Lipigard Uses

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

What is Lipigard?

Lipigard is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Lipigard 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).

Lipigard is used to treat high cholesterol, and to lower the risk of stroke, heart attack, or other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.

Lipigard is used in adults and children who are at least 10 years old.

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

Lipigard indications

Lipigard is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum TGlevels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Lipigard is also indicated for the reduction of total-C and LDL-C in patients with homozygous familial hypercholesterolemia.

Prevention of Cardiovascular Complications: In patients without clinically evident cardiovascular disease (CVD), and with or without dyslipidemia, but with multiple risk factors for coronary heart disease (CHD), such as smoking, hypertension, diabetes, low HDL-C, or a family history of early CHD, Lipigard is indicated to: Reduce the risk of fatal CHD and non-fatal myocardial infarction (MI); reduce the risk of stroke; reduce the risk of revascularization procedures and angina pectoris.

In patients with clinically evident CHD, Lipigard is indicated to: Reduce the risk of non-fatal MI; reduce the risk of fatal and non-fatal stroke; reduce the risk for revascularization procedures; reduce the risk of hospitalization for congestive heart failure (CHF); reduce the risk of angina.

As adjunct to lifestyle changes, such as proper diet and exercise, intensive Lipigard treatment has been shown to halt the progression of atherosclerosis (total atheroma or plaque volume) in patients with coronary artery disease and other individuals who are at high risk for cardiovascular disease.

Chronic Kidney Disease: In patients with diabetes with moderately decreased eGFR, Lipigard is indicated to reduce the risk for cardiovascular disease.

In patients with clinically evident coronary heart disease and CKD not requiring dialysis, Lipigard is indicated to reduce the risk of major cardiovascular events including stroke.

In patients with clinically evident coronary heart disease and/or diabetes with microalbuminuria, Lipigard is indicated to reduce the rate of GFR decline and progression of CKD.

Pediatric Patients (10-17 Years of Age): Lipigard is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hyperchlolesterolemia if, after an adequate trial of diet therapy, the following findings are present: LDL-C remains ≥190 mg/dL or, LDL-C remains ≥160 mg/dL and there is a positive family history of premature CVD or, two or more other CVD risk factors are present in the pediatric patient.

How should I use Lipigard?

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

• An extra patient leaflet is available with Lipigard. Talk to your pharmacist if you have questions about this information.
• Take Lipigard by mouth with or without food.
• Swallow Lipigard whole. Do not break, crush, or chew before swallowing.
• Taking Lipigard at the same time each day will help you remember to take it.
• Eating grapefruit or drinking grapefruit juice may increase the amount of Lipigard in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Lipigard.
• Continue to take Lipigard even if you feel well. Do not miss any doses.
• If you miss a dose of Lipigard, take it as soon as possible if you remember within 12 hours of the missed dose. If it is more than 12 hours since the missed 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 Lipigard.

Uses of Lipigard in details

Use: Labeled Indications

Heterozygous familial hypercholesterolemia: To reduce elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B (apo B), and triglyceride levels, and to increase HDL cholesterol in patients with primary hypercholesterolemia.

Heterozygous familial hypercholesterolemia (pediatrics): To reduce total-C, LDL-C, and apo B levels in pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia with LDL-C ≥190 mg/dL, LDL-C ≥160 mg/dL with positive family history of premature cardiovascular disease (CVD), or LDL-C ≥160 mg/dL with 2 or more other CVD risk factors.

Homozygous familial hypercholesterolemia: To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

Prevention of atherosclerotic cardiovascular disease:

Primary prevention of atherosclerotic cardiovascular disease (ASCVD): To reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients without a history of coronary heart disease (CHD) but who have multiple CHD risk factors.

Secondary prevention in patients with established ASCVD: To reduce the risk of MI, stroke, revascularization procedures, and angina in patients with a history of CHD.

