F

famciclovir

fam-sye-klo-veer

(Apo-Famciclovir , Famvir)

Do not confuse Famvir with Femara.

classification

PHARMACOTHERAPEUTIC: Synthetic nucleoside. CLINICAL: Antiviral (see p. 70C).

Action

Inhibits viral DNA synthesis. Therapeutic Effect: Suppresses replication of herpes simplex virus, varicella-zoster virus.

Pharmacokinetics

Rapidly, extensively absorbed after PO administration. Protein binding: 20%–25%. Rapidly metabolized to penciclovir by enzymes in GI tract, liver, plasma. Eliminated unchanged in urine. Removed by hemodialysis. Half-life: 2–3 hrs (increased in severe renal failure).

Uses

Treatment of acute herpes zoster (shingles), treatment and suppression of recurrent genital herpes in immunocompetent pts, treatment of recurrent mucocutaneous herpes simplex in HIV-infected pts. Treatment of recurrent herpes labialis (cold sores) in immunocompetent pts.

Precautions

Contraindications: Hypersensitivity to penciclovir cream. Cautions: Renal impairment. Avoid use in galactose intolerance, severe lactose deficiency, or glucose-galactose malabsorption syndromes.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if excreted in breast milk. Pregnancy Category B. Children: Safety and efficacy not established. Elderly: Age-related renal impairment may require dosage adjustment.

Interactions

DRUG: None significant. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase ALT, AST, amylase, bilirubin, lipase.

Availability (Rx)

Tablets: 125 mg, 250 mg, 500 mg.

Administration/handling

PO

• Give without regard to meals. • Give with food to decrease GI distress.

Indications/routes/dosage

Acute herpes zoster (shingles)

PO: ADULTS: 500 mg q8h for 7 days. Begin within 72 hrs of rash onset.

Initial genital herpes

PO: ADULTS: 250 mg 3 times/day for 7–10 days.

Recurrent genital herpes

PO: ADULTS: 1,000 mg twice a day for 1 day.

Suppression of recurrent genital herpes

PO: ADULTS: 250 mg twice a day for up to 1 yr.

Recurrent mucotaneous/genital herpes simplex in HIV pts

PO: ADULTS: 500 mg twice a day for 7 days or 5–10 days.

Herpes labialis (cold sores)

PO: ADULTS, ELDERLY: 1,500 mg as a single dose. Initiate at first sign or symptom.

Dosage in renal impairment

Dosage and frequency are modified based on creatinine clearance and disease process.

Creatinine Clearance	Herpes Zoster	Recurrent Genital Herpes (single-day regimen)	Recurrent Genital Herpes (suppression)	Recurrent Herpes Labialis Treatment (single-day regimen)	Recurrent Orolabial or Genital Herpes in HIV Pts
40–59 ml/min	500 mg q12h	500 mg q12h	—	750 mg	—
20–39 ml/min	500 mg q24h	500 mg	125 mg q12h	500 mg	500 mg q24h
Less than 20 ml/min	250 mg q24h	250 mg	125 mg q24h	250 mg	250 mg q24h
Hemodialysis	250 mg after each hemodialysis session	250 mg after each hemodialysis session	125 mg after each hemodialysis session	250 mg after each hemodialysis session	250 mg after each hemodialysis session

Dosage in hemodialysis pts

For adults with herpes zoster, give 250 mg after each dialysis treatment; for adults with genital herpes, give 125 mg after each dialysis treatment.

Side effects

Frequent: Headache (23%), nausea (12%). Occasional (10%–2%): Dizziness, drowsiness, paresthesia (esp. feet), diarrhea, vomiting, constipation, decreased appetite, fatigue, fever, pharyngitis, sinusitis, pruritus. Rare (less than 2%): Insomnia, abdominal pain, dyspepsia, flatulence, back pain, arthralgia.

Adverse effects/toxic reactions

Urticaria, hallucinations, confusion (delirium, disorientation occur predominantly in elderly) has been reported.

Nursing considerations

Baseline assessment

Obtain baseline chemistry tests, esp. renal function.

