Atorvastatin

Therapeutic Indications

Atorvastatin belongs to a collection of drugs, named as HMG CoA reductase inhibitors. These drugs are popularly called “Statins”. Atorvastatin is well-known and available under the brand name Lipitor. Atorvastatin assists in the reduction of low-density lipoprotein, which is nick-named as “bad” cholesterol.

This drug achieves the purpose by boosting the capacity of the body to throw out bad cholesterol through the liver and triglycerides in the blood. This statin works by elevating levels of high-density lipoprotein, or HDL, nick-named as “good” cholesterol. Atorvastatin could form part of combination therapy with other medicines.  It is used in combination with exercise, diet and lifestyle changes to have the maximum effect

Atorvastatin is prescribed to alleviate the following health problems

• Offset risk of heart attack
• Reduce the risk of stroke
• Stave off cholesterol build up in the arteries
• Main prevention method in patients with high-risk factors for coronary heart disease
• To reduce the risk of myocardial infarction (MI),
• Lower risk of angina
• Reduce the risk of revascularization procedures.
• Effectively lower risk of victims of acute coronary syndrome (ACS).
• Prevention of cardiovascular events in adult patients

Do I need a prescription?

All statins need to be consumed only on the advice of a qualified medical specialist. A prescription by a registered medical practitioner is mandatory due to the drug’s contraindications and side effects.

Dosage

Atorvastatin is sold in its generic form as well as through the brand name, Lipitor. Atorvastatin oral tablet dosage and frequency will depend upon several factors, the most important being the medical condition it is being targeted for and the age of the patient. The dosage is always fixed after considering potential drug interactions and the presence of other medical conditions. How the patient responds to the first dose is also a key indicator to fix or alter the dosage.

Atorvastatin Oral tablet

Brand: Lipitor

Generic: Atorvastatin

Adult and Pediatric Dosage Forms & Strengths

• 10 mg
• 20 mg
• 40 mg
• 80 mg

Dosage for Heart Disease Prevention

Adult dosage (ages 18–64 years)

Initial dosage: 10–20 mg – one tablet per day.

Continued Dosage: 10–80 mg – one tablet per day.

Atorvastatin for children(ages 0–17 years) has not been approved for use yet. Therefore, children in this age group should not be prescribed this drug.

Senior dosage (ages 65 years and older): Prescription of Atorvastatin to senior adults must be done with caution as it can elevate the risk of side effects. Lowered efficiency of kidneys in senior adults causes the drug to remain in the system longer than it should. This is because the kidneys are unable to effectively process these drugs.

Hyperlipidemia (Marked by elevated levels of fat in the bloodstream)

This drug is prescribed along with significant dietary changes for treatment of high levels of Apo B, TG levels, total-Cand to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial)  as well as mixed dyslipidemia (Fredrickson type IIa and IIb)

Initial dosage:

• 10-20 mg tablets oral intake, one tablet daily
• For patients that need higher LDL-C reduction, an initial dose of 40 mg is prescribed, which is one tablet to be taken once daily.

Maintenance

• 10-80 mg one tablet dosage once daily
• Lipid levels must be checked after 2-4 weeks and dosage can be adjusted accordingly.

Hypertriglyceridemia (elevated levels of triglycerides)

Lipitor is prescribed along with strict diet changes to treat high TG levels (Fredrickson type IV)

Initial dosage:10 mg one tablet oral consumption once daily

Maintenance: 10-80 mg one table oral consumption once daily

Primary Dysbetalipoproteinemia

Patients with this condition Dysbetalipoproteinemia (Fredrickson type III) and who do not adequately respond to diet changes are prescribed atorvastatin in the following dosage

Lipitor Maintenance dosage: 10-80 mg one tab once daily taken orally

Lipid levels to be checked after 4 weeks of initiation or dose titration and dosage can be adjusted according to test results.

Homozygous Familial Hypercholesterolemia

In patients where total-C and LDL-C needs to be reduced along with or in combination with other drugs to lower lipid profile.

