Diphenhydramine Hydrochloride (Injection)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1264

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Diphenhydramine Hydrochloride (Injection)
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THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.<br/>Pediatric Patients: Other than premature infants and neonates: 5 mg/kg/24 hr or 150 mg/m/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.<br/>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. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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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 the molecular weight of 291.82. The molecular formula is CHNO���HCl. The structural formula is as follows: Diphenhydramine hydrochloride injection is a sterile, pyrogen-free solution intended for I.M. or I.V. administration. Each mL contains 50 mg Diphenhydramine Hydrochloride, USP and sufficient hydrochloric acid and/or sodium hydroxide solution for pH adjustment (5.0���6.0). This product contains no antimicrobial preservative and is intended as a single use vial; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.
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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 injectionis not available.
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Diphenhydramine Hydrochloride Injection, USP, 50 mg per mL, 1 mL vial.In unit-use packages containing one single dose vial and a vial injector.Twenty-five unit-use packages per carton. Stock No. 1390 NDC 0548-1390-00 1 mL 21 G.��1 1/2" Needle
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General: Diphenhydramine hydrochloride has an atropine-like action and, therefore, should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease, including asthma.<br/>Information for Patients: Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.<br/>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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.<br/>Pregnancy:<br/>Pregnancy Category B: Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose an have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.<br/>Pediatric Use: Diphenhydramine Hydrochloride Injection should not be used in neonates and premature infants . Diphenhydramine Hydrochloride Injection may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death . See also DOSAGE AND ADMINISTRATION section.
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Diphenhydramine Hydrochloride
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Diphenhydramine Hydrochloride (Injection)
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The most frequent adverse reactions are underscored.
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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 in the oral form is impractical.<br/>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.<br/>Motion Sickness: For active treatment of motion sickness.<br/>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.
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Diphenhydramine Hydrochloride