• Pitaterol indications
• Uses of Pitaterol in details
• Pitaterol description
• Pitaterol dosage
• Pitaterol interactions
• Pitaterol side effects
• Pitaterol contraindications

What is Pitaterol?

Pitaterol (Pitaterol) belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins." Pitaterol reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Pitaterol is used to treat high cholesterol in adults. Lowering your cholesterol may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Pitaterol may also be used for purposes not listed in this medication guide.

Pitaterol indications

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

Primary Hyperlipidemia and Mixed Dyslipidemia

Pitaterol tablets is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use

Doses of Pitaterol tablets greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of Pitaterol tablets.

The effect of Pitaterol tablets on cardiovascular morbidity and mortality has not been determined.

Pitaterol tablets has not been studied in Fredrickson Type I, III, and V dyslipidemias.

How should I use Pitaterol?

Use Pitaterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pitaterol by mouth with or without food.
• Taking Pitaterol at the same time each day will help you remember to take it.
• Continue to take Pitaterol even if you feel well. Do not miss any doses.
• If you miss a dose of Pitaterol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pitaterol.

Uses of Pitaterol in details

Use: Labeled Indications

Primary hyperlipidemia and mixed dyslipidemia: As an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hyperlipidemia or mixed dyslipidemia.

Heterozygous familial hypercholesterolemia: As an adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, and apo B in children and adolescents ≥8 years of age.

Off Label Uses

Cardiac risk reduction for noncardiac surgery (perioperative therapy)

Based on the 2014 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery, perioperative initiation of statins is reasonable for patients undergoing vascular surgery and may be considered in patients with clinical indications according to guideline-directed medical therapy who are undergoing elevated risk procedures. In patients undergoing non-cardiac surgery who are currently receiving a statin, the statin should be continued.

Noncardioembolic stroke/Transient ischemic attack (secondary prevention)

Based on the American Heart Association/American Stroke Association (AHA/ASA) guidelines for the prevention of stroke in patients with stroke and transient ischemic attack, statin therapy with intensive lipid-lowering effects is recommended to reduce the risk of recurrent stroke and future cardiovascular events in patients with ischemic stroke or TIA presumed to be of atherosclerotic origin who have an LDL-C concentration ≥100 mg/dL (with or without evidence for other clinical atherosclerotic cardiovascular disease [ASCVD]) or who have an LDL-C concentration <100 mg/dL (without evidence for other clinical ASCVD).

Primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD)

Based on the American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults and the National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia, Pitaterol given for primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) is effective and recommended in the management of this condition. Based on the US Preventive Services Task Force (USPSTF) recommendation statement on Statin Use for the Primary Prevention of Cardiovascular Disease (CVD) in Adults, initiation of low to moderate dose statin therapy is recommended in adults 40 to 75 years without a history of CVD who have ≥1 CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of ≥10%. Based on the American Heart Association (AHA) scientific statement for the secondary prevention after coronary artery bypass graft surgery, statin therapy (unless contraindicated) is recommended for all coronary artery bypass graft (CABG) surgery patients to help maintain long-term graft patency and help obtain the highest level of physical health and quality of life.

Pitaterol description

Pitaterol tablet contains the following excipients: Lactose, hydroxypropylcellulose, hydroxypropylmethylcellulose, magnesium aluminometasilicate, magnesium stearate, triethyl citrate, hydrated silicon dioxide, titanium oxide, carnauba wax.

Pitaterol calcium is (+)-monocalcium bis(3R,5S,6E)-7-[2-cyclopropyl- 4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate. It has a molecular formula of C₅₀H₄₆CaF₂N₂O₈ and a molecular weight of 880.98.

It occurs as a white to pale yellowish white powder and is odorless. It is freely soluble in pyridine or in tetrahydrofuran, soluble in ethylene glycol, slightly soluble in methanol, very slightly soluble in ethanol (99.5) or in water, practically insoluble in acetonitrile or in diethyl ether. It dissolves in dilute hydrochloric acid.

Pitaterol dosage

Pitaterol Dosage

Generic name: Pitaterol calcium 1.045mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

General Dosing Information

The dose range for Pitaterol is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. The starting dose and maintenance doses of Pitaterol should be individualized according to patient characteristics, such as goal of therapy and response.

After initiation or upon titration of Pitaterol, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

Dosage in Patients with Renal Impairment

Patients with moderate and severe renal impairment (glomerular filtration rate 30 – 59 mL/min/1.73 m2 and 15 – 29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving hemodialysis should receive a starting dose of Pitaterol 1 mg once daily and a maximum dose of Pitaterol 2 mg once daily.

Use with Erythromycin

In patients taking erythromycin, a dose of Pitaterol 1 mg once daily should not be exceeded.

Use with Rifampin

In patients taking rifampin, a dose of Pitaterol 2 mg once daily should not be exceeded.

More about Pitaterol (Pitaterol)

• Side Effects
• During Pregnancy or Breastfeeding
• Dosage Information
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• Drug Interactions
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• 40 Reviews - Add your own review/rating

Consumer resources

• Pitaterol
• Pitaterol (Advanced Reading)

Professional resources

• Pitaterol (AHFS Monograph)
• Pitaterol (FDA)

Related treatment guides

• High Cholesterol

Pitaterol interactions

See also:
What other drugs will affect Pitaterol?

