Information

  • ATORFIT 5/ 10/15 mg
  • Dosage Form: Tablets
  • Pack Type: ALU-ALU
  • Pack Size: 1X15 Tablets
  • Division: Unitus

ATORFIT - 5/ 10 / 20

Atorvastatin

ATORFIT-5: Each film-coated tablet contains Atorvastatin Calcium IP equivalent to Atorvastatin 5 mg.

ATORFIT-10: Each film-coated tablet contains Atorvastatin Calcium IP equivalent to Atorvastatin 10 mg.

ATORFIT-20: Each film-coated tablet contains Atorvastatin Calcium IP equivalent to Atorvastatin 20 mg.

Clinical Pharmacology:

Atorvastatin is a lipid-lowering drug included in the statin class of medications. By inhibiting the endogenous production of cholesterol in the liver, statins lower abnormal cholesterol and lipid levels, and ultimately reduce the risk of cardiovascular disease. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase, which catalyzes the conversion of HMG-CoA to mevalonic acid. This conversion is a critical metabolic reaction involved in the production of several compounds involved in lipid metabolism and transport, including cholesterol, low-density lipoprotein (LDL) (sometimes referred to as "bad cholesterol"), and very-low-density lipoprotein (VLDL). Prescribing statins is considered standard practice for patients following any cardiovascular event, and for people who are at moderate to high risk of developing cardiovascular disease

 

Atorvastatin is indicated for the treatment of

  • dyslipidemias
  • to prevent cardiovascular events in patients with cardiac risk factors and/or abnormal lipid profiles 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin.

The recommended starting dose of Atorvastatin is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin is 80 mg once daily for adults and 20 mg once daily for children.

 

Atorvastatin should be swallowed whole with a drink of water and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

 

Atorvastatin with food and drink

  • Grapefruit juice: Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin.
  • Alcohol: Avoid drinking too much alcohol while taking this medicine.

Drug-Drug Interaction

Some medicines may change the effect of Atorvastatin or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively, it could increase the risk or severity of side-effects:

  • Medicines used to alter the way your immune system works, e.g. ciclosporin
  • Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
  • other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
  • Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone
  • Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir etc.
  • Some medicines used in the treatment of hepatitis C e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir
  • Other medicines known to interact with Atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone, colchicines (used to treat gout) and antacids
  • Medicines obtained without a prescription: St John’s wort if you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Atorvastatin. Taking Atorvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain

 

 

 

Common side effects (may affect 1 to 10 patients in 100) include

  • inflammation of the nasal passages,
  • pain in the throat,
  • nose bleed,
  • allergic reactions,
  • increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels),
  • increase in blood creatine kinase headache nausea,
  • constipation, indigestion, diarrhea,
  • joint pain, muscle pain and back pain,
  • blood test results that show your liver function can become abnormal

 

 

The following are reasons why Atorvastatin may not be suitable for you.

 

  • if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
  • if you have kidney problems
  • if you have an under-active thyroid gland (hypothyroidism)
  • if you have had repeated or unexplained muscle aches or pains, personal history or family history of muscle problems.
  • if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other -statin’ or ‘-fibrate’ medicines)
  • if you regularly drink a large amount of alcohol if you have a history of liver disease if you are older than 70 years.

 

Pregnancy and breast-feeding

  • Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant.
  • Do not take Atorvastatin if you are breast-feeding.
  • The safety of Atorvastatin during pregnancy and breast-feeding has not yet been proven.
  • Ask your doctor or pharmacist for advice before taking any medicine