Prescription Drug Information: ReadySharp Dexamethasone (Page 3 of 3)

CEREBRAL EDEMA

Dexamethasone Sodium Phosphate Injection is generally administered initially in a dosage of 10 mg intravenously followed by four 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 two mg two or three times a day may be effective.

ACUTE ALLERGIC DISORDERS

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, 4 mg/mL — First day , 1 or 2 mL (4 or 8 mg) intramuscularly.

Dexamethasone tablets, 0.75 mg — Second and third days , 4 tablets in two divided doses each day; fourth day 2 tablets in two divided doses; fifth and sixth days , 1 tablet each day; 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.

Intra-articular, Intralesional and Soft Tissue Injection

Intra-articular, intralesional and soft tissue injections are generally employed when the affected joints or areas are limited to one or two sites. Dosage and frequency of injection varies depending on the condition and the site of injection. The usual dose is from 0.2 to 6 mg. The frequency usually ranges from once every three to five days to once every two to three weeks. Frequent intra-articular injection may result in damage to joint tissues. Some of the usual single doses are:

Site of Injection Amount of Dexamethasone Phosphate (mg)
Large Joints (e.g., knee) 2 to 4
Small Joints (e.g., Interphalangeal, Temporomandibular) 0.8 to 1
Bursae 2 to 3
Tendon Sheaths 0.4 to 1
Soft Tissue Infiltration 2 to 6
Ganglia 1 to 2

Dexamethasone Sodium Phosphate Injection is particularly recommended for use in conjunction with one of the less soluble, longer-acting steroids for intra-articular and soft tissue injection.

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

HOW SUPPLIED

Dexamethasone Sodium Phosphate Injection, USP is available in the following packages:

4 mg/mL
1 mL vials packaged in 25s (NDC 0641-6145-25)
5 mL vials packaged in 25s (NDC 0641-6146-25)

10 mg/mL
1 mL vials packaged in 25s (NDC 0641-0367-25)

Storage

Protect from light: Keep covered in carton until time of use. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

REFERENCES

*1. Cavanagh, D.; Singh, K. B.: Endotoxin shock in pregnancy and abortion, in: “Corticosteroids in the Treatment of Shock”, Schumer, W.; Nyhus, L. M., Editors, Urbana, University of Illinois Press, 1970, pp. 86-96.

2. Dietzman, R. H.; Ersek, R. A.; Bloch, J. M.; Lillehei, R. C.: High-output, low-resistance, gram-negative septic shock in man, Angiology 20: 691-700, Dec. 1969.

3. Frank, E.: Clinical observations in shock and management (In: Shields, T. F., ed.: Symposium on current concepts and management of shock), J. Maine Med. Ass. 59: 195-200, Oct. 1968.

4. Oaks, W. W.; Cohen, H. E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120-130, Mar. 1967.

5. Schumer, W.; Nyhus, L. M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg. 100: 405-408, Apr. 1970.

Manufactured by:

WEST-WARD
A HIKMA COMPANY
Eatontown, NJ 07724 USA

Revised June 2016

462-331-04

Principal Display Panel — Vial

vial

NDC 0641-0367-21

Dexamethasone
Sodium Phosphate
Injection, USP
10 mg/mL Rx only

(dexamethasone phosphate equivalent)
1 mL Vial
FOR IV OR IM USE ONLY
PROTECT FROM LIGHT

Principal Display Panel

dex
(click image for full-size original)

ReadySharp Dexamethasone

CONTENTS:

1 Dexamethasone Sodium Phosphate 10 mg, 1 mL
1 Sterile Alcohol Prep Pad

1 Adhesive Bandage

3 Povidone-Iodine Swabsticks

1 Retractable Syringe w/ Needle 23G x 1
NDC 53225-3660-1

REF TRNRSS3660

Packaged in the USA for:

Terrain Pharmaceuticals

Reno, NV 89501

877-985-8377

ReadySharp.us

Non-Sterile

Single Use Only

RI16DYN 16-513

CAUTION: Federal law restricts this device for sale by or on the order of a physician. This package has not been terminally sterilized. Individual items in package can be sterile where indicated by the original manufacturer. Do not sterilize. Store between 59°F – 86°F.

READYSHARP DEXAMETHASONE
dexamethasone sodium phosphate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-3660
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 SULFITE 1.5 mg in 1 mL
SODIUM CITRATE 16.5 mg in 1 mL
BENZYL ALCOHOL 10.42 mg in 1 mL
WATER
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-3660-1 1 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087702 09/07/1982
Labeler — Terrain Pharmaceuticals (078358750)

Revised: 10/2021 Terrain Pharmaceuticals

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