DIMENHYDRINATE Solution for injection / Suppositories (2017)
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Περιεχόμενα
Name of the medicinal product
DIMENHYDRINATE INJECTION USP / SANDOZ DIMENHYDRINATE.
Summary product information
Product Routes of Administration Dosage Form / Strength Nonmedicinal Ingredients Dimenhydrinate Injection<br />USP Intramuscular injection<br /><br />(or IV administration if diluted) Parenteral / ...
Indications and clinical use
Dimenhydrinate Injection USP and Sandoz Dimenhydrinate (dimenhydrinate) are indicated for use in the prevention and relief of nausea, vomiting and/or vertigo. These symptoms may be associated with clinical ...
Contraindications
Patients who are hypersensitive to dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) or to any ingredient in the formulations or component of the container. For a complete listing, ...
Warnings and precautions
General Dimenhydrinate Injection USP for IM administration contains 50% (v/v) propylene glycol and is for intramuscular injection only. In exceptional circumstances, if Dimenhydrinate Injection USP for ...
Adverse reactions
Drowsiness and dizziness are reported most frequently, particularly on high dosage. Pain may occur at the site of IM injection. Since dimenhydrinate contains 50% diphenhydramine, the possibility of diphenhydramine ...
Drug interactions
Drug-Drug Interactions CNS Depressants Dimenhydrinate may enhance the effects of alcohol, barbiturates, tranquilizers, sedatives, or hypnotics. Caution must therefore be used, to avoid overdose. Drugs ...
Dosage and administration
Dosing Considerations Dimenhydrinate Injection USP 50 mg/mL is designed for intramuscular use only and must not be used intravenously (IV) unless it has been diluted (see Intravenous Dilution Instructions ...
Overdosage
Symptoms Accidental antihistamine overdose occurs frequently in infants and children. Symptoms of dimenhydrinate toxicity in children may resemble atropine overdosage, and include dilated pupils, flushed ...
Action and clinical pharmacology
Mechanism of Action Dimenhydrinate is a theoclate salt of the ethanolamine derivative diphenhydramine. The content ratio varies from 53%-55.5% for diphenhydramine, and 44%-47% for 8-chlorotheophylline. ...
Storage and stability
Store Sandoz Dimenhydrinate (suppositories) below 25°C. Dimenhydrinate Injection USP should be stored at controlled room temperature (15-30°C). Protect from freezing. Protect from light. A test of dimenhydrinate ...
Dosage forms, composition and packaging
NMI = Non-medicinal ingredients <u>Dimenhydrinate Injection USP for IM administration or IV administration if diluted Ampoules 50 mg/mL:</u> Active: 50 mg dimenhydrinate. NMI: propylene glycol 50% and ...
Pharmaceutical information
<u>Proper name:</u> Dimenhydrinate <u>Chemical name:</u> 8-chlorotheophyllinate of 2-[diphenylmethoxy]-n,n-dimethylethylamine <u>Other names:</u> IS = Anautinum; Dommanate, Dramamine, Gravol <u>Chemical ...
Toxicology
Acute toxicity was determined by administering dimenhydrinate to mice PO and IP, and in rats PO and IV. The results are shown in the following table. Species Oral IP IV Mice 203 mg/kg 110 mg/kg<br ...
Marketing authorization holder
Sandoz Canada Inc., Jules-Léger, Boucherville, QC, Canada, J4B 7K8
Submission control number
203644
Date of revision
December 22, 2017
References
1. Scavone JM, Luna BG, Harmatz JS, Moltke von L, Greenblatt DJ: Diphenhydramine kinetics following intravenous, oral and sublingual dimenhydrinate administration. Biophamaceut Drug Dispos 1990, 11: 185-189 ...
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