DIMENHYDRINATE Solution for injection / Suppositories

Active ingredients: Dimenhydrinate

Product name

DIMENHYDRINATE INJECTION USP / SANDOZ DIMENHYDRINATE.

Summary product information

Product Routes of AdministrationDosage Form / Strength Nonmedicinal Ingredients
Dimenhydrinate Injection
USP
Intramuscular injection

(or IV administration if diluted)
Parenteral /
50 mg/mL

1 mL ampoules
propylene glycol 50% and water for injection.
Dimenhydrinate Injection
USP
Intramuscular injection

(or IV administration if diluted)
Parenteral /
50 mg/mL

5 mL multidose vials
benzyl alcohol 5%, propylene glycol 50% and water for injection.
Dimenhydrinate Injection
USP
Intravenous injectionParenteral /
10 mg/mL

5 mL single use vials
ethyl alcohol 10% and water for injection
Sandoz Dimenhydrinate Rectal Suppositories /
50 mg
hard fat.
Suppositories /
100 mg

Dosage forms, composition and packaging

NMI = Non-medicinal ingredients

Dimenhydrinate Injection USP for IM administration or IV administration if diluted Ampoules 50 mg/mL:

Active: 50 mg dimenhydrinate.
NMI: propylene glycol 50% and water for injection.

Dimenhydrinate Injection USP for IM administration or IV administration if diluted Multidose vials 50 mg/mL:

Active: 50 mg dimenhydrinate.
NMI: benzyl alcohol 5%, propylene glycol 50% and water for injection.

Dimenhydrinate Injection USP for IV administration:

Single use vials 10 mg/mL.

Active: 10 mg dimenhydrinate.
NMI: ethyl alcohol 10% and water for injection

Sandoz Dimenhydrinate Suppositories 50 mg:

Active: 50 mg dimenhydrinate.
NMI: hard fat.

Sandoz Dimenhydrinate Suppositories 100 mg:

Active: 100 mg dimenhydrinate.
NMI: hard fat.

Availability of Dosage Forms

Dimenhydrinate Injection USP For IM administration or IV administration if diluted 50 mg/mL

For IM administration or IV administration if diluted. Each mL contains dimenhydrinate 50 mg, propylene glycol 50% and water for injection. (See Dosage and Administration, if used for IV administration). Available in ampoules of 1 mL, boxes of 10 ampoules.

Dimenhydrinate Injection USP For IM administration or IV administration if diluted 50 mg/mL

For IM administration or IV administration if diluted. Each mL contains dimenhydrinate 50 mg, benzyl alcohol 5%, propylene glycol 50% and water for injection. (See Dosage and Administration, if used for IV administration). Available in multidose vials of 5 mL, boxes of 10.

LATEX-FREE STOPPER: Stopper contains no dry natural rubber.

Dimenhydrinate Injection USP For IV administration 10 mg/mL

For IV administration only. Each mL contains: dimenhydrinate 10 mg, ethyl alcohol 10% and water for injection. Available in single use vials of 5 mL, boxes of 10.

LATEX-FREE STOPPER: Stopper contains no dry natural rubber.

Sandoz Dimenhydrinate Suppositories 50 mg

Each suppository contains 50 mg dimenhydrinate, and hard fat. Boxes of 10.

Sandoz Dimenhydrinate Suppositories 100 mg

Each suppository contains 100 mg dimenhydrinate, and fat. Boxes of 10.

Marketing Informations
Authorization Dates
Authorization holder:

Sandoz Canada Inc., Jules-L├ęger, Boucherville, QC, Canada, J4B 7K8

Submission control number:

203644

Date of revision:

December 22, 2017