Durotram XR
देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
उत्पाद विशेषताएं
(SPC)
01-06-2012
अनुरोध भेजा।
सक्रिय संघटक:
Tramadol hydrochloride 300mg
थमां उपलब्ध:
iNova Pharmaceuticals (New Zealand) Limited
INN (इंटरनेशनल नाम):
Tramadol hydrochloride 300 mg
डोज़:
300 mg
फार्मास्यूटिकल फॉर्म:
Modified release tablet
रचना:
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
पैकेज में यूनिट:
Blister pack, PVC/PVDC/Al, 2 tablets
वर्ग:
Prescription
प्रिस्क्रिप्शन प्रकार:
Class C2 Controlled Drug
द्वारा बनाया गया:
Perrigo API Ltd
चिकित्सीय संकेत:
Relief of moderate to severe pain
उत्पाद समीक्षा:
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
प्राधिकरण की तारीख:
2008-06-24
उत्पाद विशेषताएं
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.
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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
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