siamhealth

หน้าหลัก | สุขภาพดี | สุภาพสตรี | การแปลผลเลือด | โรคต่างๆ | วัคซีน | อาหารเพื่อสุขภาพ

Dosage Forms & Strengths

Hypercholesterolemia & Mixed Dyslipidemia

Start 20-40 mg PO qHS

Dose range 20-80 mg PO qDay

If 80 mg/day needed, divide into 40 mg PO q12hr

Sustained-release (Lescol XL): 80 mg PO qDay

Patients Requiring <25% Decrease in LDL-C

20 mg PO qDay; may adjust dose based on response and tolerability not to exceed 40 mg PO q12hr (immediate release capsule) or 80 mg PO q24hr extended release tablet

Renal Impairment

CrCl <30 mL/min: Adjust dose amount; not to exceed 40 mg/day

Hepatic Impairment

Contraindicated in active liver disease or unexplained transaminase elevations

Overdose Management

Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFT's, eye lens opacities

Treatment is supportive

Contraindicated (2)

Serious - Use Alternative (11)

Significant - Monitor Closely (58)

Minor (34)

Adverse Effects

1-10%

Headache (9%)

Dyspepsia (8%)

Abdominal pain (5%)

Diarrhea (5%)

Myalgia (5%)

Fatigue (3%)

Insomnia (3%)

Nausea (3%)

Sinusitis (3%)

Bronchitis (2%)

UTI (2%)

Transaminases increased (1.1%)

<1%

Rash

Back pain

Arthralgia

Myopathy

Rhabdomyolysis

Rupture of tendon

CPK increased

Pharyngitis

Rhinitis

Cough

Constipation

Pancreatitis

Dizziness

Postmarketing Reports

Musculoskeletal: Muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis

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; also rare reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use

Psychiatric: Anxiety, insomnia, depression, psychic disturbances

Hypersensitivity reactions: Hypersensitivity syndrome including anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, increased ESR, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, and 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 nonfatal hepatic failure

Skin: Rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (eg, 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

Previous

Warnings

Contraindications

Hypersensitivity to fluvastatin

Active liver disease, or unexplained elevated transminases

Pregnancy, lactation

Cautions

Non-serious and reversible cognitive side effects may occur

Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake

Heavy alcohol use, history of liver disease, renal failure

Myopathy, risk of myopathy - incr by co-administration w/ fibrates, niacin, cyclosporine, macrolides, azole antifungals.

Withhold or discontinue treatment if myopathy develops, renal failure, or transaminase levels >3 times the upper limit of normal

Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persist despite discontinuing statin

Lipid-lowering effects additive with bile-acid binding resin or niacin

Take 2 hr after bile acid sequestrant

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: enters breast milk; contraindicated