FloLipid

Last updated on RxList: 3/17/2021
FloLipid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Flolipid?

Flolipid (simvastatin) Oral Suspension is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia; and to reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

What Are Side Effects of Flolipid?

Common side effects of Flolipid include:

Dosage for Flolipid

The dose range of Flolipid is 5 to 40 mg/day.

What Drugs, Substances, or Supplements Interact with Flolipid?

Flolipid may interact with other fibrates, azole antifungals, macrolide antibiotics, HIV protease inhibitors, antivirals, nefazodone, cobicistat-containing products, gemfibrozil, cyclosporine, danazol, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, lomitapide, colchicine, niacin-containing products, and grapefruit juice. Tell your doctor all medications and supplements you use.

Flolipid During Pregnancy and Breastfeeding

Flolipid is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Flolipid passes into breast milk. Because a small amount of another drug in this class passes into breast milk and because of the potential for serious adverse reactions in nursing infants, breastfeeding while using Flolipid is not recommended.

Additional Information

Our Flolipid (simvastatin) Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
FloLipid Consumer Information

3 pharmacies near 20147 have coupons for Flolipid (Brand Names:FloLipid for 30 Tablets)

CVS Pharmacy
CVS Pharmacy
$317.99

Est. Regular Price

$256.54

with free coupon

View Coupon
Walgreens
Walgreens
$317.99

Est. Regular Price

$257.84

with free coupon

View Coupon
Costco
Costco
$317.99

Est. Regular Price

$258.33

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

  • muscle weakness in your hips, shoulders, neck, and back;
  • trouble lifting your arms, trouble climbing or standing; or
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • nausea, stomach pain, constipation; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for FloLipid (Simvastatin Oral Suspension)

SLIDESHOW

Heart Disease: Symptoms, Signs, and Causes See Slideshow
FloLipid Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In the pre-marketing controlled clinical studies and their open extensions (2,423 patients with median duration of follow-up of approximately 18 months), 1.4% of patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: gastrointestinal disorders (0.5%), myalgia (0.1%), and arthralgia (0.1%). The most commonly reported adverse reactions (incidence ≥5%) in simvastatin controlled clinical trials were: upper respiratory infections (9.0%), headache (7.4%), abdominal pain (7.3%), constipation (6.6%), and nausea (5.4%).

Scandinavian Simvastatin Survival Study

In 4S involving 4,444 (age range 35-71 years, 19% women, 100% Caucasians) treated with 20-40 mg/day of simvastatin (n=2,221) or placebo (n=2,223) over a median of 5.4 years, adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 2.

Table 2: Adverse Reactions Reported Regardless of Causality by ≥ 2% of Patients Treated with Simvastatin and Greater than Placebo in 4S

Simvastatin
(N=2,221)
%
Placebo
(N=2,223)
%
Body as a Whole
  Edema/swelling 2.7 2.3
  Abdominal pain 5.9 5.8
Cardiovascular System Disorders
  Atrial fibrillation 5.7 5.1
Digestive System Disorders
  Constipation 2.2 1.6
  Gastritis 4.9 3.9
Endocrine Disorders
  Diabetes mellitus 4.2 3.6
Musculoskeletal Disorders
  Myalgia 3.7 3.2
Nervous System / Psychiatric Disorders
  Headache 2.5 2.1
  Insomnia 4.0 3.8
  Vertigo 4.5 4.2
Respiratory System Disorders
  Bronchitis 6.6 6.3
  Sinusitis 2.3 1.8
Skin / Skin Appendage Disorders
  Eczema 4.5 3.0
Urogenital System Disorders
  Infection, urinary tract 3.2 3.1

Heart Protection Study

In the Heart Protection Study (HPS), involving 20,536 patients (age range 40-80 years, 25% women, 97% Caucasians, 3% other races) treated with simvastatin 40 mg/day (n=10,269) or placebo (n=10,267) over a mean of 5 years, only serious adverse reactions and discontinuations due to any adverse reactions were recorded. Discontinuation rates due to adverse reactions were 4.8% in patients treated with simvastatin compared with 5.1% in patients treated with placebo. The incidence of myopathy/rhabdomyolysis was <0.1% in patients treated with simvastatin.

