Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Tramadol hydrochloride 300mg
iNova Pharmaceuticals (New Zealand) Limited
Tramadol hydrochloride 300 mg
300 mg
Modified release tablet
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
Blister pack, PVC/PVDC/Al, 2 tablets
Prescription
Class C2 Controlled Drug
Perrigo API Ltd
Relief of moderate to severe pain
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
2008-06-24
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 Page 1 of 22 _ _ Durotram-PI-NZ-01May08A Page 2 of 22 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 Belgenin tamamını okuyun