Each tablet contains dimenhydrinate 50 mg. Sodium: <1 mmol (0.083 mg)/tablet. Energy: 1 kJ (0.2 kcal)/tablet. Gluten- and tartrazine-free.
Pharmacotherapeutic group: Antiemetic.
Pharmacology: Pharmacodynamics: Dimenhydrinate belongs to the antihistaminic class (amino-alkyl ether group) of drugs although it is not commonly used for this action. Its site and action are not precisely known, but there is evidence that the drug acts to depress hyperstimulated labyrinthine functions or associated neural pathways.
Fatalities have been reported in adults and particularly in children with overdose of dimenhydrinate and the closely related diphenhydramine HCl. Convulsions especially in children, delirium, hallucinations and features resembling atropine poisoning have been observed.
Prevention and relief of motion sickness and the nausea or vomiting incident to these conditions. The treatment or prophylaxis of the nausea and vomiting of radiation sickness, post-operative vomiting, and drug induced nausea and vomitng; also for the symptomatic treatment of nausea, vomiting, and vertigo due to Meniere's disease and other labyrinthine disturbances.
The initial therapeutic and prophylactic adult dose is 50 to 100 mg 3 or 4 times a day. For children 6 to 8 years, the dose is 12.5 to 25 mg 2 or 3 times daily. For children 8 to 12 years, the dosage is 25 to 50 mg 2 or 3 times daily. Children aged 12 years or more, may receive 50 mg 2 or 3 times daily.
Note: Where anticipation of subsequent nausea and vomiting is possible (pre-operatively, prior to travel, prior to radiation), consider the administration of an appropriate dimenhydrinate dosage form 30 minutes prior to that event.
Symptoms: Drowsiness is the usual clinical side effect. Convulsions, coma and respiratory depression may occur with massive overdosage.
Treatment: Empty stomach. Follow with activated charcoal and a saline cathartic. Maintain ventilation. Monitor vital signs and ECG in severe cases. Maintain fluid and electrolyte balance. Control excitation with i.v. diazepam. Propranolol may be considered for arrhythmias. Use physical measures to control hyperpyrexia. Do not give salicylates. Exchange transfusion may be considered in severe intoxications.
Antiemetics must be used with caution since they may mask the presence of underlying organic abnormalities or the toxic effects of other drugs, particularly those drugs causing ototoxicity.
Patients in whom anticholinergics may aggravate other clinical conditions, (angle-closure glaucoma, prostatism) should use dimenhydrinate with caution, and preferably on a physician's advice.
Occupational hazards: Patients receiving dimenhydrinate should be cautioned against operating automobiles or dangerous machinery because of the drowsiness associated with the drug. If drowsiness is excessive, dosage should be reduced.
Pregnancy: Safety has not been established.
Lactation: Dimenhydrinate enters breast milk but is not likely to affect infant at usual dosage.
Drowsiness may be experienced by some patients, especially at high dosages, but this action frequently is not undesirable in some conditions where the drug is used. Dizziness may also occur. Symptoms of dry mouth, lassitude, excitement and nausea have been reported (see Pharmacology under Actions).
An additive effect may be produced if alcohol or other CNS depressant drugs are given concomitantly with dimenhydrinate.
Incompatibilities: None known.
Store in a cool, dry place. Protect from light.
R06AA02 - diphenhydramine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
Tab 50 mg (round, orange, double scored, identified APO 50) x 1,000's.