Baycadron

Dexamethasone is a prescription medication used to relieve inflammation and treat a variety of conditions that involve swelling, heat, redness, and pain in many body systems.

Dexamethasone belongs to a group of drugs called corticosteroids. These work by replacing natural hormones produced by your adrenal glands when your body cannot make enough.

This medication is available as an oral concentrate, an oral elixir, an oral solution, an oral tablet, eye drops, and ear drops. The directions and frequency of use will vary with the indication for dexamethasone.

This medication is also available as an intravitreal implant for injection into the eye by a healthcare professional.

This medication is also available in an injectable form to be given directly into a vein (IV), a muscle (IM), a joint (intra-articular), a lesion (intralesional), and soft tissue by a healthcare professional.

Common side effects of dexamethasone include upset stomach, vomiting, headache, insomnia, restlessness, depression, anxiety, acne, increased hair growth, easy bruising, increased appetite and weight gain, and irregular or absent menstrual periods.

Dexamethasone can also cause dizziness. Do not drive or operate heavy machinery until you know how dexamethasone affects you.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dexamethasone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dexamethasone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from dexamethasone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take dexamethasone exactly as prescribed.

This medication is available as an oral concentrate, an oral elixir, an oral solution, an oral tablet, and eye and ear drops. Your doctor will prescribe the dose and schedule for use that is appropriate for your condition. Oral forms of dexamethasone may be taken with food or milk to decrease the risk of an upset stomach.

This medication is also available as an intravitreal implant for injection directly into the eye by a healthcare professional.

This medication is also available in an injectable form to be given directly into a vein (IV), a muscle (IM), a joint (intra-articular), a lesion (intralesional), and soft tissue by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of dexamethasone at the same time.

If you take too much dexamethasone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dexamethasone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

 

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.

  Systemic fungal infections   Hypersensitivity to this product

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible 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 should 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, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism.

When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.

False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.

When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.

Information for Patients

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

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   Tendon rupture

Gastrointestinal:

  Peptic ulcer with possible perforation and hemorrhage   Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease   Pancreatitis   Abdominal distention   Ulcerative esophagitis

Dermatologic:

  Impaired wound healing   Thin fragile skin   Petechiae and ecchymoses   Erythema   Increased sweating   May suppress reactions to skin tests   Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema

Neurologic:

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

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 diabetes   Hirsutism

Ophthalmic:

  Posterior subcapsular cataracts   Increased intraocular pressure   Glaucoma   Exophthalmos

Metabolic:

  Negative nitrogen balance due to protein catabolism

Cardiovascular:

  Myocardial rupture following recent myocardial infarction (See WARNINGS)

Other:

  Hypersensitivity   Thromboembolism   Weight gain   Increased appetite   Nausea   Malaise   Hiccups

For oral administration

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.

The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Baycadron™ Elixir and transfer the patient to other therapy.

After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.

Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

The following milligram equivalents facilitate changing to Baycadron™ Elixir from other glucocorticoids:

Baycadron™ ELIXIR	METHYLPREDNISOLONE AND TRIAMCINOLONE	PREDNISOLONE AND PREDNISONE	HYDROCORTISONE	CORTISONE
0.75 mg =	4 mg =	5 mg =	20 mg =	25 mg

Dexamethasone suppression tests

1. Tests for Cushing's syndrome.
   Give 1 mg of Dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning.
   For greater accuracy, give 0.5 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
2. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes.
   Give 2 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.