Apo-Dimenhydrinate

Apo-Dimenhydrinate

dimenhydrinate

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Dimenhydrinate.
Description
Each tablet contains dimenhydrinate 50 mg. Sodium: <1 mmol (0.083 mg)/tablet. Energy: 1 kJ (0.2 kcal)/tablet. Gluten- and tartrazine-free.
Action
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.
Indications/Uses
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.
Dosage/Direction for Use
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.
Overdosage
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.
Special Precautions
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.
Use In Pregnancy & Lactation
Pregnancy: Safety has not been established.
Lactation: Dimenhydrinate enters breast milk but is not likely to affect infant at usual dosage.
Adverse Reactions
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).
Drug Interactions
An additive effect may be produced if alcohol or other CNS depressant drugs are given concomitantly with dimen­hydrinate.
Caution For Usage
Incompatibilities: None known.
Storage
Store in a cool, dry place. Protect from light.
MIMS Class
ATC Classification
R06AA02 - diphenhydramine ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
Presentation/Packing
Tab 50 mg (round, orange, double scored, identified APO 50) x 1,000's.
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