What is Rosufid?
Rosufid (Rosufid) belongs to a a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosufid reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).
Rosufid is used in adults and children who are at least 8 years old to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in your blood vessels.
Rosufid is also used to lower the risk of stroke, heart attack, and other heart complications in certain people with diabetes, coronary heart disease, or other risk factors.
Rosufid is also used to treat hereditary forms of high cholesterol, including the heterozygous type (inherited from one parent) and the homozygous type (inherited from both parents). For the heterozygous type, Rosufid can be used in children who are at least 8 years old. For the homozygous type, Rosufid can be used in children as young as 7 years old.
Rosufid indications
Rosufid should be used as an adjunct to diet when the response to diet and exercise is inadequate.
Prevention of Cardiovascular Events: In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Rosufid is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization).
In Adult Patients with Hypercholesterolaemia: Rosufid is indicated to: Reduce elevated LDL-C, Total Cholesterol, triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolaemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Rosufid also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I in these populations.
Treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia).
Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia).
Reduce Total Cholesterol and LDL-C in patients with homozygous familial hypercholesterolaemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.
Slow or delay the progression of atherosclerosis.
Children and Adolescents 6 to 17 Years of Age: Rosufid is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).
How should I use Rosufid?
Use Rosufid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Rosufid. Talk to your pharmacist if you have questions about this information.
- Take Rosufid by mouth with or without food.
- Swallow the tablets whole.
- If you also take an antacid that has aluminum or magnesium in it, take it at least 2 hours after taking Rosufid. Check with your doctor if you have any questions.
- Taking Rosufid at the same time each day will help you remember to take it.
- Continue to take Rosufid even if you feel well. Do not miss any doses.
- If you miss a dose of Rosufid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or within 12 hours of each other.
Ask your health care provider any questions you may have about how to use Rosufid.
Uses of Rosufid in details
- Rosufid is used for the treatment of high cholesterol, high LDL, high triglycerides and low HDL in addition to diet, when response to non-medicine options (diet, exercise and weight loss) is not adequate.
- It is also used to lower the risk of stroke, heart attack, or other heart complications in people who are at high risk of heart diseases, as an adjuvant to correction of the risk factors.
Rosufid description
Rosufid also contains the following inactive ingredients: Tribasic calcium phosphate, microcrystalline cellulose (PH 102), butylated hydroxy toluene, povidone K-30, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Instacoat universal white IH, purified water; color: Titanium dioxide.
Rosufid is a synthetic lipid-lowering agent for oral administration. The chemical name for Rosufid calcium is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl 2[methyl (methylsulfonyl) amino] pyrimidin-5-yl](3R,5S)3,5-dihydroxyhept-6-enoic acid] calcium salt. The empirical formula is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14.
Rosufid dosage
General Dosing Information: The dose range for Rosufid is 5-40 mg orally once daily.
Rosufid can be administered as a single dose at any time of the day, with or without food. When initiating Rosufid therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosufid starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.
The 40 mg dose of Rosufid should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.
Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) and Slowing of the Progression of Atherosclerosis: The recommended starting dose of Rosufid is 10 mg dose once daily. For patients with marked hyperlipidemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.
After initiation or upon titration of Rosufid, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): The usual dose range of Rosufid is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses >20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of ≥4 weeks.
Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosufid is 20 mg once daily. Response to therapy should be estimated from pre-aphereses LDL-C levels.
Dosage in Asian Patients: Initiation of Rosufid therapy with 5 mg once daily should be considered for Asian patients.
Use with Cyclosporine or Lopinavir/Ritonavir: In patients taking cyclosporine, the dose of Rosufid should be limited to 5 mg once daily. In patients taking a combination of lopinavir and ritonavir, the dose of Rosufid should be limited to 10 mg once daily.
Concomitant Lipid-Lowering Therapy: The risk of skeletal muscle effects may be enhanced when Rosufid is used in combination with niacin or fenofibrate; a reduction in Rosufid is used in combination with gemfibrozil, the dose of Rosufid should be limited to 10 mg daily.
Dosage in Patients with Severe Renal Impairment: For patients with severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis, dosing of Rosufid should be started at 5 mg once daily and should not exceed 10 mg once daily.
Rosufid interactions
See also:
What other drugs will affect Rosufid?
Effect of Co-Administered Medicinal Products on Rosufid: In vitro and in vivo data indicate that Rosufid has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Rosufid is a substrate for certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP. Concomitant administration of Rosufid with medicinal products that are inhibitors of these transporter proteins may result in increased Rosufid plasma concentrations and an increased risk of myopathy.
Interactions Requiring Rosufid Dose Adjustments : When it is necessary to co-administer Rosufid with other medicinal products known to increase exposure to Rosufid, doses of Rosufid should be adjusted. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosufid. Start with a 5 mg once daily dose of Rosufid if the expected increase in exposure (AUC) is approximately 2-fold or higher. The maximum daily dose of Rosufid should be adjusted so that the expected Rosufid exposure would not likely exceed that of a 40 mg daily dose of Rosufid taken without interacting medicinal products, for example a 5 mg dose of Rosufid with ciclosporin (7.1-fold increase in exposure), a 10 mg dose of Rosufid with ritonavir/atazanavir combination (3.1-fold increase) and a 20 mg dose of Rosufid with gemfibrozil (1.9-fold increase).
