Lescol XL
- Generic Name: fluvastatin sodium extended-release tablets
- Brand Name: Lescol XL
- Drug Class: HMG-CoA Reductase Inhibitors, Lipid-Lowering Agents, Statins
Lescol XL(Fluvastatin Sodium Extended-release Tablets) side effects drug center
Lescol XL Side Effects Center
What Is Lescol XL?
Lescol XL (fluvastatin sodium) is an HMG-C oA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia; reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy; reduce the risk of undergoing revascularization procedures in patients with clinically evident coronary heart disease (CHD); and to slow the progression of atherosclerosis in patients with CHD. Lescol XL is available as a generic.
What Are Side Effects of Alkindi Sprinkle?
Side effects of Alkindi Sprinkle include:
- headache,
- indigestion/heartburn,
- muscle pain,
- abdominal pain, and
- nausea
Tell your doctor all medications and supplements you use.
Dosage for Alkindi Sprinkle
The dose range of Lescol XL is 20 mg to 80 mg/ day.
Alkindi Sprinkle In Children
The safety and efficacy of Lescol XL in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials for a duration of two years. The most common adverse events observed were influenza and infections. In these limited uncontrolled studies, there was no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls. Adolescent females should be counseled on appropriate contraceptive methods while on Lescol XL therapy.
What Drugs, Substances, or Supplements Interact with Alkindi Sprinkle?
Alkindi Sprinkle may interact with other medicines such as:
- cyclosporine,
- fluconazole,
- concomitant lipid-lowering therapies,
- gemfibrozil and other fibrates,
- glyburide,
- niacin,
- phenytoin,
- warfarin and coumarin derivates, and
- colchicine
Tell your doctor all medications and supplements you use.
Alkindi Sprinkle During Pregnancy and Breastfeeding
Lescol XL is contraindicated in women who are or may become pregnant. Because of the potential for serious adverse reactions in nursing infants, breastfeeding women should not take Lescol XL.
Additional Information
Our Lescol XL (fluvastatin sodium) Extended-Release Tablets for Oral Use 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.
Lescol XL Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, fluvastatin 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, or 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;
- signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
- liver problems--upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- muscle pain;
- headache; or
- stomach pain, nausea, or indigestion.
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 Lescol XL (Fluvastatin Sodium Extended-release Tablets)
Lescol XL Professional Information
SIDE EFFECTS
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].
- Liver Enzyme Abnormalities [see WARNINGS AND PRECAUTIONS].
Clinical Studies Experience In Adult Patients
Because clinical studies on fluvastatin capsules /LESCOL XL are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of fluvastatin capsules /LESCOL XL cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice.
In the fluvastatin capsule placebo-controlled clinical trials database of 2326 patients treated with fluvastatin1 (age range 18-75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on fluvastatin capsules and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%).
In the LESCOL XL database of controlled clinical trials of 912 patients treated with LESCOL XL (age range 21-87 years, 52% women, 91% Caucasians, 4% Blacks, 5% other ethnicities) with a median treatment duration of 24 weeks, 3.9% of patients on LESCOL XL discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation were abdominal pain (0.7%), diarrhea (0.5%), nausea (0.4%), dyspepsia (0.4%) and chest pain (0.3%).
