Dexamethasone Sodium Phosphate (Page 3 of 3)

B. Intra-articular, soft tissue or intralesional administration.

The dose for intrasynovial 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 (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows:

Product Code Unit of Sale Strength Each
PRX500601 NDC 63323-506-16Unit of 25 10 mg per mL NDC 63323-506-411 mL single dose vial

This container closure is not made with natural rubber latex.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat. Do not autoclave.

Protect from freezing.

Protect from light.

Single dose vials–Store in container until time of use. Discard unused portion.

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047
www.fresenius-kabi.com/us

451456A

Revised: February 2021
logo

PACKAGE LABEL — PRINCIPAL DISPLAY — Dexamethasone 1 mL Vial Label

NDC 63323-506-41 PRX500601
Dexamethasone Sodium Phosphate Injection, USP

10 mg per mL

For IM or IV use only. Preservative free.

Discard unused portion.

Protect from light.

1 mL Single Dose Vial Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Dexamethasone 1 mL Vial Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Dexamethasone 1 mL Vial Tray Label

NDC 63323-506-16 PRX500601
Dexamethasone Sodium Phosphate Injection, USP

10 mg per mL *

For intramuscular or intravenous use only.
Preservative free.

25 x 1 mL Single Dose Vials Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Dexamethasone 1 mL Vial Tray Label
(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:63323-506
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-506-16 25 VIAL in 1 TRAY contains a VIAL (63323-506-41)
1 NDC:63323-506-41 1 mL in 1 VIAL This package is contained within the TRAY (63323-506-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040491 05/29/2003
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 analysis (63323-506), manufacture (63323-506)

Revised: 03/2021 Fresenius Kabi USA, LLC

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