Durotram XR

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Tramadol hydrochloride 300mg

Disponibil de la:

iNova Pharmaceuticals (New Zealand) Limited

INN (nume internaţional):

Tramadol hydrochloride 300 mg

Dozare:

300 mg

Forma farmaceutică:

Modified release tablet

Compoziție:

Active: Tramadol hydrochloride 300mg Excipient: Colloidal silicon dioxide Distarch phosphate Hydrogenated vegetable oil Magnesium stearate Opacode black S-1-17823 Polyvinyl acetate Povidone Sodium laurilsulfate Xanthan gum

Unități în pachet:

Blister pack, PVC/PVDC/Al, 2 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Class C2 Controlled Drug

Produs de:

Perrigo API Ltd

Indicații terapeutice:

Relief of moderate to severe pain

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 3 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 5 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Data de autorizare:

2008-06-24

Caracteristicilor produsului

 
PRODUCT INFORMATION 

DUROTRAM
®
 XR 
Tramadol Hydrochloride 
NAME OF THE MEDICINE 
The active ingredient of 
DUROTRAM
®
 XR is tramadol hydrochloride 
Chemical name:  
(±)-_cis_-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)
cyclohexanol 
hydrochloride or (1_RS_,2_RS_)-2-[(Dimethylamino)methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride 
Chemical structure: 

.HCl 
Molecular formula: C
16
H
25
NO
2
.HCl 
Molecular weight: 299.84 
CAS registry no. 36282-47-0 
DESCRIPTION 
Tramadol hydrochloride is a white crystalline powder with a melting
point/range 
approximately of 180
o
C.  It is readily soluble in water and ethanol and has a pKa of 9.41.

The water/n-octanol partition coefficient is 1.35 at pH 7. 
DUROTRAM
®
 XR tablets are available in strengths of 100 mg, 200 mg and 300 mg 
tramadol hydrochloride. 
DUROTRAM
®
 XR tablets contain the following excipients: Contramid
® 
(Hydroxypropyl 
distarch phosphate (E 1442)), polyvinyl acetate, povidone, sodium
lauryl sulfate, xanthan 
gum, vegetable oil-hydrogenated, magnesium stearate, silica colloidal
anhydrous, 
Opacode monogramming ink S-1-17823 black.  
DUROTRAM
®
 XR tablets are comprised of a dual-matrix delivery system with an
outer 
compression coat which releases tramadol hydrochloride immediately
and a core 
containing Contramid
®
, which controls the release of tramadol hydrochloride.

Durotram-PI-NZ-01May08A 

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Durotram-PI-NZ-01May08A 

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PHARMACOLOGY 
MECHANISM OF ACTION 
The analgesic activity of tramadol hydrochloride is due to both parent
drug and the M1 
metabolite (_O_-desmethyl tramadol). 
Tramadol is a centrally acting synthetic opioid analgesic. Although
its mode of action is not 
completely understood, from animal tests, at least two complementary
mechanisms appear 
applicable:  binding of parent and M1 metabolite to µ-opioid
receptors and weak inhibition 
of reuptake of norepinephrine and serotonin.  Opioid activity is due
to both low aff