Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
HF Acquisition Co LLC, DBA HealthFirst
INTRAMUSCULAR
PRESCRIPTION DRUG
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. Use in Neonates or Premature Infants: This drug should not be used in neonates or pr
DIPHENHYDRAMINE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1218-1 DIPHENHYDRAMINE HCI INJECTION, USP 50mg/mL 1mL CARP HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms Diphenhydramine Hydrochloride Injection, USP is available as: Carpuject™ Single-use cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included. Instructions for Use of the Syringe Systems Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02. Carpuject™ Single-use cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02. 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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1300-1.0 Revised: 04/2018
Abbreviated New Drug Application
DIPHENHYDRAMINE HCI- DIPHENHYDRAMINE HCI INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- DIPHENHYDRAMINE HCI INJECTION, USP 50MG/ML 1ML CARP SPL UNCLASSIFIED DESCRIPTION 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 and 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 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. CLINICAL PHARMACOLOGY 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. 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. Mot Read the complete document