Source: Health Products and Food Branch (CA) Revision Year: 2017
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 situations such as motion sickness, radiation sickness, postoperative recovery, druginduced nausea and vomiting, Ménière’s disease and other labyrinthine disturbances. Parenteral therapy is available when rectal therapy is inappropriate.
See WARNINGS AND PRECAUTIONS — Special Populations, Geriatrics.
<2 years of age: The safety and efficacy of Dimenhydrinate Injection USP in children under the age of 2 have not been established. Dimenhydrinate Injection USP should not be used in this population.
<12 years of age: The safety and efficacy of Sandoz Dimenhydrinate in children under the age of 12 have not been established. Sandoz Dimenhydrinate should not be used in this population.
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 below). Diluted Dimenhydrinate Injection USP, prepared for IV use, should be administered by slow intravenous injection only (over 2 minutes).
Dimenhydrinate Injection USP (10 mg/mL) for IV use is not for arterial use.
Consult physical compatibility information (see Stability and Storage Recommendations) before mixing parenteral solutions.
Dimenhydrinate Injection USP and Sandoz Dimenhydrinate are not intended for prolonged use except upon advice of the physician.
Dimenhydrinate Injection USP is not recommended for children under 6 years of age, unless directed by the physician.
Sandoz Dimenhydrinate is not recommended for children under 12 years of age, unless directed by the physician.
For IV administration, each 1 mL of Dimenhydrinate Injection USP 50 mg/mL must be diluted at least 1:10 with a compatible physiological solution such as sterile saline or 5% dextrose in water, to prevent propylene glycol-associated cardiogenic shock.
Diluted solutions can be stored up to 24 hours at room temperature. Dimenhydrinate Injection USP is never to be injected intra-arterially. Always inspect the solution visually for particulate matter and discolouration prior to administration. Discard any unused portions.
For IV administration, the Dimenhydrinate Injection USP (10 mg/mL) must be administered as a slow IV injection (2 to 4 minutes).
Rectal: 50 mg – 100 mg Sandoz Dimenhydrinate suppository every 6-8 hours as necessary. For ease and comfort, smooth any edges on suppository prior to use.
Dosage should be taken at least 30 minutes, and preferably 1 or 2 hours before travelling. Do not use more than 4 suppositories in 24 hours.
≥12 years of age: Rectal: 50 mg every 8 to 12 hours as necessary. Dosage should be taken at least 30 minutes, and preferably 1 or 2 hours before travelling. Do not use more than 3 suppositories in 24 hours.
Pre-Therapy: Adults: 50 mg – 100 mg administered rectally or parenterally, 30 to 60 minutes before treatment. This dose is repeated as necessary to a maximum of 400 mg within 24 hours.
Post-therapy: Adults: 50 mg IM or IV 1½ hours post-therapy and 50 mg IM or IV 3 hours posttherapy.
To divide a suppository in two equal parts, remove from packaging and carefully cut with a sharp edge blade through the suppository.
50 mg IM or IV as preoperative dose, to be followed postoperatively by similar doses as needed to a maximum of 400 mg within 24 hours.
Over 12 years of age: 50 mg IM or IV two or three times daily
8 to 12 years of age: 25 mg – 50 mg IM or IV two or three times daily
6 to 7 years of age: 15 mg – 25 mg IM or IV two or three times daily
50 mg IM or IV, immediately after surgery, then: 50 mg IM or IV, every 4 hours for 3 doses.
Over 12 years of age: 50 mg IM or IV two or three times daily
8 to 12 years of age: 25 mg – 50 mg IM or IV two or three times daily
6 to 7 years of age: 15 mg – 25 mg IM or IV two or three times daily
If a dose is missed and Dimenhydrinate Injection USP or Sandoz Dimenhydrinate are being taken regularly, they should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. The maximum daily dose should not be exceeded.
Accidental antihistamine overdose occurs frequently in infants and children. Symptoms of dimenhydrinate toxicity in children may resemble atropine overdosage, and include dilated pupils, flushed face, excitation, hallucinations, confusion, ataxia, intermittent clonic convulsions, coma, cardiorespiratory collapse, and death. Symptoms may be delayed up to 2 hours after ingestion; death may occur within 18 hours.
