Dexamethasone

• If your course of treatment is due to last more than three weeks, you will be given a 'Steroid Treatment Card' which says that you are on steroids and contains some important advice for you. It is important that you read this card and carry it with you at all times. It also contains details about your dose, how long you have been taking dexamethasone for, and who prescribed it for you. Please make sure that this information is kept up to date. If you are having an operation or dental treatment or any treatment for an injury, tell the person carrying out the treatment that you are taking dexamethasone and show them your treatment card. This is because your dose may need adjusting.
• Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor will want you to have tests from time to time to make sure you remain free from some of the unwanted side-effects of treatment.
• Dexamethasone can suppress your immune system, so it is important if you become ill that you make an appointment to see your doctor straightaway. Also, if you come into contact with anyone who has measles, shingles or chickenpox (or anyone who suspects they might have them), you must see your doctor as soon as possible.
• Some vaccines are not suitable for you while you are being treated with dexamethasone. If you need any immunisations, make sure you mention that you are taking an oral steroid.
• If you buy any medicines, check with your pharmacist that they are suitable to take with dexamethasone.

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocorti-sone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise.

Persons who are on 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.

Before taking dexamethasone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dexamethasone or to any of its ingredients
• are allergic to aspirin
• are allergic to tartrazine (a yellow dye used in processed foods and drugs)
• have a systemic fungal infection
• have or have had liver problems
• have or have had heart problems
• have or have had kidney problems
• have or have had intestinal problems
• have or have had diabetes
• have or have had thyroid problems
• have or have had high blood pressure
• have or have had mental illness
• have myasthenia gravis
• have osteoporosis
• have or have had seizures
• have or have had tuberculosis
• have or have had ulcers
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

You should not use dexamethasone if you are allergic to it, or if you have:

• a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure dexamethasone is safe for you, tell your doctor if you have:

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• a history of malaria;

• tuberculosis;

• osteoporosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• stomach ulcers, ulcerative colitis, diverticulitis, inflammatory bowel disease;

• depression or mental illness;

• congestive heart failure; or

• high blood pressure.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Dexamethasone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.

Do not stop using dexamethasone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Wear a medical alert tag or carry an ID card stating that you take dexamethasone. Any medical care provider who treats you should know that you are using steroid medication.

Store at room temperature away from moisture and heat.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• muscle tightness, weakness, or limp feeling;

• problems with your vision;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• severe depression, unusual thoughts or behavior;

• a seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• lower back pain, blood in your urine, little or no urination;

• confusion, numbness or tingly feeling around your mouth;

• fast or slow heart rate, weak pulse;

• a pancreas disorder--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety.

Common side effects may include:

• fluid retention (swelling in your hands or ankles);

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating, increased hair growth;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating;

• muscle weakness; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Acute Mountain Sickness:

Prevention of AMS and HACE:
Usual dose: 2 mg orally every 6 hours OR 4 mg orally every 12 hours
-Very High Risk Situations (e.g. military, search and rescue at altitudes greater than 3500 m): 4 mg orally every 6 hours
Duration of Therapy: Should not exceed 10 days to prevent glucocorticoid toxicity or adrenal suppression

Treatment of AMS: 4 mg orally/IV/IM every 6 hours

Treatment of HACE: 8 mg orally/IV/IM once; followed by 4 mg orally/IV/IM every 6 hours

Comments:
-Dosing based on Wilderness and Environmental Medicine guidance.
-This drug has shown benefit for the prevention of acute mountain sickness (AMS) and high altitude cerebral edema (HACE), however, the evidence for prevention of high altitude pulmonary edema (HAPE) is lacking; this drug should be used in conjunction with non-pharmacologic measures and only in situations when the risk profile is favorable.
-Treatment does not facilitate acclimation; further ascent should be delayed until the patient is asymptomatic while off the medication.

Uses:
-For the prevention of AMS and HACE.
-For the treatment of AMS and HACE, and to treat concurrent HACE and HAPE when neurologic dysfunctions do not resolve rapidly with administration of supplemental oxygen.