Intervention/evaluation

Evaluate cutaneous lesions. Be alert to neurologic effects: headache, dizziness. Provide analgesics, comfort measures; esp. exhausting in elderly. Monitor renal function, hepatic enzymes, CBC.

Patient/family teaching

• Drink adequate fluids. • Fingernails should be kept short, hands clean. • Do not touch lesions with fingers to avoid spreading infection to new site. • Genital herpes: Continue therapy for full length of treatment. • Avoid contact with lesions during duration of outbreak to prevent cross-contamination. • Notify physician if lesions recur or do not improve. • Change position slowly from sitting/lying to standing to avoid dizziness. • Avoid tasks that require alertness, motor skills until response to drug is established.

famotidine

fa-moe-ta-deen

(Apo-Famotidine , Novo-Famotidine , Pepcid, Pepcid AC, Pepcid AC Maximum Strength, Ulcidine )

Do not confuse famotidine with fluoxetine or furosemide.

Fixed-combination(s)

Duexis: famotidine/ibuprofen (an NSAID): 26.6 mg/800 mg. Pepcid Complete: famotidine/calcium chloride/magnesium hydroxide (antacids): 10 mg/800 mg/165 mg.

classification

PHARMACOTHERAPEUTIC: H₂ receptor antagonist. CLINICAL: Antiulcer, gastric acid secretion inhibitor (see p. 111C).

Action

Inhibits histamine action of H₂ receptors of parietal cells. Therapeutic Effect: Inhibits gastric acid secretion (fasting, nocturnal, or stimulated by food, caffeine, insulin).

Pharmacokinetics

Route	Onset	Peak	Duration
PO	1 hr	1–4 hrs	10–12 hrs
IV	0.5 hr	0.5–3 hrs	10–12 hrs

Rapidly, incompletely absorbed from GI tract. Protein binding: 15%–20%. Partially metabolized in liver. Primarily excreted in urine. Not removed by hemodialysis. Half-life: 2.5–3.5 hrs (increased in renal impairment).

Uses

Short-term treatment of active duodenal ulcer. Prevention, maintenance of duodenal ulcer recurrence. Treatment of active benign gastric ulcer, pathologic GI hypersecretory conditions. Short-term treatment of gastroesophageal reflux disease (GERD), including erosive esophagitis. OTC formulation for relief of heartburn, acid indigestion, sour stomach. OFF-LABEL: H. pylori eradication, risk reduction of duodenal ulcer recurrence (part of multidrug regimen), stress ulcer prophylaxis in critically ill pts, relief of gastritis.

Precautions

Contraindications: Hypersensitivity to other H₂ antagonists. Cautions: Renal/hepatic impairment, elderly, thrombocytopenia.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is distributed in breast milk. Pregnancy Category B. Children: No age-related precautions noted. Elderly: Confusion more likely to occur, esp. in those with renal/hepatic impairment.

Interactions

DRUG: May decrease absorption of atazanavir, itraconazole, ketoconazole. HERBAL: None significant. FOOD: None known. LAB VALUES: Interferes with skin tests using allergen extracts. May increase serum alkaline phosphatase, AST, ALT. May decrease platelet count.

Availability (Rx)

Infusion, Premix: 20 mg in 50 ml 0.9% NaCl. Injection, Solution (Pepcid): 10 mg/ml. Powder for Oral Suspension (Pepcid): 40 mg/5 ml. Tablets: (Pepcid AC): 10 mg. (Pepcid): 20 mg, 40 mg. Tablets, Chewable (Pepcid AC Maximum Strength): 20 mg.

Administration/handling

IV

Reconstitution • For IV push, dilute 20 mg with 5–10 ml 0.9% NaCl. • For intermittent IV infusion (piggyback), dilute with 50–100 ml D₅W, or 0.9% NaCl.

Rate of Administration • Give IV push over at least 2 min. • Infuse piggyback over 15–30 min.

Storage • Refrigerate unreconstituted vials. • IV solution appears clear, colorless. • After dilution, IV solution is stable for 48 hrs if refrigerated.

