Therapeutic drug Profile

Prescribers Name: Drug Name: Prednisone

Chemical (Generic Name) Trade (Brand Name)
Prednisone predniSONE Intensol; Rayos

Presentation
Used in our clinical practice to treat our patient’s pustular acne

Indications / Uses
Anti-inflammatory or immunosuppressant agent in the treatment of a variety of
diseases, including allergic (eg, angioedema, contact dermatitis, new-onset urticaria),
hematologic (eg, immune thrombocytopenia, warm autoimmune hemolytic anemia),
dermatologic, GI, inflammatory, ophthalmic, neoplastic, rheumatic (eg, acute gout
flare, vasculitis, dermatomyositis, mixed cryoglobulinemia syndrome, polyarteritis
nodosa, polymyositis, polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis,
systemic lupus erythematosus), autoimmune, nervous system (eg, acute
exacerbations of multiple sclerosis), renal, respiratory (eg, asthma), and endocrine
(eg, primary or secondary adrenocorticoid deficiency); solid organ rejection
(acute/chronic).

Patient Aspect
Patient presented with pustular acne on her face, Nodules (large painful red lumps)
and Pseudocysts (cyst-like fluctuant swellings) persisting for over 6 months.

Dosage & Administration

Adult Dosing: Individualize glucocorticoid dosing and use the minimum

effective dose/duration. Evidence to support an optimal dose and duration is
lacking for most indications; recommendations provided are general
guidelines only.

Clinical considerations: HPA-axis suppression is likely in any adult

receiving >20 mg/day (daytime dosing) or ≥5 mg per 24 hours
(evening or night dosing) for >2 weeks or with Cushingoid
appearance (although HPA suppression may occur with lower
 doses or briefer exposure in some patients); do not abruptly
discontinue treatment; dose tapering may be necessary (Ref).

Usual dosage range:

Oral: 10 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses;

Low dose: 2.5 to 10 mg/day; High dose: 1 to 1.5 mg/kg/day (usually not
to exceed 80 to 100 mg/day).

The following dose taper example is from the commercially available

tapered-dosage product:

Day 1: Administer 30 mg on day 1 as 10 mg at breakfast, 5 mg at

lunch, 5 mg at dinner, and 10 mg at bedtime.

Day 2: Administer 25 mg on day 2 as 5 mg at breakfast, 5 mg at

lunch, 5 mg at dinner, and 10 mg at bedtime.

Day 3: Administer 20 mg on day 3 as 5 mg at breakfast, 5 mg at

lunch, 5 mg at dinner, and 5 mg at bedtime.

Day 4: Administer 15 mg on day 4 as 5 mg at breakfast, 5 mg at

lunch, and 5 mg at bedtime.

Day 5: Administer 10 mg on day 5 as 5 mg at breakfast and 5 mg

at bedtime.

Day 6: Administer 5 mg on day 6 as 5 mg at breakfast.

Pediatric Dosing: Individualize dosing and use the lowest possible dose to
control the condition; when dose reduction is possible, reduce dose
gradually. Consider alternate day therapy for long-term therapy. All
pediatric dosing is based on IR products; patients switching from IR
product to delayed-release product (eg, Rayos) should be dosed based
 on relative potency.

Contraindications

Hypersensitivity to prednisone or any component of the formulation; administration of

live or live attenuated vaccines with immunosuppressive doses of prednisone;
systemic fungal infections.

Cautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of

hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger
children.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been

associated with the development of Kaposi sarcoma; clinical
improvement may occur with prednisone discontinuation.

Disease-related concerns:

• Gastrointestinal disease: Use with caution in patients with GI diseases

(diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer,
ulcerative colitis [nonspecific]) due to perforation risk.

• Head injury: Increased mortality was observed in patients receiving high-

dose IV methylprednisolone; high-dose corticosteroids should not be
used for the management of head injury.

• Hepatic impairment: Use with caution in patients with hepatic impairment,

including cirrhosis; effects may be enhanced.

• Myasthenia gravis: Use may cause transient worsening of myasthenia

gravis (MG) (eg, within first 2 weeks of treatment); monitor for
 worsening MG (AAN [Narayanaswami 2021]).

• Ocular disease: Use with caution in patients with a history of ocular herpes
simplex; corneal perforation has occurred; do not use in active ocular
herpes simplex.

• Renal impairment: Use with caution in patients with renal impairment; fluid
retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a

history of seizure disorder; seizures have been reported with adrenal
crisis.

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an

increase in scleroderma renal crisis incidence has been observed with
corticosteroid use. Monitor BP and renal function in patients with
systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka
2017]).

• Thyroid disease: Changes in thyroid status may necessitate dosage

adjustments; metabolic clearance of corticosteroids increases in
hyperthyroid patients and decreases in hypothyroid patients.

