Hydrocortisone (Page 2 of 2)

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.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

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.

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

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 are available in the following strengths and package sizes:

5 mg

White to off-white oval tablets debossed on one side with a bisect and other side with “H5”.

NDC 72789-227-50: Bottles of 50 tablets

10 mg

White to off-white oval tablets debossed on one side with a bisect and other side with “H10”.

NDC 72789-228-01: Bottles of 100 tablets

20 mg

White to off-white oval tablets debossed on one side with a bisect and other side with “H20”.

NDC 72789-229-01: Bottles of 100 tablets

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

REFERENCES

1 Fekety 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.

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

Rx only

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 07/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone Tablets, USP 5 mg

Rx Only

image
(click image for full-size original)

Hydrocortisone Tablets, USP 10 mg

Rx Only

72789228 Label
(click image for full-size original)

Hydrocortisone Tablets, USP 20 mg

Rx Only

72789229 Label
(click image for full-size original)
HYDROCORTISONE
hydrocortisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-227(NDC:42543-970)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (to off White) Score 2 pieces
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code H;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-227-50 50 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207029 12/22/2021
HYDROCORTISONE
hydrocortisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-228(NDC:42543-971)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (to off White) Score 2 pieces
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code H;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-228-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207029 12/22/2021
HYDROCORTISONE
hydrocortisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-229(NDC:42543-972)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (to off White) Score 2 pieces
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code H;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-229-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207029 12/22/2021
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-227), repack (72789-228), repack (72789-229)

Revised: 04/2023 PD-Rx Pharmaceuticals, Inc.

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