Pengesic SR tablet 100 mg

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

TRAMADOL HYDROCHLORIDE

Saatavilla:

Hovid Pharmacy Sdn. Bhd.

INN (Kansainvälinen yleisnimi):

TRAMADOL HYDROCHLORIDE

Kpl paketissa:

30Tablet Tablets; 10Tablet Tablets

Valmistaja:

HOVID BERHAD

Valmisteyhteenveto

__________
_________
PENGESIC SR TABLET 100 MG
DESCRIPTION
10 mm. White, round, transparent film-coated tablet, shallow convex
faces and ‘hovid’ embossed on one face.
COMPOSITION
Each tablet contains:
Tramadol Hydrochloride 100 mg
ACTIONS AND PHARMACOLOGY
Tramadol is a centrally-acting analgesic that is not chemically
related to opiates. The mechanism of action of tramadol has not
been fully determined, but it may bind to mu-opioid receptors and
inhibit the reuptake of norepinephrine (NE) and serotonin. The
ability of tramadol to inhibit the neuronal uptake of monoamines in
the same concentration range at which it binds to mu-opioid
receptors differentiates it from typical opioids.
PHARMACOKINETICS
Absorption
Tramadol is readily absorbed after oral doses but is subject to
first-pass metabolism. Mean absolute bioavailability of
100-mg dose is approximately 75%. The rate or extent of absorption is
not significantly affected by administration
with food.
Distribution
Tramadol is widely distributed, crosses the placenta, and appears in
small amounts in breast milk.
Protein Binding
Low (20%)
Biotransformation
Tramadol is metabolized by N- and O-demethylation via the cytochrome
P450 isoenzymes CYP3A4 and CYP2D6
and glucuronidation or sulfation in the liver. The metabolite
O-des-methyltramadol is pharmacologically active. The
inactive metabolites are formed by N-demethylation.
Elimination
Tramadol is excreted mainly in the urine, predominantly as
metabolites. The elimination half life after oral doses is about 6
hours.
INDICATIONS
Pengesic SR tablet 100 mg is indicated for the management of moderate
to severe pain.
CONTRAINDICATIONS
It is generally contraindicated in the following conditions:
-
Respiratory depression, especially in the presence of cyanosis and
excessive bronchial secretion.
-
In the presence of acute alcoholism, head injuries and conditions in
which intracranial pressure is raised.
-
It should not be used in patients receiving MAO inhibitors.
-
Previous hypersensitivity to Tramadol.
-
It should not b