Product Elements:
Diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine water sodium hydroxide hydrochloric acid
Indications and Usage:
Indications & usage diphenhydramine hydrochloride injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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.
Warnings:
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.
Dosage and Administration:
Dosage and administration this product is for intravenous or intramuscular administration only. diphenhydramine hydrochloride injection is indicated when the oral form is impractical. 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 hours or 150 mg/m2/24 hours. 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 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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
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:
Adverse reactions the most frequent adverse reactions are italicized. general urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. cardiovascular system hypotension, headache, palpitations, tachycardia, extrasystoles. hematologic system hemolytic anemia, thrombocytopenia, agranulocytosis. 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. gastrointestinal system epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. genitourinary system urinary frequency, difficult urination, urinary retention, early menses. respiratory system thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Overdosage:
Overdosage 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.
Description:
Description diphenhydramine hydrochloride injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. each ml contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in water for injection. ph 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for ph adjustment. the chemical name of diphenhydramine hydrochloride is 2-(diphenylmethoxy)-n,n-dimethylethylamine hydrochloride. the structural formula is as follows: c17h21no ⢠hcl mw 291.82 diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol. structure
Clinical Pharmacology:
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 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.
How Supplied:
How supplied diphenhydramine hci injection, usp is supplied in the following dosage forms. ndc 51662-1219-1. diphenhydramine hci injection, usp 50mg/ml 1ml vial ndc 51662-1219-2 pouch containing a single diphenhydramine hci injection, usp 50mg/ml 1ml vial ndc 51662-1219-3 case of 25 pouches of diphenhydramine hci injection, usp 50mg/ml 1ml vial hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufactures dosage forms diphenhydramine hydrochloride injection, usp 50 mg/ml 1 ml vials packaged in 25s (ndc 0641-0376-25) storage protect from light. keep covered in carton until time of use. store at 20Ë-25Ëc (68Ë-77Ëf), excursions permitted to 15Ë-30Ëc (59Ë-86Ëf) [see usp controlled room temperature]. to report suspected adverse reactions, contact west-ward pharmaceutical corp. at 1-877-845-0689, or the fda at 1-800-fda-1088 or www.fda.gov/medwatch. for product inquiry call 1-877-845-0689. manufactured by: [west-ward logo] west-
Read more...ward pharmaceuticals eatontown, nj 07724 usa revised may 2011 462-220-01
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Principal display label - ndc 51662-1219-3 serialized rfid label serialized rfid label