Sealcor 20 Tablet## (null smpc)

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin tablets are an HMG Co‑A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C, total-C, and ApoB (1.5) Limitations of use (1.8) : Rosuvastatin tablets have not been studied in Fredrickso …

• Rosuvastatin tablets can be taken with or without food, at any time of day
• Dose range: 5 to 40 mg once daily
• Use 40 mg dose only for patients not reaching LDL‑C goal with 20 mg
• Adult HoFH: Starting dose 20 mg/day General Dosing Information The dose range for rosuvastatin tablet
• Adults is 5 to 40 mg orally once daily
• The usual starting dose is 10 to 20 mg once daily
• The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily
• The maximum rosuvastatin tablet dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [ see Warnings and Precautions ]
• Rosuvastatin tablets can be administered as a single dose at any time of day, with or without food
• The tablet should be swallowed whole
• When initiating rosuvastatin therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin tablets starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy
• After initiation or upon titration of rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly
• Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets
• However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. …

Rosuvastatin tablets, USP 5 mg: Yellow, round, biconvex, film-coated tablet, debossed “5” on one side and “FI” on other side. Rosuvastatin tablets, USP 10 mg: Pink, round, biconvex, film-coated tablet, debossed “10” on one side and “R” on other side. Rosuvastatin tablets, USP 20 mg: Pink, round, biconvex, film-coated tablet, debossed “20” on one side and “R” on other side. …

• Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets
• However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information

Of the 10,275 patients in clinical studies with rosuvastatin, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Patients should be instructed not to take 2 doses of rosuvastatin tablets within 12 hours of each other
• Skeletal Muscle Effects Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing rosuvastatin tablets
• Concomitant Use of Antacids When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin administration. …

• Rosuvastatin tablets are contraindicated in the following conditions: Patients with a known hypersensitivity to any component of this product
• Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [ see Adverse Reactions ]
• Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ see Warnings and Precautions ]. …

7. DRUG INTERACTIONS Combination of sofosbuvir/velpatasvir/voxilaprevir or ledipasvir/sofosbuvir: Combination increases rosuvastatin exposure. Use with rosuvastatin tablets is not recommended. ( 2.4 , 5.1 , 7.3 , 12.3 ) Cyclosporine and darolutamide: Combination increases rosuvastatin exposure. Limit rosuvastatin dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 7.4 , 12.3 ) Gemfibrozil: Combination should be avoided. If used together, limit rosuvastatin tablet dose to 10 mg once daily. …

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin tablets if signs or symptoms appear. …

The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [ see Warnings and Precautions (5.1) ] Liver enzyme abnormalities [ see Warnings and Precautions (5.3) ] Most frequent adverse reactions (rate > 2%) are headache, myalgia, abdominal pain, asthenia, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or www.accord-healthcare.us or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Rosuvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant wome …

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of rosuvastatin.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.