Label: HYDROCORTISONE tablet
- NDC Code(s): 42543-140-50, 42543-141-01, 42543-142-01
- Packager: Vensun Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 14, 2018
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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 to practically white, odorless, crystalline powder with a melting point of about 215º 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 362.46 and the structural formula is as outlined below.
Hydrocortisone tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
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
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
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
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
- Allergic corneal marginal ulcers
- Herpes zoster ophthalmicus
- Iritis and iridocyclitis
- Anterior segment inflammation
- Diffuse posterior uveitis and choroiditis
- Optic neuritis
- Sympathetic ophthalmia
7. Respiratory Diseases
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate
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
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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1
These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 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.
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 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.
Corticosteroids have been shown to impair fertility in male rats.
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.
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.
The use of hydrocortisone tablets 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.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox 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 chicken pox, 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 chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids 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.
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.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION)
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.
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.
Fluid and Electrolyte Disturbances
Congestive heart failure in susceptible patients
Loss of muscle mass
Tendon rupture, particularly of the Achilles tendon
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones
Peptic ulcer with possible perforation and hemorrhage
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.
Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
May suppress reactions to skin tests
Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
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
Central serous chorioretinopathy
Posterior subcapsular cataracts
Increased intraocular pressure
Negative nitrogen balance due to protein catabolism
Blood and lymphatic system disorders
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.
Hydrocortisone tablets, USP are available in the following strengths and package sizes:
White to off-white oval tablets debossed on one side with a bisect and other side with "P5".
NDC 42543-140-50: Bottles of 50 tablets
White to off-white oval tablets debossed on one side with a bisect and other side with "P10".
NDC 42543-141-01: Bottles of 100 tablets
White to off-white oval tablets debossed on one side with a bisect and other side with "P20".
NDC 42543-142-01: Bottles of 100 tablets
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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.
Vensun Pharmaceuticals, Inc.
Yardley, PA 19067
Pharmaceutics International, Inc.
Hunt Valley, MD 21031
Rev. 02, August 2017
- Principal Display Panel - 5 mg Bottle Label
- Principal Display Panel - 10 mg Bottle Label
- Principal Display Panel - 20 mg Bottle Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 5 mg Inactive Ingredients Ingredient Name Strength Lactose Monohydrate (UNII: EWQ57Q8I5X) Cellulose, Microcrystalline (UNII: OP1R32D61U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color WHITE (to off White) Score 2 pieces Shape OVAL (OVAL) Size 8mm Flavor Imprint Code P;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42543-140-50 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207029 07/07/2017 HYDROCORTISONE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-141 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10 mg Inactive Ingredients Ingredient Name Strength Lactose Monohydrate (UNII: EWQ57Q8I5X) Cellulose, Microcrystalline (UNII: OP1R32D61U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color WHITE (to off White) Score 2 pieces Shape OVAL (OVAL) Size 9mm Flavor Imprint Code P;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42543-141-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207029 07/07/2017 HYDROCORTISONE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-142 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 20 mg Inactive Ingredients Ingredient Name Strength Lactose Monohydrate (UNII: EWQ57Q8I5X) Cellulose, Microcrystalline (UNII: OP1R32D61U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color WHITE (to off White) Score 2 pieces Shape OVAL (OVAL) Size 10mm Flavor Imprint Code P;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42543-142-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207029 07/07/2017 Labeler - Vensun Pharmaceuticals, Inc. (078310501) Registrant - Pharmaceutics International, Inc. (Pii) (878265586) Establishment Name Address ID/FEI Business Operations Pharmaceutics International, Inc. (Pii) 878265586 MANUFACTURE(42543-140, 42543-141, 42543-142) , ANALYSIS(42543-140, 42543-141, 42543-142)