Baycadron

Name: Baycadron

Side Effects of Baycadron

Serious side effects have been reported with dexamethasone. See the “Dexamethasone Precautions” section.

Oral and injectable forms:

Common side effects of oral and injectable forms of dexamethasone include the following:

  • upset stomach
  • stomach irritation
  • vomiting
  • headache
  • dizziness
  • insomnia
  • restlessness
  • depression
  • anxiety
  • acne
  • increased hair growth
  • easy bruising
  • irregular or absent menstrual periods
  • increased appetite and weight gain

Intravitreal form:

Common side effects of the dexamethasone intravitreal implant include increased intraocular pressure and conjunctival hemorrhage.

This is not a complete list of dexamethasone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

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

Tell your doctor about all your medical conditions, and all the medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

What should I discuss with my healthcare provider before taking Baycadron (dexamethasone)?

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.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of dexamethasone.

Overdosage

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.

The oral LD50 of dexamethasone in female mice was 6.5 g/kg.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle

WOCKHARDT

NDC 64679-810-30

Baycadron™
ELIXIR

(Dexamethasone Elixir,
USP 0.5 mg/5 mL)

PROFESSIONAL SAMPLE –
NOT FOR RESALE

Rx Only

NET: 1 fl oz (30 mL)

Baycadron 
dexamethasone elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64679-810
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dexamethasone (Dexamethasone) Dexamethasone 0.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
raw sugar  
propylene glycol  
benzoic acid  
alcohol  
Anhydrous Citric Acid  
FD&C red no. 40  
water  
sodium citrate  
citric acid monohydrate  
Product Characteristics
Color RED (Clear) Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:64679-810-08 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088254 07/27/1983
Labeler - Wockhardt USA, LLC (170508365)
Revised: 07/2009   Wockhardt USA, LLC

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

Dexamethasone Pregnancy Warnings

This drug readily crosses the placenta. Teratogenicity including increased incidence of cleft palate have occurred in animal studies, however, the relevance to human has been questioned. Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however, the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women. Increases and decreases in sperm motility and number of sperm have been observed in some patients. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Benefit should outweigh risk AU TGA pregnancy category: A (oral); C (parenteral) US FDA pregnancy category: C Comments: -Observe for signs and symptoms of hypoadrenalism in infants exposed in utero. -The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or newborn infant.

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