Dimenhydrinate
Generic: DIMENHYDRINATE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
bc71539e-1a33-4709-8a24-c2894e8dbc1c
Indications & Usage
INDICATIONS AND USAGE Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Warnings
WARNINGS Caution should be used when dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since dimenhydrinate is capable of masking ototoxic symptoms, and an irreversible state may be reached.
This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.
The concomitant use of alcohol or other central nervous system depressants may have an additive effect.
Therefore, patients should be warned accordingly.
Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias).
The preparation should not be injected intra-arterially.
Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in pediatric patients.
In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in pediatric patients.
In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.
The concomitant use of alcohol or other central nervous system depressants may have an additive effect.
Therefore, patients should be warned accordingly.
Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias).
The preparation should not be injected intra-arterially.
Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in pediatric patients.
In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in pediatric patients.
In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most frequent adverse reaction to dimenhydrinate is drowsiness.
Dizziness may also occur.
Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.
The most frequent adverse reaction to dimenhydrinate is drowsiness.
Dizziness may also occur.
Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.