DailyMed Label: Cortaren Corticosteroid/Anti-Inflammatory System

DailyMed Label: Cortaren Corticosteroid/Anti-Inflammatory System

2022

DailyMed Prescription

Cortaren Corticosteroid/Anti-Inflammatory System

DEXAMETHASONE SODIUM PHOSPHATE

IT3 Medical LLC

NDC: 70529-118

NDC: 70529-118

Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water. Dexamethasone sodium phosphate is an adrenocortical steroid anti-inflammatory drug. Chemically, dexamethasone sodium phosphate is 9-Fluoro-11ß,17,21-trihydroxy-16α-methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt and has the following structural formula: Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of dexamethasone sodium phosphate in water for injection for intravenous (IV), intramuscular (IM), intra-articular, soft-tissue or intralesional use. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant; Water for Injection q.s. Citric acid and/or sodium hydroxide may have been added for pH adjustment (7.0 to 8.5). Air in the container is displaced by nitrogen. structure-1

Intravenous or Intramuscular Injection When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: • Endocrine Disorders    Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance)    Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)    Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful    Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected    Congenital adrenal hyperplasia    Nonsuppurative thyroiditis    Hypercalcemia associated with cancer • Rheumatic Disorders    As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:    Post-traumatic osteoarthritis    Synovitis of osteoarthritis    Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)    Acute and subacute bursitis    Epicondylitis    Acute nonspecific tenosynovitis    Acute gouty arthritis    Psoriatic arthritis    Ankylosing spondylitis • Collagen Diseases    During an exacerbation or as maintenance therapy in selected cases of:    Systemic lupus erythematosus    Acute rheumatic carditis • Dermatologic Diseases    Pemphigus    Severe erythema multiforme (Stevens-Johnson syndrome)    Exfoliative dermatitis    Bullous dermatitis herpetiformis    Severe seborrheic dermatitis    Severe psoriasis    Mycosis fungoides • Allergic States    Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:    Bronchial asthma    Contact dermatitis    Atopic dermatitis    Serum sickness    Seasonal or perennial allergic rhinitis    Drug hypersensitivity reactions    Urticarial transfusion reactions    Acute noninfectious laryngeal edema (epinephrine is the drug of first choice) • Ophthalmic Diseases    Severe acute and chronic allergic and inflammatory processes involving the eye, such as:    Herpes zoster ophthalmicus    Iritis, iridocyclitis    Chorioretinitis    Diffuse posterior uveitis and choroiditis    Optic neuritis    Sympathetic ophthalmia    Anterior segment inflammation    Allergic conjunctivitis    Keratitis    Allergic corneal marginal ulcers • Gastrointestinal Diseases    To tide the patient over a critical period of the disease in:    Ulcerative colitis (Systemic therapy)    Regional enteritis (Systemic therapy) • Respiratory Diseases    Symptomatic sarcoidosis    Berylliosis    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Loeffler’s  syndrome not manageable by other means    Aspiration pneumonitis • Hematologic Disorders    Acquired (autoimmune) hemolytic anemia    Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)    Secondary thrombocytopenia in adults    Erythroblastopenia (RBC anemia)    Congenital (erythroid) hypoplastic anemia • Neoplastic Diseases    For palliative management of:    Leukemias and lymphomas in adults    Acute leukemia of childhood • Edematous States    To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosus • Miscellaneous    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy    Trichinosis with neurologic or myocardial involvement • Diagnostic testing of adrenocortical hyperfunction • Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury.    Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Synovitis of osteoarthritis Rheumatoid arthritis Acute and subacute bursitis Acute gouty arthritis Epicondylitis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Keloids Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis) Discoid lupus erythematosus Necrobiosis lipoidica diabeticorum Alopecia areata May also be useful in cystic tumors of an aponeurosis or tendon (ganglia)

Dexamethasone sodium phosphate injection, 4 mg per mL– For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection. Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to Sodium Chloride Injection or Dextrose Injection and administered by intravenous drip. Solutions used for intravenous administration or further dilution of this product should be preservative free when used in the neonate, especially  the premature infant. When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain  preservatives, mixtures should be used within 24 hours. DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dosage of dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. If a satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone sodium phosphate injection and transfer the patient to other therapy. After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. When the intravenous route of administration is used, dosage usually should be the same as the oral dosage. In certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. The slower rate of absorption by intramuscular administration should be recognized. There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock. The following dosages of dexamethasone sodium phosphate injection have been suggested by various authors: Author Dosage   Cavanagh 1  3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg  Dietzman 2  2 to 6 mg/kg of bodyweight as a single intravenous injection   Frank 3  40 mg initially followed by repeat  intravenous injection every 4 to 6 hours while shock persists  Oaks 4  40 mg initially followed by repeat  intravenous injection every 2 to 6 hours while shock persists  Schumer 5  1 mg/kg of body weight as a single intravenous injection Administration of high dose corticosteroid therapy should be continued only until the patients condition has stabilized and usually not longer than 48 to 72 hours. Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur. Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with two mg two or three times a day may be effective. In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: Dexamethasone sodium phosphate injection, 4 mg per mL: first day , 1 or 2 mL (4 or 8 mg), intramuscularly. Dexamethasone tablets, 0.75 mg: second and third days, 4 tablets in two divided doses each day; fourth day, 2 tablets in two divided doses; fifth and sixth days, 1 tablet each day; seventh day, no treatment; eighth day, follow-up visit. This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases. Intra-articular, intralesional, and soft tissue injections are generally employed when the affected joints or areas are limited to one or two sites. Dosage and frequency of injection varies depending on the condition and the site of injection. The usual dose is from 0.2 to 6 mg. The frequency usually ranges from once every three to five days to once every two to three weeks. Frequent intra-articular injection may result in damage to joint tissues. Some of the usual single doses are: Site of Injection Amount of  Dexamethasone  Phosphate (mg) Large Joints (e.g., Knee) 2 to 4 Small Joints (e.g., Interphalangeal, Temporomandibular) 0.8 to 1 Bursae 2 to 3 Tendon Sheaths 0.4 to 1 Soft Tissue Infiltration 2 to 6 Ganglia 1 to 2 Dexamethasone sodium phosphate injection is particularly recommended for use in conjunction with one of the less soluble, longer-acting steroids for intra-articular and soft tissue injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Systemic fungal infections (see WARNINGS  regarding amphotericin B). Hypersensitivity to any component of this product, including sulfites (see WARNINGS ).

This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of 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 must 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 infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism. When large doses are given, some authorities advise that antacids be administered between meals to help to prevent peptic ulcer. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed. Steroids may increase or decrease motility and number of spermatozoa in some patients. Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs. False negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients. The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia. Intra-articular injection of a corticosteroid may produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise is suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Injection of a steroid into an infected site is to be avoided. Corticosteroids should not be injected into unstable joints. Patients should be impressed strongly with the importance of not overusing joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active. Frequent intra-articular injection may result in damage to joint tissues. The slower rate of absorption by intramuscular administration should be recognized. Persons 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.

Fluid and electrolyte disturbances:

Clinically Significant Drug Interactions: The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Product No.      NDC No.  16501  63323-165-01  Dexamethasone Sodium Phosphate Injection, USP (equivalent to 4 mg per mL dexamethasone phosphate) 1 mL fill, in a 2 mL flip-top vial, packaged in 25. STORE AT : 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]. Protect from freezing. Sensitive to heat. Do not autoclave. Protect from light. Store container in carton until contents have been used. Do not use if precipitate is present. www.fresenius-kabi.us 45799H Revised: March 2017

Dexamethasone sodium phosphate has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, 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. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

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