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Prednisolone

15 mg/5mL · Solution

  • Prescription only
  • Corticosteroid
Active substance
Prednisolone
Made by
PAI Holdings, LLC dba PAI Pharma

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-08-19

What it is

Corticosteroid

Used for
  • Prednisolone Oral Solution USP is indicated in the following conditions: 1.
The label’s usual adult dose

The initial dosage of prednisolone oral solution may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated.

Full directions ↓
Warning

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
6other products contain Prednisolone — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice:

  • Prednisolone Oral Solution USP is indicated in the following conditions: 1.
  • synthetic analogs may be used in conjunction with mineralocorticoids where applicable:
  • in infancy mineralocorticoid supplementation is of particular importance).
  • Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.
  • Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
  • Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
  • Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of:
  • Systemic lupus erythematosus Acute rheumatic carditis 4.
  • Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5.
  • Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
  • Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6.
  • Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
  • Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and Iridocyclitis 7.
  • Respiratory Disorders Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Aspiration pneumonitis 8.
  • Hematologic Disorders Idiopathic thrombocytopenic purpura in
  • adults Secondary thrombocytopenia in
  • adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.
  • Neoplastic Diseases For palliative management of:
  • Leukemias and lymphomas in
  • adults Acute leukemia of childhood 10.
  • Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.
  • Gastrointestinal Diseases To tide the patient over a critical period of the disease in:
  • Ulcerative colitis Regional enteritis 12.
  • Miscellaneous Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.
  • Trichinosis with neurologic or myocardial involvement.
  • In addition to the above indications, Prednisolone Oral Solution USP is indicated for systemic dermatomyositis (polymyositis).

From the official label · 2024-08-19 · DailyMed

How it works

From this product’s own US prescribing label.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-08-19

Do not take it if

Systemic fungal infections.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Dosage of prednisolone oral solution should be individualized according to the severity of the disease and the response of the patient.
  • For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
  • Hormone therapy is an adjunct to and not a replacement for conventional therapy.
  • Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.
  • The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage.
  • If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.
  • Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy.
  • Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.
  • The initial dosage of prednisolone oral solution may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated.
  • In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required.
  • The initial dosage should be maintained or adjusted until a satisfactory response is noted.
  • If after a reasonable period of time there is a lack of satisfactory clinical response, prednisolone oral solution should be discontinued and the patient transferred to other appropriate therapy.
  • IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.
  • After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
  • It should be kept in mind that constant monitoring is needed in regard to drug dosage.
  • Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment.
  • In this latter situation it may be necessary to increase the dosage of prednisolone oral solution for a period of time consistent with the patient’s condition.
  • If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
  • Immunosuppression and Increased Risk of Infection Corticosteroids, including Prednisolone Oral Solution USP, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens.
  • Corticosteroids can:
  • Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.
  • The rate of infectious complications increases with increasing corticosteroid dosages.
  • Monitor for the development of infection and consider Prednisolone Oral Solution USP withdrawal or dosage reduction as needed.
  • Do not administer Prednisolone Oral Solution USP by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.
  • Tuberculosis Prednisolone Oral Solution USP is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.
  • Closely monitor such patients for reactivation.
  • During prolonged Prednisolone Oral Solution USP therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.
  • Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including Prednisolone Oral Solution USP.
  • In corticosteroids-treated patients who have not had these diseases or are non-immune, particular care should be taken to
  • avoid exposure to varicella and measles:
  • If a Prednisolone Oral Solution USP-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated.
  • If varicella develops, treatment with antiviral agents may be considered.
  • If a Prednisolone Oral Solution USP-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.
  • Hepatitis B Virus Reactivation Hepatitis B Virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including Prednisolone Oral Solution USP.
  • Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.
  • Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with Prednisolone Oral Solution USP.
  • For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding and consideration for hepatitis B antiviral therapy.
  • Fungal Infections Corticosteroids, including Prednisolone Oral Solution USP, may exacerbate systemic fungal infections; therefore,
  • avoid Prednisolone Oral Solution USP use in the presence of such infections unless Prednisolone Oral Solution USP is needed to control drug reactions.
  • For patients on chronic Prednisolone Oral Solution USP therapy who develop systemic fungal infections, Prednisolone Oral Solution USP withdrawal or dosage reduction is recommended.
  • Amebiasis Corticosteroids, including Prednisolone Oral Solution USP, may activate latent amebiasis.
  • Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Prednisolone Oral Solution USP in patients who have spent time in the tropics or patients with unexplained diarrhea.
  • Strongyloides Infestatio n Corticosteroids, including Prednisolone Oral Solution USP, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.
  • In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
  • Cerebral Malaria
  • Avoid corticosteroids, including Prednisolone Oral Solution USP, in patients with cerebral malaria.
  • Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.
  • Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.
  • Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
  • Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
  • These effects are less likely to occur with the synthetic derivatives except when used in large doses.
  • Dietary salt restriction and potassium supplementation may be necessary.
  • All corticosteroids increase calcium excretion.
  • While on corticosteroid therapy, patients should not be vaccinated against smallpox.
  • Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.
  • Use in Pregnancy:
  • Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
  • Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
  • General:
  • Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
  • This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
  • Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
  • There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
  • Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
  • The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.
  • Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
  • Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
  • Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
  • Steroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.
  • Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
  • Information for Patients:
  • General:
  • Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.
  • This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
  • Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
  • There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
  • Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
  • The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.
  • Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
  • Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
  • Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
  • Steroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.
  • Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Quoted from the official label, section “Warnings”.

