Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) are inadequate.
Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
Prior to initiating treatment with fluvastatin, patients should be placed on a standard cholesterol-lowering diet, which should be continued during treatment.
Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished.
The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of <25% a starting dose of 20 mg may be used as one capsule in the evening. For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening. The dose may be up-titrated to 80 mg daily, administered as a single dose (one fluvastatin 80 mg prolonged-release tablet) at any time of the day or as one 40 mg capsule given twice daily (one in the morning and one in the evening).
The maximum lipid-lowering effect with a given dose is achieved within 4 weeks. Dose adjustments should be made at intervals of 4 weeks or more.
In patients with coronary heart disease after percutaneous coronary interventions the appropriate daily dose is 80 mg.
Fluvastatin is efficacious in monotherapy. When fluvastatin is used in combination with cholestyramine or other resins, it should be administered at least 4 hours after the resin to avoid significant interaction due to binding of the drug to the resin. In cases where co-administration with a fibrate or niacin is necessary, the benefit and the risk of concurrent treatment should be carefully considered (for use with fibrates or niacin see section 4.5).
Prior to initiating treatment with fluvastatin in children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia, the patient should be placed on a standard cholesterol-lowering diet, and continued during treatment.
The recommended starting dose is one 20 mg capsule. Dose adjustments should be made at 6-week intervals. Doses should be individualised according to baseline LDL-C levels and the recommended goal of therapy to be accomplished. The maximum daily dose administered is 80 mg either as immediate-release capsules 40 mg twice daily or as one 80 mg prolonged-release tablet once daily.
The use of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents has not been investigated.
Fluvastatin has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.
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.
No dose adjustments are therefore necessary in these patients, however, due to limited experience with doses >40mg/day in case of severe renal impairment (CrCL <0.5 mL/sec or 30 mL/min), these doses should be initiated with caution.
Fluvastatin is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases (see sections 4.3, 4.4 and 5.2).
No dose adjustments are necessary in this population.
Fluvastatin Capsules can be taken with or without meals and should be swallowed as whole with a glass of water.
To date there has been limited experience with overdose of fluvastatin. Specific treatment is not available for fluvastatin overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests and serum CK levels should be monitored.
OPA/Al/PVC/Al blister: 3 years.
HDPE bottle: 3 years.
After first opening of the HDPE bottle: 4 months.
OPA/Al/PVC/Al blister: Do not store above 25°C.
HDPE bottle: Do not store above 25°C.
For storage conditions after first opening of the medicinal product, see section 6.3.
Store in the original package in order to protect from light.
OPA/Al/PVC/Al blister: 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 490 hard capsules.
HDPE bottle with PP cap: 98 hard capsules.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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