Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Fresenius Kabi USA, LLC
Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride 50 mg in 1 mL
INTRAVENOUS
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
Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: 50 mg/mL in a 1 mL prefilled single-use syringe. Available in a carton of twenty-four (24) syringes. NDC 76045-102-10 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.
Abbreviated New Drug Application
DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP RX ONLY 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 C H 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. 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 AND 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. 17 21 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 contr read_full_document