PO

• Store tablets, suspension at room temperature. • Following reconstitution, oral suspension is stable for 30 days at room temperature. • Give without regard to meals. • Shake suspension well before use.

IV incompatibilities

Amphotericin B complex (Abelcet, AmBisome, Amphotec), piperacillin/tazobactam (Zosyn).

IV compatibilities

Calcium gluconate, dexamethasone (Decadron), dexmedetomidine (Precedex), dobutamine (Dobutrex), dopamine (Intropin), doxorubicin (Adriamycin), furosemide (Lasix), heparin, hydromorphone (Dilaudid), insulin (regular), lidocaine, lorazepam (Ativan), magnesium sulfate, midazolam (Versed), morphine, nitroglycerin, norepinephrine (Levophed), ondansetron (Zofran), potassium chloride, potassium phosphate, propofol (Diprivan).

Indications/routes/dosage

Duodenal ulcer

PO: ADULTS, ELDERLY: Acute therapy: 40 mg/day at bedtime or 20 mg twice daily for 4–8 wks. Maintenance: 20 mg/day at bedtime.

Peptic ulcer

PO: CHILDREN 1–16 YRS: 0.5 mg/kg/day at bedtime or 2 divided doses. Maximum: 40 mg/day.

Gastric ulcer

PO: ADULTS, ELDERLY: 40 mg/day at bedtime.

Gastroesophageal reflux disease (GERD)

PO: ADULTS, ELDERLY: 20 mg twice a day for 6 wks. CHILDREN 1–16 YRS: 1 mg/kg/day in 2 divided doses. Maximum: 40 mg 2 times/day. CHILDREN 3 MOS–11 MOS: 0.5 mg/kg/dose twice a day. CHILDREN YOUNGER THAN 3 MOS, NEONATES: 0.5 mg/kg/dose once a day.

Esophagitis

PO: ADULTS, ELDERLY, CHILDREN 12 YRS AND OLDER: 20–40 mg twice a day for up to 12 wks.

Hypersecretory conditions

PO: ADULTS, ELDERLY, CHILDREN 12 YRS AND OLDER: Initially, 20 mg q6h. May increase up to 160 mg q6h.

Acid indigestion, heartburn (OTC use)

PO: ADULTS, ELDERLY, CHILDREN 12 YRS AND OLDER: 10–20 mg q12h. May take 15–60 min before eating. Maximum: 2 doses per day.

Usual parenteral dosage

IV: ADULTS, ELDERLY, CHILDREN OLDER THAN 12 YRS: 20 mg q12h. CHILDREN 1–12 YRS: 0.25–0.5 mg/kg q12h. Maximum: 40 mg/day.

Dosage in renal impairment

Creatinine Clearance	Dosage
Less than 50 ml/min	50% normal dose or increase dosing interval to 36–48 hrs

Side effects

Occasional (5%): Headache. Rare (2% or less): Confusion, constipation, diarrhea, dizziness.

Adverse effects/toxic reactions

Agranulocytosis, pancytopenia, thrombocytopenia occur rarely.

Nursing considerations

Baseline assessment

Assess epigastric/abdominal pain.

Intervention/evaluation

Monitor daily pattern of bowel activity, stool consistency. Monitor for diarrhea, constipation, headache. Assess for confusion in elderly.

Patient/family teaching

• May take without regard to meals, antacids. • Report headache. • Avoid excessive amounts of coffee, aspirin. • If symptoms of heartburn, acid indigestion, sour stomach persist with medication, consult physician.

febuxostat

fe-bux-oh-stat

(Uloric)

Do not confuse febuxostat with Femstat.

classification

PHARMACOTHERAPEUTIC: Xanthine oxidase inhibitor. CLINICAL: Antigout agent.

Action

Decreases uric acid production by inhibiting the enzyme xanthine oxidase. Therapeutic Effect: Reduces uric acid concentrations in serum and urine.

Pharmacokinetics

Well absorbed from GI tract. Widely distributed. Protein binding: 99%. Metabolized in liver. Eliminated in urine (49%), feces (45%). Removed by hemodialysis. Half-life: 5–8 hrs.

