This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.AU TGA pregnancy category: B3US FDA pregnancy category: CComments: Corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Give 2 mg of Dexamethasone orally every 6 hours for 48 hours. Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Treatment of overdosage is by supportive and symptomatic therapy. It is recommended that an Intensol be mixed with liquid or semi-solid food such as water, juices, soda or soda-like beverages, applesauce and puddings. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, starch, sugar, D&C Yellow #10 (0.5 mg and 4 mg), FD&C Blue #1 (0.75 mg and 1.5 mg), FD&C Green #3 (4 mg and 6 mg), FD&C Red #3 (1.5 mg), FD&C Red #40 (1.5 mg), FD&C Yellow #6 (0.5 mg and 4 mg) and Yellow Iron Oxide (1 mg). Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. These effects are less likely to occur with the synthetic derivatives except when used in large doses. The cherry brandy flavored oral solution contains the following inactive ingredients: anhydrous citric acid, cherry brandy flavor, disodium edetate, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol solution and water. Co-adminstration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentration. Pregnancy. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. •Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes. ... Pregnancy Category Explanation; In addition, the oral solution contains the following inactive ingredients: alcohol 30% v/v, anhydrous citric acid, benzoic acid, disodium edetate, propylene glycol and water. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. That means two things: Research in animals has shown adverse effects to the fetus when the mother takes the drug. It is stable in air. Dexamethasone Onset. Measure the concentrated liquid with the special oral dropper that comes with the package. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Vaccines: Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. lntraocular pressure may become elevated in some individuals. This reduces the incidence of respiratory distress syndrome in the new-born (Liggins and Howie, 1972; Crowley, 1995), enhances the efficacy of neonatal surfactant therapy, and reduces the associated risk of intravascular haemorrhage, necrotising enterocolitis, neonatal hyperbilirubinaemia and neonatal death (Sinclair, 1994). Medically reviewed by Drugs.com. In cerebral edema, Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Thalidomide: Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. (See the respective package inserts for VZIG and IG for complete prescribing information.) Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. Their synthetic analogs including Dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems. Ciprofloxacin is approved for prophylaxis following inhalational anthrax exposure 1. The entire amount of the mixture, of drug and liquid or drug and food, should be consumed immediately. 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. aspirin, acetaminophen, prednisone, ibuprofen, albuterol, meloxicam, fluticasone, fluticasone nasal, naproxen, lorazepam. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, starch, sugar, D&C Yellow #10 (0.5 mg and 4 mg), FD&C Blue #1 (0.75 mg and 1.5 mg), FD&C Green #3 (4 mg and 6 mg), FD&C Red #3 (1.5 mg), FD&C Red #40 (1.5 mg), FD&C Yellow #6 (0.5 mg and 4 mg) and Yellow Iron Oxide (1 mg).Dexamethasone Ora… [See USP Controlled Room Temperature.] Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. There are no adequate and well-controlled studies in pregnant women; topical ocular administration of dexamethasone in mice and rabbits during period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than recommended human … Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. Corticosteroids may also mask some signs of current infection. Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Pregnancy Category C. Dosage & Route. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The long-term use of dexamethasone may result in thrush, bone loss, cataracts, easy bruising, or muscle weakness. Select one or more newsletters to continue. Individualize dosage based on severity of condition and response. Store at 20° to 25°C (68° to 77°F). Pregnancy Category: C. Pregnancy. Do not freeze. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. Steroids may increase or decrease motility and number of spermatozoa in some patients. Hepatic Enzyme Inducers, Inhibitors and Substrates: Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. It is now common practice to administer dexamethasone to pregnant women whenever delivery before 34 weeks is anticipated. Give 1 mg of Dexamethasone orally at 11:00 p.m. As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is: Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Medically reviewed by Drugs.com. Dexamethasone ophthalmic is also known as: AK-Dex, Decadron Ocumeter, Decadron Phosphate, Ophthalmic, Dexasol, Dextenza, Dexycu, Maxidex, Ocu-Dex, Ozurdex. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Corticosteroids should not be used in active ocular herpes simplex. Discontinuation of corticosteroids may result in clinical improvement. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. Last updated on Nov 18, 2020. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of Dexamethasone for a week followed by 4 mg to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS: Neuro-Psychiatric). Fungal Infections:Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. For both men and women: Do not conceive a child (get pregnant) while taking dexamethasone. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. These work by replacing natural hormones produced by your adrenal glands when your body cannot make enough. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Last updated on Jan 22, 2021. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see DOSAGE AND ADMINISTRATION). Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. Pregnancy Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. When reduction in dosage is possible, the reduction should be gradual. Aminoglutethimide: Aminoglutethimide may diminish adrenal suppression by corticosteroids. Dexamethasone is used to treat many different inflammatory conditions such as allergic disorders and skin conditions. The Intensol formulation blends quickly and completely. Animal studies have not been conducted with ciprofloxacin; dexamethasone otic. Stir the mixture well and drink or eat it right away. Skin Tests: Corticosteroids may suppress reactions to skin tests. The Dexamethasone Intensol™ solution is a concentrated liquid. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Corticosteroids should not be used in cerebral malaria. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. Draw into the dropper the amount prescribed for a single dose. "Product Information. Dexamethasone belongs to pregnancy category C,meaning use should be based on benefits being predicted to be greater than risks. 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. Nonsteroidal Anti-Inflammatory Agents (NSAIDS): Concomitant use of aspirin (or other nonsteroidal antiinflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Merck & Co, Inc, West Point, PA. Cerner Multum, Inc. "Australian Product Information." Dexamethasone when planning pregnancy. In the mouse, corticosteroids produce fetal … If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. O 0, Cerner Multum, Inc. "UK Summary of Product Characteristics." In the case of acute overdosage, according to the patient's condition, supportive therapy may include gastric lavage or emesis. There may be decreased resistance and inability to localize infection when corticosteroids are used. However, there has been some concern about … Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Dexamethasone is a synthetic steroid that is chemically related to the natural hormones secreted by the adrenal cortex. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Special Pathogens: Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma. No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Glucocorticoids cause varied metabolic effects. We comply with the HONcode standard for trustworthy health information -, dexamethasone intraocular Consumer Information. Corticosteroids have been shown to be teratogenic (causes birth defects) in many species when given in … Dexamethasone Oral Solution USP is formulated for oral administration containing 0.5 mg per 5 mL of Dexamethasone USP. There are no adequate and well-controlled studies in pregnant women. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Because of the minimal systemic absorption of ciprofloxacin and dexamethasone after topical otic administration, there is expected to be minimal risk for maternal and fetal toxicity when administered during pregnancy. The following adverse reactions have been reported with Dexamethasone or other corticosteroids: Anaphylactoid reaction, anaphylaxis, angioedema. In the control group consists … 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. 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. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infections: Vaccination). Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Available for Android and iOS devices. Dexamethasone is a category C pregnancy drug. Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Killed or inactivated vaccines may be administered. Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Antitubercular Drugs: Serum concentrations of isoniazid may be decreased. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. Systemic administration. Amphotericin B Injection and Potassium-depleting agents, Hepatic Enzyme Inducers, Inhibitors and Substrates, e.g., barbiturates, phenytoin, carbamazepine, rifampin, e.g., ketoconazole, macrolide antibiotics such as erythromycin, Nonsteroidal Anti-Inflammatory Agents (NSAIDS). Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. Dexamethasone was approved by the Food and Drug Authority for use in October 1958. If long-term therapy is needed, alternate-day therapy with a short-acting steroid should be considered. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. 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. Convulsions have been reported with this concurrent use. Thus, results of the DST should be interpreted with caution in these patients. 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. The liquid should be added to water, juice, soda or a soda-like beverage, applesauce, or pudding. PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. Pregnancy Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents). Estrogens, Including Oral Contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Dexamethasone is a synthetic analogue of the hormone of the adrenal cortex. Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Available for Android and iOS devices. In pediatric patients, the initial dose of Dexamethasone may vary depending on the specific disease entity being treated. Dexamethasone is listed as a pregnancy Category C drug. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Preterm birth is a leading cause of death in infants and children younger than 5 years of age globally. Dexamethasone is a moderate inducer of CYP 3A4. In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, We comply with the HONcode standard for trustworthy health information -. This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. An Intensol is a concentrated oral solution as compared to standard oral liquid medications. Ozurdex (dexamethasone ophthalmic)." Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of Dexamethasone USP. In general, a woman should only take dexamethasone in pregnancy when she has a medical condition that … Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts. The safety of using dexamethasone in pregnancy is unknown. The clearance of salicylates may be increased with concurrent use of corticosteroids. It is in pregnancy category C in the United States, meaning that it should only be used when the benefits are predicted to be greater than the risks. Cleft lip and cleft palate. Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Phenytoin: In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with Dexamethasone co-administration, leading to alterations in seizure control. Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. Teratogenic Effects: Pregnancy Category C: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Dexamethasone Suppression Test (DST): False-negative results in the Dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates). Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. Pregnancy: Teratogenic Effects: Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids.AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
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