927_964_pac3l389-1.ps, page 1 @ preflight ( 927_964_pac3l389-1.indd )

DIMENHYDRINATE INJECTION USP
THERAPEUTIC CATEGORY : ANTIEMETIC
Children are very susceptible to the convulsant action of antihistamines anddoses of 150 to 800 mg of diphenhydramine in children aged 11 2 PHARMACOLOGY: While the precise mode of action of dimenhydrinate is not
been reported to produce convulsions. A suspected dose of 700 mg of known, it has a depressant action on hyperstimulated labyrinthine functions or dimenhydrinate produced death in a 22-month-old boy and a dose greater than 800 mg directly caused death in a 2-year-old boy. There has been a INDICATIONS: Prevention and relief of motion sickness and the nausea or
report of hallucinations after ingesting 500 mg of diphenhydramine HCI as well vomiting incident to these conditions. The treatment of prophylaxis of the as a few reports of delirium and hallucinations following the ingestion of nausea and vomiting of radiation sickness, postoperative vomiting, and drug- approximately 750 mg of dimenhydrinate. A single case of severe delirium, induced nausea and vomiting; also for the symptomatic treatment of nausea, closely resembling atropine poisoning and with possible extrapyramidal vomiting and vertigo due to Ménière’s disease and other labyrinthine symptoms, following ingestion of a massive overdose of dimenhydrinate taken by an 18-year-old man has been reported.
CONTRAINDICATIONS: Neonates and patients with a history of
hypersensitivity to dimenhydrinate or its components (diphenhydramine or 8-
Treatment: No specific antidote is known. If respiratory depression occurs,
chlorotheophylline) should not be treated with dimenhydrinate.
mechanically assisted respiration should be initiated and oxygen administered.
Convulsions should be treated with appropriate doses of diazepam.
WARNINGS: Antiemetics must be used with caution since they may mask the
Phenobarbital (5 to 6 mg/kg) may be given to control convulsions in children.
presence of underlying organic abnormalities or the toxic effects of certainantibiotics and other drugs, particularly those drugs causing ototoxicity. DOSAGE: Substances which are physically incompatible with injectable
Occupational hazards: Patients receiving dimenhydrinate should be
solutions of dimenhydrinate include: phenothiazine derivatives, aminophylline, cautioned against operating automobiles or dangerous machinery because of ammonium chloride, sodium amobarbital, diphenylhydantoin, heparin, the drowsiness associated with the drug. If drowsiness is excessive, dosage hydrocortisone sodium succinate, pentobarbital, phenobarbital, thiopental and PRECAUTIONS: Rarely, prolonged therapy with antihistaminic drugs can
Adult: Nausea or vomiting may be expected to be controlled for approximately
produce blood dyscrasia. Dimenhydrinate should be used with caution in 4 hours with 25 to 50 mg of dimenhydrinate, and prevented by a similar dose patients in whom anticholinergics may aggravate other clinical conditions (i.e.; every 4 hours. This dosage regimen may cause some degree of drowsiness prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, in some patients and 100 mg every 4 hours may be given in conditions in which bladder-neck obstruction, narrow-angle glaucoma, bronchial asthma, or drowsiness is not objectionable or is even desirable. For I.M administration, 1 to 2 mL (50 to 100mg) of the 50 mg/mL solution is injected as needed. The An addictive effect may be produced if alcohol or other CNS depressant drugs preparation designed for I.M use (50 mg/mL) must not be used I.V unless it has are given concomitantly with dimenhydrinate.
been diluted at least 1:10 with a compatible I.V solution such as 0.9% Sodium Pregnancy: The use of dimenhydrinate by women who are pregnant or may
Chloride Injection USP. The maximum daily dose should not exceed 300 mg become pregnant requires that the potential benefits be weighed against the Children: I.M : 6 to 8 years: 12.5 to 25 mg, 2 or 3 times daily; 8 to 12 years:
Labour and Delivery: The safety of dimenhydrinate injection given during
25 mg to 50 mg, 2 or 3 times daily; over 12 years: 50 mg, 2or 3 times daily.
labour and delivery has not been established. Reports have indicateddimenhydrinate may have oxytocic effect. Caution is advised when this effect AVAILIBILITY: Dimenhydrinate Injections USP 50 mg/mL. Each mL of sterile
is unwanted or in situations where it may prove detrimental.
solution contains dimenhydrinate USP 50 mg in a mixture of propylene glycol Nursing Mothers: Small amounts of dimenhydrinate are excreted in breast
(50%) and water for injection. Ampoules of 1mL also contains sulphuric acid milk. Because of the potential for adverse reactions in nursing infants from to adjust pH, packaged in boxes of 10, Vials of 5 mL also contain methyl dimenhydrinate, a decision should be made whether to discontinue nursing or paraben 1 mg/mL and propyl paraben 0.1 mg/mL and may also contain sodium to discontinue the drug, taking into account the importance of the drug to the hydroxide or hydrochloric acid to adjust pH, packaged in boxes of 10.
STORAGE: Store at room temperature (15 to 30°C). Protect from freezing.
ADVERSE EFFECTS: Drowsiness may be experienced by some patients,
especially at high dosages. Dizziness may also occur. Symptoms of dry mouth,
lassitude, excitement and nausea have been reported.
OVERDOSE: Symptoms: Drowsiness is the usual clinical side effect.
Convulsions, coma and respiratory depression may occur with massive

Source: http://www.alvedapharma.com/PDF/DimenhydrinateEnglish.pdf