TaperDex 12-day 1.5 mg/1

DEXAMETHASONE · TABLET · Proficient Rx LP

No Recall HistoryCurrently in Shortage

Plain English

Taperdex is a prescription oral tablet containing dexamethasone, a corticosteroid used to reduce inflammation and suppress the immune system in various conditions. It comes in a 12-day tapering pack designed to gradually decrease the dose over time.

Key Facts

Brand Name: TaperDex 12-day
Generic Name: DEXAMETHASONE
NDC Code (Product): 71205-013
Manufacturer: Proficient Rx LP
Strength: 1.5 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA088237
Drug Class: Corticosteroid [EPC]
Marketing Start: 01/19/2018

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Allergic states: 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. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: 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. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond- Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected…

Dosage & Administration

DOSAGE AND ADMINISTRATION For oral administration: The initial dosage of TaperDex 12-Day 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 acut…

Warnings

WARNINGS General: Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). 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. Cardiorenal: Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. 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. Endocrine: Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result fr…

Contraindications

CONTRAINDICATIONS Systemic fungal infections (see WARNINGS, Fungal Infections ). TaperDex 12-Day tablets are contraindicated in patients who are hypersensitive to any components of this product.

Drug Interactions

Drug Interactions: Aminoglutethimide: Aminoglutethimide may diminish adrenal suppression by corticosteroids. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. 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. Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see Drug Interactions, Hepatic Enzyme lnducers, Inhibitors and Substrates). Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulants, oral: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should…

Adverse Reactions

ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with TaperDex 12-Day 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 un…

Frequently Asked Questions

What is TaperDex 12-day used for?

Is TaperDex 12-day a controlled substance?

TaperDex 12-day is not classified as a controlled substance by the DEA.

What is the generic name for TaperDex 12-day?

The generic name for TaperDex 12-day is DEXAMETHASONE. There are 12 other brand versions of DEXAMETHASONE.

What is the NDC code for TaperDex 12-day 1.5 mg/1?

The NDC (National Drug Code) for TaperDex 12-day 1.5 mg/1 is 71205-013, listed by Proficient Rx LP.

Product NDC

71205-013

Package NDC

71205-013-49

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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