Off Label Uses

Transplantation, post heart or post kidney

Based on the 2010 International Society of Heart and Lung Transplantation guidelines for the care of heart transplant recipients, Lipigard is effective and recommended following heart transplant, regardless of cholesterol levels, to reduce cardiac allograft vasculopathy and improve long-term outcomes.

Based on the 2013 Kidney Disease: Improving Global Outcomes clinical practice guideline for lipid management in chronic kidney disease, Lipigard is suggested following kidney transplant to reduce cardiovascular events (eg, myocardial infarction, stroke, cardiovascular death).

Lipigard description

Lipigard 10: Each tablet contains Atorvastatin calcium equivalent to 10 mg Lipigard.

Lipigard 20 mg: Each tablet contains Atorvastatin calcium equivalent to 20 mg Lipigard.

Lipigard 40 mg: Each tablet contains Atorvastatin calcium equivalent to 40 mg Lipigard.

Lipigard 80 mg: Each tablet contains atorvastin calcium equivalent to 80 mg Lipigard.

Lipigard is a white, elliptical film coated tablet containing Lipigard calcium. Lipigard calcium is a synthetic lipid-lowering agent, which is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

The empirical formula of Lipigard calcium is (C₃₃H₃₄FN₂O₅)₂Ca·3H₂O and its molecular weight is 1209.42.

Lipigard calcium is a white to off-white crystalline powder, practically insoluble in aqueous solutions of pH 4 and below. It is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.

Lipigard dosage

Always take Lipigard Sandoz exactly as prescribed.

The following instructions may apply only if the doctor has not prescribed a different regimen for administering Lipigard Sandoz. Observe the instructions closely, otherwise the medicine cannot be effective.

Before the start of treatment, the physician will prescribe a low-cholesterol diet and should be strictly observe throughout the treatment with Lipigard Sandoz.

Usual Starting Dose: Adults and Children ≥10 years: 10 mg once daily. The physician will determine further doses to achieve the desired blood cholesterol levels. Thereafter, the dose will be adjusted individually every ≤4 weeks frequently. Maximum Daily Dose: 80 mg for adults and 20 mg once daily for children.

Elevated Blood Cholesterol Levels (Hypercholesterolemia) or Concurrent Elevation of Blood Cholesterol and Triglyceride Levels (Mixed Hyperlipidemia): In the majority of patients, the effective daily dose of Lipigard is 20 mg. The effect of treatment can be seen after 2 weeks; it is usually greatest after 4 weeks. This therapeutic effect is then maintained with long-term administration of Lipigard Sandoz.

Hereditary Increase of Blood Cholesterol Levels (Familial Hypercholesterolemia): Heterozygous Familial Hypercholesterolemia: Starting Dose: 10 mg once daily. The dose should be determined for each individual patient. The physician will increases the dose up to 80 mg daily every 4 weeks.

Homozygous Familial Hypercholesterolemia: Adults: In the majority of patients (taking Lipigard 80 mg daily), blood cholesterol levels (LDL cholesterol) decreased by 17-31% in clinical trials.

Patients with Renal Insufficiency and the

Elderly: Kidney diseases do not affect treatment with Lipigard Sandoz. Consequently, dosage adjustment is not necessary in patients with renal insufficiency.

In clinical trials, it was ascertained that no dosage adjustment is necessary in elderly patients.

Administration: Take Lipigard Sandoz with some liquid at any time of the day and regardless of food intake.

Lipigard Sandoz are designated for long-term administration.

Missed Dose: Do not take a double dose, but only the normal dose.

Lipigard interactions

See also:
What other drugs will affect Lipigard?

The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).

Strong Inhibitors of CYP 3A4

Lipigard is metabolized by cytochrome P450 3A4. Concomitant administration of Lipigard with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of Lipigard. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4.

Clarithromycin

Lipigard AUC was significantly increased with concomitant administration of Lipigard 80 mg with clarithromycin (500 mg twice daily) compared to that of Lipigard alone. Therefore, in patients taking clarithromycin, caution should be used when the Lipigard dose exceeds 20 mg.