Uses

Management of hyperuricemia in pts with gout. Not recommended for treatment of asymptomatic hyperuricemia.

Precautions

Contraindications: Concurrent use with azathioprine, mercaptopurine. Canada: Concomitant use with theophylline. Cautions: Severe renal/hepatic impairment, history of heart disease or stroke.

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: May increase concentration, toxicity of azathioprine, mercaptopurine, theophylline. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum alkaline phosphatase, AST, ALT, LDH, amylase, sodium, potassium, cholesterol, triglycerides, BUN, creatinine. May decrease platelet count, Hgb, Hct, neutrophil count. May prolong prothrombin time.

Availability (Rx)

Tablets: 40 mg, 80 mg.

Administration/handling

PO

• May give without regard to meals or antacids.

Indications/routes/dosage

◀ ALERT ▶ Recommended to take an NSAID or colchicine with initiation of therapy and continue for up to 6 mos to prevent exacerbations of gout.

Hyperuricemia

PO: ADULTS, ELDERLY: 40 mg once daily. If pt does not achieve serum uric acid level less than 6 mg/dl after 2 wks with 40 mg, may give 80 mg once daily.

Side effects

Rare (1%): Nausea, arthralgia, rash, dizziness.

Adverse effects/toxic reactions

Hepatic function abnormalities occur in 6% of pts.

Nursing considerations

Baseline assessment

Assess baseline renal/hepatic function; concomitant medication (azathioprine, mercaptopurine, theophylline) contraindicated.

Intervention/evaluation

Discontinue medication immediately if rash appears. Encourage high fluid intake (3,000 ml/day). Monitor I&O (output should be at least 2,000 ml/day). Monitor CBC, serum uric acid, renal/hepatic function levels. Assess urine for cloudiness, unusual color, odor. Assess for therapeutic response (reduced joint tenderness, swelling, redness, limitation of motion).

Patient/family teaching

• Encourage drinking 8–10 glasses (8 oz) of fluid daily while taking medication. • Report rash, chest pain, shortness of breath, symptoms suggestive of stroke. • Gout attacks may occur for several months after starting treatment (medication is not a pain reliever). • Continue taking even if gout attack occurs.

felodipine

fe-loe-di-peen

(Plendil , Renedil )

Do not confuse Plendil with Isordil, Pletal, Prilosec, or Prinivil, or Renedil with Prinivil.

Fixed-combination(s)

Lexxel: felodipine/enalapril (ACE inhibitor): 2.5 mg/5 mg, 5 mg/5 mg.

classification

PHARMACOTHERAPEUTIC: Calcium channel blocker. CLINICAL: Antihypertensive, antianginal (see pp. 62C, 79C).

Action

Inhibits calcium movement across cardiac, vascular smooth muscle cell membranes (does not depress SA, AV nodes). Potent peripheral vasodilator. Therapeutic Effect: Increases myocardial contractility, heart rate, cardiac output; decreases peripheral vascular resistance, B/P.

Pharmacokinetics

Route	Onset	Peak	Duration
PO	2–5 hrs	N/A	24 hrs

Rapidly, completely absorbed from GI tract. Protein binding: greater than 99%. Metabolized in liver. Primarily excreted in urine. Not removed by hemodialysis. Half-life: 11–16 hrs.

Uses

Management of hypertension. May be used alone or with other antihypertensives. OFF-LABEL: Management of pediatric hypertension.

Precautions

Contraindications: Hypersensitivity to felodipine or other calcium channel blocker. Cautions: Severe left ventricular dysfunction, HF, hepatic impairment, hypertrophic cardiomyopathy with outflow tract obstruction, edema, severe aortic stenosis. Concomitant CYP3A4 inhibitors (see Appendix J).

 ​Lifespan considerations

Pregnancy/Lactation: Unknown if drug crosses placenta or is distributed in breast milk. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: May experience greater hypotensive response. Constipation may be more problematic.

Interactions

DRUG: CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine) may increase concentration. HERBAL: St. John’s wort may decrease concentration. Ephedra, ginseng, yohimbe may worsen hypertension. Garlic may increase antihypertensive effect. FOOD: Grapefruit products may increase absorption, concentration. LAB VALUES: None significant.

Availability (Rx)

Tablets (Extended-Release): 2.5 mg, 5 mg, 10 mg.

Administration/handling

PO

• Give without food. • Do not cut, crush, break extended-release tablets. Swallow whole.

Indications/routes/dosage

Hypertension

PO: ADULTS: Initially, 5 mg/day as single dose. Increase by 5 mg at 2-wk intervals. Maximum: 20 mg/day. ELDERLY, PTS WITH HEPATIC IMPAIRMENT: Initially, 2.5 mg/day. Adjust dosage at no less than 2-wk intervals. Range: 2.5–20 mg/day. CHILDREN: Initially, 2.5 mg once daily. Maximum: 10 mg/day.

Side effects

Frequent (22%–18%): Headache, peripheral edema. Occasional (6%–4%): Flushing, respiratory infection, dizziness, light-headedness, asthenia (loss of strength, energy). Rare (less than 3%): Angina, gingival hyperplasia, paresthesia, abdominal discomfort, anxiety, muscle cramping, cough, diarrhea, constipation.

Adverse effects/toxic reactions

Overdose produces nausea, drowsiness, confusion, slurred speech, hypotension, bradycardia.

Nursing considerations

Baseline assessment

Assess B/P, apical pulse immediately before drug administration (if pulse is 60 or less/min or systolic B/P is less than 90 mm Hg, withhold medication, contact physician).

Intervention/evaluation

Assist with ambulation if dizziness occurs. Assess for peripheral edema behind media malleolus (sacral area in bedridden pts). Monitor pulse rate for bradycardia. Assess skin for flushing. Monitor hepatic function. Question for headache, asthenia (loss of strength, energy).

Patient/family teaching

• Do not abruptly discontinue medication. • Compliance with therapy regimen is essential to control hypertension. • To avoid hypotensive effect, go from lying to standing slowly. • Avoid tasks that require alertness, motor skills until response to drug is established. • Contact physician if palpitations, shortness of breath, pronounced dizziness, nausea occur. • Swallow tablet whole; do not crush, chew. • Avoid grapefruit products, alcohol. • Report exacerbation of angina.

fenofibrate

fen-oh-fye-brate

(Antara, Apo-Fenofibrate , Fenoglide, Lipofen, Lofibra, Novo-Fenofibrate , Tricor, Triglide)

Do not confuse Tricor with Fibricor or Tracleer.

classification

PHARMACOTHERAPEUTIC: Fibric acid derivative. CLINICAL: Antihyperlipidemic (see p. 57C).

Action

Enhances synthesis of lipoprotein lipase (VLDL). Therapeutic Effect: Increases VLDL catabolism, reduces total plasma cholesterol, LDL, VLDL, triglycerides.

Pharmacokinetics

Well absorbed from GI tract. Absorption increased when given with food. Protein binding: 99%. Metabolized in liver. Excreted in urine (60%), feces (25%). Not removed by hemodialysis. Half-life: 10–35 hrs.

Uses

Adjunct to diet for reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides (types IV and V hyperlipidemia), apo-lipoprotein B, and to increase high-density lipoprotein cholesterol (HDL-C) in pts with primary hypercholesterolemia, mixed dyslipidemia.

Precautions

Contraindications: Gallbladder disease, severe renal/hepatic dysfunction (including primary biliary cirrhosis, unexplained persistent hepatic function abnormality), breast-feeding (Fenoglide, Lipofen, Tricor, Triglide). Cautions: Anticoagulant therapy (e.g., warfarin), history of hepatic disease, renal impairment, substantial alcohol consumption, statin or colchicine therapy (increased risk of myopathy, rhabdomyolysis).

