Dexamethasone injection

Dexamethasone injection comes as powder to be mixed with liquid to be injected intramuscularly (into a muscle) or intravenously (into a vein). Your personal dosing schedule will depend on your condition and on how you respond to treatment.

You may receive dexamethasone injection in a hospital or medical facility, or you may be given the medication to use at home. If you will be using dexamethasone injection at home, your healthcare provider will show you how to inject the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using dexamethasone injection.

Your doctor may change your dose of dexamethasone injection during your treatment to be sure that you are always using the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to dexamethasone injection.

If you are having any skin tests such as allergy tests or tuberculosis tests, tell the doctor or technician that you are receiving dexamethasone injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using dexamethasone injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.

Dexamethasone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, breathing disorders, inflammatory eye conditions, blood cell disorders, leukemia, or endocrine disorders.

Dexamethasone may also be used for purposes not listed in this medication guide.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using dexamethasone. Steroids may increase your risk of harmful effects from a live vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

A. By intravenous or intramuscular injection when oral therapy is not feasible:

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).

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 treatement 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.

Keratitis.

Allergic corneal marginal ulcers.

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:

Systematic sarcoidosis.

Berylliosis.

Fulmination or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.

Loeffler's syndrome not manageable by other means.

Aspiration pneumonitis.

9. 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.

10. Neoplastic Diseases:

Palliative management of:

Leukemias and lymphomas in adults.

Acute leukemia of childhood.

11. Neoplastic Diseases:

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

12. Miscellaneous:

Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Trichinosis with neurologic or myocardial involvement.

13. Diagnostic testing of adrenocortical hyperfunction.

14. 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 neruosurgery or other specific therapy.

B. 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.

C. By intralesional injection:

Keloids.

Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simples chronicus (neurodermatitis).

Discoid lupus erythematosus.

Necrobiosis lipoidica diabeticorum.

Alopecia areata.

May also be useful in cystic tumors of an aponeurosis or tendion (ganglia).

Systemic fungal infections. (See WARNINGS regarding amphotericin B)

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 included, 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 has not been established, and corticosteroids are not approved for this use.
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. Anaphylactoid and hypersensitivity reactions have been reported for dexamethasone sodium phosphate injection. (See ADVERSE REACTIONS).
Corticosteriods may exacerbate systemic fungal infections and, therefore, should not be used in the presence of such infections unless they are needed to control in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive failure.
In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a minerealcorticoid should be administered concurrently.
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. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results.
In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.
Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.
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.
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. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.
Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. The risk of developing a disseminated infection varies amove individuals and can be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.)
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 appropriate antituberculous 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.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
Use in Pregnancy
Since adequate human reporduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighted against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefuly observed for signs of hypoadrenalism.
Corticosteroids appear in breast milk and could cuppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

Mylan

Manufacturered for:

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufacturered by:

Mylan Laboratories Limited

Banglore, Indiea

1026791

December 2015