Clinically relevant adverse experiences occurring in the fluvastatin capsules and LESCOL XL controlled studies with a frequency ≥ 2%, regardless of causality, included the following:
Table 1 Clinical adverse events reported in ≥ 2% in patients treated with fluvastatin capsules /LESCOL XL and at an incidence greater than placebo in placebo-controlled trials regardless of causality (% of patients) Pooled Dosages
| Fluvastatin capsules1 N=2326 (%) | Placebo1 N=960 (%) | LESCOL XL2 N=912 (%) | ||
| Musculoskeletal | Myalgia | 5.0 | 4.5 | 3.8 |
| Arthritis | 2.1 | 2.0 | 1.3 | |
| Arthropathy | NA | NA | 3.2 | |
| Respiratory | Sinusitis | 2.6 | 1.9 | 3.5 |
| Bronchitis | 1.8 | 1.0 | 1.6 | |
| Gastrointestinal | Dyspepsia | 7.9 | 3.2 | 3.5 |
| Diarrhea | 4.9 | 4.2 | 3.3 | |
| Abdominal pain | 4.9 | 3.8 | 3.7 | |
| Nausea | 3.2 | 2.0 | 2.5 | |
| Flatulence | 2.6 | 2.5 | 1.4 | |
| Tooth disorder | 2.1 | 1.7 | 1.4 | |
| Psychiatric | Insomnia | 2.7 | 1.4 | 0.8 |
| Genitourinary | Urinary tract infection | 1.6 | 1.1 | 2.7 |
| Miscellaneous | Headache | 8.9 | 7.8 | 4.7 |
| Influenza-like symptoms | 5.1 | 5.7 | 7.1 | |
| Accidental Trauma | 5.1 | 4.8 | 4.2 | |
| Fatigue | 2.7 | 2.3 | 1.6 | |
| Allergy | 2.3 | 2.2 | 1.0 | |
| 1Controlled trials with fluvastatin capsules (20 and 40 mg daily and 40 mg twice daily) compared to placebo 2Controlled trials with LESCOL XL 80 mg Tablets as compared to fluvastatin capsules | ||||
LESCOL Intervention Prevention Study
In the LESCOL Intervention Prevention Study (LIPS), the effect of LESCOL (fluvastatin capsules) 40 mg, administered twice daily on the risk of recurrent cardiac events was assessed in 1677 patients with CHD who had undergone a percutaneous coronary intervention (PCI) procedure. This was a multicenter, randomized, double-blind, placebo-controlled study, patients were treated with dietary/lifestyle counseling and either fluvastatin capsules 40 mg (n=844) or placebo (n=833) given twice daily for a median of 3.9 years [see Clinical Studies].
Table 2 Clinical adverse events reported in ≥ 2% in patients treated with Fluvastatin Capsules /LESCOL XL and at an incidence greater than placebo in the LIPS Trial regardless of causality (% of patients)
| Fluvastatin Capsules 40 mg twice daily N=822 (%) | Placebo N=818 (%) | ||
| Cardiac disorders | Atrial fibrillation | 2.4 | 2.0 |
| Gastrointestinal disorders | Abdominal pain upper | 6.3 | 4.5 |
| Constipation | 3.3 | 2.1 | |
| Dyspepsia | 4.5 | 4.0 | |
| Gastric disorder | 2.7 | 2.1 | |
| Nausea | 2.7 | 2.3 | |
| General disorders | Fatigue | 4.7 | 3.8 |
| Edema peripheral | 4.4 | 2.9 | |
| Infections and infestations | Bronchitis | 2.3 | 2.0 |
| Nasopharyngitis | 2.8 | 2.1 | |
| Musculoskeletal and connective tissue disorders | Arthralgia | 2.1 | 1.8 |
| Myalgia | 2.2 | 1.6 | |
| Pain in extremity | 4.1 | 2.7 | |
| Nervous system disorders | Dizziness | 3.9 | 3.5 |
| Syncope | 2.4 | 2.2 | |
| Respiratory disorders | Dyspnea exertional | 2.8 | 2.4 |
| Vascular disorders | Hypertension | 5.8 | 4.2 |
| Intermittent claudication | 2.3 | 2.1 |
Clinical Studies Experience In Pediatric Patients
In patients aged < 18 years, efficacy and safety have not been studied for treatment periods longer than two years.
In two open-label, uncontrolled studies, 66 boys and 48 girls with heterozygous familial hypercholesterolemia (9-16 years of age, 80% Caucasian, 19% Other [ mixed ethnicity], 1% Asians) were treated with fluvastatin sodium administered as fluvastatin capsules 20 mg-40 mg twice daily, or LESCOL XL 80 mg extended-release tablet [see Clinical Studies and Use In Specific Populations].
Postmarketing Experience
Because adverse reactions from spontaneous reports 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 effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with fluvastatin sodium therapy.
Musculoskeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see WARNINGS AND PRECAUTIONS].
Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, hypoesthesia, dysesthesia, peripheral neuropathy, peripheral nerve palsy.
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).
Psychiatric: anxiety, insomnia, depression, psychic disturbances
Respiratory: interstitial lung disease
Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR (erythrocyte sedimentation rate) increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and non-fatal hepatic failure.
Skin: rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (e.g. nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails).
Reproductive: gynecomastia, loss of libido, erectile dysfunction.
Eye: progression of cataracts (lens opacities), ophthalmoplegia.
Laboratory abnormalities: elevated transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase and bilirubin; thyroid function abnormalities.
Read the entire FDA prescribing information for Lescol XL (Fluvastatin Sodium Extended-release Tablets)
&Copy; Lescol XL Patient Information is supplied by Cerner Multum, Inc. and Lescol XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.