Adult dosage (ages 18–64 years)

Initial dosage: 10–20 mg one tablet per day.

Continued dosage: 10–80 mg one tablet per day.

Heterozygous familial hypercholesterolemia.

Child dosage (ages 10–17 years)

This tablet is prescribed for children between 10-17 years only if they are victims of heterozygous familial hypercholesterolemia. Children below the age of 10 are not prescribed Atorvastatin as the effect of this drug on children below 10 has not been fully understood yet.

Initial dosage: 10 mg one tablet per day.

Dosage can be increased till 20 mg – one tablet per day but not exceed this dosage in children

Senior dosage (ages 65 years and older)

Prescription of Atorvastatin to senior adults must be done with caution as it can elevate the risk of side effects. This is due to the fact that the efficiency of kidneys in senior adults is not adequate enough to process the drugs causing the drugs to remain in the system longer than it should.

For the senior adults that require the drug, a lower dosage is advised to reduce the side effects.

Chemical Composition

Atorvastatin Calcium Tablets

Brand Name: LIPITOR®

LIPITOR Tablets to be taken orally with the strengths 10, 20, 40 or 80 mg of atorvastatin contains the following ingredients.

• Magnesium stearate

Mechanism of Action (MOA)

LIPITOR works as a synthetic lipid- reducing agent. Atorvastatin is an HMG-CoA Reductase Inhibitor. This inhibits hepatic hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that is in-charge of catalyzing the conversion of HMG-CoA to mevalonate. This is a significant step in the synthesis of cholesterol.

Further, Atorvastatin works to improve the number of LDL receptors on hepatic cell surfaces to boost the catabolism of LDL. Also, helps to lower LDL production and  LDL particles. This agent helps to reduce lipoprotein levels and plasma cholesterol while also regulating immune responses. (NCI04)

This drug works to reduce levels of serum LDL cholesterol and triglycerides as well as Apolipoprotein B. It also works to increase levels of HDL cholesterol which aids in the effective treatment of Hyperlipidemias. These improvements in cholesterol levels help to stave off risks of cardiovascular disease, especially in those who portray risk factors of cardiovascular disease

Contraindications

Atorvastatin is not be prescribed in the presence of certain medical conditions or while consuming certain other medications. Details are indicated below:

• Do not co-administer Telaprevir, Cyclosporine, tipranavir plus ritonavir, and gemfibrozil  with Atorvastatin, as the chances of Rhabdomyolysis is high
• Bile acid sequestrant: The medication atorvastatin should be taken 2 hours before or 4 hours after taking bile acid sequestrant
• While consuming any of these drugs – Fosamprenavir: Itraconazole, Clarithromycin, Darunavir plus ritonavir, Saquinavir plus ritonavir, Fosamprenavir, care must be taken not to exceed Atorvastatin dose of 20 mg per day.
• While on Lopinavir plus ritonavir, Atorvastatin dose should be as low as possible
• While on Nelfinavir, boceprevir dosage of Atorvastatin should not exceed 40 mg/day

Adverse Reactions

Atorvastatin can trigger adverse reactions with the following type of drugs.

• Birth control pills
• Heart medication
• Antibiotic
• Antifungal medicine
• Medication to reduce cholesterol
• HIV or AIDS medication

Other drug interactions with ATORVASTATIN (LIPITOR)

It is imperative to ascertain the exact dosage, possible drug side effects, and interactions, with the doctor before starting, changing or cessation of Atorvastatin.

Major drug interactions of atorvastatin:

• Pazopanib
• Tipranavir
• Orlistat
• Gemfibrozil
• Cyclosporine
• Telaprevir
• Red yeast rice

Moderate Interactions of Atorvastatin:

• Coenzyme q10
• Colestipol
• Trazodone
• Fluvoxamine
• Loratadine
• Ruxolitinib
• Alvimopan
• Armodafinil
• Fexofenadine
• Isradipine

Atorvastatin Disease Interactions

Caution is advised on the use of atorvastatin among victims of the following medical conditions. It is imperative to check with a medical specialist regarding use, dosage, and interactions of the drug especially among victims of the below outlined medical conditions.

