Product image of Koleros (Rosuvastatin) supplied by GNH India

Koleros

Active Ingredient:
Rosuvastatin
Origin:
EU

Koleros (Rosuvastatin)

Rosuvastatin, the active ingredient in Koleros, is a HMG‑CoA reductase inhibitor presented as a tablet for oral use. It treats hypercholesterolemia, mixed dyslipidemia and helps prevent cardiovascular events in adult patients who require lipid‑lowering therapy.

GNH India supplies Koleros as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established distribution networks across Europe, Asia and the Americas. Our quality‑assured product meets EU regulatory standards and is available for bulk and retail orders.

Manufacturer / TM Owner

Konpharma S.R.L.

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Indications & Clinical Uses

Rosuvastatin is indicated for disorders of lipid metabolism and for reducing cardiovascular risk.

  • Hypercholesterolemia: lowers low‑density lipoprotein cholesterol (LDL‑C) to achieve target lipid levels and reduce atherosclerotic risk.
  • Mixed dyslipidemia: decreases total cholesterol, LDL‑C and triglycerides while modestly raising high‑density lipoprotein cholesterol (HDL‑C).
  • Prevention of cardiovascular events: used in patients with established coronary artery disease or multiple risk factors to lower the incidence of myocardial infarction, stroke and related vascular events.

How It Works

  • Rosuvastatin inhibits HMG‑CoA reductase, the rate‑limiting enzyme in hepatic cholesterol synthesis. This inhibition reduces intracellular cholesterol, prompting up‑regulation of LDL receptors on hepatocyte surfaces, which accelerates clearance of circulating LDL particles and modestly improves HDL and triglyceride levels.

Side Effects

Rosuvastatin may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Headache: mild to moderate intensity, often transient.
  • Myalgia: muscle aches without weakness, usually dose‑related.
  • Abdominal discomfort: nausea, dyspepsia or flatulence.
  • Constipation: infrequent, resolves with continued therapy.
  • Dizziness: occasional light‑headed sensation.

Serious or Rare Side Effects

  • Rhabdomyolysis: severe muscle breakdown with possible renal impairment.
  • Elevated liver enzymes: significant increase in ALT/AST indicating hepatic stress.
  • Severe allergic reaction: rash, angioedema or anaphylaxis.
  • Myopathy: muscle weakness with elevated creatine kinase.
  • Pancreatitis: acute inflammation of the pancreas presenting with abdominal pain.

Precautions & Warnings

Rosuvastatin requires careful monitoring and adherence to safety guidelines.

  • Pregnancy: contraindicated (Category X); avoid use in pregnant or nursing women.
  • Liver disease: assess hepatic function before initiation and periodically thereafter.
  • Renal impairment: dose adjustment may be needed in patients with reduced creatinine clearance.
  • Drug interactions: review concomitant medications for potential statin‑related interactions.
  • Lipid monitoring: obtain baseline lipid profile and repeat after 4–12 weeks of therapy.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original container.

Avoid Interactions

Rosuvastatin can interact with several medicines, affecting its safety and efficacy.

Major Interactions (Avoid)

  • Cyclosporine: markedly increases rosuvastatin plasma concentrations, raising risk of myopathy.
  • Gemfibrozil: synergistic effect on muscle toxicity, may precipitate rhabdomyolysis.
  • High‑dose niacin: enhances risk of severe muscle injury.

Moderate Interactions (Monitor Closely)

  • Warfarin: may potentiate anticoagulant effect, requiring INR monitoring.
  • Antacids containing aluminum or magnesium: can reduce rosuvastatin absorption; separate dosing by at least 2 hours.
  • Digoxin: modest increase in serum levels; monitor for toxicity.
  • Certain antifungals (e.g., itraconazole): may raise rosuvastatin exposure, warranting dose review.

Frequently Asked Questions

Koleros contains rosuvastatin, a statin medication prescribed to lower elevated cholesterol levels, manage mixed dyslipidemia, and reduce the risk of cardiovascular events such as heart attacks and strokes in adult patients.

Rosuvastatin blocks the enzyme HMG‑CoA reductase in the liver, which is essential for cholesterol synthesis. This inhibition lowers intracellular cholesterol, leading to increased LDL‑receptor expression and enhanced removal of LDL‑cholesterol from the bloodstream.

The specific dose of Koleros is determined by the prescribing clinician based on the patient’s lipid profile, cardiovascular risk, age, renal function and other individual factors. Patients should follow the prescriber’s instructions precisely.

Rosuvastatin is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy because of potential fetal harm. It is also not recommended while breastfeeding, as it may pass into breast milk.

To place an order, submit an enquiry on the Koleros product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Koleros (rosuvastatin) is a high‑potency statin with a longer half‑life, allowing once‑daily dosing and effective LDL‑C reduction at lower doses compared with some older statins. Its metabolic pathway involves minimal CYP450 metabolism, which can result in fewer drug‑interaction concerns for certain patients.

Koleros should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the tablets away from moisture, heat and direct sunlight to maintain product stability.

Koleros is taken orally, usually once daily, with or without food. The tablet should be swallowed whole with a glass of water and not chewed or crushed.

Serious risks include rhabdomyolysis (severe muscle breakdown), significant liver enzyme elevations indicating hepatic injury, and rare allergic reactions such as anaphylaxis. Patients should report unexplained muscle pain, weakness, dark urine, or signs of liver dysfunction promptly.

Koleros is contraindicated in pregnant or nursing women, patients with active liver disease, and individuals with known hypersensitivity to rosuvastatin or any tablet excipients. Caution is also advised for patients with severe renal impairment unless dose‑adjusted by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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