Dexamethasone (Page 4 of 4)

Dexamethasone sodium phosphate injection, 4 mg per mL

First Day

1 or 2 mL, intramuscularly

Dexamethasone tablets, 0.75 mg

Second Day

4 tablets in two divided doses

Third Day

4 tablets in two divided doses

Fourth Day

2 tablets in two divided doses

Fifth Day

1 tablet

Sixth Day

1 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 , 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. 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 dexamethasone sodium phosphate injection or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone Suppression Tests

1. Tests for Cushing’s syndrome

Give 1 mg of dexamethasone 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 dexamethasone 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 ACTH excess from Cushing’s syndrome due to other causes.

Give 2 mg of dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-

hydroxycorticosteroid excretion.

HOW SUPPLIED

Dexamethasone Tablets USP

1 mg tablets are supplied as a yellow, flat tablet with beveled edges, scored on one side and product identification “54 489” debossed on the other side.

NDC 69306-111-60 (repackaged from NDC 0054-4181-25): Bottle of 60 Tablets

2 mg tablets are supplied as a white, flat tablet with beveled edges, scored on one side and product identification “54 662” debossed on the other side.

NDC 69306-112-30 (repackaged from NDC 0054-4183-25): Bottle of 30 Tablets

4 mg tablets are supplied as a green, flat tablet with beveled edges, scored on one side and product identification “54 892” debossed on the other side.

NDC 69306-114-30 (repackaged from NDC 0054-4184-25): Bottle of 30 Tablets

Store and Dispense

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF.

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

fpl-bl-1mg
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

fpl-bl-2mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

label
(click image for full-size original)

DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69306-111(NDC:0054-4181)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 54;489
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69306-111-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088306 09/15/1983
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69306-112(NDC:0054-4183)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 54;662
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69306-112-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087916 08/26/1982
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69306-114(NDC:0054-4184)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 4 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C GREEN NO. 3
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
FD&C YELLOW NO. 6
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:69306-114-06 6 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:69306-114-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084612 07/19/1978
Labeler — Doc Rx (833677136)

Revised: 06/2021 Doc Rx

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