Stator-GM2 Uses

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What is Stator-GM2?

Stator-GM2 is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Stator-GM2 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).

Stator-GM2 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.

Stator-GM2 is used in adults and children who are at least 10 years old.

Stator-GM2 may also be used for purposes not listed in this medication guide.

Stator-GM2 indications

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Stator-GM2 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.

Stator-GM2 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, Stator-GM2 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, Stator-GM2 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 Stator-GM2 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, Stator-GM2 is indicated to reduce the risk for cardiovascular disease.

In patients with clinically evident coronary heart disease and CKD not requiring dialysis, Stator-GM2 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, Stator-GM2 is indicated to reduce the rate of GFR decline and progression of CKD.

Pediatric Patients (10-17 Years of Age): Stator-GM2 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 Stator-GM2?

Use Stator-GM2 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Stator-GM2.

Uses of Stator-GM2 in details

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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, Stator-GM2 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, Stator-GM2 is suggested following kidney transplant to reduce cardiovascular events (eg, myocardial infarction, stroke, cardiovascular death).

Stator-GM2 description

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Stator-GM2 10: Each tablet contains Atorvastatin calcium equivalent to 10 mg Stator-GM2.

Stator-GM2 20 mg: Each tablet contains Atorvastatin calcium equivalent to 20 mg Stator-GM2.

Stator-GM2 40 mg: Each tablet contains Atorvastatin calcium equivalent to 40 mg Stator-GM2.

Stator-GM2 80 mg: Each tablet contains atorvastin calcium equivalent to 80 mg Stator-GM2.

Stator-GM2 is a white, elliptical film coated tablet containing Stator-GM2 calcium. Stator-GM2 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 Stator-GM2 calcium is (C33H34FN2O5)2Ca·3H2O and its molecular weight is 1209.42.

Stator-GM2 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.

Stator-GM2 dosage

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Always take Stator-GM2 Sandoz exactly as prescribed.

The following instructions may apply only if the doctor has not prescribed a different regimen for administering Stator-GM2 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 Stator-GM2 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 Stator-GM2 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 Stator-GM2 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 Stator-GM2 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 Stator-GM2 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 Stator-GM2 Sandoz with some liquid at any time of the day and regardless of food intake.

Stator-GM2 Sandoz are designated for long-term administration.

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

Stator-GM2 interactions

See also:
What other drugs will affect Stator-GM2?

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

Stator-GM2 is metabolized by cytochrome P450 3A4. Concomitant administration of Stator-GM2 with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of Stator-GM2. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4.

Clarithromycin

Stator-GM2 AUC was significantly increased with concomitant administration of Stator-GM2 80 mg with clarithromycin (500 mg twice daily) compared to that of Stator-GM2 alone. Therefore, in patients taking clarithromycin, caution should be used when the Stator-GM2 dose exceeds 20 mg.

Combination of Protease Inhibitors

Stator-GM2 AUC was significantly increased with concomitant administration of Stator-GM2 40 mg with ritonavir plus saquinavir (400 mg twice daily) or Stator-GM2 20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) compared to that of Stator-GM2 alone. Therefore, in patients taking HIV protease inhibitors, caution should be used when the Stator-GM2 dose exceeds 20 mg.

Itraconazole

Stator-GM2 AUC was significantly increased with concomitant administration of Stator-GM2 40 mg and itraconazole 200 mg. Therefore, in patients taking itraconazole, caution should be used when the Stator-GM2 dose exceeds 20 mg.

Grapefruit Juice

Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of Stator-GM2, especially with excessive grapefruit juice consumption ( > 1.2 liters per day).

Cyclosporine

Stator-GM2 and Stator-GM2-metabolites are substrates of the OATP1B1 transporter. Inhibitors of the OATP1B1 (e.g., cyclosporine) can increase the bioavailability of Stator-GM2. Stator-GM2 AUC was significantly increased with concomitant administration of Stator-GM2 10 mg and cyclosporine 5.2 mg/kg/day compared to that of Stator-GM2 alone. In cases where co-administration of Stator-GM2 with cyclosporine is necessary, the dose of Stator-GM2 should not exceed 10 mg.

Rifampin or other Inducers of Cytochrome P450 3A4

Concomitant administration of Stator-GM2 with inducers of cytochrome P450 3A4 (e.g., efavirenz, rifampin) can lead to variable reductions in plasma concentrations of Stator-GM2. Due to the dual interaction mechanism of rifampin, simultaneous co-administration of Stator-GM2 with rifampin is recommended, as delayed administration of Stator-GM2 after administration of rifampin has been associated with a significant reduction in Stator-GM2 plasma concentrations.

Digoxin

When multiple doses of Stator-GM2 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 Stator-GM2 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 Stator-GM2.

Warfarin

Stator-GM2 had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

Stator-GM2 side effects

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What are the possible side effects of Stator-GM2?

Adverse reactions have usually been mild and transient. Less than 2% of patients were discontinued from clinical trials due to adverse reactions attributed to Stator-GM2.

