Dexacen-4 injection

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.

Before using dexamethasone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: infections (e.g., tuberculosis, herpes, cerebral malaria, threadworm, fungal infections), blood clots, brittle bones (osteoporosis), high blood pressure, asthma, heart problems (e.g., congestive heart failure, recent heart attack), diabetes, eye diseases (e.g., cataracts, glaucoma, herpes infection of the eye), kidney disease, severe liver disease (cirrhosis), mental/mood conditions (e.g., psychosis, anxiety, depression), seizures, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), thyroid problems, untreated mineral problems (e.g., low potassium/calcium).

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report to your doctor any injuries or signs of infection (e.g., persistent sore throat/cough/fever, pain during urination, muscle aches) that occur while using this medication or within 12 months after stopping it.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Do not have immunizations, vaccinations, or skin tests unless specifically directed by your doctor. Live vaccines may cause serious problems (e.g., infection) if given while you are using this medication. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

If you have a history of ulcers, or if you take large doses of aspirin or other arthritis medication, limit alcoholic beverages while using this medication to decrease the risk of stomach/intestinal bleeding. Consult your doctor or pharmacist for more details.

If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially osteoporosis. Talk with your doctor about ways to prevent bone loss.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to an unborn baby when corticosteroids are used during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk and are unlikely to harm a nursing infant. Consult your doctor before breast- feeding.

Applies to dexamethasone: compounding powder, inhalation aerosol with adapter, injectable solution, injectable suspension, intravenous solution, oral concentrate, oral liquid, oral tablet

General

The most commonly occurring side effects have included alteration in glucose tolerance, behavioral and mood changes, increased appetite, and weight gain; the incidence generally correlates with dosage, timing of administration, and duration of treatment.[Ref]

Psychiatric

A wide range of psychiatric reactions including affective disorders (e.g., irritable, euphoric, depressed, labile mood, and suicidal ideation) psychotic reactions (e.g., mania, delusions, hallucinations, aggravation of schizophrenia), behavioral disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction (e.g., confusion, amnesia) have been reported. These reactions have been reported in adults and children. In adults, the occurrence of severe reactions has been estimated to be about 5% to 6%.[Ref]

Frequency not reported: Depression, affective disorders, anxiety, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders, confusional states, anxiety, abnormal behavior, irritability, aggravated schizophrenia[Ref]

Nervous system

Frequency not reported: Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, benign intracranial hypertension, neuropathy[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine, ulcerative esophagitis, gastric hemorrhage, vomiting, abdominal pain, diarrhea, dyspepsia, nausea, flatulence[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Endocrine

Frequency not reported: Cushingoid state, hirsutism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), moon face[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, hyperglycemia, glycosuria, manifestations of latent diabetes, hypokalemic alkalosis, potassium loss, sodium retention, increased appetite, negative nitrogen balance due to protein catabolism, weight gain, metabolic acidosis, hypercholesterolemia, hypertriglyceridemia, dyslipidemia[Ref]

Ocular

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, blindness, chorioretinopathy, worsening of symptoms associated with corneal ulcers, retinopathy of prematurity[Ref]

Rare instances of blindness have been associated with corticosteroid intralesional therapy around the face and head.[Ref]

Cardiovascular

Frequency not reported: 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, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, edema[Ref]

Musculoskeletal

Frequency not reported: Suppression of growth in pediatric patients, aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like atrophy, loss of muscle mass, muscle weakness, steroid myopathy. osteoporosis, pathologic fracture of long bones, postinjection flare, tendon rupture, particularly of the Achilles tendon, vertebral compression fractures, myalgia, muscle atrophy, osteonecrosis, neuropathic arthralgia, growth retardation[Ref]

Corticosteroids can cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence due to it causing early closure of the epiphyses, which may be irreversible.[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, dry scaly skin, ecchymosis, hirsutism, petechiae, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis, angioedema, skin atrophy, hyperhidrosis, pruritus, burning or tingling especially in the perineal area (after IV injection), telangiectasia, pigment disorders[Ref]

Hematologic

Frequency not reported: Leucocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation, polymorphonuclear leukocytosis[Ref]

Genitourinary

Frequency not reported: Menstrual irregularities, amenorrhea, increased or decreased motility and number of spermatozoa, increased urine calcium[Ref]

Hepatic

Frequency not reported: Hepatomegaly, elevation in liver enzymes[Ref]

Immunologic

Frequency not reported: Opportunistic infection, exacerbation of latent infections, decreased resistance to infection, immunosuppression, candidiasis, chicken pox (varicella)

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise, sterile abscess, impaired healing, fatigue, malaise

Respiratory

Frequency not reported: Hiccups, pulmonary edema

Some side effects of Dexacen-4 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.