Combination of Protease Inhibitors

Lipigard AUC was significantly increased with concomitant administration of Lipigard 40 mg with ritonavir plus saquinavir (400 mg twice daily) or Lipigard 20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) compared to that of Lipigard alone. Therefore, in patients taking HIV protease inhibitors, caution should be used when the Lipigard dose exceeds 20 mg.

Itraconazole

Lipigard AUC was significantly increased with concomitant administration of Lipigard 40 mg and itraconazole 200 mg. Therefore, in patients taking itraconazole, caution should be used when the Lipigard dose exceeds 20 mg.

Grapefruit Juice

Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of Lipigard, especially with excessive grapefruit juice consumption ( > 1.2 liters per day).

Cyclosporine

Lipigard and Lipigard-metabolites are substrates of the OATP1B1 transporter. Inhibitors of the OATP1B1 (e.g., cyclosporine) can increase the bioavailability of Lipigard. Lipigard AUC was significantly increased with concomitant administration of Lipigard 10 mg and cyclosporine 5.2 mg/kg/day compared to that of Lipigard alone. In cases where co-administration of Lipigard with cyclosporine is necessary, the dose of Lipigard should not exceed 10 mg.

Rifampin or other Inducers of Cytochrome P450 3A4

Concomitant administration of Lipigard with inducers of cytochrome P450 3A4 (e.g., efavirenz, rifampin) can lead to variable reductions in plasma concentrations of Lipigard. Due to the dual interaction mechanism of rifampin, simultaneous co-administration of Lipigard with rifampin is recommended, as delayed administration of Lipigard after administration of rifampin has been associated with a significant reduction in Lipigard plasma concentrations.

Digoxin

When multiple doses of Lipigard and digoxin were coadministered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

Oral Contraceptives

Co-administration of Lipigard and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol. These increases should be considered when selecting an oral contraceptive for a woman taking Lipigard.

Warfarin

Lipigard had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

Lipigard side effects

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

Adverse reactions have usually been mild and transient. Less than 2% of patients were discontinued from clinical trials due to adverse reactions attributed to Lipigard.

The most frequent (≥1%) adverse effects associated with Lipigard therapy, in patients participating in controlled clinical studies were: Psychiatric Disorders: Insomnia.

Nervous System Disorders: Headache.

Gastrointestinal Disorders: Abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhea.

Musculoskeletal and Connective Tissue Disorders: Myalgia.

General Disorders and Administration Site Conditions: Asthenia.

Elevated serum ALT levels have been reported in 1.3% of patients receiving Lipigard. Clinically important (>3 x UNL) elevations in serum ALT levels occurred in 19 of the 2,483 (0.8%) patients on Lipigard. It was dose-related and was reversible in all 19 patients. In 10 cases, the increase was first observed within 12 weeks of starting the treatment. Only 1 case occurred after 36 weeks and only 1 patient had symptoms suggestive of hepatitis. Treatment was discontinued in only 9 of these 19 cases.

Elevated serum CPK levels (>3x ULN) occurred in 62 of the 2,452 (2.5%) patients on Lipigard compared with 3.1% with other HMG-CoA reductase inhibitors in clinical trials. Levels >10 times the normal upper range occurred in only 11 (0.4%) Lipigard-treated patients. Only 3 (0.1%) of these 11 patients had concurrent muscle pain, tenderness or weakness.

Lipigard contraindications

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

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels

Hypersensitivity to any component of this medication

Pregnancy

Women who are pregnant or may become pregnant. Lipigard may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of Lipigard use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, Lipigard revealed no evidence of teratogenicity. Lipigard SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this drug, Lipigard should be discontinued immediately and the patient apprised of the potential hazard to the fetus.

Nursing mothers

It is not known whether Lipigard is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require Lipigard treatment should not breastfeed their infants.

Active ingredient matches for Lipigard:

Atorvastatin in Oman.

References

1. DailyMed. "AMLODIPINE BESYLATE; ATORVASTATIN 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. "atorvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "atorvastatin". http://www.drugbank.ca/drugs/DB01076 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology