Dexcel Pharma Technologies Ltd

Antiplatelet Agent. Clopidogrel (as Besylate) 75 mg.
TABS: 30
75 mg dly as single dose with/without food. Non-ST seg. elevat. acute coronary syndr. (unstab. ang. non-Q-wave MI). Init.: 300 mg load. dose, cont. with 75 mg 1 x dly (with ASA 75-325 mg dly – optimal: 100 mg dly). Max benefit within 3 mths. but can cont. for up to 12 mths. ST seg. elevat. acute MI: 75 mg 1 x dly. Load dose (in comb. with ASA with/without thrombolyts.): Pts. over 75 yrs: Init. without load dose. Comb ther. as soon as possible aft. onset sympts. Cont. for at least 4 wks. Atrial fibrillat.: 75 mg 1 x dly with ASA (75-100 mg dly) Under 18 yrs: not indicated.  
Second. prevent. atherothromb: In adult. with M.I.(from a few days until less than 35 d.),.ischem. stroke (from 7 days-6 mths) or estab. periph. art. dis.
Adults with Acute coron. syndr. non-ST seg. elevat. acute coron. syndr. (unstable angina/non-Q-wave M.I.) includ. pts. undergoing stent placement foll. percutan. coron. intervent., in comb. with ASA. ST seg. elevat. acute MI, in comb. with ASA in medically treat. pts. eligible for thrombolyt. ther.
Prevent. atherothromb/thromboemb. events in atrial fibrillat: Adult. with atrial fibrillat. with at least one risk factor for vasc. events, and not suitable for tmt. with VKA, anti-thrombin or anti factor Xa, who have low bleed. risk. in combinat. with ASA for prevent. atherothrombotic/thromboemb. events, includ. stroke.
C/I: Hypersens., severe hep. impair., active path. bleed. as peptic ulc., intracran. hemorrhage. See lit.

HMG-CoA Reductase Inhibitor, Statin. Atorvastatin (as Calcium) 10, 20, 40, 80 mg.
Tabs.: 30 X 10, 20 mg, 40 mg, 80mg.
Usual start. dose :10 mg or 20 mg once/day. Dosage range is 10 to 80 mg once/day. Doses should be individualiz. accord. to baseline LDL-C levels, goal of ther., and ptt. resp. Adjust. should be made at intervals of 4 weeks or more. Max. dose is 80 mg once /day.
After init. and/or upon titr., lipid levels should be analyzed within 2 to 4 weeks and dosage adjust. accord. See lit.
Indic. as adjunct to diet for reduct. of elev. total cholesterol, LDL-cholest., apolipoprotein B and triglycerides and to increase HDL Cholesterol in pts. with primary hypercholesterol. includ. familial hypercholesterol. (heterozygous variant) or combined (mixed) hyperlipidemia (correspond. to types IIa and IIb of the fredrickson classification) when resp. to diet and other non-pharmacol. measures is inadeq.
Also indic. to reduce total-C and LDL-C in pts. with homozygous familial hypercholesterol. as an adjunct to other lipid-lowering tmt. (e.g. LDL apheresis) or if such tmts. are unavailable.
Ped. pts. (10-17 years of age):
indic. as adjunct to diet to reduce total-C, LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age, with heterozygous familial hypercholesterol. if after an adeq. trial of diet ther. the follow. findings are present:
1. LDL-C remains >or = 190 mg/dl or
2. LDL-C remains >or = 160 mg/dl and: there is a posit. family hist. of premature cardiovasc. dis. or two or more other CVD risk factors  in the ped. ptt.
Prevent. of CV and/or cerebrovasc. event such as MI or stroke as adjunct to correct. of other risk factors such as hypertens. in pt.s with three or more addit. risk factors or diabetes with one addit. risk factor.
In pts. with clin. evident coron. heart disease, indic. to:
Red. risk of non-fatal MI.
Red. risk of fatal and non-fatal stroke.
Red. the risk for revascular. procedures.
Red. the risk of hospitaliz. for CHF.
Red. the risk of angina.
C/I:
Ac. liver fail. or decompens. cirrhosis.
Hypersens. to atorvastatin or to excipts. Hypersens. reactions, incl. anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndr. and toxic epiderm. necrol. have been reported.
See lit.