GNH USA

Europe — EMA

Horime

Horime combines ezetimibe and rosuvastatin calcium to treat hypercholesterolemia and mixed dyslipidemia. Learn uses, mechanism, side effects, and precautions.

Ezetimibe, Rosuvastatin Calcium

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What is Ezetimibe, Rosuvastatin Calcium?

Horime is an oral prescription medication that combines the active ingredients ezetimibe and rosuvastatin calcium in a single tablet. The combination belongs to the statin and cholesterol absorption inhibitor class and is marketed in the European Union. It is designed to lower elevated blood cholesterol and triglyceride levels by targeting both intestinal absorption and hepatic synthesis of cholesterol, helping to manage hypercholesterolemia and mixed dyslipidemia.

What is Ezetimibe, Rosuvastatin Calcium used for?

Horime is indicated for the treatment of abnormal lipid profiles in adult patients who require additional cholesterol lowering.

- Primary hypercholesterolemia, including familial forms, when diet and lifestyle changes are insufficient. - Mixed dyslipidemia characterized by elevated LDL‑cholesterol and triglycerides. - Patients with high cardiovascular risk who need combined reduction of LDL‑C and non‑HDL‑C. - Adjunct therapy for individuals already on a statin who need further LDL‑C lowering. - Secondary prevention of cardiovascular events in patients with established atherosclerotic disease.

What are the side effects of Ezetimibe, Rosuvastatin Calcium?

Adverse reactions to Horime have been observed in clinical practice; they can be mild and transient or, less frequently, severe and potentially life‑threatening. The frequency of each event varies.

Common: - Headache, dizziness, or fatigue, which are usually mild and transient. - Upper abdominal discomfort, nausea, or diarrhea that may resolve without intervention. - Myalgia or mild muscle cramps without significant creatine kinase elevation. - Transient elevations in liver enzymes (ALT/AST) that typically return to baseline. - Dry mouth or altered taste sensation occasionally reported. - Insomnia or sleep disturbances noted in some patients. - Elevated blood glucose levels in individuals with pre‑existing glucose intolerance.

Serious: - Clinically significant myopathy or rhabdomyolysis, which can lead to severe muscle injury. - Severe liver injury or hepatitis presenting with marked enzyme elevations. - Allergic reactions such as rash, angioedema, or anaphylaxis requiring immediate medical attention. - Acute renal failure secondary to rhabdomyolysis in rare cases.

What precautions apply to Ezetimibe, Rosuvastatin Calcium?

Before initiating Horime, clinicians should evaluate patient history and laboratory parameters to identify conditions that may increase the risk of adverse outcomes.

- Assess baseline liver function tests; avoid use in patients with active hepatic disease. - Check creatine kinase levels if there is a history of muscle disorders or concomitant statin therapy. - Use caution in patients with renal impairment; dose adjustment may be required. - Avoid in pregnant or breastfeeding women unless benefits outweigh risks. - Review concomitant medications for potential drug‑drug interactions, especially CYP3A4 inhibitors. - Monitor lipid profile and glucose levels periodically during therapy.

What does Ezetimibe, Rosuvastatin Calcium interact with?

Horime may interact with other medicines, potentially altering its efficacy or increasing the risk of toxicity.

Avoid: - Strong CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, which can markedly reduce rosuvastatin exposure. - Cyclosporine or gemfibrozil, which significantly increase rosuvastatin plasma concentrations and risk of myopathy. - Concomitant use with high-dose niacin, which can increase the risk of hepatotoxicity.

Use with caution: - Other lipid‑lowering agents (e.g., fibrates, niacin) that may raise the chance of muscle toxicity. - Anticoagulants like warfarin, as rosuvastatin can modestly affect INR. - Antacids containing aluminum or magnesium, which may decrease ezetimibe absorption. - Macrolide antibiotics (e.g., clarithromycin) that inhibit CYP3A4 and may raise rosuvastatin levels. - Drugs that affect bile acid metabolism (e.g., cholestyramine) may reduce ezetimibe absorption.

Frequently asked questions

What is the therapeutic purpose of Horime?+
Horime is prescribed to lower elevated cholesterol and triglyceride levels in patients with hypercholesterolemia or mixed dyslipidemia.
How does the combination of ezetimibe and rosuvastatin work in Horime?+
Ezetimibe reduces intestinal cholesterol absorption, while rosuvastatin inhibits hepatic cholesterol synthesis, together providing a complementary cholesterol‑lowering effect.
Is Horime available as an over‑the‑counter medication?+
No. Horime is a prescription‑only (Rx) product and must be prescribed by a qualified healthcare professional.
Can Horime be used during pregnancy?+
Horime should be avoided in pregnancy unless the potential benefit justifies the potential risk to the fetus; it is generally not recommended for pregnant or breastfeeding women.
What laboratory tests should be monitored while taking Horime?+
Baseline and periodic monitoring of liver enzymes (ALT/AST), creatine kinase, lipid profile, and fasting glucose are commonly recommended.
What are common side effects of Horime?+
Common adverse effects include headache, gastrointestinal discomfort, mild muscle aches, transient liver‑enzyme elevations, dry mouth, insomnia, and occasional increases in blood glucose.
What serious adverse reactions require immediate medical attention?+
Signs of severe muscle injury (e.g., unexplained muscle pain, dark urine), significant liver injury, allergic reactions such as rash or swelling, and acute kidney failure should be evaluated promptly.
Should I avoid any specific foods while taking Horime?+
There are no specific dietary restrictions, but a heart‑healthy diet low in saturated fat and cholesterol is recommended to enhance treatment effectiveness.
Can Horime be taken with other cholesterol‑lowering drugs?+
Co‑administration with other lipid‑lowering agents (e.g., fibrates, niacin) may increase the risk of muscle toxicity and should be managed carefully by a clinician.
How often should the lipid profile be checked after starting Horime?+
A follow‑up lipid panel is typically performed 4–12 weeks after initiation or dose adjustment, then periodically as directed by the prescriber.
Is dose adjustment of Horime needed for patients with kidney disease?+
Patients with moderate to severe renal impairment may require dose adjustment; the prescribing clinician should assess renal function before initiating therapy.
What should I do if I miss a dose of Horime?+
If a dose is missed, take it as soon as remembered unless it is close to the time of the next scheduled dose; do not double‑dose. Consult your healthcare provider for specific guidance.
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
Ezetimibe, Rosuvastatin Calcium
Route
Oral Use
Manufacturer
Bausch Health Ireland Limited
Origin
EU

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