NDC 70518-2084 Prednisolone

Prednisolone

NDC Product Code 70518-2084

NDC 70518-2084-0

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Prednisolone with NDC 70518-2084 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Prednisolone is prednisolone. The product's dosage form is solution and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prednisolone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PREDNISOLONE 15 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CHERRY (UNII: BUC5I9595W)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA040401 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prednisolone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Prednisolone Oral Solution 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). Its molecular weight is 360.45. The molecular formula is C


21H


28O


5 and the structural formula is:


Prednisolone Oral Solution 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, edetate disodium, glycerin, propylene glycol, purified water, sodium saccharin, sucrose, artificial wild cherry flavor, FD&C blue #1 and red #40.

Clinical Pharmacology

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. Glucocorticoids such as prednisolone cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

Indications And Usage

  • PREDNISOLONE Oral Solution is indicated in the following conditions:
  • 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: 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 DisordersAs 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 DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosus
  • Acute rheumatic carditis
  • 4. Dermatologic DiseasesPemphigus
  • Bullous dermatitis herpetiformis
  • Severe erythema multiforme (Stevens-Johnson syndrome)
  • Exfoliative dermatitis
  • Mycosis fungoides
  • Severe psoriasis
  • Severe seborrheic dermatitis
  • 5. Allergic StatesControl 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 DiseasesSevere 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 DiseasesSymptomatic sarcoidosis Loeffler’s syndrome not manageable by other meansBerylliosis
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
  • Aspiration pneumonitis
  • 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9. Neoplastic DiseasesFor palliative management of:Acute leukemia of childhood
  • Leukemias and lymphomas in adults
  • 10. Edematous StatesTo 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 DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitis
  • Regional enteritis
  • 12. MiscellaneousTuberculous 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 is indicated for systemic dermatomyositis (polymyositis).

Contraindications

Systemic fungal infections.

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.Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.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.Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.The use of


Prednisolone Oral Solution in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.


If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.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

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.

Adverse Reactions

  • Fluid and Electrolyte DisturbancesSodium retention
  • Fluid retention
  • Congestive heart failure in susceptible patients
  • Potassium loss
  • Hypokalemic alkalosis
  • Hypertension
  • MusculoskeletalMuscle weakness
  • Steroid myopathy
  • Loss of muscle mass
  • Osteoporosis
  • Vertebral compression fractures
  • Aseptic necrosis of femoral and humeral heads
  • Pathologic fracture of long bones
  • GastrointestinalPeptic ulcer with possible perforation and hemorrhage
  • Pancreatitis
  • Abdominal distention
  • Ulcerative esophagitis
  • DermatologicImpaired wound healing
  • Thin fragile skin
  • Petechiae and ecchymoses
  • Facial erythema
  • Increased sweating
  • May suppress reactions to skin tests
  • NeurologicalConvulsions
  • Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
  • Vertigo
  • Headache
  • EndocrineMenstrual irregularities
  • Development of Cushingoid state
  • Suppression of growth in children
  • 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
  • OphthalmicPosterior subcapsular cataracts
  • Increased intraocular pressure
  • Glaucoma
  • Exophthalmos
  • MetabolicNegative nitrogen balance due to protein catabolism
  • To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

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 Gl 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.

How Supplied

Prednisolone Oral Solution containing 15 mg of Prednisolone in each 5 mL (teaspoonful) is a red cherry flavored liquid and is supplied in 240 mL bottles and 480 mL bottles.


Pharmacist: Dispense 15 mg/5 mL Prednisolone Oral Solution with suitable calibrated measuring device to assure proper measuring of dose.


Dispense in tight, light-resistant and child-resistant container as defined in USP/NF.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT REFRIGERATE.HI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev.042:05 01/17

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