DEXAMETHASONE SODIUM PHOSPHATE injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Available from:
General Injectables & Vaccines, Inc.
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
A. Intravenous or intramuscular administration.  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
Product summary:
Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: 4 mg per mL 1 mL Single-Dose Vials in a carton of 25                                           NDC 55150-237-01 20 mg per 5 mL (4 mg / mL)  5 mL Multiple-Dose Vials in a carton of 25                                          NDC 55150-238-05 120 mg per 30 mL (4 mg / mL) 30 mL Multiple-Dose Vials in a carton of 25                                          NDC 55150-239-30 Store at  20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sensitive to heat - Do not autoclave. Protect from light. The vial stoppers are not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited  Hyderabad - 500038 India Revised: July 2017
Authorization status:
Abbreviated New Drug Application
Authorization number:
52584-239-30

DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection,

solution

General Injectables & Vaccines, Inc.

----------

Dexamethasone Sodium Phosphate Injection USP

Rx only

DESCRIPTION

Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible

particles and a water-soluble inorganic ester of dexamethasone which produces a rapid response even

when injected intramuscularly.

Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular weight of 516.41 and

chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-,

disodium salt, (11β, 16α).

It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its

solutions have a pH between 7.0 and 8.5. It has the following structural formula:

Dexamethasone sodium phosphate injection USP is available in 4 mg/mL concentration.

Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL, contains 4.37 mg of

dexamethasone sodium phosphate, USP equivalent to 4 mg dexamethasone phosphate; 1 mg sodium

sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric

acid or sodium hydroxide.

ACTIONS — 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.

INDICATIONS AND USAGE

A. Intravenous or intramuscular administration. 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.

B. Intra-articular or soft tissue administration. 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.

C. Intralesional administration. 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).

CONTRAINDICATIONS

Systemic fungal infections.

WARNINGS

Serious Neurologic Adverse Reactions with Epidural Administration

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. Corticosteroids may mask

some signs of infection, and new infections may appear during their use. 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.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children.

Chickenpox and measles, for example, can have a more serious or even fatal course in children on

immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases,

particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune

globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If

chickenpox 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.

Usage in Pregnancy. 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.

The use of dexamethasone sodium phosphate injection USP 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 anti-tuberculosis 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.

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 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.

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. 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.

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

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

Postinjection flare, following intra-articular use

Charcot-like arthropathy

Itching, burning, tingling in the ano-genital region

DOSAGE AND ADMINISTRATION

A. Intravenous or intramuscular administration. The initial dosage of dexamethasone sodium phosphate

injection USP may vary from 0.50 mg/day to 9 mg/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. Usually the parenteral dosage ranges are one-third to one-half the

oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations,

administration of dosages exceeding the usual dosages may be justified and may be in multiples of the

oral dosages.

For the treatment of unresponsive shock high pharmacologic doses of this product are currently

recommended. Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous

injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock

persists.

For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended

followed by 4 mg intramuscularly every six hours until maximum response has been noted. This

regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral

dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a

period of five to seven days. Nonoperative cases may require continuous therapy to remain free of

symptoms of increased intracranial pressure. The smallest effective dose should be used in children,

preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses.

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a

week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for 1 month have

been shown to be effective.

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, dexamethasone sodium

phosphate injection USP 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 later situation it may be

necessary to increase the dosage of dexamethasone sodium phosphate injection USP for a period of

time consistent with the patient’s condition. If after a long-term therapy the drug is to be stopped, it is

recommended that it be withdrawn gradually rather than abruptly.

B. Intra-articular, soft tissue or intralesional administration. The dose for instrasynovial 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.

HOW SUPPLIED

Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible

particles and is supplied as follows:

4 mg per mL

1 mL Single-Dose Vials

in a carton of 25 NDC 55150-237-01

20 mg per 5 mL (4 mg / mL)

5 mL Multiple-Dose Vials

in a carton of 25 NDC 55150-238-05

120 mg per 30 mL (4 mg / mL)

30 mL Multiple-Dose Vials

in a carton of 25 NDC 55150-239-30

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

Sensitive to heat - Do not autoclave.

Protect from light.

The vial stoppers are not made with natural rubber latex.

Distributed by:

AuroMedics Pharma LLC

279 Princeton-Hightstown Rd.

E. Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad - 500038

India

Revised: July 2017

SAMPLE LABEL

DEXAMETHASONE SODIUM PHOSPHATE

dexamethasone sodium phosphate injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:5258 4-

239 (NDC:55150 -

239 )

Route of Administration

INTRAVENOUS, INTRAMUSCULAR, INTRA-

ARTICULAR, INTRALESIONAL, SOFT TISSUE

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXAMETHASO NE SO DIUM PHO SPHATE (UNII: AI9 376 Y6 4P) (DEXAMETHASONE -

UNII:7S5I7G3JQ L)

DEXAMETHASONE

PHOSPHATE

4 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

General Injectables & Vaccines, Inc.

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

10 mg in 1 mL

SO DIUM SULFITE (UNII: VTK0 1UQK3G)

1 mg in 1 mL

ANHYDRO US TRISO DIUM CITRATE (UNII: RS7A450 LGA)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:5258 4-239 -

1 in 1 BAG

0 8 /0 9 /20 19

1

1 mL in 1 VIAL, MULTI-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 6 78 1

0 8 /0 9 /20 19

Labeler -

General Injectables & Vaccines, Inc. (108250663)

Revised: 8/2019

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