• Cognitive Impairment
• Rhabdomyolysis
• Liver Disease
• Renal Disease
• Pregnant or breastfeeding women should not take atorvastatin

Alcohol and Food Interactions

Completely give up eating foods that are laden with fat and cholesterol.

Alcohol is to be avoided as it can contribute to elevated levels of triglycerides. This may increase the risk of liver damage

Side Effects

The list below outlines common as well as rare side effects of Atorvastatin. This is just to give an idea of what the side effects could be, although all of them may not occur. It is important to consult with a doctor in the event of side effects after the consumption of this drug.

In rare cases, Atorvastatin can trigger a situation that causes the breakdown of skeletal muscle tissue, leading to kidney failure. With such an occurrence, medical help must be sought without delay. Unexpected pain in the muscle, tiredness, fever and such symptoms must be addressed.

Following symptoms demand immediate attention:

• Burning sensation or pain during urination
• Liver problems which can show up as symptoms like fatigue, discolored urine, upper stomach pain, appetite loss, jaundice
• Kidney problems- Swelling in the ankle and legs, insufficient urine output, fatigue, breathlessness.

Common side –effects

• Lower back pain
• Difficulty in urination
• Headache
• Stuffy nose

 Rare Side effects

• Hives
• Fatigue
• tightness in the chest
• fever
• skin rash
• Difficulty with swallowing
• Faster heartbeats
• Dizziness
• Cough
• Itching
• Wheezing
• Stiffness in muscles
• Cramps
• Pain/swelling and weakness of muscles
• Puffiness of the face and features especially eyes

Side effects manifest during the body’s adjustment process. They usually go away as the treatment progresses. Either way consulting with the medical practitioner is important to reduce the side effects.

What to Do If You Skip a Dose

The immediate action is to consume the dose as soon as you remember. Alternatively, let go of the missed dose in case the next dose is close or less than 12 hours away. It is very important not to take extra medicine to compensate for the missed statin.

Overdose

Important to seek immediate medical attention in case of an overdose of Atorvastatin

Generic Brand Names of Atorvastatin

• Lescol (fluvastatin)
• Pravachol (pravastatin, already available in generic form)
• Livalo (pitavastatin)
• Zocor (simvastatin, already available in generic form)
• Crestor (rosuvastatin)
• Lipitor (atorvastatin)
• Mevacor (lovastatin, already available in generic form)

Different Brands and Manufacturing Companies of the drug

Nearly 266 companies are involved in the manufacture of generic Atorvastatin.  This is not all, the newer brands and generics are being updated as and when they receive approval by the drug controller. A few examples of the different Atorvastatin brands are indicated below:

• A Vin (10mg) Bestochem Formulations (India) Ltd.
• Ctor (10mg) Clanthis Life Sciences (P) Ltd.
• Atorva (10mg) Zydus Cadila Healthcare Ltd. (CND
• Aarpik (20mg) Mefro Pharmaceuticals Pvt Ltd
• AB Vas (10mg) Abs Remedies Pvt. Ltd.
• Aarpik (10mg) Mefro Pharmaceuticals Pvt Ltd
• Ab-Vas (10mg) Abs Remedies Pvt. Ltd.
• Acrostatin (20mg) Acron Pharmaceuticals
• Acrostatin (10mg) Acron Pharmaceuticals
• Alip (10mg) Talent Healthcare

Substitutes for the Drug

Atorvastatin has six other substitute drugs which can be bought with a prescription. They are :

• Simvastatin (simvastatin)
• Lovastatin (lovastatin)
• Crestor (rosuvastatin)
• Pravastatin (pravastatin)
• Vytorin (ezetimibe / simvastatin)
• Zetia (ezetimibe)

References
https://medlineplus.gov/statins.html
https://www.cdc.gov/cholesterol/treating_cholesterol.htm
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2849981/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4385811/

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