Other Interacting Medicinal Products: Antacid: The simultaneous dosing of Rosufid with an antacid suspension containing aluminum and magnesium hydroxide resulted in a decrease in Rosufid plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after Rosufid. The clinical relevance of this interaction has not been studied.
Fusidic Acid: Interaction studies with Rosufid and fusidic acid have not been conducted. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with Rosufid and fusidic acid given concurrently. Patients should be closely monitored and temporary suspension of Rosufid treatment may be appropriate.
Effect of Rosufid on Co-Administered Medicinal Products: Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with Rosufid. However, as with other HMG-CoA reductase inhibitors, co-administration of Rosufid and warfarin may result in a rise in INR compared to warfarin alone. In patients taking vitamin K antagonists monitoring of INR is recommended both at initiation or cessation of therapy with Rosufid or following dose adjustment.
Fenofibrates/Fibric Acid Derivatives: Although no pharmacokinetic interaction between Rosufid and fenofibrate was observed; a pharmacodynamic interaction may occur. Gemfibrozil, fenofibrate and other fibric acids, including nicotinic acid, may increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors.
Cyclosporin: Co-administration of Rosufid with cyclosporin resulted in no significant changes in cyclosporin plasma concentration.
Other Medications: There were no clinically significant interactions with an oral contraceptive, digoxin, ezetimibe, or fenofibrate.
In clinical studies Rosufid was co-administered with antihypertensive agents, antidiabetic agents and hormone replacement therapy. These studies did not produce any evidence of clinically significant adverse interactions.
Rosufid side effects
See also:
What are the possible side effects of Rosufid?
Rosufid is generally well tolerated. The adverse events seen with Rosufid are generally mild and transient. In controlled clinical trials less than 4% of Rosufid treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo.
Common (≥1/100, <1/10): Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus*.
Uncommon (≥1/1000, <1/100): Pruritus, rash and urticaria.
Rare (≥1/10,000, <1/1000): Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis.
*Observed in the JUPITER study (reported overall frequency 2.8% in Rosufid and 2.3% in placebo) primarily in patients already at high risk for developing diabetes.
As with other HMG CoA reductase inhibitors, the incidence of adverse drug reactions tends to increase with increasing dose.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with Rosufid and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking Rosufid. Increases in HbA1c have also been observed in patients treated with Rosufid. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosufid and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.
Other Effects: In a long-term controlled clinical trial Rosufid was shown to have no harmful effects on the ocular lens.
In Rosufid treated patients, there was no impairment of adrenocortical function.
Post Marketing Experience: In addition to the previously mentioned effects, the following adverse events have been reported during post marketing experience of Rosufid: Haematological Disorders: Frequency Unknown: Thrombocytopenia.
Hepatobiliary Disorders: Very Rare: Jaundice, hepatitis. Rare: Increased hepatic transaminases.
Musculoskeletal Disorder: Frequency Unknown: Immune-mediated necrotising myopathy. Very Rare: Arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous System Disorder: Very Rare: Memory loss. Frequency Unknown: Peripheral neuropathy.
Psychiatric Disorders: Frequency Unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive System and Breast Disorders: Frequency Unknown: Gynaecomastia.
Children and Adolescents 6 to 17 Years of Age: The safety profile of Rosufid is similar in children or adolescent patients and adults although CK elevations >10 x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents.
Rosufid contraindications
See also:
What is the most important information I should know about Rosufid?
Hypersensitivity to Rosufid or to any of the excipients of Rosufid Sandoz.
Hepatic impairment; severe renal impairment; repeated or unexplained muscle aches or pain (myopathy); ciclosporin (eg, used after organ transplants).
In addition, the 40 mg dose of Rosufid Sandoz is contraindicated in: Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; moderate renal impairment; thyroid gland disorders; regular consumption of large amounts of alcohol; if taking fibrates to lower cholesterol; Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Use in pregnancy & lactation: Rosufid Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rosufid Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rosufid Sandoz by using suitable contraception.
