Dexamethasone Sodium Phosphate Injection, Usp

Systemic fungal infections.

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
• Vertebral compression fractures
• Aseptic necrosis of femoral and humeral heads
• Pathologic fracture of long bones

Gastrointestinal:

• Peptic ulcer with possible subsequent perforation and hemorrhage
• Pancreatitis
• Abdominal distention
• Ulcerative esophagitis

Dermatological:

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

Neurological:

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

Ophthalmic:

• Posterior subcapsular cataracts
• Increased intraocular pressure
• Glaucoma

Endocrine:

• Menstrual 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

Metabolic:

• Negative nitrogen balance due to protein catabolism

Miscellaneous:

• Hyperpigmentation or hypopigmentation
• Subcutaneous and cutaneous atrophy
• Sterile abscess
• Post-injection flare, following intra-articular use
• Charcot-like arthropathy
• Itching, burning, tingling in the ano-genital region

To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Dexamethasone Sodium Phosphate Injection USP, is a sterile, clear colorless to almost colorless solution free from foreign visible particles is supplied as:

Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly.

Dexamethasone Sodium Phosphate, USP C ₂₂H ₂₈FNa ₂O ₈P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt.

It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:

Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations.

Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5.

Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL ( Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.

SAGENT ^®

Rx only

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

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 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.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

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 are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into a previously infected joint is to be avoided. Corticosteroids should not be injected into unstable joints.

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 they 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 Section).

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.

If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged dexamethasone sodium phosphate injection therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Avoid corticosteroids, including dexamethasone sodium phosphate injection, in patients with cerebral malaria.

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.

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

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

Protect from light.Retain in carton until time of use.

Single dose vials -Discard unused portion.

Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

SAGENT ^®Mfd. for SAGENT Pharmaceuticals

Schaumburg, IL 60195 (USA)

Made in India

©2024 Sagent Pharmaceuticals

July 2024

Sagent Pharmaceuticals ^®

Since adequate human reproduction studies have not been done with corticosteroids, 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.

Average and large doses of cortisone or hydrocortisone 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. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. 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 in high doses, because of possible hazards of neurological complications and lack of antibody response.

Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Dexamethasone sodium phosphate injection, 4 mg per mL contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Naturally occurring glucocorticoids (hydrocortisone), 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.

Corticosteroids, including dexamethasone sodium phosphate injection, 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.

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including dexamethasone sodium phosphate injection. 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 dexamethasone sodium phosphate injection. 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.

When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:

• 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.
• They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).

Dexamethasone Sodium Phosphate Injection, USP

20 mg per 5 mL

(4 mg per mL)

5 mL Multi-Dose Vial

For Intravenous or Intramuscular Use

Rx only

NDC 71872-7347-1

Dexamethasone Sodium Phosphate Injection, USP

20 mg per 5 mL

(4 mg per mL)

1 x 5 mL Multi-Dose Vial

For Intravenous or Intramuscular Use

Rx only

Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone sodium phosphate injection. 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 dexamethasone sodium phosphate-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If varicella develops, treatment with antiviral agents may be considered.
• If a dexamethasone sodium phosphate-treated patient is exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.

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:

1. 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.

2. 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.

3. Collagen Diseases

• During an exacerbation or as maintenance therapy in selected cases of:
• Systemic lupus erythematosus.
• Acute rheumatic carditis.

4. Dermatologic Diseases

• Pemphigus.
• Severe erythema multiforme (Stevens-Johnson syndrome).
• Exfoliative dermatitis.
• Bullous dermatitis herpetiformis.
• Severe seborrheic dermatitis.
• Severe psoriasis.
• Mycosis fungoides.

5. 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).

6. 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.
• Allergic corneal marginal ulcers.
• Keratitis.

7. Gastrointestinal Diseases

• To tide the patient over a critical period of the disease in:
• Ulcerative colitis (systemic therapy).
• Regional enteritis (systemic therapy).

8. Respiratory Diseases

• Symptomatic sarcoidosis.
• Berylliosis.
• Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy.
• Loeffler's syndrome not manageable by other means.
• Aspiration pneumonitis.

9. Hematologic Disorders

• Acquired (autoimmune) hemolytic anemia.
• Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated).
• Secondary thrombocytopenia in adults.
• Erythroblastopenia (RBC anemia).
• Congenital (erythroid) hypoplastic anemia.

10. Neoplastic Diseases

• For palliative management of:
• Leukemias and lymphomas in adults.
• Acute leukemia of childhood.

11. 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.

12. Nervous System

• Acute exacerbations of multiple sclerosis.

13. Miscellaneous

• Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.
• Trichinosis with neurologic or myocardial involvement.
• Diagnostic testing of adrenocortical hyperfunction.
• Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management.

When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated 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.

Corticosteroids, including dexamethasone sodium phosphate injection, 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 dexamethasone sodium phosphate injection withdrawal or dosage reduction as needed.

Do not administer dexamethasone sodium phosphate injection by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.

