Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
20 mg are hard gelatin capsules with ivory opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates. Cap imprinted with “TEVA” and body imprinted with “7442”. 40 mg are hard gelatin capsules with yellow opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates. Cap imprinted with “TEVA” and body imprinted with “7443”.
To date, there has been limited experience with overdosage of fluvastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required. The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present [ see Warnings and Precautions ( 5 ) ]. In the pediatric population, there have been reports of overdosage with fluvastatin sodium in children including a 2-year-old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 x 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems. In the postmarketing experience there have been reports of accidental ingestion of fluvastatin tablets in infants up to 3 years of age. In one case, increased serum CPK values were noted. There have been reports of intentional overdose in adolescents with the development of hepatic enzyme elevations, convulsions and gastroenteritis/vomiting/diarrhea.
Fluvastatin Capsules, USP are available as follows: 40 mg - Hard gelatin capsules with yellow opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates, cap imprinted with “TEVA” and body imprinted with “7443”. NDC: 72162-1034-1: 100 Capsules in a BOTTLE Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Fluvastatin Sodium 40 mg Capsule #100
| Class | Version | Type | Effective |
|---|---|---|---|
| FLUVASTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 22ca7ed4-2e69-d74c-9eff-803d6d02a7be | Product name | 4 | 20211021 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72162-1034-1 | Fluvastatin | 100 in 1 BOTTLE | CAPSULE | 100 | 101 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72162-1034-1 | EA - Each | 72162-1034 | 8c37cf78-45ff-459d-8965-52c57be661cf | 1 | 2024-06-10 |
| 0093-7443-01 | EA - Each | 0093-7443 | 7e929a90-a8c7-45ff-9b9d-e28f4f190e96 | 1 | 2013-02-13 |
| 0093-7443-56 | EA - Each | 0093-7443 | 124c9cc0-81a4-4adc-a6f5-a47aa127bc3b | 1 | 2013-02-13 |
| Product NDC | Package NDC |
|---|---|
| 72162-1034 | 72162-1034-1 |
| 0093-7443 |
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
20 mg are hard gelatin capsules with ivory opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates. Cap imprinted with “TEVA” and body imprinted with “7442”. 40 mg are hard gelatin capsules with yellow opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates. Cap imprinted with “TEVA” and body imprinted with “7443”.
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 ) ].
To date, there has been limited experience with overdosage of fluvastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required. The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present [ see Warnings and Precautions ( 5 ) ]. In the pediatric population, there have been reports of overdosage with fluvastatin sodium in children including a 2-year-old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 x 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems. In the postmarketing experience there have been reports of accidental ingestion of fluvastatin tablets in infants up to 3 years of age. In one case, increased serum CPK values were noted. There have been reports of intentional overdose in adolescents with the development of hepatic enzyme elevations, convulsions and gastroenteritis/vomiting/diarrhea.
Fluvastatin sodium, USP is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [ R *, S *-( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H -indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. Its structural formula is: C 24 H 25 FNNaO 4 M.W. 433.45 This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow, hygroscopic powder soluble in water, ethanol, and methanol. Fluvastatin Capsules, USP contain fluvastatin sodium, USP (hydrated form), equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. Active Ingredient: fluvastatin sodium, USP (hydrated form) Inactive Ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. The imprinting ink may contain potassium hydroxide.
National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics . 89(3):495-501.1992. Manson, J.M., Freyssinges, C., Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy, Reproductive Toxicology, 10(6): 439-446, 1996.
Fluvastatin Capsules, USP are available as follows: 40 mg - Hard gelatin capsules with yellow opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates, cap imprinted with “TEVA” and body imprinted with “7443”. NDC: 72162-1034-1: 100 Capsules in a BOTTLE Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Information for Patients Patients taking fluvastatin capsules should be advised that high cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel to determine goal attainment. Patients should be advised about substances they should not take concomitantly with fluvastatin capsules [ see Warnings and Precautions ( 5.1 ) ]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking fluvastatin capsules.
