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Brand Name :
Roszet
Synonyms :
Class :
Antihyperlipidemic combinations
Brand Name :
Roszet
Synonyms :
Class :
Antihyperlipidemic combinations
Dosage Forms & Strengths
Tablet
5mg/10mg- rosuvastatin/ezetimibe
10mg/10mg – rosuvastatin/ezetimibe
20mg/10mg – rosuvastatin/ezetimibe
40mg/10mg – rosuvastatin/ezetimibe
Safety and efficacy not established
Refer adult dosing
Adverse drug reactions:
Frequency defined
>10%
Rosuvastatin H4
Arthralgia (10.1%)
Myalgia (2.8-12.7%)
1-10%
Rosuvastatin
Dizziness (4%)
Nausea (3.4%)
Abdominal (2.4%)
ALT >3x ULN (2.2%)
Headache (5.5-6.4%)
Asthenia (2.7%)
Constipation (2.4%)
Increased CPK (2.6%)
Ezetimibe
Diarrhea (4.1%)
Upper respiratory tract infection (2.9%)
Arthralgia (3%)
Fatigue (2.4%)
Influenza (2%)
Arthralgia (2.6%)
Sinusitis (2.8%)
Pain in extremity (2.7%)
Nasopharyngitis (3.7%)
Myalgia (3.2%)
Pregnancy warnings:
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Lactation:
Excreted into human milk is Unknown (ezetimibe); known (rosuvastatin)
Pregnancy Categories:
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.
Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient Information Leaflet
Generic Name: rosuvastatin/ezetimibe
Why do we use rosuvastatin/ezetimibe?
rosuvastatin/ezetimibe is Antihyperlipidemic combination used to treat Homozygous Familial Hypercholesterolemia and hyperlipidemia.
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