What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Roszet (Rosuvastatin/Ezetimibe)
Prescription Required
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Product Details
Description
Roszet contains two drugs: rosuvastatin, a HMG CoA-reductase inhibitor (statin) and ezetimibe, a dietary cholesterol absorption inhibitor.
Roszet (rosuvastatin and ezetimibe) is used:
- With diet to decrease low-density lipoprotein cholesterol (LDL-C) in adult patients who have primary non-familial hyperlipidemia
- By itself or with other medications that lower LDL-C in adult patients who have homozygous familial hypercholesterolemia (HoFH)
Fact Table
Formula
C24H21F2NO3. C22H28FN3O6S
License
US DailyMed
Bioavailability
20%
Legal status
Rx-Only
Chemical Name
Ezetimibe/rosuvastatin
Elimination half-life
19 hours
Dosage (Strength)
5/10mg, 10/10mg, 20/10mg, 40/10mg
Pregnancy
Consult Doctor
Brands
Roszet
Protein binding
90%
PubChem CID
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MedlinePlus
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ChEBI
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ATC code
C10BA06
DrugBank
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KEGG
D11520
Routes of administration
By Mouth
Directions
Roszet is available in the following tablet strengths:
- 5 mg rosuvastatin/10 mg ezetimibe
- 10 mg rosuvastatin/10 mg ezetimibe
- 20 mg rosuvastatin/10 mg ezetimibe
- 40 mg rosuvastatin/10 mg ezetimibe
The tablets should be swallowed whole.Take Rosset 2 hours before or 4 hours after taking a bile acid sequestrant.
Take Roszet at least 2 hours before taking an antacid that contains aluminum and magnesium hydroxide.
The recommended dosage depends on the indication, LDL-C, and your cardiovascular risks. The dosage range of Roszet is 5 mg rosuvastatin/10 mg ezetimibe to 40 mg rosuvastatin/10 mg ezetimibe by mouth once daily. Your doctor may change your dose based on LDL-C levels.
In Asian patients, the recommended starting dose is 5 mg rosuvastatin/10 mg ezetimibe by mouth once daily.
In patients with severe kidney problems without hemodialysis, the recommended starting dose is 5 mg rosuvastatin/10 mg ezetimibe by mouth once daily. The daily dose should not be more than 10 mg rosuvastatin/10 mg ezetimibe.
Ingredients
The active ingredients in Roszet are rosuvastatin and ezetimibe.
Contraindications
Do not take Roszet if you have liver failure or decompensated liver cirrhosis.
Do not take Roszet if you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients or excipients in Roszet.
Cautions
- Before you start taking Roszet, tell your doctor:
- About all the medications you take. These include prescription and over-the-counter medicines, vitamins, and herbal supplements.
- About your allergies.
- About your health conditions.
- If you are pregnant or have plans to become pregnant.
- If you are currently breastfeeding or have plans to breastfeed.
- Roszet can cause myopathy. Your risk is higher if you are 65 years old or older, have uncontrolled hypothyroidism, have kidney problems, take certain other drugs for cholesterol, or take a higher Roszet dose. Asian patients who are taking Roszet may be at greater risk. Roszet can also cause rhabdomyolysis that can lead to acute kidney damage or death. Call your doctor right away if you develop muscle pain, tenderness, weakness, or a fever.
- Roszet can cause liver problems. You should not take Roszet if you have liver failure or decompensated liver cirrhosis. You may be at an increased risk for liver problems if you have a history of liver disease and/or consume considerable amounts of alcohol.
Side Effects
Like with any medication, Roszet can cause side effects. The most common include common cold, muscle pain, joint pain, back pain, diarrhea, fatigue, pain in extremity, influenza, and upper respiratory tract infection.
Contact your doctor right away if you experience bothersome or persistent side effects.
Reference:
Roszet. Morristown, NJ: Althera Pharmaceuticals LLC; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13639
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