Names and pronunciation
(em-tri-sit′uh-bean) Emtriva
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Individual generic drug information
Extracted information for emtricitabine only.
(em-tri-sit′uh-bean) Emtriva
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Func. class.: Antiretroviral
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Chem. class.: Nucleoside reverse transcriptase inhibitor (NRTI)
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ACTION: A synthetic nucleoside analog of cytosine; inhibits replication of HIV virus by competing with the natural substrate and then becoming incorporated into cel- lular DNA by viral reverse transcriptase, thereby terminating the cellular DNA chain
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USES: HIV-1 infection with other antiretrovirals
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Unlabeled uses: HBV infection with HIV, HIV prophylaxis
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Extracted information for emtricitabine only.
CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, geriatric patients, renal disease, lactic acidosis
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Black Box Warning: Hepatic insufficien- cy, chronic hepatitis B virus (HBV) Black Box Warning: Hepatotoxicity: do not use in those with risk factors such as alcoholism; discontinue if hepatotoxicity occurs • Hepatitis B and HIV coinfection (unla- beled); perform HBV screening in any pa- tient who has HIV to ensure appropriate treatment; avoid single-drug treatments in HBV • Pregnancy/breastfeeding: use if clearly needed; register pregnant women in the Antiretroviral Pregnancy Registry at 800- 258-4263; to reduce the risk of postnatal transmission, HIV-infected mothers are advised to avoid breastfeeding Black Box Warning: Hepatotoxicity: to notify prescriber of dark urine, yellowing of skin/eyes, clay-colored stools, anorex- ia, nausea, vomiting • To report planned or suspected preg- nancy; not to breastfeed while taking product
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SIDE EFFECTS CNS: Headache, abnormal dreams, depression, dizziness, insomnia, neuropa- thy, paresthesia, asthenia, weakness GI: Nausea, vomiting, diarrhea, anorexia, abdominal pain, dyspepsia, hepatomeg- aly with steatosis (may be fatal) INTEG: Rash, skin discolorization MS: Arthralgia, myalgia RESP: Cough SYST: Change in body fat distribution, lactic acidosis, immune reconstitution syndrome
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INTERACTIONS Decrease: emtricitabine level—interferons • Complex interactions—ribavirin, cau- tious use Drug/Lab Test Increase: AST/ALT, glucose, amylase, bili- rubin, CK, lipase Decrease: neutrophils
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Extracted information for emtricitabine only.
DOSAGE AND ROUTES • Adult: PO Capsules 200 mg/day; oral solution 240 mg (24 mL)/day • Adolescent/child >33 kg: PO Capsules 200 mg/day; child 3 mo-17 yr: oral solution 6 mg/kg/day, max 240 mg (24 mL) • Infants <3 mo: PO oral solution 3 mg/ kg daily, do not use capsules Renal dose • Adult: PO Capsules CCr 30-49 mL/min, 200 mg q48hr; oral solution 120 mg q24hr; cap- sules CCr 15-29 mL/min, 200 mg q72hr; oral solution 80 mg q24hr; capsules CCr <15 mL/ min, 200 mg q96hr; oral solution 60 mg q24hr
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Available forms: Capsules 200 mg; oral solution 10 mg/mL
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Administer: • Give without regard to meals • Refrigerate oral solution • Oral capsules and solution not inter- changeable • Store capsules at 77°F (25°C); oral solution refrigerated, use within 3 mo
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Extracted information for emtricitabine only.
Assess: • HIV: monitor for infections and im- provement in symptoms of HIV • Renal/hepatic function tests: AST, ALT, bilirubin, amylase, lipase, triglycer- ides periodically during treatment • Lactic acidosis, severe hepatomeg- aly with steatosis: if lab reports confirm these conditions, discontinue treatment; may be fatal; more common in females or those who are overweight; monitor lactic acid levels, LFTs
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Evaluate: • Therapeutic response: decreased signs, symptoms of HIV; decreased viral load, increased CD4 counts
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That GI complaints resolve after 3-4 wk of treatment • That product must be taken at same time of day to maintain blood level; that solution and capsule are not interchangeable; that if dose is missed, to take as soon as remem- bered; not to double doses; not to share with others, refrigerate oral solution • That product will control symptoms but is not a cure for HIV; patient still infectious, may pass HIV virus on to others; that other products may be necessary to prevent other infections; to practice safe sex and use a condom; not to share needles or donate blood • That changes in body fat distribution may occur • Lactic acidosis: to notify prescriber immediately if fatigue, muscle aches/ pains, abdominal pain, difficulty breathing, nausea, vomiting, change in heart rhythm occur
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Extracted information for emtricitabine only.
PHARMACOKINETICS Rapidly, extensively absorbed; peak 1-2 hr; protein binding <4%; excreted unchanged in urine (86%), feces (14%); half-life 10 hr
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Filter the extracted dose blocks for this individual drug.
• Adult: PO Capsules 200 mg/day; oral solution 240 mg (24 mL)/day
Candidate age grouping · source page 462
• Adult: PO Capsules CCr 30-49 mL/min, 200 mg q48hr; oral solution 120 mg q24hr; cap- sules CCr 15-29 mL/min, 200 mg q72hr; oral solution 80 mg q24hr; capsules CCr <15 mL/ min, 200 mg q96hr; oral solution 60 mg q24hr
Candidate age grouping · source page 462