Rolip 10mg Tablet

Uses of Rolip 10mg Tablet

• Manage high blood cholesterol levels
• Prevents the risk of heart attack or stroke

How does Rolip 10mg Tablet work?

It works by reducing the amount of “bad” cholesterol (LDL) and raising the amount of “good” cholesterol (HDL) in your blood. Lowering the amount of cholesterol reduces the chances of heart diseases and helps you remain healthier for longer.

Side Effects of Rolip 10mg Tablet

The following are the most common side effects of Rosuvastatin:

• Abdominal discomfort
• Cough
• Dark coloured urine
• Decreased urine output
• Fever
• Muscle cramps
• Muscle stiffness
• Muscle weakness

The following are the severe side effects and you may require immediate medical attention:

• Allergic reactions
• Blood vomiting
• Unusual lethargy
• Difficulty in breathing
• Paleness of eyes and skin
• Severe diarrhoea

Quick Suggestions:

• In general, Rolip 10mg 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 Rolip 10mg Tablet may cause an increase in your blood sugar level.
• Do not take Rolip 10mg Tablet if you are pregnant, planning a pregnancy, or breastfeeding.

Indication of Rolip 10mg Tablet

Rolip is indicated for:

• Heterozygous Hypercholesterolemia (Familial and Non-familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Pharmacology

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin works by:

1. Increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL.
2. Inhibiting hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dosage & Administration of Rolip 10mg Tablet

• General Dose Range: 5-40 mg once daily. Use the 40 mg dose only for patients not reaching the LDL-C goal with 20 mg.
• HoFH (Homozygous Familial Hypercholesterolemia): Starting dose 20 mg/day.
• Pediatric Patients with HeFH (Heterozygous Familial Hypercholesterolemia):
  • 5-10 mg/day for patients 8 to less than 10 years of age.
  • 5-20 mg/day for patients 10 to 17 years of age.
• Pediatric Patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Children: Safety and effectiveness in pediatric patients have not been established.

Swallow the tablet/capsule whole. Do not crush or chew the tablet/capsule. Take the drug with or without food. However, taking the drug with food prevents stomach upset.

If you miss a dose of Rosuvastatin, please take it immediately once you remember. However, if it is almost time for your next dose, then skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

Significant drug interactions of Rolip include:

• Cyclosporine: Increases Rolip exposure. Limit the Rolip dose to 5 mg once daily.
• Gemfibrozil: Combination should be avoided. If used together, limit the Rolip dose to 10 mg once daily.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir: Increases Rolip exposure. Limit the Rolip dose to 10 mg once daily.
• Coumarin Anticoagulants: Prolongs international normalized ratio (INR). Achieve stable INR before starting Rolip and monitor frequently until stable.
• Concomitant Lipid-lowering Therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Rosuvastatin is contraindicated in patients with:

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

Precautions & Warnings

• Safety in pregnant women has not been established.
• It is not known whether Rosuvastatin is excreted in human milk.

Precautions & Warnings

• Skeletal Muscle Effects (e.g., myopathy and rhabdomyolysis): Risks increase with the use of 40 mg dose, advanced age (>65 years), hypothyroidism, renal impairment, and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or certain other lipid-lowering drugs. Patients should report unexplained muscle pain, tenderness, or weakness. Discontinue Rolip if signs or symptoms appear.
• Liver Enzyme Abnormalities and Monitoring: Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment.

Storage Conditions

• Keep below 30°C, protected from light and moisture.
• Keep out of reach of children.