GNH USA

Europe — EMA

Kexrolt

GNH USA supplies Kexrolt (atorvastatin calcium and ezetimibe), a lipid‑lowering agent for primary hypercholesterolaemia, mixed dyslipidaemia and heterozygous

Atorvastatin Calcium, Ezetimibe

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What is Atorvastatin Calcium, Ezetimibe?

Atorvastatin calcium and ezetimibe, the active ingredient in Kexrolt, is a lipid‑lowering agent presented as a tablet for oral use. It provides additive reduction of LDL‑cholesterol in adults with primary hypercholesterolaemia, mixed dyslipidaemia, or heterozygous familial hypercholesterolaemia, and is marketed in the European Union.

GNH USA supplies Kexrolt as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality and regulatory compliance for global distribution, and customers benefit from reliable supply chains and responsive technical support.

What is Atorvastatin Calcium, Ezetimibe used for?

Kexrolt is used to treat disorders of lipid metabolism, primarily by lowering LDL‑cholesterol. - Primary hypercholesterolaemia: reduces LDL‑cholesterol and total cholesterol levels. - Mixed dyslipidaemia: lowers LDL‑cholesterol and triglycerides while modestly raising HDL‑cholesterol. - Heterozygous familial hypercholesterolaemia: provides additive LDL‑cholesterol reduction when diet and lifestyle alone are insufficient.

What are the side effects of Atorvastatin Calcium, Ezetimibe?

Kexrolt may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Muscle pain or weakness: mild myalgia without significant creatine kinase elevation, often transient. - Elevated liver enzymes: transient increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels. - Gastrointestinal discomfort: nausea, abdominal pain, flatulence or diarrhea that usually resolves. - Headache: mild to moderate intensity, may improve with continued therapy. - Fatigue: general tiredness that can affect daily activities.

Serious or Rare Side Effects: - Rhabdomyolysis: severe muscle breakdown with marked creatine kinase rise, possible renal failure. - Acute liver injury: significant hepatitis or liver failure requiring discontinuation. - Severe allergic reaction: rash, angioedema, or anaphylaxis demanding immediate medical attention. - Myopathy with renal impairment: muscle toxicity especially in patients with reduced kidney function. - Interstitial lung disease: rare pulmonary inflammation presenting with cough and dyspnea.

What precautions apply to Atorvastatin Calcium, Ezetimibe?

When prescribing Kexrolt, clinicians should consider several precautionary measures to ensure safe use. - Liver function monitoring: assess ALT/AST before initiation and periodically during therapy. - Muscle toxicity vigilance: evaluate for unexplained muscle pain or weakness and check CK if suspected. - Drug interactions: review concomitant use of strong CYP3A4 inhibitors or other lipid‑lowering agents. - Pregnancy and lactation: avoid use unless potential benefit justifies potential risk to the fetus or infant. - Renal impairment adjustment: use caution in patients with severe renal dysfunction, monitoring renal function. - Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture and light.

What does Atorvastatin Calcium, Ezetimibe interact with?

Kexrolt can interact with other medicines; interactions are classified by clinical significance.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole): may increase atorvastatin exposure and risk of myopathy. - Gemfibrozil or other fibrates: additive risk of muscle toxicity. - Cyclosporine: enhances statin levels, raising rhabdomyolysis risk.

Moderate Interactions (Monitor Closely): - Antacids containing aluminum or magnesium: may reduce ezetimibe absorption. - Warfarin: may potentiate anticoagulant effect, requiring INR monitoring. - Digoxin: possible increase in serum concentration when combined with statins.

Frequently asked questions

What is Kexrolt used for?+
Kexrolt is indicated for the treatment of primary hypercholesterolaemia, mixed dyslipidaemia, and heterozygous familial hypercholesterolaemia in adults. It is prescribed when lifestyle measures alone are insufficient to achieve target LDL‑cholesterol levels.
How does atorvastatin calcium and ezetimibe work?+
Atorvastatin calcium blocks HMG‑CoA reductase, reducing the liver’s production of cholesterol, while ezetimibe inhibits the NPC1L1 transporter in the intestine, decreasing absorption of dietary and biliary cholesterol. Together they produce an additive lowering of circulating LDL‑cholesterol.
What is the usual dose of Kexrolt?+
The dose of Kexrolt is individualized by the prescribing clinician based on the patient’s lipid profile, cardiovascular risk, and tolerability. The prescriber determines the appropriate strength and dosing schedule.
Is Kexrolt safe in pregnancy or breastfeeding?+
Kexrolt is generally avoided during pregnancy and lactation because the safety of atorvastatin and ezetimibe for the fetus or infant has not been established. Use only if the potential benefit outweighs the potential risk and after consulting a healthcare professional.
How do I order Kexrolt from GNH USA?+
To order Kexrolt, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Kexrolt compare with other cholesterol‑lowering options?+
Compared with a statin alone, Kexrolt adds ezetimibe, which blocks intestinal cholesterol absorption, resulting in greater LDL‑cholesterol reduction. This combination can achieve target lipid levels in patients who do not respond adequately to statin monotherapy.
How should Kexrolt be stored and handled?+
Kexrolt tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, excessive heat and direct light to maintain product stability.
How is Kexrolt administered?+
Kexrolt is taken orally, usually once daily, with or without food as directed by the prescriber. Swallow the tablet whole with a glass of water; do not crush or chew unless specifically instructed.
What are the most serious risks to watch for while taking Kexrolt?+
Serious risks include rhabdomyolysis (severe muscle breakdown), acute liver injury, and severe allergic reactions such as anaphylaxis. Patients should report unexplained muscle pain, dark urine, jaundice, or signs of hypersensitivity immediately.
Who should not use Kexrolt?+
Kexrolt should not be used by individuals with active liver disease, unexplained persistent elevations of hepatic enzymes, known hypersensitivity to atorvastatin, ezetimibe, or any excipients, and it is contraindicated during pregnancy and breastfeeding. Caution is advised in severe renal impairment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Atorvastatin Calcium, Ezetimibe
Route
Oral Use
Manufacturer
Organon Italia S.R.L.
Origin
EU

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