If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reaction: Skin rash.

Headache, dizziness, insomnia.

Acid indigestion, abdominal distention.

Muscle cramping and weakness.

Acne, excessive growth of facial hair.

Serious Adverse Effects

Mental and emotional disturbances of serious magnitude.

Reactivation of latent tuberculosis.

Development of peptic ulcer.

Increased blood pressure.

Development of inflammation of the pancreas.

Thrombophlebitis (inflammation of a vein with the formation of blood

clot)—pain or tenderness in thigh or leg, with or without swelling of

the foot, ankle or leg.

Pulmonary embolism (movement of a blood clot to the lung)—sudden

shortness of breath, pain in the chest, coughing, bloody sputum.

Possible Effects on Sexual Function: Altered timing and pattern of menstruation.

Adverse Effects That May Mimic Natural Diseases or Disorders

Pattern of symptoms and signs resembling Cushing's syndrome.

Natural Diseases or Disorders That May Be Activated by This Drug

Latent diabetes, glaucoma, peptic ulcer disease, tuberculosis.

Possible Effects on Laboratory Tests

Blood amylase level: increased (possible pancreatitis). Blood glucose level: increased. Glucose tolerance test (GTT): decreased. Blood potassium level: decreased.

CAUTION

1. It is advisable to carry a card of personal identification with a notation that you are taking this drug, if your course of treatment is to exceed 1 week.

2. Do not discontinue this drug abruptly if you are using it for long-term treatment.

3. If vaccination against measles, rabies, smallpox or yellow fever is required, discontinue this drug 72 hours before vaccination and do not resume it for at least 14 days after vaccination.

Precautions for Use

By Infants and Children: Avoid prolonged use if possible. During long-term use, observe for suppression of normal growth and the possibility of increased intracranial pressure. Following long-term use, the child may be at risk for adrenal gland deficiency during stress for as long as 18 months after cessation of this drug.

By Those over 60 Years of Age: Cortisone-like drugs should be used very sparingly after 60 and only when the disorder under treatment is unresponsive to adequate trials of unrelated drugs. Avoid prolonged use of this drug. Continual use (even in small doses) can increase the severity of diabetes, enhance fluid retention, raise blood pressure, weaken resistance to infection, induce stomach ulcer and accelerate the development of cataract and osteoporosis.

Advisability of Use During Pregnancy

Pregnancy Category: C (tentative). See Pregnancy Code inside back cover.

Animal studies: Birth defects reported in mice, rats and rabbits.

Human studies: Information from adequate studies of pregnant women is not available.

Avoid completely during the first 3 months. Limit use during the last 6 months as much as possible. If used, examine infant for possible deficiency of adrenal gland function.

Advisability of Use if Breast-Feeding

Presence of this drug in breast milk: Yes. Avoid drug or refrain from nursing.

Habit-Forming Potential: Use of this drug to suppress symptoms over an extended period of time may produce a state of functional dependence. In the treatment of conditions like asthma and rheumatoid arthritis, it is advisable to keep the dose as small as possible and to attempt drug withdrawal after periods of reasonable improvement. Such procedures may reduce the degree of "steroid rebound"—the return of symptoms as the drug is withdrawn.

Effects of Overdosage: Fatigue, muscle weakness, stomach irritation, acid indigestion, excessive sweating, facial flushing, fluid retention, swelling of extremities, increased blood pressure.

Possible Effects of Long-Term Use: Increased blood sugar (possible diabetes), increased fat deposits on the trunk of the body ("buffalo hump"), rounding of the face ("moon face"), thinning and fragility of skin, loss of texture and strength of bones (osteoporosis, aseptic necrosis), cataracts, glaucoma, retarded growth and development in children.

Suggested Periodic Examinations While Taking This Drug (at physician's

discretion)

Measurements of blood pressure, blood sugar and potassium levels. Complete eye examinations at regular intervals. Chest X-ray if history of tuberculosis. Determination of the rate of development of the growing child to detect

retardation of normal growth.

While Taking This Drug, Observe the Following

Foods: No interactions expected. Ask physician regarding need to restrict salt intake or to eat potassium-rich foods. During long-term use of this drug, it is advisable to eat a high-protein diet.

Nutritional Support: During long-term use, take a vitamin D supplement. During wound repair, take a zinc supplement.

Beverages: No restrictions. Drink all forms of milk liberally.

Alcohol: No interactions expected. Use caution if you are prone to peptic

ulcer disease.

Tobacco Smoking: Nicotine increases the blood levels of naturally produced cortisone and related hormones. Heavy smoking may add to the expected actions of this drug and requires close observation for excessive effects.

Marijuana Smoking: May cause additional impairment of immunity.

Other Drugs

Dexamethasone may decrease the effects of

• isoniazid (INH, Niconyl, etc.)

• salicylates (aspirin, sodium salicylate, etc.) Dexamethasone taken concurrently with

• oral anticoagulants may either increase or decrease their effectiveness; consult physician regarding the need for prothrombin time testing and dosage adjustment.

The following drugs may decrease the effects of dexamethasone

• antacids may reduce its absorption.

• barbiturates (Amytal, Butisol, phenobarbital, etc.).

• phenytoin (Dilantin, etc.).

• rifampin (Rifadin, Rimactane, etc.).

Driving, Hazardous Activities: Usually no restrictions. Be alert to the rare

occurrence of dizziness.

Aviation Note: The use of this drug may be a disqualification for piloting. Consult a designated Aviation Medical Examiner.

Exposure to Sun: No restrictions.

Occurrence of Unrelated Illness: This drug may decrease natural resistance to infection. Inform your physician if you develop an infection of any kind. It may also reduce your body's ability to respond to the stress of acute illness, injury or surgery. Keep your physician fully informed of any significant changes in your state of health.

Discontinuation: If you have been taking this drug for an extended period of time, do not discontinue it abruptly. Ask physician for guidance regarding gradual withdrawal. For a period of 2 years after discontinuing this drug, it is essential in the event of illness, injury or surgery that you inform attending medical personnel that you have used this drug in the past. The period of impaired response to stress following the use of cortisone-like drugs may last for 1 to 2 years.

TEXT 7. Read the following text and say how this drug works.