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Diphenhydramine (Diphenhydramine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:

Antihistaminic

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

Motion Sickness

For active treatment of motion sickness.

Antiparkinsonism

For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

DOSAGE AND ADMINISTRATION

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine Hydrochloride Injection is indicated when the oral form is impractical.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric Patients, Other Than Premature Infants and Neonates

5 mg/kg/24 hours or 150 mg/m2/24 hours. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults

10 to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg.

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

HOW SUPPLIED

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL

1 mL vials packaged in 25s (NDC 0641-0376-25)

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].

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical 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.

Manufactured by:

WEST-WARD
PHARMACEUTICALS
Eatontown, NJ 07724 USA

Revised May 2011
462-220-01

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