DiphenhydrAMINE Hydrochloride Injection, USP

Rx only

Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride.  It occurs as a white, crystalline powder, is freely soluble in water and alcohol.

The structural formula is as follows:

Structural Formula

C₁₇H₂₁NO•HCl                         M.W. 291.82

Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL.  pH 4.0 to 6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects.  Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

Diphenhydramine hydrochloride in the injectable form has a rapid onset of action.  Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of diphenhydramine hydrochloride injection is not available.

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine hydrochloride.

The most frequent adverse reactions are underscored.

1. General:  Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive   perspiration, chills, dryness of mouth, nose and throat.
2. Cardiovascular System:  Hypotension, headache, palpitations, tachycardia, extrasystoles.
3. Hematologic System:  Hemolytic anemia, thrombocytopenia, agranulocytosis.
4. Nervous System:  Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
5. GI System:  Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
6. GU System:  Urinary frequency, difficult urination, urinary retention, early menses.
7. Respiratory System:  Thickening  of  bronchial  secretions, tightness of chest or throat and wheezing, nasal stuffiness.

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation.  Stimulation is particularly likely in pediatric patients.  Atropine-like signs and symptoms; dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

Stimulantsshould not be used.

Vasopressors may be used to treat hypotension.

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine hydrochloride 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/m ²/24 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.

DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as:

NDC: 70518-3685-00

NDC: 70518-3685-01

PACKAGING: 25 in 1 TRAY

PACKAGING: 1 mL in 1 VIAL SINGLE DOSE, TYPE 0

It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution.

The container closure is not made with natural rubber latex.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.  Keep from freezing.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Diphenhydramine

GENERIC: DIPHENHYDRAMINE HYDROCHLORIDE

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAVENOUS

NDC: 70518-3685-0

NDC: 70518-3685-1

PACKAGING: 1 mL in 1 VIAL, SINGLE-DOSE

OUTER PACKAGING: 25 in 1 TRAY

ACTIVE INGREDIENT(S):

• DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL

INACTIVE INGREDIENT(S):

• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Remedy_Label

MM2