The most frequent (≥1%) adverse effects associated with Stator-GM2 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 Stator-GM2. Clinically important (>3 x UNL) elevations in serum ALT levels occurred in 19 of the 2,483 (0.8%) patients on Stator-GM2. 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 Stator-GM2 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%) Stator-GM2-treated patients. Only 3 (0.1%) of these 11 patients had concurrent muscle pain, tenderness or weakness.

Stator-GM2 contraindications

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What is the most important information I should know about Stator-GM2?

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. Stator-GM2 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 Stator-GM2 use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, Stator-GM2 revealed no evidence of teratogenicity. Stator-GM2 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, Stator-GM2 should be discontinued immediately and the patient apprised of the potential hazard to the fetus.

Nursing mothers

It is not known whether Stator-GM2 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 Stator-GM2 treatment should not breastfeed their infants.



Active ingredient matches for Stator-GM2:

Atorvastatin in India.

Glimepiride/metformin in India.


Unit description / dosage (Manufacturer)Price, USD
Stator-GM2 Metformin / SR 500 mg, Glimepiride 2 mg, Atorvastatin10 mg. Bilayered TAB / 10$ 1.01
10's$ 1.01
STATOR-GM2 bilayer coated tab 10's (AHPL)$ 1.01

List of Stator-GM2 substitutes (brand and generic names):

STATOR-GM1 bilayer coated tab 10's (AHPL)$ 0.93
Statrox 10mg TAB / 10 (Wonder (Asrox))$ 0.72
STATROX tab 10 mg x 10's (Wonder (Asrox))$ 0.72
Statwa 20 mg Tablet (Kaytross Healthcare Limited)$ 0.15
Statwa 5 mg Tablet (Kaytross Healthcare Limited)$ 0.06
Statwa 10 mg Tablet (Kaytross Healthcare Limited)$ 0.10
Storclop 10+75 Capsule (Ranbaxy Laboratories Ltd.,)$ 0.13
Stortin 10 mg Tablet (Perk Pharmaceuticals Ltd.)$ 0.05
STORVAS Capsule/ Tablet / 20mg / 10 units (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.17
STORVAS Capsule/ Tablet / 10mg / 10 units (Cardiovascular (Ranbaxy Laboratories Ltd))$ 1.12
STORVAS Capsule/ Tablet / 5mg / 10 units (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.69
Storvas 10mg FC-TAB / 10 (Cardiovascular (Ranbaxy Laboratories Ltd))$ 1.12
Storvas 20mg FC-TAB / 10 (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.17
Storvas 10 mg x 1 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 10 mg x 3 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 10 mg x 10 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 1 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 3 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 10 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 1 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 3 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 10 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 80 mg x 1 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 80 mg x 3 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 80 mg x 10 Blister x 10 Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))
10 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))$ 1.12
20 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.17
Storvas 10 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 10 mg x 30's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 10 mg x 100's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 30's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg x 100's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 30's (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 40 mg x 100's (Cardiovascular (Ranbaxy Laboratories Ltd))
Tablets, Film-Coated; Oral; Atorvastatin 5 mg (Cardiovascular (Ranbaxy Laboratories Ltd))
Tablets, Film-Coated; Oral; Atorvastatin 10 mg (Cardiovascular (Ranbaxy Laboratories Ltd))
Tablets, Film-Coated; Oral; Atorvastatin 20 mg (Cardiovascular (Ranbaxy Laboratories Ltd))
Tablets, Film-Coated; Oral; Atorvastatin 40 mg (Cardiovascular (Ranbaxy Laboratories Ltd))
Tablets, Film-Coated; Oral; Atorvastatin 80 mg (Cardiovascular (Ranbaxy Laboratories Ltd))
Storvas 20 mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.22
Storvas 10 mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.12
Storvas 40 mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.30
Storvas 5 mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.08
Storvas 80 mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.34
STORVAS 10MG TABLET 1 strip / 15 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.97
STORVAS 20MG TABLET 1 strip / 15 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.34
STORVAS 40MG TABLET 1 strip / 10 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.27
STORVAS 5MG TABLET 1 strip / 15 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.80
STORVAS 5MG TABLET 1 strip / 10 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.53
STORVAS 80MG TABLET 1 strip / 10 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 3.87
STORVAS CP 10 MG TABLET 1 strip / 30 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.46
STORVAS CP 20 MG TABLET 1 strip / 30 tablets each (Cardiovascular (Ranbaxy Laboratories Ltd))$ 4.68
STORVAS film-coated tab 10 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.75
STORVAS film-coated tab 20 mg x 10's (Cardiovascular (Ranbaxy Laboratories Ltd))$ 2.17
Storvas 10mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.08
Storvas 20mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.16
Storvas 40mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.23
Storvas 5mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.06
Storvas 80mg Tablet (Cardiovascular (Ranbaxy Laboratories Ltd))$ 0.39
Storvas -AMF Atorvastatin 10mg, Amlodipine5mg TAB / 10$ 1.18

References

  1. DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: 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. 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).
  3. PubChem. "atorvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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