Zyrovazet 5/10mg 30 tablets
زيروفازيت 5/10مجم 30 قرص
Rosuvastatin+ezetimibe
Unit price: 44.00 EGP
Specifications
Uses & Indications
Ezetimibe + Rosuvastatin is indicated as an adjunct to diet for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in adult patients for whom treatment with rosuvastatin alone is not appropriate or sufficient. It is also used in patients with homozygous familial hypercholesterolemia (HoFH) to reduce elevated total cholesterol (TC), LDL-C, and ApoB levels, typically in conjunction with other lipid-lowering treatments.
How It Works
This combination medication works through two complementary mechanisms. 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. This inhibition leads to a reduction in hepatic cholesterol synthesis and an increase in the number of LDL receptors on the surface of liver cells, enhancing the uptake and catabolism of LDL-C. Ezetimibe inhibits the absorption of cholesterol from the small intestine by targeting the Niemann-Pick C1-Like 1 (NPC1L1) protein, which is involved in intestinal cholesterol uptake. This reduces the delivery of intestinal cholesterol to the liver, leading to a decrease in hepatic cholesterol stores and an increase in cholesterol clearance from the blood.
Dosage & Administration
tablet
Adults: The usual starting dose is one tablet once daily, typically containing 10 mg rosuvastatin and 10 mg ezetimibe, or 20 mg rosuvastatin and 10 mg ezetimibe. The dose should be individualized based on the patient's lipid levels, risk factors, and response to treatment. The maximum recommended dose is 40 mg rosuvastatin and 10 mg ezetimibe once daily. Doses should be taken at approximately the same time each day, with or without food.
Children: The safety and efficacy of ezetimibe + rosuvastatin in pediatric patients (under 18 years of age) have not been established. Use in children is generally not recommended unless specifically advised by a specialist for certain conditions like HoFH, and under strict medical supervision.
Side Effects
- Headache (approximately 5-10%)
- Myalgia (muscle pain, approximately 4-12%)
- Nausea (approximately 3-8%)
- Abdominal pain (approximately 3-7%)
- Fatigue (approximately 2-6%)
- Diarrhea (approximately 2-5%)
- Constipation (approximately 2-4%)
- Arthralgia (joint pain, approximately 2-5%)
Serious Side Effects
- Rhabdomyolysis (severe muscle breakdown leading to kidney damage)
- Hepatotoxicity (liver damage, indicated by elevated liver enzymes)
- Pancreatitis (inflammation of the pancreas)
- Hypersensitivity reactions (e.g., rash, angioedema)
- New-onset diabetes mellitus (rare, primarily with higher statin doses)
Contraindications
Ezetimibe + Rosuvastatin is contraindicated in patients with known hypersensitivity to ezetimibe, rosuvastatin, or any component of the formulation. It is also contraindicated in patients with active liver disease, including unexplained persistent elevations of serum transaminases, and in pregnant or lactating women. Severe renal impairment (creatinine clearance <30 mL/min) is also a contraindication for higher doses of rosuvastatin.
Drug Interactions
Significant drug interactions include cyclosporine (increases rosuvastatin and ezetimibe exposure), gemfibrozil (increases rosuvastatin and ezetimibe exposure, increasing risk of myopathy), warfarin or other coumarin anticoagulants (may increase INR, requiring monitoring), protease inhibitors (e.g., atazanavir, lopinavir/ritonavir, tipranavir/ritonavir, simeprevir, sofosbuvir/velpatasvir/voxilaprevir) which can significantly increase rosuvastatin exposure, and niacin (may increase risk of myopathy). Colchicine and fusidic acid may also increase the risk of myopathy/rhabdomyolysis when co-administered with statins. Consult your doctor or pharmacist before taking any new medications.
Pregnancy & Lactation
Category: X
Ezetimibe + Rosuvastatin is contraindicated during pregnancy. Statins, including rosuvastatin, can cause fetal harm when administered to pregnant women. There is no known benefit of lipid-lowering therapy during pregnancy. Women of childbearing potential should use effective contraception during treatment. If a patient becomes pregnant while taking this medication, treatment should be discontinued immediately.
Storage
Store tablets at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F). Keep the medication in its original packaging to protect it from moisture and light. Do not store in the bathroom. Keep out of reach of children.
Clinical Tips
Take this medication consistently at the same time each day, as prescribed by your doctor, to maintain stable drug levels. It can be taken with or without food. Continue to follow a cholesterol-lowering diet and engage in regular exercise as advised by your healthcare provider. Regular blood tests will be necessary to monitor your lipid levels and liver function. Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
Frequently Asked Questions
How long does it take for ezetimibe+rosuvastatin to lower cholesterol?
Significant reductions in cholesterol levels are typically observed within 2 to 4 weeks of starting treatment. Your doctor will monitor your lipid levels regularly to assess the effectiveness of the medication.
Can I stop taking this medication once my cholesterol levels are normal?
No, you should not stop taking this medication without consulting your doctor. Cholesterol-lowering medications are usually prescribed for long-term management, and stopping them can lead to your cholesterol levels rising again, increasing your risk of cardiovascular events.
What should I do if I miss a dose of ezetimibe+rosuvastatin?
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Does this medication interact with grapefruit or grapefruit juice?
Unlike some other statins, rosuvastatin is not significantly metabolized by the CYP3A4 enzyme, so interactions with grapefruit or grapefruit juice are generally not expected to be clinically significant. However, it is always prudent to discuss your diet with your doctor or pharmacist.
Is it normal to experience muscle pain while taking ezetimibe+rosuvastatin?
Muscle pain (myalgia) is a common side effect of statins, affecting a small percentage of patients. If you experience persistent or severe muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, contact your doctor immediately as it could be a sign of a more serious condition called rhabdomyolysis.
Similar — Rosuvastatin+ezetimibe
Medical Disclaimer
The information provided is for educational purposes only and is not a substitute for professional medical advice. Always consult your doctor or pharmacist before starting or changing any medication.