MABRON INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

KOMEDIC SDN BHD

INN (International Name):

TRAMADOL HYDROCHLORIDE

Units in package:

2.0ml mL

Manufactured by:

MEDOCHEMIE LTD (AMPOULE INJECTABLE FACILITY)

Patient Information leaflet

Not Applicable

Summary of Product characteristics

MABRON
COMPOSITION
2ml of aqueous solution for injection contain 100mg of Tramadol HCl.
This is equivalent to one ampoule MABRON. The chemical
designation is
(+)-trans-2-(dimethlaminomethyl)-1-(m-methoxyphenyl)-cyclohexanol-hydrochloride.
PRESENTATION
A solution for injection or infusion containing 50mg of tramadol
hydrochloride per 1ml was developed. The solution is
presented as a clear, colorless or almost colorless solution in Type I
(Ph.Eur) amber glass ampoules, of nominal volume 2.0ml.
INDICATIONS
Treatment of moderate to severe pain.
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: other opioids; ATC-code N 02: AX 02.
Tramadol is a centrally acting opioid analgesic. It is a non-selective
pure agonist at μ, δ and κ opioid receptors with a higher
affinity for the μ receptor. Other mechanisms which contribute to its
analgesic effect are inhibition of neuronal reuptake of
noradrenaline and enhancement of serotonin release.
Tramadol has an antitussive effect. In contrast to morphine, analgesic
doses of tramadol over a wide range have no respiratory
depressant effect. Also gastrointestinal motility is less affected.
Effects on the cardiovascular system tend to be slight. The
potency of tramadol is reported to be 1/10 (one tenth) to 1/6 (one
sixth) that of morphine.
_PHARMACOKINETIC PROPERTIES _
More than 90% of tramadol is absorbed after oral administration. The
mean absolute bioavailability is approximately 70%,
irrespective of the concomitant intake of food. The difference between
absorbed and non-metabolised available tramadol is
probably due to the low first-pass effect. The first-pass effect after
oral administration is a maximum of 30 %.
Tramadol has a high tissue affinity (V
d,ß
= 203 ± 40 l). It has a plasma protein binding of about 20%.
Following a single oral dose administration of tramadol 100mg as
capsules or tablets to young healthy volunteers, plasma
concentrations were detectable within approximately 15 to 45 minutes
within a mean C
max
of 280 to 208 mcg/L and T
max
of 1