Dexamethasone Sodium Phosphate: Package Insert and Label Information (Page 2 of 2)

DOSAGE AND ADMINISTRATION

A. Intravenous or intramuscular administration. The initial dosage of dexamethasone sodium phosphate injection may vary from 0.50 mg/day to 9 mg/day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. Reported regimens range from 1 mg/kg to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists.

For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. This regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral dexamethasone, 1 mg to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. Non-operative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose should be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses.

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 mg to 8 mg dexamethasone every other day for 1 month have been shown to be effective.

The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection should be discontinued and the patient transferred to other appropriate therapy. 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 which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the 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 later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection for a period of time consistent with the patient’s condition. If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

B. Intra-articular, soft tissue or intralesional administration. The dose for instrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.

HOW SUPPLIED

Dexamethasone sodium phosphate injection USP, 4 mg/mL is supplied as a clear, colorless solution, in single-dose and multiple-dose vials as follows:

4 mg/mL, 1 mL vial
1 mL, Single-Dose Vial: NDC 70121-1450-1
1 mL, 25 Single-Dose Vials in a Carton: NDC 70121-1450-5

4 mg/mL, 5 mL vial
5 mL, Multiple-Dose Vial: NDC 70121-1451-1
5 mL, 25 Multiple-Dose Vials in a Carton: NDC 70121-1451-5

4 mg/mL, 30 mL vial
30 mL, Multiple-Dose Vial in a Carton: NDC 70121-1452-1

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CAUTION: Federal law prohibits dispensing without a prescription.

Discard unused portion of single-dose vials.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Parenteral Unit

Ahmedabad 382213, INDIA

Distributed by:

Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2020-02

PRINCIPAL DISPLAY PANEL

NDC 70121-1450-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

1 mL Single-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1450-5

Dexamethasone sodium phosphate injection USP, 4 mg/mL

1 mL Single-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1451-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

5 mL Multiple-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1451-5

Dexamethasone sodium phosphate injection USP, 4 mg/mL

5 mL Multiple-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1452-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

30 mL Multiple-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1452-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

30 mL Multiple-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1450
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1450-5 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70121-1450-1)
1 NDC:70121-1450-1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70121-1450-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1451
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1451-5 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (70121-1451-1)
1 NDC:70121-1451-1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70121-1451-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1452
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1452-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70121-1452-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
Labeler — Amneal Pharmaceuticals LLC (827748190)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited, Parenteral Unit 860156658 ANALYSIS (70121-1450), ANALYSIS (70121-1451), ANALYSIS (70121-1452), MANUFACTURE (70121-1450), MANUFACTURE (70121-1451), MANUFACTURE (70121-1452), PACK (70121-1450), PACK (70121-1451), PACK (70121-1452), STERILIZE (70121-1450), STERILIZE (70121-1451), STERILIZE (70121-1452)

Revised: 07/2020 Amneal Pharmaceuticals LLC

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