Usual Adult Dose for Cerebral Edema:

Initial dose: 10 mg IV once, followed by 4 mg IM every 6 hours until maximal response is noted
-After 2 to 4 days, dose should be reduced and then gradually discontinued over a period of 5 to 7 days

Comments:
-After symptoms subside, may switch to oral therapy (1 to 3 mg orally 3 times a day) and then taper gradually over 5 to 7 days.
-In patients undergoing brain surgery, may continue treatment for several days postoperatively.
-In nonoperative cases, continuous therapy may be needed to remain symptom-free.

Use: For the treatment of cerebral edema.

Usual Adult Dose for Cushing's Syndrome:

Dexamethasone Suppression Tests:

-Short suppression test: 1 mg orally at 11 PM; draw plasma cortisol at 8 AM the following morning

-Long suppression test: 0.5 mg orally every 6 hours for 48 hours; 24-hour urine collections are made before, during, and at the end of the test for determination of 17-hydroxycorticosteroids

-Test to distinguish Cushing's syndrome: 2 mg orally every 6 hours for 48 hours; 24-hour urine collections are made before, during, and at the end of the test for determination of 17-hydroxycorticosteroids

Comment: The long suppression test provides greater accuracy in diagnosing Cushing's syndrome.

Uses: Diagnostic testing for Cushing's syndrome.

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Highly emetogenic chemotherapy regimens:
12 to 20 mg oral/IV prior to chemotherapy followed by 8 mg oral/IV once or twice a day for 2 to 4 days

Moderately emetogenic chemotherapy regimens:
8 mg oral/IV prior to chemotherapy followed by 4 to 8 mg oral/IV on days 2 and 3

Low emetogenic chemotherapy regimens:
4 to 8 mg oral/IV prior to chemotherapy

Comments:
-This drug may be used alone but is most often used in combination with other agents, e.g. neurokinin 1 (NK1) antagonists and 5-hydroxytryptamine-3 (5-HT3) antagonists.
-When used in combination regimens, it is the combination of agents that defines the dose and duration of use for this drug; this is not a labeled indication.
-When receiving combination chemotherapy, the agent with the most emetic potential should determine the regimen of anti-emetic therapy that should be used.

Use: For prophylaxis and treatment of chemotherapy induced nausea and vomiting.

Usual Adult Dose for Shock:

Unresponsive shock:
1 to 6 mg/kg IV as a single dose or up to 40 mg initially followed by repeat IV doses every 2 to 6 hours while shock persists

Published protocols:
20 mg IV as a single dose followed by IV infusion of 3 mg/kg/24 hours
1 to 6 mg/kg IV as a single dose
40 mg IV as a single dose followed by repeat IV doses every 4 to 6 hours while shock persists

Comments:
-High-dose therapy should only be continued until patient's condition has stabilized and usually no longer than 48 to 72 hours.

Use: For the treatment of unresponsive shock.

Usual Adult Dose for Multiple Myeloma:

40 mg oral/IV on days 1, 8, 15, 22, and repeated every 4 weeks

Comments:
-This drug is a part of most major treatment regimens in multiple myeloma; treatment regimens should be consulted.
-In regimens containing bortezomib, the day 1 dexamethasone dose may be split to provide 20 mg on the day of and 20 mg on the day after bortezomib.
-Doses may need to be adjusted for performance status or other toxicities

Use: For the treatment of multiple myeloma.

Usual Adult Dose for Multiple Sclerosis:

Acute exacerbation: 30 mg orally once a day for 1 week followed by 4 to 8 mg orally every other day for 1 month

Comments:
-Short-term high-dose corticosteroids are an accepted standard of care for treating relapses of multiple sclerosis; chronic daily corticosteroids are not recommended.
-IV methylprednisolone, oral prednisone and prednisolone are the corticosteroids most studied and cited in clinical guidelines; while this drug has been used, efficacy studies and comparative data are lacking.

Use: For the treatment of acute exacerbations of multiple sclerosis.

Usual Adult Dose for Anti-inflammatory:

Dosing should be individualized on the basis of disease and patient response

Oral:
-Initial dose: 0.75 mg to 9 mg orally per day
Parenteral:
-Initial dose: 0.5 mg to 9 mg IV or IM per day in divided doses every 12 hours

Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses, may suffice in less severe disease; doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-When oral therapy is not feasible IV or IM therapy in doses ranging from one-third to one-half the oral dose may be given every 12 hours.
-Patients should be closely monitored for signs requiring dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous. gastrointestinal, respiratory, musculoskeletal, and hematologic.

