Diphenhydramine Hydrochloride
Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Basic Information
Manufacturer
Medical Purchasing Solutions, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
95fbf4c2-c96e-2d41-e053-2995a90a0d54
Indications & Usage
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.
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.
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 hydrochloride injection.
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.
Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine hydrochloride injection.
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.
Adverse Reactions
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.
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.