Side effects

Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Neurological Convulsions Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Suppression of growth in pediatric patients Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Patients who are on immunosuppressant doses of corticosteroids should be warned to
  • avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Prednisolone Oral Solution USP, 15 mg/5 mL is a clear, pink to red liquid containing 15 mg of Prednisolone in each 5 mL (teaspoonful) and is supplied as NDC 0121-0885-08:
  • 240 mL bottles NDC 0121-0885-16:
  • 480 mL bottles Pharmacist:
  • Dispense Prednisolone Oral Solution USP, 15 mg/5 mL with a suitable calibrated measuring device to assure proper measuring of dose.
  • Dose/Volume Chart 15 mg prednisolone = 1 teaspoon 10 mg prednisolone = 2/3 teaspoon 7.5 mg prednisolone = 1/2 teaspoon 5 mg prednisolone = 1/3 teaspoon Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF.
  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • DO NOT REFRIGERATE.

Quoted from the official label, section “How Supplied”.

What is in it

  • Prednisolone Oral Solution USP contains prednisolone which is a glucocorticoid.
  • Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
  • Prednisolone is a white to practically white, odorless, crystalline powder.
  • It is very slightly soluble in water, soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.
  • The chemical name for prednisolone is Pregna-1,4-diene-3,20-dione,11,17,21-trihydroxy-,(11β)-.
  • C 21 H 28 O 5 M.W.
  • 360.45 Prednisolone Oral Solution USP, 15 mg/5 mL contains 15 mg of prednisolone in each 5 mL.
  • Benzoic acid, 0.1% is added as a preservative.
  • It also contains alcohol 5%, citric acid (anhydrous), edetate disodium, glycerin, propylene glycol, purified water, saccharin sodium, sucrose, FD&C blue #1 and FD&C red #40.
  • Prednisolone Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byPAI Holdings, LLC dba PAI Pharma
Active substancePrednisolone
Used inHormones, such as thyroid and steroids
Strength15 mg/5mL
FormSolution
RouteOral
Packs240 mL in 1 BOTTLE · 480 mL in 1 BOTTLE
NDC0121-0885

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

12 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Prednisolone15 mg/5mLPrescription onlySyrup Lannett Company, Inc. · PrednisolonePrednisolone5 mgPrescription onlyTablet Hisun Pharmaceuticals USA, Inc. · PrednisolonePrednisolone15 mg/5mLPrescription onlySolution A-S Medication Solutions · PrednisolonePrednisolone5 mgPrescription onlyTablet Aurobindo Pharma Limited · PrednisolonePrednisolone5 mgPrescription onlyTablet Zhejiang Xianju Pharmaceutical Co., Ltd. · PrednisolonePrednisolone5 mgPrescription onlyTablet Chartwell RX, LLC · Prednisolone

See every product with Prednisolone