Dexamethsone (Page 3 of 3)

Adverse Reactions

(listed alphabetically, under each subsection)

The following adverse reactions have been reported with dexamethasone or other corticosteroids:

Allergic Reactions

Anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular

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 (see WARNINGS: Cardio-Renal), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic

Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine

Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and Electrolyte Disturbances

Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal

Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic

Negative nitrogen balance due to protein catabolism.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures.

Neurological/Psychiatric

Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic

Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Other

Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

Overdosage

Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient’s condition, supportive therapy may include gastric lavage or emesis.

Dosage and Administration

For Oral Administration

The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated.

It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS: Neuro-Psychiatric).

In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

PLEASE REVIEW THE MANUFACTURER’S COMPLETE DRUG INFORMATION AT THIS FDA SITE:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b15200fb-1826-472b-a907-e677a272513b

LABEL

NDC: 51655-012-03

MFG: 0054-4184-25

Dexamethasone

4 MG

3 Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains 4 mg of dexamethasone

Dosage: See dispensing document

Store at 68 to 77 degrees F

Store in a tight, light-resistant container. Protect from moisture. Keep out of the reach of children.

Dist. by: Roxane Laboratories, Inc

Columbus, OH 43216 for Boehringer Ingelheim Lot#

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-012-03
(click image for full-size original)

NDC: 51655-012-87

MFG: 0054-4184-25

Dexamethasone

4 MG

36 Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains 4 mg of dexamethasone

Dosage: See dispensing document

Store at 68 to 77 degrees F

Store in a tight, light-resistant container. Protect from moisture. Keep out of the reach of children.

Dist. by: Roxane Laboratories, Inc

Columbus, OH 43216 for Boehringer Ingelheim Lot#

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-012-87
(click image for full-size original)
DEXAMETHSONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-012(NDC:0054-4184)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 4 mg
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 54;892
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-012-03 3 TABLET in 1 BOTTLE, DISPENSING None
2 NDC:51655-012-87 6 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084612 08/11/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-012)

Revised: 01/2015 Northwind Pharmaceuticals, LLC

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