Indications

Rosugen tablet is indicated for:

• Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non HDL-C and TG levels and to increase HDL-C.
• Patients with hypertriglyceredemia as an adjunct to diet.
• Patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet.
• Patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.
• Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet.
• Pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy.
• Risk reduction of Myocardial Infarction (MI), stroke and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.

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Pharmacology

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dosage & Administration

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age): The usual dose range of Rosuvastatin is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Very High Cholesterol and High Risk of Ml or Stroke: 40 mg once daily.

Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosuvastatin is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.

Dosage in Asian Patients: Initiation of Rosuvastatin therapy with 5 mg once daily should be considered for Asian patients

Use with Cyclosporine, Lopinavir/Ritonavir or Atazanavir/Ritonavir: In patients taking Cyclosporine, the dose of Rosuvastatin should be limited to 5 mg once daily. In patients taking a combination of Lopinavir and Ritonavir or Atazanavir and Ritonavir, the dose of Rosuvastatin should be limited to 10 mg once daily.

Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rosuvastatin is used in combination with Niacin or Fenofibrate; a reduction in Rosuvastatin dosage should be considered in this setting. Combination therapy with Gemfibrozil should be avoided because of an increase in Rosuvastatin exposure with concomitant use; if Rosuvastatin is used in combination with Gemfibrozil, the dose of Rosuvastatin should be limited to 10 mg once daily.

Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (ClCr<30 mL/min/1.73 m²) not on hemodialysis, dosing of Rosuvastatin should be started at 5 mg once daily and not exceed 10 mg once daily.

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Interaction

Remarkable drug interactions of Rosugen are-

• Cyclosporine: Combination increases Rosugen exposure. Rosugen dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosugen dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosugen exposure. Rosugen dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosugen. INR should be monitored frequently until stable upon initiation or alteration of Rosugen therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Contraindications

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Side Effects

Rosugen is generally well tolerated. The most frequent adverse events thought to be related to Rosugen were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Pregnancy & Lactation

Rosuvastatin 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, therapy should be discontinued immediately. It is not known whether Rosuvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.

Precautions & Warnings

Rosugen should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age >65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with Rosugen may be increased with concurrent administration of some other lipid-lowering therapies (Fibrates or Niacin), Gemfibrozil, Cyclosporine, Lopinavir/Ritonavir, or Atazanavir/Ritonavir. Rosugen therapy should be discontinued if markedly elevated creatinine kinase levels occur or myopathy is diagnosed or suspected. Rosugen therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures). It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.

Overdose Effects

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of Rosugen.

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

Storage Conditions

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Chemical Structure

Common Questions about Rosugen 5 mg Tablet

What is Rosugen 5 mg Tablet?

Rosugen 5 mg Tablet is a HMG-CoA reductase inhibitor drug which is helpful in lowering the cholesterol level and triglycerides in the body.

What are the uses of Rosugen 5 mg Tablet?

Rosugen 5 mg Tablet is useful against the conditions like Hyperlipidemia, Hypertriglyceridemia, Type 3 Hyperlipoproteinemia and Stroke.

What are the side effects of Rosugen 5 mg Tablet?

Side effects of Rosugen 5 mg Tablet include Muscle pain, Weakness, Headache and Abdominal pain.

For how long should I take Rosugen 5 mg Tablet?

Rosugen 5 mg Tablet should be taken till you see improvement in your medical condition. Follow your doctor’s instructions to know the duration for Rosugen 5 mg Tablet.

Does Rosugen 5 mg Tablet cause weight gain?

Weight gain is a very rare side effect of Rosugen 5 mg Tablet. This medication does not lead to weight gain and in case you are observing this symptom, please consult a doctor for diagnosis.

Does Rosugen 5 mg Tablet make you tired?

Tiredness and fatigue is a common side effect of Rosugen 5 mg Tablet however, the exact reason behind it is still not known. Consult a doctor if it persists for a longer duration of time.

Should Rosugen 5 mg Tablet be taken at night?

Rosugen 5 mg Tablet is not mandatory to take Rosugen 5 mg Tablet at night. You can take it in the morning too, however, it should be consumed once a day only. Ideally, you must follow your doctor’s instructions regarding the dosage.

What foods should be avoided when taking Rosugen 5 mg Tablet?

Avoid eating junk food and foods that are high in calories as they can increase the cholesterol levels. You must eat only a low-cholesterol diet during the course of Rosugen 5 mg Tablet treatment.

How do I know whether Rosugen 5 mg Tablet is beneficial for me or not?

If you start noticing improvement in your condition, then Rosugen 5 mg Tablet is beneficial for you. In case, you do not see any positive effects of Rosugen 5 mg Tablet or experience adverse side effects after consuming this medicine, then consult a doctor to know a safer substitute of Rosugen 5 mg Tablet.

Can Rosugen 5 mg Tablet cause memory loss?

Memory loss is a very unusual side effect that can occur. If this symptom occurs, stop taking this medicine and consult a doctor immediately.

Is it true that Rosugen 5 mg Tablet can cause diabetes?

This medicine does not cause diabetes, however, if you already are at higher risk of having this disorder, then this medicine can enhance the risk factor by increasing the blood sugar levels. In such a case, regular monitoring of blood sugar level is mandatory.

Can I take alcohol with Rosugen 5 mg Tablet?

Do not take alcohol during the course of treatment with this medicine as it can increase the risk of having liver problems. Also, alcohol can increase the levels of triglyceride levels in the body.

Can Rosugen 5 mg Tablet cause muscle problems or muscle injury?

Muscle pain or any other problem associated with muscles is the most common side effect of this medicine. Consult your doctor if this side effect is causing discomfort in doing day to day activities.

Quick Tips

• Rosugen 5 mg Tablet treats high cholesterol by lowering "bad" cholesterol (LDL) and triglycerides (fats). It should be taken in addition to regular exercise and low-fat diet.
• In general, Rosugen 5 mg Tablet is safe. It may cause diarrhea, gas or an upset stomach. If any of these happen to you, take it with food.
• Inform your doctor if you experience fatigue, muscle weakness or muscle pain.
• Your doctor may check your liver function before starting the treatment and regularly thereafter. Inform your doctor if you notice signs of liver problems such as stomach pains, unusually dark urine or yellowing of skin or eyes.
• Inform your doctor if you have kidney disease, liver disease or diabetes before starting treatment with this medicine. If you are diabetic, monitor your blood sugar level regularly as Rosugen 5 mg Tablet may cause an increase in your blood sugar level.
• Do not take Rosugen 5 mg Tablet if you are pregnant, planning a pregnancy or breastfeeding.

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