Fluvastatin sodium API

Haorui supplies high quality Fluvastatin sodium API produced by our GMP facility that has been successfully inspected by the FDA. We offer competitive prices and support our products with reliable technical and regulatory services.  Fluvastatin sodium API is available from R&D to commercial quantities. Please contact us for more details.

  The following information is provided for general information purposes ONLY.

 

What is Fluvastatin sodium?
Fluvastatin (Fluvastatin sodium, Canef) is in a class of medications called HMG-CoA reductase inhibitors (statins); used to treat hypercholesterolemia and to prevent cardiovascular disease. It has also been shown to exhibit antiviral activity against Hepatitis C.
How does Fluvastatin sodium work?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph. Fluvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and certain other fatty substances in the blood. Fluvastatin Sodium is indicated as an adjunct to diet for the reduction of elevated total-C, LDL-C, apo B and TG levels in patients with primary hypercholesterolaemia and mixed dyslipidaemia (Fredrickson types IIa and IIb). Fluvastatin sodium reduces the amount of cholesterol produced in the body. In people with high cholesterol it can help to prevent certain heart and circulation events such as a heart attack or stroke. It may also be useful in reducing the chances of having certain heart and circulation events, such as a heart attack or stroke, in people who have already had them. Fluvastatin Sodium is also indicated to slow the progression of coronary atherosclerosis in patients with primary hypercholesterolaemia and concomitant coronary heart disease who do not adequately respond to dietary control. Fluvastatin Sodium is also indicated in patients with coronary heart disease for the secondary prevention of coronary events after percutaneous coronary intervention
Who should not use Fluvastatin sodium?
Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you: are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine drink alcohol heavily have had muscular toxicity caused by a statin or a fibrate have or have had liver problems have risk factors for developing muscle problems such as if you are over 70 years of age, have kidney problems, have hypothyroidism, have muscle disorders or have a family history of muscle disorders Furthermore, the prescriber may not prescribe this medicine for someone who is under 18 years of age. As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests: to determine whether or not the medicine is suitable and whether it must be prescribed with extra caution to check that this medicine is having the desired effect to check that this medicine is not having any undesired effects Over time it is possible that Fluvastatin sodium can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Fluvastatin sodium has become unsuitable, it is important that the prescriber is contacted immediately.
How should I use Fluvastatin sodium?
Prior to initiating Fluvastatin Sodium, secondary causes of hypercholesterolaemia should be excluded, and the patient placed on a standard cholesterol-lowering diet. Dietary therapy should be continued during treatment. •Dose recommendations for lipid lowering effect The recommended starting dose is 40 mg (1 capsule Fluvastatin Sodium 40 mg) once daily in the evening, although a dose of 20 mg fluvastatin (1 capsule Fluvastatin Sodium 20 mg) once daily may be adequate in mild cases. Most patients will require a dose of 20 mg to 40 mg once daily but the dose may be increased to 80 mg daily (1 tablet Fluvastatin Sodium XL 80 mg or 1 capsule Fluvastatin Sodium 40 mg twice daily), individualized according to baseline LDL-C levels and the recommended goal of therapy to be accomplished. The maximum recommended daily dose is 80 mg. The maximum lipid-lowering effect with a given dose of the drug is achieved within 4 weeks. Doses should be adjusted according to the patient's response and dose adjustment made at intervals of 4 weeks or more. The therapeutic effect of Fluvastatin Sodium is maintained with prolonged administration. For patients requiring a dose of 40 mg twice daily, a calendar pack of 56 Fluvastatin Sodium Capsules 40 mg is available containing morning and evening doses in marked blister strips Fluvastatin Sodium is efficacious in monotherapy or in combination with bile acid sequestrants. When Fluvastatin Sodium is used in combination with cholestyramine or other resins, it should be administered at least 4 hours after the resin to avoid a significant interaction due to binding of the drug to the resin. Minimal data exist to support the efficacy and safety of Fluvastatin Sodium in combination with nicotinic acid or fibrates. •Dose recommendations for slowing the progression of coronary atherosclerosis In a study in patients with primary hypercholesterolaemia and concomitant coronary heart disease 40 mg daily slowed the progression of coronary