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FloLipid
Overview
What is FloLipid?
FLOLIPID Oral Suspension is a lipid-lowering agent that is derived synthetically from a fermentation product of
.After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an
inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to
mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.
Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1-[1α,3α,7β,8β(2,4),-8aβ]]. The empirical formula of simvastatin is CHO and its molecular weight is 418.57. Its structural formula is:
Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in
chloroform, methanol and ethanol.
FLOLIPID Oral Suspension contains either 20 mg of simvastatin per 5 mL (corresponding to 4 mg per mL) or 40 mg of simvastatin
per 5 mL (corresponding to 8 mg per mL) and the following inactive ingredients: acesulfame potassium, carboxymethylcellulose
sodium, citric acid monohydrate, ethylparaben, magnesium aluminum silicate, methylparaben, propylene glycol, propylparaben,
purified water, simethicone emulsion, sodium lauryl sulfate, sodium phosphate, diabasic, anhydrous, and strawberry flavor.
What does FloLipid look like?
What are the available doses of FloLipid?
Oral suspension: 20 mg/5 mL (4 mg per mL) and 40 mg/5 mL (8 mg per mL) ()
What should I talk to my health care provider before I take FloLipid?
How should I use FloLipid?
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 nonpharmacologic measures alone has been inadequate. In
patients with coronary heart disease (CHD) or at high risk of CHD, FLOLIPID can be started simultaneously with diet.
The usual dosage range is 5 to 40 mg/day. FLOLIPID should be taken in the evening on an empty stomach . Shake bottle well for at least 20 seconds before using. In patients with CHD or at high risk of CHD,
FLOLIPID can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day. For patients at
high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease,
the recommended starting dose is 40 mg/day. It is recommended to use FLOLIPID 40 mg/5 mL for dosages greater than or equal to 40
mg. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.
Patients should be advised to measure FLOLIPID with an accurate measuring device. A household teaspoon is not an accurate
measuring device and could lead to overdosage. A pharmacist can recommend an appropriate measuring device and can provide
instructions for measuring the correct dose.
What interacts with FloLipid?
Sorry No Records found
What are the warnings of FloLipid?
Sorry No Records found
What are the precautions of FloLipid?
Sorry No Records found
What are the side effects of FloLipid?
Sorry No records found
What should I look out for while using FloLipid?
FLOLIPID is contraindicated in the following conditions:
What might happen if I take too much FloLipid?
Significant lethality was observed in mice after a single oral dose of 9 g/m. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools.
A few cases of overdosage with simvastatin have been reported; the maximum dose taken was 3.6 g. All patients recovered without
sequelae. Supportive measures should be taken in the event of an overdose. The dialyzability of simvastatin and its metabolites in man
is not known at present.
How should I store and handle FloLipid?
FLOLIPID (simvastatin) Oral Suspension 20 mg/5 mL (4 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-401-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureFLOLIPID (simvastatin) Oral Suspension 40 mg/5 mL (8 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-402-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureStorageStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat.Do not freeze or refrigerate.Use within 30 days after openingFLOLIPID (simvastatin) Oral Suspension 20 mg/5 mL (4 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-401-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureFLOLIPID (simvastatin) Oral Suspension 40 mg/5 mL (8 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-402-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureStorageStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat.Do not freeze or refrigerate.Use within 30 days after openingFLOLIPID (simvastatin) Oral Suspension 20 mg/5 mL (4 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-401-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureFLOLIPID (simvastatin) Oral Suspension 40 mg/5 mL (8 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-402-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureStorageStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat.Do not freeze or refrigerate.Use within 30 days after openingFLOLIPID (simvastatin) Oral Suspension 20 mg/5 mL (4 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-401-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureFLOLIPID (simvastatin) Oral Suspension 40 mg/5 mL (8 mg per mL) is an off white to pinkish orange suspension with a strawberry flavor. It is supplied as follows:NDC 29273-402-04 – 150 mL amber glass bottle with a white HDPE Child Resistant ClosureStorageStore at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat.Do not freeze or refrigerate.Use within 30 days after opening
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a
specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of
HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces
VLDL and TG and increases HDL-C.
Non-Clinical Toxicology
FLOLIPID is contraindicated in the following conditions:There was no evidence of drug interactions in clinical studies in which dobutamine was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. Preliminary studies indicate that the concomitant use of dobutamine and nitroprusside results in a higher cardiac output and, usually, a lower pulmonary wedge pressure than when either drug is used alone.
Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of statin activity in plasma. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment.
The risk of myopathy, including rhabdomyolysis, is dose related.
In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with simvastatin (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] >10 times upper limit of normal [ULN]) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis (defined as myopathy with a CK >40 times ULN) in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded.
The risk of myopathy, including rhabdomyolysis, is greater in patients on simvastatin 80 mg compared with other statin therapies with similar or greater LDL-C-lowering efficacy and compared with lower doses of simvastatin. Therefore, an 80-mg dose of FLOLIPID should be used only in patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity
[see
]
If, however, a patient who is currently tolerating the 80-mg dose of FLOLIPID needs to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin, that patient should be switched to an alternative statin with less potential for the drug-drug interaction. Patients should be advised of the increased risk of myopathy, including rhabdomyolysis, and to report promptly any unexplained muscle pain, tenderness or weakness. If symptoms occur, treatment should be discontinued immediately.
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There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
All patients starting therapy with FLOLIPID, or whose dose of FLOLIPID is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing FLOLIPID. FLOLIPID therapy should be discontinued immediately if myopathy is diagnosed or suspected.
Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring. FLOLIPID therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. FLOLIPID therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
Drug Interactions
The risk of myopathy and rhabdomyolysis is increased by high levels of statin activity in plasma. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, voriconazole, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, cobicistat-containing products, or grapefruit juice . Combination of these drugs with simvastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with simvastatin must be suspended during the course of treatment.
The combined use of simvastatin with gemfibrozil, cyclosporine, or danazol is contraindicated
Caution should be used when prescribing other fibrates with simvastatin, as these agents can cause myopathy when given alone and the risk is increased when they are co-administered .
Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be exercised when prescribing simvastatin with colchicine .
The benefits of the combined use of simvastatin with the following drugs should be carefully weighed against the potential risks of combinations: other lipid-lowering drugs (other fibrates, ≥1 g/day of niacin, or, for patients with HoFH, lomitapide), amiodarone, dronedarone, verapamil, diltiazem, amlodipine, or ranolazine .
Cases of myopathy, including rhabdomyolysis, have been observed with simvastatin coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. In an ongoing, double-blind, randomized cardiovascular outcomes trial, an independent safety monitoring committee identified that the incidence of myopathy is higher in Chinese compared with non-Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses of a niacin-containing product. Caution should be used when treating Chinese patients with simvastatin in doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. It is unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients .
Prescribing recommendations for interacting agents are summarized in .
Table 1:Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
Interactions
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