FDA-Approved Patient Labeling Fluvastatin (floo'' va stat' in) Capsules 20 mg, 40 mg You must read and follow all instructions before using fluvastatin capsules. Read the Patient Information every time you or a family member gets fluvastatin capsules. There may be new information. This Patient Information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about fluvastatin capsules, ask your doctor or pharmacist. What are fluvastatin capsules? Fluvastatin capsules are a prescription medicine called "statins" that lower cholesterol in your blood. They lower the "bad" cholesterol and triglycerides in your blood. They can raise your "good" cholesterol as well. Fluvastatin capsules are for people whose cholesterol does not come down enough with exercise and a low-fat diet alone. Fluvastatin capsules may be used in patients with heart disease (coronary artery disease) to: lower the chances of heart problems which would require procedures to help restore blood flow to the heart. slow the buildup of too much cholesterol in the arteries of the heart. Treatment with fluvastatin capsules has not been shown to prevent heart attacks or stroke. Fluvastatin capsules are taken one or two times a day. Who should not take fluvastatin capsules? Do not take fluvastatin capsules if you: are pregnant or think you may be pregnant, or are planning to become pregnant. Fluvastatin capsules may harm your unborn baby. If you get pregnant, stop taking fluvastatin capsules and call your doctor right away. are breast-feeding. Fluvastatin sodium can pass into your breast milk and may harm your baby have liver problems are allergic to fluvastatin capsules or any of their ingredients. The active ingredient in fluvastatin capsules is fluvastatin. See the end of this leaflet for a complete list of ingredients in fluvastatin capsules. Fluvastatin capsules have not been studied in children under 9 years of age. Before taking fluvastatin capsules, tell your doctor if you: have muscle aches or weakness drink more than 2 glasses of alcohol daily have diabetes have a thyroid problem have kidney problems Some medicines should not be taken with fluvastatin capsules. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Fluvastatin capsules and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for: your immune system cholesterol infections heart failure seizures diabetes heartburn or stomach ulcers Know all the medicines you take. Keep a list of all the medicines you take with you to show your doctor and pharmacist. How should I take fluvastatin capsules? Your doctor will prescribe the medicine that is right for you. Take fluvastatin capsules exactly as prescribed. Do not change your dose or stop fluvastatin capsules without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during treatment with fluvastatin capsules. Your dose of fluvastatin capsules may be changed based on these blood test results. Take fluvastatin capsules at the same time every evening. When fluvastatin capsules are taken twice daily, the capsules may be taken once in the morning and once in the evening. Fluvastatin capsules can be taken with or without food. Do not open fluvastatin capsules. Your doctor should start you on a low-fat and low-cholesterol diet before giving you fluvastatin capsules. Stay on this low-fat and low-cholesterol diet while taking fluvastatin capsules. If you miss a dose of fluvastatin capsules, take it as soon as you remember. Do not take fluvastatin capsules if it has been more than 12 hours since your last dose. Wait and take the next dose at your regular time. Do not take 2 doses of fluvastatin capsules at the same time. If you take too many fluvastatin capsules or overdose, call your doctor or Poison Control Center right away. Or, go to the nearest emergency room. What should I avoid while taking fluvastatin capsules? Talk to your doctor before you start any new medicines. This includes prescription and nonprescription medicines, vitamins and herbal supplements. Fluvastatin capsules and certain other medicines can interact causing serious side effects. Do not get pregnant. If you get pregnant, stop taking fluvastatin capsules right away and call your doctor. What are the possible side effects of fluvastatin capsules? When taking fluvastatin capsules, some patients may develop serious side effects, including: muscle problems. Call your health care professional right away if you experience unexplained muscle pain, tenderness, or weakness especially with fever. This may be an early sign of a rare muscle problem that could lead to serious kidney problems. The risk of muscle problems is greater in people who are 65 years of age or older, or who already have thyroid or kidney problems. The chance of muscle problems may be increased if you are taking certain other medicines with fluvastatin capsules. If you have muscle problems that do not go away even after your health care professional has advised you to stop taking fluvastatin capsules, notify your health care professional. Your health care professional may do further tests to diagnose the cause of your muscle problems. liver problems . Your doctor should do blood tests to check your liver before you start taking fluvastatin capsules, and if you have symptoms of liver problems while you take fluvastatin capsules. Call your doctor right away if you have the following symptoms of liver problems: feel tired or weak loss of appetite upper belly pain dark amber colored urine yellowing of your skin or the whites of your eyes The most common side effects of fluvastatin capsules are headache, upset stomach and stomach pain, diarrhea, flu-like symptoms, muscle pain, sinus infection, tiredness, or trouble sleeping. These side effects are usually mild and may go away. The following additional side effects have been reported with fluvastatin capsules: memory loss, and confusion. Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away. These are not all the side effects of fluvastatin capsules. Ask your doctor or pharmacist for a complete list. How should I store fluvastatin capsules? Store fluvastatin capsules at room temperature, 20° to 25°C (68° to 77°F). Protect from light. Do not keep medicine that is out of date or that you no longer need. Keep fluvastatin capsules out of the reach of children. Be sure that if you throw medicines away, they are out of the reach of children. General information about fluvastatin capsules Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use fluvastatin capsules for a condition for which they were not prescribed. Do not give fluvastatin capsules to other people, even if they have the same problem you have; they may harm them. For more information, call 1-888-838-2872. What are the ingredients in fluvastatin capsules? Active Ingredient: fluvastatin sodium (hydrated form) Inactive Ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. The imprinting ink may contain potassium hydroxide. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. E 7/2020
Fluvastatin Sodium 40 mg Capsule #100