In adults, 500 mg or more of dimenhydrinate may cause extreme difficulty in speech and swallowing, and produces a psychosis indistinguishable from that of atropine poisoning. CNS excitation may be preceded by sedation, leading to a cycle of CNS excitation, seizures, and postictal depression.
Treatment of dimenhydrinate toxicity is symptomatic and supportive. Emetics are usually ineffective but in the absence of seizures, early gastric lavage (with an endotracheal tube with cuff inflate in place to prevent aspiration of gastric contents) may be beneficial. Patients should be kept quiet, to minimize CNS stimulation; seizures may be treated with diazepam in adults and phenobarbital in children (additional methods may include IV sodium bicarbonate, or IV physostigmine salicylate in children). Mechanical respiratory assistance may be required.
Positive and negative mode of ion mobility spectrometry (IMS) and ion mobility spectrometry/mass spectrometry (IMS/MS) have shown efficacy for the preliminary screening of emergency patients suspected of dimenhydrinate and other drug overdose.
For management of suspected drug overdose, contact your regional Poison Control Centre.
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 solutions at pH 2–10 showed no separation or precipitation at pH 5.4–8.6 on extended room temperature storage. Below pH 5.4, a white powdery precipitate of 8-chloro-theophylline formed within 24 hours; above pH 8.6, an oily liquid separated within 30 min. The Handbook on Injectable Drugs should be consulted prior to mixing dimenhydrinate with other drugs.
A hydromorphone – dimenhydrinate combination was compatible and stable for 24 hours; by 48 hours, 8-chlorotheophylline had precipitated and the degree of precipitation was enhanced by increasing hydromorphone concentration.
A glycopyrrolate (Robinul) injectable (IM) – dimenhydrinate injectable (for IM administration) combination showed several tiny particles at 5 minutes and remained unchanged up to 48 hours. Despite a marginal amount, Carter-Horner interpreted the result as physically incompatible.
| INJECTIONS EVALUATED AT CARTER-HORNER, INC. (As of May, 1999) | POTENCY OF SOLUTION | PHYSICALLY COMPATIBLE WITH DIMENHYDRINATE INJECTABLEFOR IM ADMINISTRATION |
|---|---|---|
| Atropine sulfate | 0.4 mg/mL | Yes |
| Buscopan (Hyoscine butyl bromide) | 20 mg/mL | Yes |
| Calcium chloride | 1 g/10 mL | Yes |
| Calcium gluconate | 1 g/10 mL | Yes |
| Codeine phosphate | 30 mg/mL | Yes |
| Codeine phosphate | 60 mg/mL | Yes |
| Demerol (Meperidine HCl Inj.) + Dextrose 5% in water + Sodium chloride 0.9% | 50 mg/mL | Yes Yes Yes |
| Dextrose 5% in sterile water | 5% | Yes |
| Hyoscine Injection BP | 0.6 mg/mL | Yes |
| Innovar (Fentanyl citrate) | 0.05 mg/mL | Yes |
| Isotonic potassium chloride | 40 mEq/20 mL diluted to 0.16 mEq/mL | Yes |
| Morphine Injection USP | 15 mg/mL | Yes |
| Nubain (Nalbuphine Inj.) | 10 mg/mL | No |
| Nubain (Nalbuphine Inj.) | 20 mg/mL | No |
| Pantopon Injection | 20 mg/mL | No |
| Pentazocine lactate (base) | 30 mg/mL | Yes |
| Phenergan | 25 mg/mL | No |
| Ringer’s lactate | ----- | Yes |
| Sodium chloride in sterile water | 0.9% | Yes |
| Sterile water for injection USP with or without multivitamins for inj. | ----- | Yes |
| 1cc (mL) plastic syringe (single use) | ----- | Yes (not exceeding 24 hours) |
| 5 mL multi-dose glass vial (IM) Use under strictly aseptic conditions | 50 mg/mL | STABILITY (at 4°C, not exceeding 2 weeks) (at 21°C, not exceeding 2 weeks) |
| COMPATIBLE WITH DIMENHYDRINATE INJECTABLE FOR IV ADMINISTRATION | ||
| Buscopan (Hyoscine butyl bromide inj.) | 20 mg/ml | Yes |
| Calcium chloride | 1 g/10 mL | Yes |
| Calcium gluconate | 1 g/10 mL | Yes |
| Demerol (Meperidine HCl) | 50 mg/mL | Yes |
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