Solurex injection

Name: Solurex injection

What is the most important information I should know about Solurex (dexamethasone injection)?

You should not use this medication if you have a fungal infection anywhere in your body.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts, blood glucose/mineral levels, blood pressure, bone density tests, height/weight measurements, eye examinations, X-rays) should be performed periodically to monitor your progress or check for side effects during long-term treatment. Consult your doctor for more details.

Lifestyle changes that help reduce the risk of bone loss (osteoporosis) during long-term treatment include doing weight-bearing exercise, getting adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Talk with your doctor about lifestyle changes that might benefit you.

If you use this medication for prolonged periods, you should wear or carry identification stating that you are using it.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.

For the Consumer

Applies to dexamethasone: oral elixir, oral solution, oral tablet

Along with its needed effects, dexamethasone (the active ingredient contained in Solurex) 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 while taking dexamethasone:

More common
  • 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
Incidence not known
  • 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 of dexamethasone 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:

More common
  • Increased appetite
Incidence not known
  • 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

For Healthcare Professionals

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 Solurex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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