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DILAUDID
®
tablets, oral liquid, injection; DILAUDID
®
-HP injections PI
mfpdilau10512
Supersedes PI 22 Feb 10
Page 1 of 12
PRODUCT INFORMATION
DILAUDID
®
TABLETS (2 MG, 4 MG AND 8 MG)
DILAUDID
®
ORAL LIQUID (1 MG/ML)
DILAUDID
®
INJECTION (AMPOULE: 2 MG/1 ML)
DILAUDID
®
-HP INJECTION (AMPOULES: 10 MG/1 ML AND 50 MG/5 ML)
DILAUDID
®
-HP INJECTION (VIAL: 500 MG/50 ML)
NAME OF THE MEDICINE
DILAUDID
®
preparations contain hydromorphone hydrochloride. The structural formula of
hydromorphone hydrochloride is:
DESCRIPTION
Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.
Chemical name: 4,5
α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride.
Molecular weight: 321.81.
Hydromorphone hydrochloride is a fine, white or practically
white, odourless, crystalline powder. It is freely soluble in
water, sparingly soluble in ethanol
and practically insoluble in ether. CAS registration
number: 71-68-1.
The inactive ingredients in DILAUDID
®
tablets are lactose anhydrous and magnesium
stearate. Additionally, the 2 mg tablet contains vat red 1 aluminium
lake (CI73360) and
quinoline yellow aluminium lake (CI47005) as colourant and the 4 mg tablet contains
quinoline yellow aluminium lake (CI47005) as colourant.
The inactive ingredients in DILAUDID
®
oral liquid are sucrose, glycerol, propyl
hydroxybenzoate, methyl hydroxybenzoate and purified water.
The inactive ingredients in DILAUDID
®
ampoules and DILAUDID
®
-HP ampoules and vials
are sodium citrate, citric acid monohydrate and Water for Injections.
PHARMACOLOGY
Hydromorphone i
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