Usual Adult Dose for Immunosuppression:

Dosing should be individualized on the basis of disease and patient response

Oral:
-Initial dose: 0.75 mg to 9 mg orally per day
Parenteral:
-Initial dose: 0.5 mg to 9 mg IV or IM per day in divided doses every 12 hours

Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses, may suffice in less severe disease; doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-When oral therapy is not feasible IV or IM therapy in doses ranging from one-third to one-half the oral dose may be given every 12 hours.
-Patients should be closely monitored for signs requiring dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous. gastrointestinal, respiratory, musculoskeletal, and hematologic.

Usual Adult Dose for Brain/Intracranial Tumor:

2 mg oral/IV/IM 2 to 3 times a day

Use: For palliative management of recurrent or inoperable brain tumors.

Usual Adult Dose for Allergic Reaction:

First day: 4 to 8 mg IM once
Second and third day: 1.5 mg orally twice per day
Fourth day: 0.75 mg orally twice per day
Fifth and sixth day: 0.75 mg orally once a day
Seventh day: No treatment
Eighth day: Reassessment

Comments: This dosing schedule is designed to ensure adequate therapy during an acute episode while minimizing the risk of overdose in chronic cases.

Use: For the treatment of acute, self-limited allergic disorder or exacerbation of chronic allergic disorder.

Usual Adult Dose for Bursitis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Osteoarthritis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Rheumatoid Arthritis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Tendonitis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Gouty Arthritis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Epicondylitis:

Suggested doses:
Large joints: 2 to 4 mg
Small joints: 0.8 to 1 mg
Bursae: 2 to 4 mg
Tendon Sheaths: 0.4 to 1 mg

Injections may be repeated from once every 3 to 5 days to once every 2 to 3 weeks

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Intrasynovial and soft tissue injections should be limited to 1 or 2 sites; frequent intra-articular injections may cause damage to joint tissue.

Use: As adjunctive therapy for an acute episode or exacerbation of synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and posttraumatic osteoarthritis.

Usual Adult Dose for Alopecia:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Lichen Simplex Chronicus:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Psoriasis:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Granuloma Annulare:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Lichen Planus:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Keloids:

Suggested doses:
Soft tissue infiltration: 2 to 6 mg
Ganglia: 1 to 2 mg

Comments:
-Dose will vary according to the degree of inflammation and the size and location of the affected site.
-Soft tissue and intralesional injections should be limited to 1 or 2 sites.

Uses: As adjunctive therapy for keloids; localized hypertrophic, infiltrated, inflammatory lesion of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. May be useful in cystic tumors of an aponeurosis tendon (ganglia).

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

40 mg orally once a day for 4 days
-An additional 4-day course may be given if bleeding symptoms are present on day 7 or platelet count remains below 30 x10(9)/L

Comments:
-The American Society of Hematology (2011) has recommended a longer course of corticosteroids (e.g. prednisone for 21 days) over a shorter course (high-dose dexamethasone) due to longer time to loss of response, however, a recent prospective multicenter trial has shown 1 or 2 courses of high-dose dexamethasone are at least comparable to longer courses.

Use: For the treatment of immune thrombocytopenia.

Usual Pediatric Dose for Cerebral Edema:

0.2 mg/kg/24 hr oral/IV/IM in divided doses

Comments:
-The smallest effective dose should be used, preferably oral.

Use: For the treatment of cerebral edema

Usual Pediatric Dose for Meningitis:

Meningitis (H. influenzae type b):
Infants and Children 6 weeks or older: 0.15 mg/kg/dose IV every 6 hours for the first 2 to 4 days of antibiotic treatment

Comments:
-Dexamethasone should be started 10 to 20 minutes before or with the first dose of antibiotic; if antibiotics have already been administered, dexamethasone use has not been shown to improve patient outcomes and is not recommended.
-This is not a labeled indication.
-This drug has not been shown to reduce overall mortality, but has been shown to reduce hearing loss and neurological sequelae.