Interaction with other medicinal products and other forms of interaction

Prednisone (Rayos) interacts with medications like warfarin (Coumadin, Jantoven),
NSAIDs like ibuprofen (Advil, Motrin), and antibiotics like ciprofloxacin (Cipro). It can
also interact with live vaccines like the MMR (measles, mumps, and rubella) vaccine.

Side Effects
Sleep disturbance Increased appetite. weight gain, Increase in postprandial blood
sugar, psychological effects, including increased or decreased energy.

Additional Notes
Absorption
Prednisone is a synthetic corticosteroid that is typically administered orally. It is well
absorbed in the gastrointestinal (GI) tract, with rapid absorption into the bloodstream.
The bioavailability of prednisone when taken orally is high, generally between 70% to
90%.

Unlike some medications, food does not have a significant impact on the absorption
of prednisone, and it can be taken with or without meals. However, taking it with food
may help minimize GI irritation, which can occur with corticosteroid therapy.

After oral administration, prednisone is quickly converted to its active metabolite,

prednisolone, in the liver. This conversion happens rapidly and is crucial for its
pharmacological effect. Liquid formulations of prednisone may have a slightly faster
absorption rate than tablet forms.

Distribution
Once absorbed, prednisone (and its active metabolite, prednisolone) is widely
distributed throughout the body. It has a moderate volume of distribution, and the
drug can be found in tissues and fluids, including the liver, kidneys, muscles, and
intestines.

Prednisolone is approximately 60% to 90% bound to plasma proteins, particularly

albumin and corticosteroid-binding globulin. The degree of protein binding can
influence the drug’s bioavailability and distribution. Prednisone and prednisolone are
able to cross the blood-brain barrier and reach the cerebrospinal fluid, as well as
pass into breast milk.

Metabolism
Prednisone is a prodrug and is rapidly converted to its active form, prednisolone,
primarily in the liver. Prednisolone is then metabolized by the liver through hepatic
enzymes, undergoing hydroxylation and other biotransformations.

The liver metabolism of prednisone can be influenced by factors such as liver

function, genetic variability in enzyme activity, and interactions with other drugs that
affect hepatic enzymes, especially cytochrome P450 enzymes (such as CYP3A4).
Medications that induce or inhibit these enzymes can either increase or decrease the
effectiveness of prednisone.

Excretion
Prednisone and its active metabolite, prednisolone, are primarily excreted through
the kidneys. After hepatic metabolism, the inactive metabolites are eliminated in the
urine. The elimination half-life of prednisolone is about 2 to 4 hours, depending on
individual factors such as renal and liver function.

A small amount of prednisone is excreted unchanged in the urine. The total

clearance of prednisone is affected by renal function, and impaired kidney function
may prolong the elimination of the drug.

Overall, prednisone’s pharmacokinetic profile—characterized by rapid absorption,

widespread distribution, hepatic metabolism, and renal excretion—makes it an
effective and versatile treatment for a range of inflammatory and autoimmune
conditions.

Clinical Governance

Following NICE guidelines and other relevant protocols, clinical governance is vital in
ensuring the appropriate use of prednisone. This includes adhering to
recommendations for indications, dosing regimens, duration of therapy, and the
monitoring of patients on corticosteroid therapy.

1. Indications for Use: Prednisone is commonly prescribed for a wide range of

conditions, including autoimmune diseases, inflammatory conditions, and allergies.
Clinical guidelines help to ensure that prednisone is used appropriately for these
indications, with careful consideration of the risk-benefit ratio, especially for long-term
use.
2. Dosing Regimens: Adhering to established dosing regimens based on patient-
specific factors such as age, weight, and severity of the condition is critical.
Guidelines also emphasize the importance of using the lowest effective dose for the
shortest duration to minimize side effects. Tapering doses appropriately after
prolonged use is key to avoiding adrenal insufficiency.

3. Duration of Treatment: NICE guidelines and similar protocols provide

recommendations on the duration of prednisone therapy, particularly for chronic
conditions, to avoid long-term adverse effects like osteoporosis, diabetes, and
infections. Regular review of the necessity of ongoing corticosteroid therapy is part of
good clinical governance.

4. Monitoring of Therapy: Continuous monitoring of patients on prednisone is crucial

for preventing and managing potential adverse effects. Monitoring includes regular
assessments of blood pressure, glucose levels, bone density, and mental health.
Patients should also be evaluated for signs of infection, as immunosuppression is a
significant risk with prednisone use.

5. Adverse Event Reporting: It is essential to report any adverse reactions or safety

concerns related to prednisone use to pharmacovigilance systems. Early
identification and reporting of side effects can help refine treatment guidelines and
improve patient safety.

6. Monitoring and Audit: Regular monitoring and audit of prednisone prescribing

practices are essential for ensuring adherence to clinical guidelines. Audits may
include reviewing patient outcomes, evaluating the appropriateness of prescriptions,
and identifying any deviations from recommended protocols. This process helps
maintain the quality of care and ensures that any trends or issues are promptly
addressed.