 ​Lifespan considerations

Pregnancy/Lactation: Safety in pregnancy not established. Breastfeeding not recommended. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions

DRUG: Potentiates effects of anticoagulants (e.g., warfarin). Bile acid sequestrants may impede absorption. Cyclosporine may increase concentration/risk of nephrotoxicity. Colchicine, HMG-CoA reductase inhibitors (statins) may increase risk of severe myopathy, rhabdomyolysis, acute renal failure. HERBAL: None significant. FOOD: All foods increase absorption. LAB VALUES: May increase serum creatine kinase (CK), AST, ALT. May decrease Hgb, Hct, serum uric acid, WBC count.

Availability (Rx)

Capsules: (Antara): 43 mg, 130 mg. (Lipofen): 50 mg, 150 mg. (Lofibra): 67 mg, 134 mg, 200 mg. Tablets: (Fenoglide): 40 mg, 120 mg. (Lofibra): 54 mg, 160 mg. (Tricor): 48 mg, 145 mg. (Triglide): 50 mg, 160 mg.

Administration/handling

PO

• Give Fenoglide, Lipofen, Lofibra with meals. • Antara, Tricor, and Triglide may be given without regard to food.

Indications/routes/dosage

Hypertriglyceridemia

PO (Antara): ADULTS, ELDERLY: 43–130 mg/day.

PO (Fenoglide): ADULTS, ELDERLY: 40–120 mg/day with meals.

PO (Lipofen): ADULTS, ELDERLY: 50–150 mg/day with meals.

PO (Lofibra): ADULTS, ELDERLY: 67–200 mg/day with meals.

PO (Tricor): ADULTS, ELDERLY: 48–145 mg/day.

PO (Triglide): ADULTS, ELDERLY: 50–160 mg/day.

Hypercholesterolemia, mixed hyperlipidemia

PO (Antara): ADULTS, ELDERLY: 130 mg/day.

PO (Fenoglide): ADULTS, ELDERLY: 120 mg/day with meals.

PO (Lipofen): ADULTS, ELDERLY: 150 mg/day with meals.

PO (Lofibra): ADULTS, ELDERLY: 200 mg/day with meals.

PO (Tricor): ADULTS, ELDERLY: 145 mg/day.

PO (Triglide): ADULTS, ELDERLY: 160 mg/day.

Dosage in renal impairment

Monitor renal function/lipid profile before adjusting dose. Decrease dose or increase dosing interval for pts with renal failure.

Initial doses:	Antara: 43 mg/day	Lofibra: 67 mg/day
	Fenoglide: 40 mg/day	Tricor: 48 mg/day
	Lipofen: 50 mg/day	Triglide: 50 mg/day

Side effects

Frequent (8%–4%): Pain, rash, headache, asthenia (loss of strength, energy), fatigue, flu-like symptoms, dyspepsia, nausea/vomiting, rhinitis. Occasional (3%–2%): Diarrhea, abdominal pain, constipation, flatulence, arthralgia, decreased libido, dizziness, pruritus. Rare (less than 2%): Increased appetite, insomnia, polyuria, cough, blurred vision, eye floaters, earache.

Adverse effects/toxic reactions

May increase cholesterol excretion into bile, leading to cholelithiasis. Pancreatitis, hepatitis, thrombocytopenia, agranulocytosis occur rarely.

Nursing considerations

Baseline assessment

Obtain diet history, esp. fat consumption. Obtain serum cholesterol, triglycerides, hepatic function tests, blood counts during initial therapy and periodically during treatment. Treatment should be discontinued if hepatic enzyme levels persist greater than 3 times normal limit.

Intervention/evaluation

For pts on concurrent therapy with HMG-CoA reductase inhibitors, monitor for complaints of myopathy (muscle pain, weakness). Monitor serum creatine kinase (CK). Monitor serum cholesterol, triglyceride for therapeutic response.

Patient/family teaching

• Report severe diarrhea, constipation, nausea. • Report skin rash/irritation, insomnia, muscle pain, tremors, dizziness.

fenofibric acid

fen-oh-fye-brick as-id

(Fibricor, Trilipix)

Do not confuse Fibricor with Tricor or Trilipix with Trileptal.

classification

PHARMACOTHERAPEUTIC: Fibric acid derivative. CLINICAL: Antihyperlipidemic (see p. 57C).

