Label: HYDROCORTISONE tablet

  • NDC Code(s): 0115-1696-06, 0115-1697-01, 0115-1700-01
  • Packager: Amneal Pharmaceuticals of New York LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 3, 2024

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  • DESCRIPTION

    Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white or practically white, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

    The chemical name for hydrocortisone is pregn-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.5 g/mol and the structural formula is as outlined below.

    1

    Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP.

    Inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.

  • ACTIONS

    Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

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

  • INDICATIONS AND USAGE

    Hydrocortisone Tablets are indicated in the following conditions.

    1. Endocrine Disorders

    Primary 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
    Non suppurative 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
    Systemic dermatomyositis (polymyositis)
    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
    Serum sickness
    Bronchial asthma
    Contact dermatitis
    Atopic dermatitis
    Drug hypersensitivity reactions

    6. Ophthalmic Diseases

    Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
    Allergic conjunctivitis
    Keratitis
    Allergic corneal marginal ulcers
    Herpes zoster ophthalmicus
    Iritis and iridocyclitis
    Chorioretinitis
    Anterior segment inflammation
    Diffuse posterior uveitis and choroiditis
    Optic neuritis
    Sympathetic ophthalmia

    7. Respiratory Diseases

    Symptomatic sarcoidosis
    Loeffler's syndrome not manageable by other means
    Berylliosis
    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous 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 when used concurrently with appropriate antituberculous chemotherapy
    Trichinosis with neurologic or myocardial involvement

  • CONTRAINDICATIONS

    Systemic fungal infections and known hypersensitivity to components.

  • 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 hydrocortisone, 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 hydrocortisone withdrawal or dosage reduction as needed.

    Tuberculosis

    If hydrocortisone 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 hydrocortisone 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 hydrocortisone. In corticosteroid-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 hydrocortisone-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 hydrocortisone-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 hydrocortisone. 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 hydrocortisone. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

    Fungal Infections

    Corticosteroids, including hydrocortisone, may exacerbate systemic fungal infections; therefore, avoid hydrocortisone use in the presence of such infections unless hydrocortisone is needed to control drug reactions. For patients on chronic hydrocortisone therapy who develop systemic fungal infections, hydrocortisone withdrawal or dosage reduction is recommended.

    Amebiasis

    Corticosteroids, including hydrocortisone, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating hydrocortisone in patients who have spent time in the tropics or patients with unexplained diarrhea.

    Strongyloides Infestation

    Corticosteroids, including hydrocortisone, 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 hydrocortisone, in patients with cerebral malaria.

    Ophthalmic Effects

    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.

    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.

    Hypertension, Volume Overload, and Hypokalemia

    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.

    Vaccinations

    Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

    Usage 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 child bearing 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.

    Corticosteroids have been shown to impair fertility in male rats.

  • PRECAUTIONS

    General Precautions

    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.

    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.

    Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; 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.

    Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

    Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. In patients with suspected pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids.

    In post-marketing experience tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.

    Drug Interactions

    The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

    Information for the Patient

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

  • ADVERSE REACTIONS

    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
    Tendon rupture, particularly of the Achilles tendon
    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
    Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

    Dermatologic

    Impaired wound healing
    Thin fragile skin
    Petechiae and ecchymoses
    Facial erythema
    Increased sweating
    May suppress reactions to skin tests

    Neurological

    Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
    Convulsions
    Vertigo
    Headache
    Epidural lipomatosis

    Endocrine

    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
    Menstrual irregularities
    Decreased carbohydrate tolerance
    Manifestations of latent diabetes mellitus
    Increased requirements for insulin or oral hypoglycemic agents in diabetics

    Ophthalmic

    Central serous chorioretinopathy
    Posterior subcapsular cataracts
    Increased intraocular pressure
    Glaucoma
    Exophthalmos

    Metabolic

    Negative nitrogen balance due to protein catabolism

    Blood and lymphatic system disorders

     Leukocytosis

    To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    The initial dosage of hydrocortisone tablets may vary from 20 mg to 240 mg of hydrocortisone 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, hydrocortisone tablets 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 hydrocortisone tablets 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

    Hydrocortisone Tablets, USP 5 mg are white, round tablets bisected, debossed “CP” score “331” on one side and plain on the other side.

    They are available as follows:

    Bottles of 50:                          NDC 0115-1696-06

    Hydrocortisone Tablets, USP 10 mg are white, round tablets bisected, debossed “CP” score “332” on one side and plain on the other side.

    They are available as follows:

    Bottles of 100:                        NDC 0115-1697-01

    Hydrocortisone Tablets, USP 20 mg are white, round tablets bisected, debossed “CP” score “333” on one side and plain on the other side.

    They are available as follows:

    Bottles of 100:                        NDC 0115-1700-01

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

  • REFERENCES

    1Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WB Saunders Company 1992:1050-1.

    2Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.

    Manufactured by:
    Amneal Pharmaceuticals Pvt. Ltd.
    Ahmedabad 382220, INDIA

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ 08807

    Rev. 07-2024-02

  • PRINCIPAL DISPLAY PANEL

    NDC 0115-1696-06

    Hydrocortisone Tablets USP, 5 mg

    Rx only

    50 Tablets

    Bottle Label

    Amneal Pharmaceuticals LLC

    1

    NDC 0115-1697-01

    Hydrocortisone Tablets USP, 10 mg

    Rx only

    100 Tablets

    Bottle Label

    Amneal Pharmaceuticals LLC

    1

    NDC 0115-1700-01

    Hydrocortisone Tablets USP, 20 mg

    Rx only

    100 Tablets

    Bottle Label

    Amneal Pharmaceuticals LLC

    1

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0115-1696
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code CP;331
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0115-1696-0650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04064603/30/2007
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0115-1697
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code CP;332
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0115-1697-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04064603/30/2007
    HYDROCORTISONE 
    hydrocortisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0115-1700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code CP;333
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0115-1700-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04064603/30/2007
    Labeler - Amneal Pharmaceuticals of New York LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals Private Limited915076126analysis(0115-1696, 0115-1697, 0115-1700) , label(0115-1696, 0115-1697, 0115-1700) , manufacture(0115-1696, 0115-1697, 0115-1700) , pack(0115-1696, 0115-1697, 0115-1700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mikart, Inc.030034847manufacture(0115-1696, 0115-1697, 0115-1700) , pack(0115-1696, 0115-1697, 0115-1700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mikart, LLC013322387manufacture(0115-1696, 0115-1697, 0115-1700)