- Atorvastatin is a selective competitive inhibitor of HMG – COA reductase which is the rate - limiting 
 enzyme responsible for conversion of (HMG – COA) to Mevalonate, a precursor of sterols including  
- Atorvastatin is rapidly absorbed after oral administration , plasma concentration(Cmax) occured 
 within1- 2 hours .
- More than 98% of Atorvastatin is bound to plasma proteins. 
- Atorvastatin undergoes an extensive metabolism to active ortho and para   hydroxylated Metabolites 
 which 70% of circulatory inhibitory activity of HMG -COA reductase is attributed to active 
 metabolites .
- Atorvastatin is eliminated primarily in bile following hepatic and / or extra-hepatic metabolism.  
 Mean plasma elimination half – life of Atorvastatin in humans is approximately 14 hours.The half life 
 of  inhibitory activity for HMG-COA reductase is approximately 20- 30 hours due to the contribution 
 of active metabolites. 

- Each film coated tablet of Atorva® 40 contains:
 Atorvastatin 40 mg (as Calcium Trihydrate)     
-  Each film coated tablet of  Atorva®  20 contains: 
 Atorvastatin 20 mg (as Calcium Trihydrate)
 - Each film coated tablet of  Atorva®  10 contains:
 Atorvastatin 10 mg (as Calcium Trihydrate)

 Atorva®  is Contraindicated in patients with :-
- Hypersensitivity to Atorvastatin 
-Liver diseases or unexplained elevations of hepatic function test values (Serum transaminases).
-Skeletal Muscle diseases .

-Inhibitors of CYP 450  3A4: (e.g :cyclosporine, macrolide antibiotics including erythromycin 
 and Clarithromycin, nefazodone,azole antifungals including itraconazole and HIV protease inhibitors) 
 Concomitant administration with Atorva® can lead to increased plasma concentration of Atorvastatin 
 which leads to increase the risk of myopathy and on rare occasions has resulted in rhabdomyolysis 
 with renal dysfunction secondary to myoglobinuria .
- Inhibitors of P-glycoprotein :( e.g : cyclosporine) can increased the bioavailability of Atorvastatin.
- Protease inhibitors: co-administration of Atorva® with protease inhibitors was associated with 
 increase concentration in blood of Atorvastatin.
- Gemfibrozil/ fibric acid derivatives: the risk of Atorvastatin- induced myopathy may be increased 
 with the concomitant use of fibric acid derivative.
-Warfarin: co-administration of  Atorva®  and warfarin caused a small decrease in pro-thrombin time 
 during the first days of dosing which returned to normal within 15 days of  Atorva®  treatment.
- Phenazone: co-administration of multiple doses of  Atorva®   and phenazone show little or no 
 detectable effect in the clearance of phenazone.
- Concurrent use of digoxin in large dose with Atorva® may increase digoxin serum concentrations 
- Concurrent use of Atorva® and cholesterol decrease plasma   concentration of Atorvastatin .
- Co-administration of Atorva® with oral Contraceptives produce increases in plasma   
 concentrations of norethindrone and ethinyloestradiol .  
- Co-administration of Atorva® with an oral antacid Suspension containing magnesium and aluminum 
 hydroxides lead to decreased plasma concentrations of Atorvastatin.
- Concurrent use of Atorva® with grapefruit juice Can increase plasma Concentrations of  
 Atorvastatin since grapefruit juice contains one or more components that inhibit CYP3A4;So 
 concomitant intake of large quantities of grapefruit juice and Atorva® is therefore not 
 recommended .

-  Atorva®  is Contraindicated in Pregnancy and nursing mothers. Women of child – bearing potential  
 should use appropriate contraceptive measures. 
-It is unknown whether this drug or its metabolites are excreted in human milk or not .

 Atorva® is generally well tolerated , the adverse effects observed are usually mild and transient.
 Gastrointestinal disorders:
 Common: constipation, flatulence, dyspepsia, nausea, diarrhea.
 Uncommon: anorexia, vomiting.
 Blood and lymphatic system disorders:
 Uncommon: thrombocytopenia.
 Immune system disorders:
 Common: allergic reactions.
 Very rare: anaphylaxis.
 Endocrine disorders:
 Uncommon: alopecia, , hypoglycaemia, pancreatitis.
 Common: insomnia.
 Uncommon: amnesia.
 Nervous system disorders:
 Common: headache, dizziness, paraesthaesia, hypoesthesia.
 Uncommon: peripheral neuropathy.
 Hepato-biliary disorders: 
 Rare: hepatitis, cholestatic jaundice.
 Skin/appendages :
 Common: skin rash, urticaria.
 Uncommon: urticaria.
 Very rare: angioneurotic oedema, bullous rashes (including erthema multiforme, stevens-Johnson  
 syndrome and toxic epidermal necrolysis).
 Ear and labyrinth disorders:
 Uncommon: tinnitus.
 Musculoskeletal disorders:
 Common: myalgia, arthralgia.
 Uncommon: myopathy.
 Rare: myositis, rhabdomyolysis.
 Reproductive system disorders:
 Uncommon: impotence.
 General disorders:
 Common: asthenia, chestpain, back pain, peripheral oedema.
 Uncommon: malaise, weight gain.

  *Effects of Atorva® on the liver.
- liver function Should be tested prior the initiation of therapy then at regular intervals  also patients who 
 develop increased  transaminase  levels  should be monitored until  the abnormalities resolve .
 In case of increasment  of  liver functions' values to more than triple the normal level and persist over  
 longer period , dose reduction or  withdrawal of Atorva® is recommended .
* Effects of Atorva® on skeletal muscle.
 Atorvastatin may in rare occasions affect the skeletal muscel and cause myalgia , myositis and myopthy .  
 The increase of muscle enzyme (CPK) in blood Should be monitored if it remains clearly elevated over a 
 longer period, the dose should be reduced or withdrawn.

Over dose :
 No specific treatment is available for  Atorva®  over dosage. If an overdose occur, the patient should be 
 treated symptomatically and supportive measures instated, as required. Liver function tests should be 
 performed and serum CPK levels should be monitored.

Whilst on treatment:
- Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied 
 by malaise or fever.
- If such symptoms occur whilst a patients is receiving treatment with Atorva® , their CPK levels 
 should be measured. If these levels are found to be significantly elevated ( >5 times ULN), treatment 
 should be stopped.
- If muscular symptoms are severe and cause daily discomfort, even if the CPK levels are elevated to
 ≤ 5 × ULN, Atorva® discontinuation should be considered.
-If symptoms resolve and CPK levels return to normal, then re-introduction of Atorva® or 
 introduction of an alternative statin may be considered at the lowest dose and with close monitoring.
- Atorva® must be discontinued if clinically significant elevation of CPK levels (> 10 × ULN )  
 occur, or if rhabdomyolysis is diagnosed or suspected.        

 Blister of 10 tablets, pack of 3 blisters. 

 Store in a dry  place  at a temperature  below 25oC.