Note: For pneumococcal meningitis, data has not shown clear benefit from dexamethasone administration; risk and benefits should be considered prior to use.

Use: To reduce hearing loss and neurological sequelae associated with meningitis.

Usual Pediatric Dose for Anti-inflammatory:

Dosing should be individualized on the basis of disease and patient response

Oral:
-Initial dose: 0.02 mg to 0.3 mg/kg/day OR 0.6 to 9 mg/m2/day orally in 3 or 4 divided doses
-Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses may suffice in less severe disease, while doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-When oral therapy is not feasible IV or IM therapy in doses ranging from one-third to one-half the oral dose may be given every 12 hours.
-Patients should be observed closely for signs that require dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous. gastrointestinal, respiratory, musculoskeletal, and hematologic.

Usual Pediatric Dose for Immunosuppression:

Dosing should be individualized on the basis of disease and patient response

Oral:
-Initial dose: 0.02 mg to 0.3 mg/kg/day OR 0.6 to 9 mg/m2/day orally in 3 or 4 divided doses
-Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses may suffice in less severe disease, while doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-When oral therapy is not feasible IV or IM therapy in doses ranging from one-third to one-half the oral dose may be given every 12 hours.
-Patients should be observed closely for signs that require dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous. gastrointestinal, respiratory, musculoskeletal, and hematologic.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

Highly Emetogenic Chemotherapy Regimens:
6 mg/m2 oral/IV every 6 hours

Moderately Emetogenic Chemotherapy Regimens:
-BSA 0.6 m2 or less: 2 mg IV/oral every 12 hours
-BSA greater than 0.6 m2: 4 mg IV/oral every 12 hours

Comments:
-The addition of dexamethasone to anti-emetic regimens improves control of vomiting, although the risk-benefit remains uncertain.
-For regimens containing aprepitant, the dose of dexamethasone should be reduced by one-half.
-This is not a labeled indication, but recommended in many anti-emetic protocols.

Use: For the prevention of nausea and vomiting associated with chemotherapy.

Usual Pediatric Dose for Asthma -- Acute:

0.6 mg/kg oral/IV/IM once

Comments:
-Studies have shown dexamethasone in single doses (0.3 mg/kg up to 1.7 mg/kg; maximum single dose 36 mg) or multiple doses (0.6 mg/kg once a day for 2 days) is comparable to a 5-day course of prednisone/prednisolone in the treatment of acute asthma exacerbations.

Use: For the treatment of acute asthma exacerbation.

Usual Pediatric Dose for Croup:

0.6 mg/kg oral/IM/ IV once
Maximum dose: 16 mg

Comment: Further dosing and route of administration determined by clinical course

Use: For the treatment of childhood croup (laryngotracheobronchitis).

Usual Pediatric Dose for Acute Mountain Sickness:

0.15 mg/kg oral/IV/IM every 6 hours

Comments:
-Dosing based on Wilderness and Environmental Medicine guidance.
-Prophylactic use of this drug for acute mountain sickness (AMS) is not recommended in pediatric patients due to the potential for toxicity; safer alternatives such as graded ascent and acetazolamide should be considered.
-Treatment does not facilitate acclimation; further ascent should be delayed until the patient is asymptomatic while off the medication.

Use: For the treatment of acute mountain sickness.

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

0.6 mg/kg/day oral/IV for 4 days every 4 weeks for 6 cycles

Comments:
-High-dose dexamethasone may be considered appropriate second-line treatment in those who have significant bleeding despite IVIg, anti-D, or a short course of corticosteroids.
-Additionally, it may be considered in patients with chronic immune thrombocytopenia as an alternative to splenectomy or in patients who do not response to splenectomy.
-There is limited data on use of this drug in the pediatric population; the above dose is from a study in a small number of patients.

Use: For the treatment of immune thrombocytopenia.

Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.a b c

Usually, inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.a b c

Adrenocortical Insufficiency

Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.b

Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.a b c d f

If dexamethasone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.a b c d f

In suspected or known adrenal insufficiency, parenteral therapy may be used preoperatively or during serious trauma, illness, or shock unresponsive to conventional therapy.d f

In shock, IV therapy in conjunction with other therapy for shock is essential; hydrocortisone is preferred, but a synthetic glucocorticoid like dexamethasone can be substituted.b

Adrenogenital Syndrome

Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.a c d f

In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.b

A glucocorticoid, usually alone, for long-term therapy after early childhood.b

In hypertensive forms, do not use dexamethasone because of tendency toward overdosage and growth retardation.b

Hypercalcemia

Treatment of hypercalcemia associated with malignancy.a b c d f

Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.b

Treatment of hypercalcemia associated with sarcoidosis†.b

Treatment of hypercalcemia associated with vitamin D intoxication†.b

Not effective for hypercalcemia caused by hyperparathyroidism†.b

Thyroiditis

Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.a c d f

Anti-inflammatory action relieves fever, acute thyroid pain, and swelling.b

May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).b

Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.b

Rheumatic Disorders and Collagen Diseases

Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, Reiter syndrome†, rheumatic fever† [especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, dematomyositis† [polymyositis], polyarteritis nodosa†, vasculitis†) refractory to more conservative measures.a c d f

Relieves inflammation and suppresses symptoms but not disease progression.b

Rarely indicated as maintenance therapy.b

May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.a b c d f

Glucocorticoid withdrawal is extremely difficult if used for maintenance; relapse and recurrence usually occur with drug discontinuance.b

Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae;b inflammation tends to recur and sometimes is more intense after drug cessation.b

Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.b

Controls acute manifestations of rheumatic carditis more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and no better than salicylates for long-term treatment.b

Adjunctively for severe systemic complications of Wegener’s granulomatosis†, but cytotoxic therapy is the treatment of choice.b

Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with dermatomyositis† and polymyositis†, polyarteritis nodosa†, relapsing polychondritis†, polymyalgia rheumatica† and giant-cell (temporal) arteritis†, or mixed connective tissue disease syndrome†.b High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.b

Polymyositis† associated with malignancy and childhood dermatomyositis may not respond well.b

Rarely indicated in psoriatic arthritis, diffuse scleroderma† (progressive systemic sclerosis), acute and subacute bursitis, or osteoarthritis†; risks outweigh benefits.b

In osteoarthritis†, intraarticular injections may be beneficial but should be limited in number as joint damage may occur.b

Dermatologic Diseases

Treatment of pemphigus and pemphigoid†, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema†, cutaneous sarcoidosis†, mycosis fungoides, lichen planus†, severe psoriasis, and severe seborrheic dermatitis.a c d f

Usually reserved for acute exacerbations unresponsive to conservative therapy.b

Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid†, and high or massive doses may be required.b

For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.a c d f

Chronic skin disorders seldom an indication for systemic glucocorticoids.b

Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders (e.g., keloids†, psoriatic plaques†, alopecia areata†, discoid lupus erythematosus†, granuloma annulare†) unresponsive to topical therapy.b

Rarely indicated for psoriasis†; if used, exacerbation may occur when the drug is withdrawn or dosage is decreased.b

Rarely indicated for alopecia† (areata, totalis, or universalis); may stimulate hair growth, but hair loss returns when the drug is discontinued.b

Allergic Conditions

For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including anaphylactic and anaphylactoid reactions, angioedema†, acute noninfectious laryngeal edema, serum sickness, allergic symptoms of trichinosis, urticarial transfusion reactions†, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.a b c d f

Systemic therapy usually reserved for acute conditions and severe exacerbations.b

For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).b

Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.b

Ocular Disorders

To suppress a variety of allergic and nonpyogenic ocular inflammations.b

To reduce scarring in ocular injuries†.b

For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, retrobulbar neuritis†, sympathetic ophthalmia).a c d

Acute optic neuritis optimally treated with initial high-dose IV therapy followed by chronic oral therapy.b Can slow progression to clinically definite multiple sclerosis.b

Less severe allergic and inflammatory allergic conditions of the eye are treated with topical (to the eye) corticosteroids.j

Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.b

Asthma

Adjunctively for moderate to severe exacerbations of asthma and for maintenance in persistent asthma.b j

Systemically (oral or IV) for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred); speeds resolution of airflow obstruction and reduces rate of relapse.j

Because onset of effects is delayed, do not use alone for emergency treatment.b

Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.j

In hospital management of an acute asthma exacerbation, systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.b

For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral glucocorticoids for maintenance because inhaled corticosteroids have fewer systemic effects.

Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthmab (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).b

Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.b

Oral glucocortocoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.

COPD

For severe exacerbations of COPD†, a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.

Effects of glucocorticoids in stable COPD are much less dramatic than in asthma, and role of glucocorticoids in the management of stable COPD is limited to very specific indications.

Croup

Adjunctive treatment of croup† in pediatric patients.j

Decreases edema in laryngeal mucosa.j

Reduces need for hospitalization, shorter duration of hospitalization, and reduces need for subsequent interventions (e.g., epinephrine).j

Sarcoidosis

Management of symptomatic sarcoidosis.a b c d f

Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.b

Advanced Pulmonary and Extrapulmonary Tuberculosis

Systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary tuberculosis.a

Adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities) in advanced pulmonary tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary disease (e.g., meningitis, pericarditis).

Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival in moderate to severe tuberculous meningitis.

Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion) in acute tuberculous pericarditis.

Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.b

Lipid Pneumonitis

Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids in lipid pneumonitis.b

Pneumocystis carinii Pneumonia

Systemic adjunctive glucocorticoids decrease the likelihood of deterioration of oxygenation, respiratory failure, and/or death in moderate to severe Pneumocystis carinii pneumonia in acquired immunodeficiency syndrome† (AIDS).

Prevents early deterioration in oxygenation associated with antipneumocystis therapy; initiate adjunctive glucocorticoid therapy as early as possible in moderate to severe pneumocystis pneumonia.

Not known whether patients with mild pneumocystis pneumonia (arterial oxygen pressure >70 mm Hg or arterial-alveolar gradient <35 mm Hg on room air) will have clinically important benefit with adjunctive glucocorticoid therapy.

Other glucocorticoids (e.g., oral prednisone, parenteral methylprednisolone) generally are preferred.

Loeffler’s Syndrome

Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.a b c d f

Berylliosis

Symptomatic relief of acute manifestations of berylliosis.a b c d f

Aspiration Pneumonitis

Symptomatic relief of acute manifestations of aspiration pneumonitis.a b c d f

Anthrax

Adjunct to anti-infective therapy in the treatment of anthrax† in an attempt to ameliorate toxin-mediated effects associated with Bacillus anthracis infections.

For cutaneous anthrax† if there are signs of systemic involvement or extensive edema involving the neck and thoracic region, anthrax meningitis†, and inhalational anthrax† that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism if extensive edema, respiratory compromise, or meningitis is present.

Antenatal Use in Preterm Labor

Short-course IM therapy in selected women with preterm labor to hasten fetal maturation† (e.g., lungs, cerebral blood vessels), including women with preterm premature rupture of membranes, preeclampsia, or third-trimester hemorrhage.

Reduces the incidence and/or severity of neonatal respiratory distress syndrome† (RDS) as indicated by a reduction in requirements for neonatal ventilatory support or surfactant therapy; beneficial effects are additive with those of surfactant.

Combined effects on multiple organ maturation reduces neonatal mortality; beneficial effects extend to a broad range of gestational ages (i.e., 24–34 weeks).

Can improve neonatal circulatory stability and reduce the incidence or severity of intraventricular hemorrhage†.

Maternal use of tocolytic agents in conjunction with glucocorticoids may delay delivery in preterm labor long enough for the fetus to derive benefit from glucocorticoid-induced accelerated fetal maturation.

Additive effect with postnatal prophylactic lung surfactant therapy in reducing the incidence of RDS† and neonatal mortality. In addition, antenatal glucocorticoids can reduce the incidence and/or severity of intraventricular hemorrhage†, which surfactant therapy alone does not appear to benefit.

Conflicting data concerning the effects on the incidence of necrotizing colitis†, bronchopulmonary dysplasia†, and patent ductus arteriosus† in neonates.

Efficacy and safety of antenatal glucocorticoid therapy before 24 weeks or after 34 weeks of gestation have not been established.

