Hexadrol

Description for Hexadrol

Hexadrol® Phosphate Injection (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, 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 creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 10.5. It has the following structural formula:

Hexadrol® Phosphate Injection is available in 4 mg/mL and 10 mg/mL concentrations.

Each mL of Hexadrol® Phosphate Injection 4 mg/mL, contains 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.

Each mL of Hexadrol® Phosphate Injection 10 mg/mL, contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 1.5 mg sodium sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide.

Uses for Hexadrol

Endocrine Disorders

• Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
• 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:

• Psoriatic arthritis.
• Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
• Ankylosing spondylitis.
• Acute and subacute bursitis.
• Acute nonspecific tenosynovitis.
• Acute gouty arthritis.
• Post-traumatic osteoarthritis.
• Synovitis of osteoarthritis.
• Epicondylitis.
• spondylitis.

Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:

• Systemic lupus erythematosus.
• Acute rheumatic carditis.

Dermatologic Diseases

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

Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

• Seasonal or perennial allergic rhinitis. Serum sickness.
• Bronchial asthma.
• Contact dermatitis.
• Atopic dermatitis.
• Drug hypersensitivity reactions.

Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

• Allergic conjunctivitis.
• Keratitis.
• Allergic corneal marginal ulcers.
• Herpes zoster ophthalmicus.
• lritis and iridocyclitis.
• Chorioretinitis.
• Anterior segment inflammation.
• Diffuse posterior uveitis and choroiditis.
• Optic neuritis.
• Sympathetic ophthalmia.

Respiratory Diseases

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

Hematologic Disorders

• Idiopathic thrombocytopenic purpura in adults.
• Secondary thrombocytopenia in adults.
• Acquired (autoimmune) hemolytic anemia.
• 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 a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:

• Ulcerative colitis.
• Regional enteritis.

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.

Dosage for Hexadrol

Intravenous Or Intramuscular Administration

The initial dosage of Hexadrol® (dexamethasone elixir, USP) may vary from 0.75 mg to 9.0 mg per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hexadrol® (dexamethasone elixir, 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 favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Hexadrol® (dexamethasone elixir, USP) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Patients currently being treated with other corticosteroids may be transferred conveniently to this agent using the following dosage equivalents:

• 25 mg cortisone
• 20 mg hydrocortisone
• 0.75 mg dexamethasone equivalent to 5 mg prednisone or prednisolone
• 4 mg methylprednisolone
• 4 mg triamcinolone

HOW SUPPLIED

Storage And Handling

Hexadrol^® (dexamethasone elixir, USP)

0.5mg/5mL elixir (alcohol 5%), bottles of 120 mL - NDC XXXXX-XXX-XX

Storage

Store at controlled room temperature, 15°-30°C (59°-86°F).

Caution: Federal law prohibits dispensing without prescription.

Manufactured for: Aspen Global, Inc. Grand Bay, Mauritius. Revised: Mar 2024.

Side Effects for Hexadrol

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 perforation and hemorrhage
• Pancreatitis
• Abdominal distention
• Ulcerative esophagitis

Dermatologic

• Impaired wound healing
• Thin fragile skin
• Petechiae and ecchymoses
• Facial erythema
• Increased sweating

Neurological

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

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
• Posterior subcapsular cataracts.
• Increased intraocular pressure.
• Glaucoma.
• Exophthalmos.

Metabolic

• Negative nitrogen balance due to protein catabolism

Drug Interactions for Hexadrol

No Information Provided

Warnings for Hexadrol

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, corticosteroidinduced 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 Hexadrol® Phosphate Injection (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.

Hexadrol® 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 for Hexadrol

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.

Overdose Information for Hexadrol

No information provided.

Contraindications for Hexadrol

Systemic fungal infections.

Clinical Pharmacology for Hexadrol

Naturally occurring glucocorticoids (hydrocortisone and cortisone), 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 response to diverse stimuli.

Patient Information for Hexadrol

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.