Neuromaquel Neuroma

Name: Neuromaquel Neuroma

Dexamethasone Sodium Phosphate Injection, USP

Rx only

Clinical pharmacology

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.

Indications and usage

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.

By Intra-articular or Soft Tissue Injection

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

By Intralesional Injection

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)

Contraindications

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

Precautions

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.

Information for Patients

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.

Purpose

First Aid Antiseptic

Packaging-kit label

Packaging-kit components labeling

Neuromaquel Neuroma/ANTI-INFLAMMATORY SYSTEM 
dexamethasone sodium phosphate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70529-112
Packaging
# Item Code Package Description
1 NDC:70529-112-01 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 1 mL
Part 2 1 VIAL, SINGLE-DOSE 10 mL
Part 3 4 PACKET 4 mL
Part 1 of 3
DEXAMETHASONE SODIUM PHOSPHATE 
dexamethasone sodium phosphate injection, solution
Product Information
Item Code (Source) NDC:63323-165
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM 11 mg  in 1 mL
SODIUM SULFITE 1 mg  in 1 mL
BENZYL ALCOHOL 10 mg  in 1 mL
SODIUM HYDROXIDE  
CITRIC ACID MONOHYDRATE  
Packaging
# Item Code Package Description
1 1 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084916 09/07/2000
Part 2 of 3
MARCAINE 
bupivacaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-1560
Route of Administration EPIDURAL, PERINEURAL, INTRACAUDAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016964 08/16/2005
Part 3 of 3
MCKESSON ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Item Code (Source) NDC:68599-5804
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 1 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084916 03/01/2017
Labeler - IT3 Medical LLC (079971231)
Revised: 02/2018   IT3 Medical LLC
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