy bruising or skin thinning
  • Increased thirst or urination

Special Patient Groups

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Pregnancy

Prednisone is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. While animal studies show teratogenic effects (e.g., cleft palate), human data are less clear and do not consistently demonstrate a clear risk of congenital malformations, though some studies suggest a slightly increased risk of oral clefts.

Trimester-Specific Risks:

First Trimester: Potential, but unconfirmed, slight increased risk of oral clefts. Generally avoided if safer alternatives exist, but often used for severe maternal conditions.
Second Trimester: Generally considered safer than first trimester, but still used with caution.
Third Trimester: Risk of fetal adrenal suppression if used in high doses or for prolonged periods close to term. Neonates should be monitored for signs of hypoadrenalism.
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Lactation

Prednisone is excreted into breast milk. However, the amount is generally considered low, especially with typical doses. The American Academy of Pediatrics considers corticosteroids compatible with breastfeeding. To minimize infant exposure, mothers can take the dose immediately after breastfeeding and wait 3-4 hours before the next feeding.

Infant Risk: Low risk of adverse effects in breastfed infants, especially with doses up to 20 mg/day. Higher doses or prolonged use may theoretically lead to growth suppression or adrenal suppression in the infant, but this is rarely observed.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity closely. Long-term use should be carefully weighed against benefits. Alternate-day therapy may reduce growth suppression and other side effects. Increased susceptibility to infections.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects of corticosteroids, including osteoporosis, hypertension, diabetes, fluid retention, and skin thinning. Use the lowest effective dose for the shortest duration possible. Close monitoring for side effects is crucial.

Clinical Information

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Clinical Pearls

  • Prednisone is a prodrug; its conversion to active prednisolone occurs in the liver. Patients with severe liver dysfunction may have impaired conversion.
  • Always taper prednisone doses gradually after prolonged therapy (typically >7-10 days) to prevent adrenal insufficiency.
  • Administering prednisone as a single dose in the morning (before 9 AM) can help minimize adrenal suppression and mimic the body's natural diurnal cortisol rhythm.
  • Alternate-day therapy can be considered for chronic conditions to reduce side effects, particularly adrenal suppression and growth retardation in children.
  • Patients on chronic prednisone therapy should carry a steroid card or wear medical alert identification.
  • Educate patients about the signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
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Alternative Therapies

  • NSAIDs (for inflammatory conditions, less potent)
  • Disease-modifying antirheumatic drugs (DMARDs) for autoimmune diseases (e.g., methotrexate, biologics)
  • Immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
  • Bronchodilators (for asthma, e.g., albuterol, salmeterol)
  • Antihistamines (for allergic reactions)
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Cost & Coverage

Average Cost: $10 - $50 per 120ml bottle (5mg/5ml)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.