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Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients glycerol monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, polysorbate 80, silicon dioxide 25-and 50-mg tablets only , titanium dioxide, triethyl citrate, carmine 250-mg tablet only , iron oxide black 50-, 250-, and 300-mg tablets only , iron oxide yellow 25-, 50-, and 100-mg tablets only , iron oxide red 100-mg tablet only , fd c blue no.
In a 26-wk, placbo-contolld, dos-anging monothapy study, man sum tiglycids dcasd in th 15 mg, 30 mg, and 45 mg ACTOS dos goups compad ta man incas in th placbgoup. Man HDL cholstol incasd ta gat xtnt in patints tatd with ACTOS than in th placbo-tatd patints. Th w nconsistnt dincs LDL and total cholstol in patints tatd with ACTOS compad tplacb(s Tabl 14).
Twclinical tials w conductd with ACTOS in combination with mtomin. Both tials includd patints with typ 2 diabts on any dos mtomin, ith alon in combination with anoth antidiabtic agnt. All oth antidiabtic agnts w withdawn at last th wks pitstating study tatmnt.
Hat nlagmnt has bn obsvd in mic (100 mg/kg), ats (4 mg/kg and abov) and dogs (3 mg/kg) tatd oally with pioglitazon hydochloid (appoximatly 11, 1, and 2 tims th maximum commndd human oal dos mic, ats, and dogs, spctivly, basd on mg/m 2 ). In a on-ya at study, dug-latd aly dath du tappant hat dysunction occud at an oal dos 160 mg/kg/day (appoximatly 35 tims th maximum commndd human oal dos basd on mg/m 2 ). Hat nlagmnt was sn in a 13-wk study in monkys at oal doss 8.9 mg/kg and abov (appoximatly ou tims th maximum commndd human oal dos basd on mg/m 2 ), but not in a 52-wk study at oal doss up t32 mg/kg (appoximatly 13 tims th maximum commndd human oal dos basd on mg/m 2 ).
Igu 1. Man Chang om Baslin HbA1c in a 26-Wk Placbo-Contolld Dos-anging Study (Obsvd Valus)
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