Cyclosporine

Cyclosporine significantly increased Pitaterol exposure. Co-administration of cyclosporine with Pitaterol is contraindicated.

Erythromycin

Erythromycin significantly increased Pitaterol exposure. In patients taking erythromycin, a dose of Pitaterol 1 mg once daily should not be exceeded.

Rifampin

Rifampin significantly increased Pitaterol exposure. In patients taking rifampin, a dose of Pitaterol 2 mg once daily should not be exceeded.

Gemfibrozil

Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Pitaterol with gemfibrozil should be avoided.

Other Fibrates

Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, Pitaterol should be administered with caution when used concomitantly with other fibrates.

Niacin

The risk of skeletal muscle effects may be enhanced when Pitaterol is used in combination with niacin; a reduction in Pitaterol dosage should be considered in this setting.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing Pitaterol with colchicine.

Warfarin

Pitaterol had no significant pharmacokinetic interaction with R-and S-warfarin. Pitaterol had no significant effect on prothrombin time (PT) and international normalized ratio (INR) when administered to patients receiving chronic warfarin treatment. However, patients receiving warfarin should have their PT and INR monitored when Pitaterol is added to their therapy.

Pitaterol side effects

See also:
What are the possible side effects of Pitaterol?

Applies to Pitaterol: oral tablet

As well as its needed effects, Pitaterol (the active ingredient contained in Pitaterol) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Pitaterol, check with your doctor immediately:

Less common:

• Difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• pain in the arms and legs
• swollen joints

Incidence not known:

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• loss of appetite
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Minor Side Effects

Some Pitaterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Back pain
• difficulty having a bowel movement (stool)

Incidence not known:

• Hives or welts, itching skin, or rash
• redness of the skin

Pitaterol contraindications

See also:
What is the most important information I should know about Pitaterol?

You should not take Pitaterol if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease or severe kidney disease. You should not take Pitaterol if you are also taking cyclosporine (Gengraf, Neoral, Sandimmune) or lopinavir and ritonavir (Kaletra).

Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking Pitaterol, tell your doctor if you have a thyroid disorder, if you have ever had liver or kidney disease, or if you drink more than 2 alcoholic beverages daily.

In rare cases, Pitaterol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Avoid eating foods that are high in fat or cholesterol. Pitaterol will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Pitaterol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Active ingredient matches for Pitaterol:

Pitavastatin in South Korea.

List of Pitaterol substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Pitarova (South Korea)
Pitava (Greece)
Pitava 1 mg x 1 Blister x 10 Tablet
PITAVA 1 MG TABLET 1 strip / 10 tablets each (Zydus Cadila)	$ 1.08
PITAVA 2 MG TABLET 1 strip / 10 tablets each (Zydus Cadila)	$ 1.86
Pitava 1mg Tablet (Zydus Cadila)	$ 0.11
Pitava 2mg Tablet (Zydus Cadila)	$ 0.19
Pitavan (South Korea)
Pitavas (Bangladesh)
Pitavastatin Ca (Japan)
Pitavastatin Ca Amel (Japan)
Pitavastatin Ca Chemiphar (Japan)
Pitavastatin Ca EE (Japan)
Pitavastatin Ca FFP (Japan)
Pitavastatin Ca Kaken (Japan)
Pitavastatin Ca Kyorin (Japan)
Pitavastatin Ca MEEK (Japan)
Pitavastatin Ca Meiji (Japan)
Pitavastatin Ca Nisshin (Japan)
Pitavastatin Ca NP (Japan)
Pitavastatin Ca OD (Japan)
Pitavastatin Ca OD Towa (Japan)
Pitavastatin Ca Pfizer (Japan)
Pitavastatin Ca Sandoz (Japan)
Pitavastatin Ca Sanwa (Japan)
Pitavastatin Ca Sawai (Japan)
Pitavastatin Ca Takata (Japan)
Pitavastatin Ca TCK (Japan)
Pitavastatin Ca Towa (Japan)
Pitavastatin Ca YD (Japan)
Pitavastatin Calcium KO (Japan)
Pitavastatin Calcium Mochida (Japan)
Pitavastatin Calcium Nichi-Iko (Japan)
Pitavastatin Calcium Teva (Japan)
Pitavastatin Calcium ZE (Japan)
Pivalo (Bangladesh)
Pivast (Brazil)
PIVASTA
PIVASTA 1 MG TABLET 1 strip / 10 tablets each (Zydus (Cardiva))	$ 0.64
PIVASTA-2 TABLET 1 strip / 10 tablets each (Zydus (Cardiva))	$ 1.36
PIVASTA-4 TABLET 1 strip / 10 tablets each (Zydus (Cardiva))	$ 1.96
PIVASTA 4MG TABLET 1 strip / 2 tablets each (Zydus (Cardiva))	$ 1.63
PIVASTA film-coated tab 1 mg x 10's (Zydus (Cardiva))	$ 0.53
PIVASTA film-coated tab 2 mg x 10's (Zydus (Cardiva))	$ 0.84
See 84 substitutes for Pitaterol

References

1. DailyMed. "PITAVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "Pitavastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Pitavastatin". http://www.drugbank.ca/drugs/DB08860 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Pitaterol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Pitaterol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology