Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: Product Code Unit of Sale Strength Each RF787210 NDC 76045-235-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-235-01 1 mL Prefilled Single-Use Syringe This Product Contains an RFID. 787210 NDC 76045-102-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-102-00 1 mL Prefilled Single-Use Syringe Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from freezing and light. Retain in carton until time of use. Do not place syringe on a sterile field.; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Carton Rx only NDC 76045-102-10 DiphenhydrAMINE HCl Injection, USP HIGH POTENCY 50 mg per mL For Intravenous or Intramuscular Use. Do NOT place syringe on a Sterile Field. 24 x 1mL Prefilled Single-use Syringes Discard unused portion. diphe-label-01.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Blister Pack Label NDC 76045-102-00 DiphenhydrAMINE HCl Injection, USP 50 mg per mL HIGH POTENCY 1 mL Prefilled single use syringe. Rx Only For IV or IM use. diphe-label-02.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Syringe Label 1 mL Single-use For IV or IM use. DiphenhydrAMINE HCl Injection, USP HIGH POTENCY, Rx Only 50 mg per mL diphe-label-03.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Syringe Label 1 mL Single-use For IV or IM use. DiphenhydrAMINE HCl Injection, USP HIGH POTENCY, Rx Only 50 mg per mL diphe-label-04.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Blister Pack Label NDC 76045-235-01 DiphenhydrAMINE HCl Injection, USP 50 mg per mL HIGH POTENCY 1 mL Prefilled single use syringe. Rx Only For IV or IM use. diphe-label-05.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Carton Rx only NDC 76045-235-10 DiphenhydrAMINE HCl Injection, USP HIGH POTENCY 50 mg per mL For Intravenous or Intramuscular Use. Do NOT place syringe on a Sterile Field. 24 x 1mL Prefilled Single-use Syringes Discard unused portion. diphe-label-06.jpg
- HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: Product Code Unit of Sale Strength Each RF787210 NDC 76045-235-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-235-01 1 mL Prefilled Single-Use Syringe This Product Contains an RFID. 787210 NDC 76045-102-10 Unit of 24 50 mg/mL in a 1 mL Prefilled Single-Use Syringe NDC 76045-102-00 1 mL Prefilled Single-Use Syringe Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from freezing and light. Retain in carton until time of use. Do not place syringe on a sterile field.
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Carton Rx only NDC 76045-102-10 DiphenhydrAMINE HCl Injection, USP HIGH POTENCY 50 mg per mL For Intravenous or Intramuscular Use. Do NOT place syringe on a Sterile Field. 24 x 1mL Prefilled Single-use Syringes Discard unused portion. diphe-label-01.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Blister Pack Label NDC 76045-102-00 DiphenhydrAMINE HCl Injection, USP 50 mg per mL HIGH POTENCY 1 mL Prefilled single use syringe. Rx Only For IV or IM use. diphe-label-02.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Syringe Label 1 mL Single-use For IV or IM use. DiphenhydrAMINE HCl Injection, USP HIGH POTENCY, Rx Only 50 mg per mL diphe-label-03.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Syringe Label 1 mL Single-use For IV or IM use. DiphenhydrAMINE HCl Injection, USP HIGH POTENCY, Rx Only 50 mg per mL diphe-label-04.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Blister Pack Label NDC 76045-235-01 DiphenhydrAMINE HCl Injection, USP 50 mg per mL HIGH POTENCY 1 mL Prefilled single use syringe. Rx Only For IV or IM use. diphe-label-05.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Diphenhydramine 1 mL Carton Rx only NDC 76045-235-10 DiphenhydrAMINE HCl Injection, USP HIGH POTENCY 50 mg per mL For Intravenous or Intramuscular Use. Do NOT place syringe on a Sterile Field. 24 x 1mL Prefilled Single-use Syringes Discard unused portion. diphe-label-06.jpg
Overview
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 C 17 H 21 NO·HCl and the structural formula is as follows: Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution. Each mL contains a concentration of 50 mg of diphenhydramine hydrochloride and water for injection, for intramuscular or intravenous use. The solution for parenteral use has been adjusted to a pH between 4 and 6.5 with either sodium hydroxide or hydrochloric acid. Structural Formula
Indications & Usage
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. 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 & Administration
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 mg 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.
Warnings & Precautions
WARNINGS 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. Use in Pediatric Patients: In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Contraindications
Use in Neonates or Premature Infants: This drug should not be used in neonates or premature infants. Use in Nursing Mothers: Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic: Because of the risk of local necrosis, this drug should not be used as a local anesthetic. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
Adverse Reactions
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.
Drug Interactions
Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.