atherosclerosis. •Dose recommendations for the secondary prevention of coronary events after percutaneous coronary intervention In patients with coronary heart disease after percutaneous coronary intervention, the dose is 80 mg daily. Patients with impaired kidney function Fluvastatin is cleared by the liver, with less than 6% of the administered dose excreted into the urine. The pharmacokinetics of fluvastatin remain unchanged in patients with mild to severe renal insufficiency (creatinine > 260 µmol/L). No dose adjustments are therefore necessary in these patients. Patients with impaired liver function Fluvastatin Sodium is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases. USE IN THE ELDERLY There is no evidence of reduced tolerability or altered dosage requirements in elderly patients. USE IN CHILDREN As there is no experience with the use of Fluvastatin Sodium in individuals less than 18 years of age, its use is contraindicated in this group.
What happens if I miss a Fluvastatin sodium dose?
Take the missed Fluvastatin sodium dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What happens if I overdose?
The experience with overdoses of Fluvastatin Sodium is very limited. Should an accidental overdosage occur, administration of activated charcoal is recommended. In the case of a very recent oral intake gastric lavage may be considered. Treatment should be symptomatic.
What should I avoid while using Fluvastatin sodium?
Before taking fluvastatin, tell your doctor and pharmacist if you are allergic to fluvastatin or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin; cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); diclofenac (Cataflam, Voltaren); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); glyburide (DiaBeta, Glynase, Micronase); ketoconazole (Nizoral); omeprazole (Prilosec); other cholesterol-lowering medications such as fenofibrate (Tricor) and gemfibrozil (Lopid); phenytoin (Dilantin); ranitidine (Zantac); rifampin (Rifadin, Rimactane); and spironolactone (Aldactone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. if you are taking cholestyramine (Questran), take it at least 4 hours before fluvastatin. tell your doctor if you have liver disease. Your doctor will probably tell you not to take fluvastatin. tell your doctor if you drink large amounts of alcohol and if you have ever had liver or have or ever had diabetes or thyroid or kidney disease. tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking fluvastatin, stop taking fluvastatin and call your doctor immediately. Fluvastatin may harm the fetus. do not breastfeed while you are taking this medication. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fluvastatin. ask your doctor about the safe use of alcoholic beverages while you are taking fluvastatin. Alcohol can increase the risk of serious side effects.
What are the possible side effects of Fluvastatin sodium?
Fluvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: headache heartburn difficulty falling asleep or staying asleep sinus pain cough Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: muscle pain, tenderness, or weakness lack of energy fever yellowing of the skin or eyes pain in the upper right part of the stomach nausea extreme tiredness unusual bleeding or bruising loss of appetite flu-like symptoms rash hives itching difficulty breathing or swallowing swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs hoarseness pain during urination frequent urge to urinate Fluvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What other drugs will affect Fluvastatin sodium?
The following medicines may interact with Fluvastatin sodium: amlodipine bezafibrate ciclosporin cimetidine ciprofibrate colchicine colestyramine erythromycin fluconazole gemfibrozil glibenclamide itraconazole nicotinic acid omeprazole phenytoin ranitidine rifampicin warfarin The following types of medicine may interact with Fluvastatin sodium: bile acid sequestrants coumarin anticoagulants fibrates immunosuppressant medicines liver enzyme inhibitors nicotinic acid derivatives
What special dietary instructions should I follow?
Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.
Where can I get more information?
If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider
Fluvastatin sodium Storage
Do not store above 25°C.
Nursing Mothers use of Fluvastatin sodium
In the case of Fluvastatin sodium, women who are breast-feeding must not take this medicine Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.
Pregnancy and use of Fluvastatin sodium
In the case of Fluvastatin sodium you must not take Fluvastatin sodium during pregnancy. If you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while taking Fluvastatin sodium This medicine is not suitable during pregnancy. It is essential that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine. If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.
Disclaimer:
Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.