Clinical governance ensures that prednisone is used safely and effectively,

enhancing patient care and minimizing risks associated with corticosteroid therapy.
Ongoing review and audit processes are essential to improving treatment outcomes
and patient safety.
Pharmacoeconomics

When evaluating prednisone from a pharmacoeconomic perspective, several key

factors are involved:

1. Cost-effectiveness analysis: Pharmacoeconomic assessments compare the cost

of prednisone therapy to other corticosteroids or immunosuppressants, particularly in
conditions like asthma, rheumatoid arthritis, and autoimmune diseases. This involves
weighing the cost of prednisone against clinical outcomes, such as symptom relief,
reduction in disease progression, and improvement in quality of life.

2. Budget impact: Healthcare providers must consider the overall budgetary impact of
prednisone use, including the direct cost of the drug, as well as indirect costs like
monitoring for side effects, managing long-term adverse effects (e.g., osteoporosis,
glucose intolerance), and the cost of treating potential complications related to long-
term corticosteroid use.

3. Cost-minimization strategies: Cost-minimization strategies for prednisone use

might involve optimizing dosing schedules, tapering regimens to minimize long-term
exposure, or combining prednisone with other treatments to enhance efficacy and
reduce the need for higher doses. These approaches can improve the cost-
effectiveness of therapy while reducing healthcare expenditures.

4. Health economic modeling: Economic models can help estimate the long-term
costs and benefits of prednisone use across different patient populations. For
example, models might consider the cost of managing chronic conditions with
prednisone versus alternative therapies, factoring in the rate of adverse events, drug
efficacy, and healthcare utilization.

Overall, pharmacoeconomic analyses of prednisone are essential for ensuring that

the drug is used cost-effectively, maximizing patient outcomes while minimizing the
financial burden on healthcare systems. These analyses inform prescribing practices
and help optimize resource allocation in healthcare.

Legal & Ethical Issues

When considering the legal and ethical issues surrounding the use of prednisone,
several factors come into play:

1. Prescription and dispensing regulations: Prenisone is a prescription medication,

and healthcare providers must adhere to legal regulations regarding its prescription
and dispensing. This includes ensuring that the drug is prescribed only for
appropriate indications and in the correct dosage.

2. Informed consent: Healthcare providers have an ethical obligation to provide

patients with relevant information about erythromycin, including its potential benefits,
risks, and alternatives, to enable patients to make informed decisions about their
treatment.

3. Patient safety: Ensuring patient safety is a key ethical consideration when

prescribing erythromycin. Healthcare providers must consider factors such as
potential drug interactions, allergies, and contraindications, and proper tapering when
prescribing the medication to minimize the risk of adverse effects.

4. Privacy and confidentiality: Healthcare providers must adhere to legal and ethical
standards regarding patient privacy and confidentiality when prescribing prednisone.
This includes safeguarding patient information and only sharing it with authorized
individuals or entities.

5. Equity and access: Healthcare providers should consider issues of equity and
access when prescribing erythromycin, ensuring that all patients have equal access
to appropriate treatment options, regardless of factors such as socioeconomic status
or geographic location.
Overall, navigating the legal and ethical considerations surrounding the use of
prednisone requires healthcare providers to act in accordance with relevant laws,
regulations, and ethical guidelines to ensure the safe, effective, and equitable use of
the medication.

Integrated Approach to Care

An integrated approach to care for patients receiving prednisone involves

coordinating various aspects of healthcare, including medical, pharmaceutical, and
nursing, to ensure comprehensive and patient-centered treatment. Here are some
key components of an integrated approach to care for patients receiving
erythromycin in dermatology context:

1. Consultant dermatologists and nurses conduct a thorough medical assessment of

the patient

2. Pharmacological Management: Pharmacists play a crucial role in ensuring the safe

and effective use of prednisone. They can provide information on dosing,
administration, potential drug interactions, and monitoring parameters to optimize
therapy.

3. Monitoring and Follow-up: Regular monitoring of the patient's response by

dermatologists / nurses to erythromycin is essential to assess treatment efficacy and
detect any adverse effects. Follow-up appointments allow healthcare providers to
adjust treatment as needed and ensure continuity of care.

4. Patient Education: Providing patients with information about prednisone, including

how to take the medication, potential side effects to watch for, and the importance of
completing the full course of treatment, promotes medication adherence and patient
empowerment

5. Interprofessional Collaboration: Collaboration among healthcare team members,

including consultants
, pharmacists, nurses, and other allied health professionals, ensures a holistic and
coordinated approach to patient care, leading to improved outcomes and patient
satisfaction.

By integrating these components into the care of patients receiving prednisone,

healthcare providers can deliver a comprehensive and patient-centered approach
that optimizes treatment outcomes and promotes overall well-being

References
BNF
⬥ UptoDate
⬥ GoRx
⬥DermNetz