Antenatal glucocorticoids to reduce infant morbidity and mortality in women with preterm premature rupture of membranes is somewhat controversial, since the magnitude of neonatal benefit on RDS† appears to be less and the risk of neonatal infection greater than those in women with intact membranes.

Postnatal Use for Bronchopulmonary Dysplasia

Has been used for prevention or treatment of bronchopulmonary dysplasia in very low-birth-weight infants (i.e., <1.5 kg) who require mechanical ventilation. However, the AAP states that routine use of systemic glucocorticoids in such patients is not recommended.

May provide short-term pulmonary benefits but does not reduce mortality and is associated with an increased risk of serious adverse effects (e.g., hyperglycemia, hypertension, GI bleeding or intestinal perforation, hypertrophic obstructive cardiomyopathy, poor weight gain, poor growth of head circumference) and long-term sequelae (e.g., neurodevelopmental delay, cerebral palsy, impaired cognitive function, and stunted growth at or before school age).

Hematologic Disorders

Management of acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.a b c d f

High or even massive dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.b

Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.

May not affect or prevent renal complications in Henoch-Schoenlein purpura.b

Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.b

Shock

Although IV glucocorticoids may be life-saving in shock secondary to adrenocortical insufficiency (see Adrenocortical Insufficiency under Uses), the value of the drugs in the treatment of shock resulting from other causes† is controversial.b

Management of shock should be based on specific treatment of the primary cause and secondary abnormalities, and glucocorticoids, if used, should be regarded only as adjunctive supportive treatment.b

Value in adjunctive treatment of septic shock† is particularly controversial. Conflicting evidence regarding effects of high-dose regimens on morbidity and mortality in septic shock.

Pericarditis

To reduce the pain, fever, and inflammation of pericarditis†, including that associated with MI.b

Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for postmyocardial infarction pericarditis because of greater evidence establishing benefit.

Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.

Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development.

Glucocorticoids may cause thinning of developing scar and myocardial rupture.

Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)

GI Diseases

Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis, and celiac disease†.a b c d f n o

Do not use if a probability of impending perforation, abscess, or other pyogenic infection.b

Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis, celiac disease) since does not prevent relapses and may produce severe adverse reactions with long-term administration.b

Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.b

Crohn’s Disease

Management of mildly to moderately active and moderately to severely active Crohn’s disease.n o

Some experts state that conventional glucocorticoids should not be used for the management of mildly to moderately active disease, because of the high incidence of adverse effects and therefore, their use should be reserved for patients with moderately to severely active disease.

Parenteral glucocorticoids recommended for patients with severe fulminant Crohn’s disease†. Once patients respond to parenteral therapy, they should gradually be switched to an equivalent regimen of an oral glucocorticoid.

Glucocorticoids should not be used for maintenance therapy of Crohn’s disease, because they usually do not prevent relapses and the drugs may produce severe adverse reactions with long-term administration.

Glucocorticoids been used in the management of moderately to severely active Crohn’s disease and in mild esophageal or gastroduodenal Crohn’s disease† in pediatric patients.

Neoplastic Diseases

Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).a b c d f

Treatment of breast cancer; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.b

Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer.

Cancer Chemotherapy-induced Nausea and Vomiting

Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy†.100 101 102 103 104 129 130 131

Addition of dexamethasone to monotherapy with a selective 5-HT3 antagonist (e.g., granisetron, ondansetron) or a substituted benzamide (e.g., metoclopramide) increases antiemetic efficacy; combined therapy may be useful for nausea and vomiting refractory to monotherapy.

Cerebral Edema

To decrease cerebral edema associated with brain tumors and neurosurgery (e.g., craniotomy).a b c d f

Cerebral edema associated with pseudotumor cerebri may also benefit, but efficacy of glucocorticoids is controversial and remains to be established.b

Edema resulting from brain abscesses is less responsive than that resulting from brain tumors.b

Pharmacologic management of cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.a c d f

Head Injury

Efficacy of glucocorticoid therapy is not established; such therapy can be detrimental and is associated with a substantial increase in risk of death. Use in improving outcomes or reducing intracranial pressure in patients with head injury not recommended.

