Generic Name
Intensol
Brand Names
TaperDex 12-day, TaperDex 6-day, Hemady, Maxidex, Valtoco, Ozurdex, RAYOS, Dextenza
FDA approval date: November 15, 1963
Classification: Benzodiazepine
Form: Gel, Injection, Spray, Insert, Elixir, Tablet, For, Implant, Solution
What is TaperDex 12-day (Intensol)?
Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology ; spasticity caused by upper motor neuron disorders ; athetosis; stiff-man syndrome; and tetanus. Diazepam Injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.
Approved To Treat
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Brand Information
TaperDex 12-day (DEXAMETHASONE)
1DESCRIPTION
TaperDex 12-Day contains dexamethasone tablets USP, 1.5mg for oral administration. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 1.5 mg tablet contains FD&C Red #40.
TaperDex 12-Day contains dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.
2CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including TaperDex 12-Day are primarily used for their anti-inflammatory effects in disorders of many organ systems. At equipotent anti-inflammatory doses, TaperDex 12-Day almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
3CONTRAINDICATIONS
Systemic fungal infections (see WARNINGS,
4ADVERSE REACTIONS (listed alphabetically, under each subsection)
The following adverse reactions have been reported with TaperDex 12-Day or other corticosteroids:
5OVERDOSAGE
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.
6DOSAGE 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 acute exacerbations of multiple sclerosis, daily doses of 30 mg of TaperDex 12-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 12-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/m2body surface area/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:
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 12-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 12-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/m2body surface area/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:
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:
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
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.
7HOW SUPPLIED
TaperDex 12-Day tablets USP 1.5mg are scored, pink, pentagonal-shaped tablets debossed “par 086”. These are available in compliance packages of 49 tablets (
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:
Manufactured by:
Relabeled By;
Proficient Rx LP
Thousand Oaks CA.91320
Rev. 01/2018
8Packaging