The dose for intrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.

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.

SAGENT ^®

Rx only

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

Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly.

Dexamethasone Sodium Phosphate, USP C ₂₂H ₂₈FNa ₂O ₈P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt.

It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:

Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations.

Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5.

Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL ( Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.

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 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.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

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 are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into a previously infected joint is to be avoided. Corticosteroids should not be injected into unstable joints.

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 they 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 Section).

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.

Dexamethasone Sodium Phosphate Injection USP, is a sterile, clear colorless to almost colorless solution free from foreign visible particles is supplied as:

If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged dexamethasone sodium phosphate injection therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Avoid corticosteroids, including dexamethasone sodium phosphate injection, in patients with cerebral malaria.

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.

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
• Vertebral compression fractures
• Aseptic necrosis of femoral and humeral heads
• Pathologic fracture of long bones

Gastrointestinal:

• Peptic ulcer with possible subsequent perforation and hemorrhage
• Pancreatitis
• Abdominal distention
• Ulcerative esophagitis

Dermatological:

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

Neurological:

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

Ophthalmic:

• Posterior subcapsular cataracts
• Increased intraocular pressure
• Glaucoma

Endocrine:

• Menstrual 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

Metabolic:

• Negative nitrogen balance due to protein catabolism

Miscellaneous:

• Hyperpigmentation or hypopigmentation
• Subcutaneous and cutaneous atrophy
• Sterile abscess
• Post-injection flare, following intra-articular use
• Charcot-like arthropathy
• Itching, burning, tingling in the ano-genital region

To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Systemic fungal infections.

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

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

Protect from light.Retain in carton until time of use.

Single dose vials -Discard unused portion.

Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

SAGENT ^®Mfd. for SAGENT Pharmaceuticals

Schaumburg, IL 60195 (USA)

Made in India

©2024 Sagent Pharmaceuticals

July 2024

Sagent Pharmaceuticals ^®

Since adequate human reproduction studies have not been done with corticosteroids, 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.

Average and large doses of cortisone or hydrocortisone 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. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. 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 in high doses, because of possible hazards of neurological complications and lack of antibody response.

Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Dexamethasone sodium phosphate injection, 4 mg per mL contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Naturally occurring glucocorticoids (hydrocortisone), 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.

Corticosteroids, including dexamethasone sodium phosphate injection, 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.

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including dexamethasone sodium phosphate injection. 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 dexamethasone sodium phosphate injection. 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.

When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:

• 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.
• They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).

Dexamethasone Sodium Phosphate Injection, USP

20 mg per 5 mL

(4 mg per mL)

5 mL Multi-Dose Vial

For Intravenous or Intramuscular Use

Rx only

NDC 71872-7347-1

Dexamethasone Sodium Phosphate Injection, USP

20 mg per 5 mL

(4 mg per mL)

1 x 5 mL Multi-Dose Vial

For Intravenous or Intramuscular Use

Rx only

Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone sodium phosphate injection. 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 dexamethasone sodium phosphate-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If varicella develops, treatment with antiviral agents may be considered.
• If a dexamethasone sodium phosphate-treated patient is exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.

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:

1. 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.

2. 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.

3. Collagen Diseases

• During an exacerbation or as maintenance therapy in selected cases of:
• Systemic lupus erythematosus.
• Acute rheumatic carditis.

4. Dermatologic Diseases

• Pemphigus.
• Severe erythema multiforme (Stevens-Johnson syndrome).
• Exfoliative dermatitis.
• Bullous dermatitis herpetiformis.
• Severe seborrheic dermatitis.
• Severe psoriasis.
• Mycosis fungoides.

5. 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).

6. 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.
• Allergic corneal marginal ulcers.
• Keratitis.

7. Gastrointestinal Diseases

• To tide the patient over a critical period of the disease in:
• Ulcerative colitis (systemic therapy).
• Regional enteritis (systemic therapy).

8. Respiratory Diseases

• Symptomatic sarcoidosis.
• Berylliosis.
• Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy.
• Loeffler's syndrome not manageable by other means.
• Aspiration pneumonitis.

9. Hematologic Disorders

• Acquired (autoimmune) hemolytic anemia.
• Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated).
• Secondary thrombocytopenia in adults.
• Erythroblastopenia (RBC anemia).
• Congenital (erythroid) hypoplastic anemia.

10. Neoplastic Diseases

• For palliative management of:
• Leukemias and lymphomas in adults.
• Acute leukemia of childhood.

11. 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.

12. Nervous System

• Acute exacerbations of multiple sclerosis.

13. Miscellaneous

• Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.
• Trichinosis with neurologic or myocardial involvement.
• Diagnostic testing of adrenocortical hyperfunction.
• Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management.

When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated 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.

Corticosteroids, including dexamethasone sodium phosphate injection, 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 dexamethasone sodium phosphate injection withdrawal or dosage reduction as needed.

Do not administer dexamethasone sodium phosphate injection by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.

The dose for intrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.

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.