Active ingredient matches for Rosufid:
| Unit description / dosage (Manufacturer) | Price, USD |
| ROSUFID 10MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd) | $ 0.96 |
| ROSUFID 20MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd) | $ 1.81 |
| ROSUFID 5MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd) | $ 0.60 |
| Rosufid 20mg Tablet (Fidelity Lifesciences Pvt Ltd) | $ 0.18 |
| Rosufid 5mg Tablet (Fidelity Lifesciences Pvt Ltd) | $ 0.06 |
List of Rosufid substitutes (brand and generic names): | |
| Rosufer (Indonesia) | |
| ROSUFIT | |
| ROSUFIT 10 MG TABLET 1 strip / 15 tablets each (Ajanta) | $ 1.40 |
| ROSUFIT 20 MG TABLET 1 strip / 10 tablets each (Ajanta) | $ 1.66 |
| ROSUFIT 5 MG TABLET 1 strip / 15 tablets each (Ajanta) | $ 0.70 |
| ROSUFIT tab 5 mg x 10's (Ajanta) | $ 0.40 |
| ROSUFIT tab 10 mg x 10's (Ajanta) | $ 0.78 |
| Rosufit 10mg Tablet (Ajanta) | $ 0.10 |
| Rosufit 20mg Tablet (Ajanta) | $ 0.18 |
| Rosufit 5mg Tablet (Ajanta) | $ 0.05 |
| Rosufix (Turkey) | |
| ROSUFLO | |
| ROSUFLO 10 MG TABLET 1 strip / 10 tablets each (Cadila Pharmaceuticals Ltd) | $ 1.56 |
| ROSUFLO 20 MG TABLET 1 strip / 10 tablets each (Cadila Pharmaceuticals Ltd) | $ 3.24 |
| ROSUFLO 5 MG TABLET 1 strip / 10 tablets each (Cadila Pharmaceuticals Ltd) | $ 0.82 |
| Rosuflo 10mg Tablet (Cadila Pharmaceuticals Ltd) | $ 0.16 |
| Rosuflo 20mg Tablet (Cadila Pharmaceuticals Ltd) | $ 0.32 |
| Rosuflo 5mg Tablet (Cadila Pharmaceuticals Ltd) | $ 0.08 |
| Rosugen (Bangladesh, Poland) | |
| ROSUGRAF | |
| ROSUGRAF 10MG TABLET 1 strip / 10 tablets each (GRAF Laboratories Pvt Ltd) | $ 1.11 |
| ROSUGRAF 5MG TABLET 1 strip / 10 tablets each (GRAF Laboratories Pvt Ltd) | $ 0.66 |
| Rosugraf 5mg Tablet (GRAF Laboratories Pvt Ltd) | $ 0.07 |
| Rosuhol (Serbia) | |
| ROSUKAA | |
| ROSUKAA 10 MG TABLET 1 strip / 10 tablets each (Troikaa Pharmaceuticals Ltd) | $ 1.47 |
| ROSUKAA 20MG TABLET 1 strip / 10 tablets each (Troikaa Pharmaceuticals Ltd) | $ 2.92 |
| ROSUKAA 5 MG TABLET 1 strip / 10 tablets each (Troikaa Pharmaceuticals Ltd) | $ 0.84 |
| Rosukaa 10mg Tablet (Troikaa Pharmaceuticals Ltd) | $ 0.16 |
| Rosukaa 20mg Tablet (Troikaa Pharmaceuticals Ltd) | $ 0.32 |
| Rosukaa 40mg Tablet (Troikaa Pharmaceuticals Ltd) | $ 0.51 |
| Rosukaa 5mg Tablet (Troikaa Pharmaceuticals Ltd) | $ 0.08 |
| Rosukaa A 10/150 Capsule (Troikaa Pharmaceuticals Ltd) | $ 0.08 |
| Rosukaa A 10/75 Tablet (Troikaa Pharmaceuticals Ltd) | $ 0.07 |
| Rosukaa A 20/150 Capsule (Troikaa Pharmaceuticals Ltd) | $ 0.10 |
| Rosukaa Gold 75mg/10mg/75mg Capsule (Troikaa Pharmaceuticals Ltd) | $ 0.17 |
| ROSUKEM | |
| ROSUKEM -10 TABLET 1 strip / 15 tablets each (Alkem Laboratories Ltd) | $ 1.29 |
| ROSUKEM -20 TABLET 1 strip / 10 tablets each (Alkem Laboratories Ltd) | $ 1.59 |
| ROSUKEM -20 TABLET 1 strip / 15 tablets each (Alkem Laboratories Ltd) | $ 2.61 |
| ROSUKEM 40MG TABLET 1 strip / 10 tablets each (Alkem Laboratories Ltd) | $ 2.77 |
| ROSUKEM 5 MG TABLET 1 strip / 10 tablets each (Alkem Laboratories Ltd) | $ 0.51 |
| ROSUKEM 5 MG TABLET 1 strip / 15 tablets each (Alkem Laboratories Ltd) | $ 0.76 |
| Rosukem 20mg Tablet (Alkem Laboratories Ltd) | $ 0.19 |
| Rosukem 40mg Tablet (Alkem Laboratories Ltd) | $ 0.28 |
| Rosukem 5mg Tablet (Alkem Laboratories Ltd) | $ 0.06 |
| ROSULESS (Georgia, India) | |
| ROSULESS 10 MG TABLET 1 strip / 10 tablets each (Corona (Wellness)) | $ 0.40 |
See 1843 substitutes for Rosufid | |
References
- DailyMed. "ROSUVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "Rosuvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Rosuvastatin". http://www.drugbank.ca/drugs/DB01098 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Rosufid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rosufid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