Action

Increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, reducing lipase activity. Therapeutic Effect: Produces alteration in size, composition of LDL allowing for greater affinity for catabolism, decreasing plasma triglycerides, cholesterol.

Pharmacokinetics

Well absorbed from GI tract. Protein binding: 99%. Does not undergo oxidative metabolism. Excreted primarily in urine. Half-life: 20 hrs.

Uses

Fibricor, Trilipix: Adjunct to diet for treatment of severely elevated serum triglycerides; adjunct for reduction of LDL-C, total cholesterol, triglycerides, apoprotein B, and increased HDL-C in primary hypercholesterolemia or mixed hyperlipidemia. Trilipix: With statin to reduce triglycerides, elevate HDL-C in pts with mixed lipidemia and/or at risk for coronary heart disease.

Precautions

Contraindications: Severe renal impairment, primary biliary cirrhosis, active hepatic disease, gallbladder disease, nursing mothers. Cautions: Anticoagulant therapy, history of hepatic disease, substantial alcohol consumption.

 ​Lifespan considerations

Pregnancy/Lactation: Safety in pregnancy not established. Avoid use in nursing mothers. Pregnancy Category C. Children: Safety and efficacy not established. Elderly: Age-related renal impairment may require monitoring.

Interactions

DRUG: Potentiates effects of anticoagulants (e.g., warfarin). Bile acid sequestrants (cholestyramine, colestipol) may impede absorption; give Trilipix 1 hr before or 4–6 hrs after dosing. Cyclosporine may increase risk of nephrotoxicity. HMG-CoA reductase inhibitors (statins) may increase risk of severe myopathy, rhabdomyolysis, acute renal failure. HERBAL: None significant. FOOD: All foods increase absorption. LAB VALUES: May increase serum creatine kinase (CK), AST, ALT. May decrease Hgb, Hct, serum uric acid, WBC count.

Availability (Rx)

Delayed-Release Capsules (Trilipix): 45 mg, 135 mg. Tablets (Fibricor): 35 mg, 105 mg.

Administration/handling

PO

• Give without regard to meals. • Do not break, crush, or cut capsule. • May be given at the same time as a statin.

Indications/route/dosage

Mixed dyslipidemia, primary hypercholesterolemia

PO: ADULTS, ELDERLY: (Trilipix): 135 mg once daily. (Fibricor): 105 mg once daily.

Hypertriglyceridemia

PO: ADULTS, ELDERLY: (Trilipix): 45–135 mg once daily. (Fibricor): 35–105 mg once daily.

Mixed lipidemia (with statin)

PO: ADULTS, ELDERLY: (Trilipix): 135 mg once daily.

Renal impairment (creatinine clearance: 30–80 ml/min)

PO: ADULTS, ELDERLY: (Trilipix): 45 mg once daily. (Fibricor): 35 mg once daily. (Contraindicated with creatinine clearance less than 30 ml/min.)

Side effects

Frequent (13%): Headache. Occasional (6%–4%): Back pain, upper respiratory tract infection, extremity pain, nausea, dizziness, diarrhea, arthralgia, dyspepsia, nasopharyngitis. Rare (3%–2%): Constipation, sinusitis, myalgia, fatigue, muscle spasm.

Adverse effects/toxic reactions

Increased risk for myopathy, rhabdomyolysis, particularly in elderly, those with diabetes, renal failure, hypothyroidism. May increase cholesterol excretion into the bile, leading to cholelithiasis. Pancreatitis, hepatitis, thrombocytopenia, agranulocytosis occur rarely.

Nursing considerations

Baseline assessment

Assess baseline cholesterol, triglycerides, hepatic function tests, blood counts during initial therapy and periodically during treatment.

Intervention/evaluation

For those on concurrent therapy with HMG-CoA reductase inhibitors, monitor for complaints of myopathy (muscle pain, weakness), including serum creatine kinase levels. Monitor cholesterol, triglyceride concentrations for therapeutic response.

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