Other Clinical Studies

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.

Other adverse reactions reported in clinical trials were: diarrhea, rash, dyspepsia, flatulence, and asthenia.

Laboratory Tests

Marked persistent increases of hepatic transaminases have been noted [See WARNINGS AND PRECAUTIONS]. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have also been reported. About 5% of patients had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK. [See WARNINGS AND PRECAUTIONS]

Adolescent Patients (Ages 10 To 17 Years)

In a 48-week, controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10 to 17 years of age (43.4% female, 97.7% Caucasians, 1.7% Hispanics, 0.6% Multiracial) with heterozygous familial hypercholesterolemia (n=175), treated with placebo or simvastatin (10 to 40 mg daily), the most common adverse reactions observed in both groups were upper respiratory infection, headache, abdominal pain, and nausea [see Use In Specific Populations and Clinical Studies].

Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during postapproval use of simvastatin: pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting, anemia, erectile dysfunction, interstitial lung disease, rhabdomyolysis, hepatitis/jaundice, fatal and non-fatal hepatic failure, and depression.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [See WARNINGS AND PRECAUTIONS].

An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors, Cyclosporine, Or Danazol

Strong CYP3A4 inhibitors: Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4.

Elevated plasma levels of HMG-CoA reductase inhibitory activity increases the risk of myopathy and rhabdomyolysis, particularly with higher doses of simvastatin. [See WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] Concomitant use of drugs labeled as having a strong inhibitory effect on CYP3A4 is contraindicated [see CONTRAINDICATIONS]. If treatment with itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin must be suspended during the course of treatment.

Cyclosporine or Danazol: The risk of myopathy, including rhabdomyolysis is increased by concomitant administration of cyclosporine or danazol. Therefore, concomitant use of these drugs is contraindicated [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone

Gemfibrozil

Contraindicated with simvastatin [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Other fibrates

Caution should be used when prescribing with simvastatin [See WARNINGS AND PRECAUTIONS].

Amiodarone, Dronedarone, Ranolazine, Or Calcium Channel Blockers

The risk of myopathy, including rhabdomyolysis, is increased by concomitant administration of amiodarone, dronedarone, ranolazine, or calcium channel blockers such as verapamil, diltiazem, or amlodipine [See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS, and Table 3 in CLINICAL PHARMACOLOGY].

Niacin

Cases of myopathy/rhabdomyolysis have been observed with simvastatin coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. In particular, caution should be used when treating Chinese patients with simvastatin 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. [See WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]

Digoxin

In one study, concomitant administration of digoxin with simvastatin resulted in a slight elevation in digoxin concentrations in plasma. Patients taking digoxin should be monitored appropriately when simvastatin is initiated [see CLINICAL PHARMACOLOGY].

Coumarin Anticoagulants

In two clinical studies, one in normal volunteers and the other in hypercholesterolemic patients, simvastatin 20-40 mg/day modestly potentiated the effect of coumarin anticoagulants: the prothrombin time, reported as International Normalized Ratio (INR), increased from a baseline of 1.7 to 1.8 and from 2.6 to 3.4 in the volunteer and patient studies, respectively. With other statins, clinically evident bleeding and/or increased prothrombin time has been reported in a few patients taking coumarin anticoagulants concomitantly. In such patients, prothrombin time should be determined before starting simvastatin and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of simvastatin is changed or discontinued, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be exercised when prescribing simvastatin with colchicine.

Read the entire FDA prescribing information for FloLipid (Simvastatin Oral Suspension)

IMAGES

See Images

© FloLipid Patient Information is supplied by Cerner Multum, Inc. and FloLipid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors