Benadryl (Diphenhydramine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Benadryl in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when Benadryl in 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.

Benadryl in the injectable form is indicated when the oral form is impractical.

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

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 hr or 150 mg/m²/24 hr. 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.

HOW SUPPLIED

Benadryl in parenteral form is supplied as:

Benadryl Steri-Vials®
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in 10-mL (N 0071-4402-10) Steri-Vials.

—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution. Available in packages of twenty-five 1-mL (N 0071-4259-13) Steri-Vials.

Benadryl Steri-Dose ®
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in a 1-mL disposable syringe (Steri-Dose). Available in packages of ten syringes (N 0071-4259-45).

Benadryl Ampoule
—sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in a 1-mL ampoule. Available in packages of ten (N 0071-4259-03).

Store at controlled room temperature 15°–30°C (59°–86°F). Protect from freezing and light.

Rx only

Manufactured by:
Parkedale Pharmaceuticals, Inc.
Rochester, MI 48307

LAB-0064-3.0