TaperDex 6-day (Page 3 of 4)

ADVERSE REACTIONS (listed alphabetically, under each subsection)

The following adverse reactions have been reported with TaperDex 6-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 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 of TaperDex 6-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 acute exacerbations of multiple sclerosis, daily doses of 30 mg of TaperDex 6-Day for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS, Neuropsychiatric). In pediatric patients, the initial dose of TaperDex 6-Day 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/m2 body surface area/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:

TaperDex 6-Day, 1.5

Methylprednisolone, 8

Predisone, 10

Triamcinolone, 8

Prednisolone, 10

Betamethasone, 1.5

Hydrocortisone, 40

Paramethasone, 4

Cortisone, 50

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: Dexamethasone Sodium Phosphate injection, USP 4 mg per mL:

First Day
1 or 2 mL, intramuscularly
Dexamethasone Tablets, USP, 1.5 mg, one-half tablet:
Second Day
2 tablets in two divided doses
Third Day
2 tablets in two divided doses
Fourth Day
1 tablet in two divided doses
Fifth Day
One half tablet
Sixth Day
One half tablet
Seventh Day
No treatment
Eighth Day
Follow-up visit

This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
In cerebral edema, TaperDex 6-Day Sodium Phosphate injection, USP 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. 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. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either TaperDex 6-Day Sodium Phosphate injection, USP or TaperDex 6-Day tablets in a dosage of 2 mg two or three times daily may be effective.

TaperDex 6-Day suppression tests:
1. Tests for Cushing’s syndrome.
Give 1 mg of TaperDex 6-Day USP orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of TaperDex 6-Day USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
2. Test to distinguish Cushing’s syndrome due to pituitary AGTH excess from Cushing’s syndrome due to other causes.
Give 2 mg of TaperDex 6-Day USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

HOW SUPPLIED

TaperDex 6-Day tablets USP 1.5mg are scored, pink, pentagonal-shaped tablets debossed “par 086”. These are available in compliance packages of 21 tablets (TaperDex® 6-Day Taper Package® , NDC#71205-012-21).

Storage: Store at controlled room temperature 20º to 25ºC (68º to 77ºF), see USP.

Dispense in tight, light resistant container as defined in the USP/NF.

Rx Only

Keep This and All Medications Out of the Reach of Children

Manufactured for:
Xspire Pharma
Ridgeland, MS 39157

Manufactured by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

Relabeled By;

Proficient Rx LP

Thousand Oaks CA 91320

Rev. 01/2018

Usual Adult Dosage: See enclosed package insert for full prescribing information.

Use only as directed by a healthcare practitioner

TaperDex is not bioequivalent to any dexamethasone 1.5 mg and has no generic substitute.

INSTRUCTIONS: Pull tab up and push tablet through the back by pressing from the front of the pack.

Unless otherwise instructed by your healthcare practitioner, the first (6) tablets should be taken on the day you receive your prescription. If the medication is received late in the day, take three (3) tablets with evening meal and three (3) tablets at bedtime. These doses should be at least three (3) hours apart. Follow the dosage instructions listed below thereafter.

Do not discontinue this medication without consulting your healthcare practitioner.

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