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Medicines/Generics/Rosuvastatin

Rosuvastatin

Generic medicine reference

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This entry was migrated from the earlier Pharmapedia app bundle and has not been reviewed by a named clinician on this site. It is provided for educational reference only — verify dosage and safety information against current, authoritative sources and a qualified healthcare professional before any clinical use.

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Overview
Rosuvastatin (Crestor, Ezallor Sprinkle) is a prescription medication used to treat high cholesterol and prevent heart attacks and strokes . Rosuvastatin belongs to a class of drugs called statins. It works in two ways. Rosuvastatin works by blocking an enzyme in the liver called HMG-CoA reductase, which leads to the liver making less cholesterol. It also works by increasing the liver's uptake of cholesterol from your blood and its breakdown. Rosuvastatin comes as a tablet and a capsule. The tablet formulation for rosuvastatin was first approved by the US Food and Drug Administration (FDA) in 2003 under the brand name Crestor. Many generic versions of rosuvastatin tablets have since been approved. Rosuvastatin is also available as a capsule, which was approved in 2018 under the brand name Ezallor Sprinkle. Adults who can't easily swallow a tablet or capsule can open the capsules and sprinkle the granules onto soft food and eat it. A generic version of the capsules has not been approved.
Indications
Rosuvastatin (Crestor, Ezallor Sprinkle) is a prescription medication used to treat high cholesterol and prevent heart attacks and strokes . Rosuvastatin belongs to a class of drugs called statins. It works in two ways. Rosuvastatin works by blocking an enzyme in the liver called HMG-CoA reductase, which leads to the liver making less cholesterol. It also works by increasing the liver's uptake of cholesterol from your blood and its breakdown. Rosuvastatin comes as a tablet and a capsule. The tablet formulation for rosuvastatin was first approved by the US Food and Drug Administration (FDA) in 2003 under the brand name Crestor. Many generic versions of rosuvastatin tablets have since been approved. Rosuvastatin is also available as a capsule, which was approved in 2018 under the brand name Ezallor Sprinkle. Adults who can't easily swallow a tablet or capsule can open the capsules and sprinkle the granules onto soft food and eat it. A generic version of the capsules has not been approved.
Contraindications
Do not take rosuvastatin if you: are allergic to rosuvastatin calcium or any of the ingredients in your rosuvastatin tablet or capsule. See below for a complete list of ingredients. have liver problems.
Side Effects
Serious side effects of rosuvastatin include: Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if: you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take this medication. you have muscle problems that do not go away even after your doctor has told you to stop taking this medication. Your doctor may do further tests to diagnose the cause of your muscle problems. Your chances of getting muscle problems are higher if you: are taking certain other medicines while you take rosuvastatin are 65 years of age or older have thyroid problems (hypothyroidism) that are not controlled have kidney problems are taking higher doses of this medication Liver problems. Your doctor should do blood tests to check your liver before you start taking this medication and if you have symptoms of liver problems while you taking it. Call your doctor right away if you have any of the following symptoms of liver problems: feel unusually tired or weak loss of appetite upper belly pain dark urine yellowing of your skin or the whites of your eyes The most common side effects of rosuvastain may include: headache muscle aches and pains abdominal pain weakness nausea Additional side effects that have been reported with rosuvastatin include memory loss and confusion. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warnings
Rosuvastatin therapy should be discontinued if markedly elevated creatinine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
High Risk Groups
Drug should not be given to Pregnant Mothers, and patients suffering from Liver Malfunction. If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.
Adult Dosage
5 to 20 mg/day (12 (12.5)) As recommended. PO —
Child Dosage
No child dosage information is recorded for this medicine yet.
Neonatal Dosage
No neonatal dosage information is recorded for this medicine yet.
Drug Interactions
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your doctor before you start taking any new medicines. Taking rosuvastatin with certain other medicines may affect each other causing side effects. Especially tell your doctor if you take: cyclosporine (a medicine for your immune system) gemfibrozil (a fibric acid medicine for lowering cholesterol) darolutamide (a medicine for the treatment of prostate cancer) regorafenib (a medicine used to treat cancer of the colon and rectum) anti‑viral medicines including certain HIV or hepatitis C virus drugs such as: lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir combination of: sofosbuvir/velpatasvir/voxilaprevir dasabuvir/ombitasvir/paritaprevir/ritonavir elbasvir/grazoprevir sofosbuvir/velpatasvir glecaprevir/pibrentasvir and all other combinations with ledipasvir including ledipasvir/sofosbuvir certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole) coumarin anticoagulants (medicines that prevent blood clots, such as warfarin) niacin or nicotinic acid fibric acid derivatives (such as fenofibrate) colchicine (a medicine used to treat gout) Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.
Storage
Tabs Store at room temperature, Between 15°C-30°C. Protect from Moisture and Heat.

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