Label: DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

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 and has a molecular weight of 291.82. The molecular formula is C17H21NO • HCl. The structural formula is as follows:

Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL. The solutions for parenteral use have been adjusted to a pH between 5.0 and 6.0 with either sodium hydroxide or hydrochloric acid and contains 0.1 mg/mL benzethonium chloride as a germicidal agent.

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 injection, 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.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine hydrochloride injection, 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.

Diphenhydramine Hydrochloride Injection, USP is supplied as a sterile solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in multi-dose 10 mL (NDC 67457-124-10) vials.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing and light.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

1012L101
MI:DIHYIJ:R4
Revised: 6/2021

NDC 67457-124-10     10 mL

diphenhydrAMINE
Hydrochloride
Injection, USP
500 mg/10 mL
(50 mg/mL)

For Intravenous or
Intramuscular Use

HIGH POTENCY
Rx only     Multi-Dose Vial

Usual Adult Dosage:
0.2 mL to 1 mL
intravenously or
intramuscularly, or more
as required. See
accompanying
prescribing information.

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

Protect from freezing
and light.

MI:124:1C:R6

Sterile. Pyrogen-Free.

Each mL contains:
Diphenhydramine
Hydrochloride 50 mg,
Benzethonium Chloride
0.1 mg, as a germicidal
agent in Water for
Injection. The pH may
have been adjusted
with Sodium Hydroxide
and/or Hydrochloric
Acid.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

Mylan.com