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.

Anticonvulsant. Levetiracetam 250, 500, 750, 1000 mg.
Tabs. 60 X 250/500/750/1000 mg
 Monother.: Adult. & adolesc.from 16 yrs. of age:starting recommen. dose is 250 mg ×2/d which should be incr. to an init. therap. dose of 500 mg ×2/d after two wks. The dose can be further incr. by 250 mg ×2/d every two wks. depend. upon clinical response. Max. dose is 1500 mg ×2/d.
Add-on ther.: Adult. (≥18 yrs.) and adolesc. (12 - 17 yrs.) weigh.≥50 kg: The init. therap. dose is 500 mg ×2/d. This dose can be init. on the 1^st day of tmt. Depend. upon the clinic. response and tolerab., dly. dose can be incr. up to 1,500×2/d. Dose changes can be made in 500 mg ×2/d incr. or decr.every 2-4 wks.
Childr.  aged 6 - 11 yrs. and adolesc (12 - 17 yrs.) weigh. <50 kg:  The init. therap. dose is 10 mg/kg×2/d. Depend. upon clinic. response and tolerab., dose can be incr. up to 30 mg/kg ×2/d . Dose changes should not exceed incr. or decr. of 10 mg/kg ×2/d  every 2 wks. The lowest effect. dose should be used.
Add-on therapy for childr. (4 to 11 years) and adolesc. (12 to 17 years) weighing less than 50 kg :oral sol. is the preferred formul. for use in childr. under the age of 6.
For childr. 6 years and above, the oral sol. should be used for doses under 250 mg, for doses not multiple of 250 mg, when dosing recomm. is not achievable by taking multiple tabs. and for pts. unable to swallow tabs. The lowest effective dose should be used. Start. dose for a child or adolesc. of 25 kg should be 250 mg x2/d with a max. dose of 750 mg X2/d.
Dose in childr. 50 kg or greater is the same as in adults.
The init. therap. dose is 10 mg/kg X2/d.
Depending upon clinical resp. and tolerab., dose can be incr. up to 30 mg/kg X2/d. Dose changes should not exceed incr. or decr. of 10 mg/kg X2/d every two weeks. The lowest effective dose should be used. See lit
As monother. in the tmt. of partial onset seizures. with/without second. generalisat. in pts. from 16 yrs  of age with newly diagnos. epilepsy.
As adjunct. ther. in the tmt. of partial onset seizures with/without second. generalisat. in adult. & childr. from 4 yrs. of age with epilepsy.
In the tmt. of myoclon. seizures in adult. & adolesc. from 12 yrs. of age with Juvenile Myoclonic Epilepsy.
In the tmt. of prim. generalised. tonic-clonic seizures in adults & adolesc. from 12 yrs. of age with Idiopathic Generalised Epilepsy.
C/I: Hypersens. to levetiracetam or other pyrrolidone derivat.

Statin. Atorvastatin (as calcium) 10, 20, 40, 80 mg.
F.C. TABS: 30 x 10 mg, 20 mg. Init: 10-20-
mg 1 x dly. Pts requir. larger reduct. in
LDL (more than 45%) may be started
at 40 mg 1 x dly. Adjust. dose at
intervals of 4 wks or more. Max. dose:
80 mg 1 x dly. Doses may be given at
any time of day w/o regard to
meals. Lipid levels to be analyzed
within 2-4 wks and dose adjust.
accord. See lit.
F.C. TABS: 30 x 40 mg, 80 mg.
Initial: 10 mg 1 x dly. Incr. grad. to max.
80 mg 1 x dly w/o regard to meals.
Hypercholesterol.:adjunct. to diet for tmt. elevated total
and LDL cholesterol, apo B, triglyc. in pts.
with prim. hypercholesterolem.,
incl. famil. hypercholesterolem. (heterozyg.)
or combined (mixed) hyperlipidemia
(types IIa, IIb Fredrickson classific.) when
resp. to diet and other non-pharm.
meas. alone has been inad. To reduce
total-C and LDL-C in pts. with homozyg.
famil. hypercholesterolem. as adjunct to
other tmts. Ped: 10-17 yrs: Adjunct to diet
to reduce total-C, LDL-C, apo B levels in
boys and postmenarchal girls with
heterozyg. famil. hypercholest. aft.
an adeq. trial of diet ther. with foll.
findings: LDL-C remains ≥ 190 mg/dL or
LDL-C remains ≥ 160 mg/dL with
posit. fam. history of prem. CV dis. or 2
or more other CVD risk factors present.
Prevent. CV and/or cerebrovasc. events
such as MI or stroke. Adjunct to correct.
other risk factors such as hypertens. (in
pts. with 3 or more addit. risk factors
or diabetes with one addit. risk factor).
In pts. with clin. coronary heart dis., for
risk red. of non-fatal MI, of fatal and non-fatal stroke,
for revasculariz. proced. and hospitaliz. for CHF.
Risk red. of angina.
C/I: Ac. liver fail. or decompens. cirrhosis
Hypersens. Hypersens. react., incl. anaphylaxis, angioneurot. edema, erythema multif., Stevens-Johnson syndr. and toxic epid. necrolys. have been reported.

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.

SSRI. Sertraline HCl 50 mg, 100 mg.
TABS.: 28. Init. tmt.: 50 mg/d.
Titrat.: Pts. not respond. to a 50 mg
dose may benefit from dose increases.
Dose changes should be made in steps
of 50 mg at interv. of at least 1 wk., up
to a max. of 200 mg/d. Changes in
dose should not be made more freq.
than once per week given the 24-h.
elimin. half life of sertraline.
The onset of therap. effect may be
seen within 7 d. See lit.
Tmt. of sympt. of depress. in pts. with/
without a hist. of mania. Follow.
satisfact. response, continuat. with
sertraline ther. is effect. in prevent.
relapse of the init. episode of depress. or
recur. of further depress. episodes.
C/I: Hypersens.
Concom. tmt. with irrevers. MAOIs, ther.
must not be init. for at least 14 d. after
discount. of tmt. with an irrevers. MAOI.
7 d. before start. tmt. with an irrevers.
MAOI.
Concom. intake of pimozide.

Calcium Channel Blocker. Amlodipine Besylate 5 mg, 10 mg.
TABS: 20, 30 x 5 mg, 10mg. Initial: 5 mg 1 x dly. Can incr. to max. 10 mg dly. depend. on pt. response.
Mild to mod. hypertens, chron. stable angina, vasospastic angina (Prinzmetal’s or variant angina).
C/I: Hypersens. to dihydropyridine derivat., amlodipine. Sev. hypotension. Shock (includ.. cardiogen. shock). Obstruct. of the outflow tract of the left ventricle (e.g., high grade aortic stenosis). Haemodynam. unstab. HF after acute MI.