Cerebral Malaria

Glucocorticoids are not effective and can have detrimental effects in the management of cerebral malaria caused by Plasmodium falciparum; no longer recommended for this condition.b

Bacterial Meningitis

Short-term adjunctive therapy (i.e., IV dexamethasone for the first 2–4 days of anti-infective therapy) of bacterial meningitis†.

To benefit CSF abnormalities involving prostaglandin, lactate, glucose, and protein concentrations and to decrease neurologic manifestations and sequelae (e.g., development of hearing loss).b

AAP currently recommends that adjunctive therapy with IV dexamethasone for bacterial meningitis be considered on an individualized basis in infants and children ≥6 weeks of age after weighing the relative risks and benefits.127

Multiple Sclerosis

Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosis†.

Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.

Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.

Myasthenia Gravis

Management of myasthenia gravis†, usually when there is an inadequate response to anticholinesterase therapy.

Parenterally for the treatment of myasthenic crisis.

Organ Transplants

In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs†.b

Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.b

Trichinosis

Treatment of trichinosis with neurologic or myocardial involvement.a c d f

Nephrotic Syndrome and Lupus Nephritis

Treatment of idiopathic nephrotic syndrome without uremia.a c d f f

Can induce diuresis and remission of proteinuria in nephrotic syndromea b c d f secondary to primary renal disease, especially when there is minimal renal histologic change.b

Treatment of lupus nephritis.a b c d

Diagnostic Uses

Diagnosis (dexamethasone suppression test; DST) of adrenocortical hyperfunction (e.g., Cushing’s syndrome, adrenal hyperplasia, adrenal adenoma).a b d f

Inhibits pituitary corticotropin (ACTH) release and decreases output of endogenous corticosteroids when given in an amount that does not itself appreciably affect levels of urinary 17-hydroxycorticosteroids.b

Diagnosis (DST) of mental depression; however, considerable controversy currently exists regarding the clinical utility of the test.

Sensitivity of DST in depression is relatively modest (about 40–50%), and a positive test result (nonsuppression) does not appear to reliably predict response to antidepressant therapy and a negative test result (suppression) is not an indication for withholding antidepressant therapy.

Absorption

Bioavailability

Systemic absorption occurs more slowly following IM injection compared with IV administration.d

Onset

In the treatment of cerebral edema with IV then IM injection, response is usually noted within 12–24 hours.d

Duration

The duration of anti-inflammatory activity of dexamethasone approximately equals the duration of HPA-axis suppression, about 2.75 days for a single 5-mg oral dose.b

Distribution

Extent

Most glucocorticoids are removed rapidly from the blood and distributed to muscle, liver, skin, intestines, and kidneys.b Glucocorticoids appear in breast milk and the placenta.b

Plasma Protein Binding

Bound weakly to transcortin.b

Elimination

Metabolism

Metabolized by CYP3A4.c

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal cramping and/or burning (severe)
• abdominal pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS).

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

Cardio-Renal

Average and large doses of corticosteroids can cause elevation of blood pressure, sodium 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.

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.

Endocrine

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. 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.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Infections

General

Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.

Fungal Infections:Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents).

Special Pathogens: Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

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.

Corticosteroids should not be used in cerebral malaria.

Tuberculosis: The use of corticosteroids 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 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.

Vaccination: Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Viral Infections: Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. 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.) If chickenpox develops, treatment with antiviral agents should be considered.

Ophthalmic

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 bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.

(Listed alphabetically, under each subsection)

The following adverse reactions have been reported with Dexamethasone or other corticosteroids:

Allergic Reactions

Anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic

Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine

Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and Electrolyte Disturbances

Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal

Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic

Negative nitrogen balance due to protein catabolism.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures.

Neurological/Psychiatric

Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic

Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Other

Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

Dexamethasone Tablets USP

0.75 mg tablets are supplied as a pale blue, flat tablet with beveled edges, scored on one side and product identification “54 960” debossed on the other side.

Store and Dispense

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Do not use if solution contains a precipitate. Dispense only in this bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of dexamethasone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

• Dexamethasone is a type of corticosteroid called a glucocorticoid. Dexamethasone helps to reduce inflammation and calms an overactive immune system.
• Dexamethasone mimics the effect of cortisol, a hormone released by the adrenal glands (located on top of the kidneys) that controls metabolism and stress.