Emtricitabine

Indications
 Oral
HIV infection
Adult: Combined with other antiretrovirals: ≥18 yr: As 10 mg/ml solution: 240 mg (24 ml) once daily; as capsules: 200 mg once daily.
Child: Combined with other antiretrovirals: 4 mth -18 yr: As 10 mg/ml solution, 6 mg/kg once daily to a max of 240 mg daily; as capsules, 200 mg once daily (for children >33 kg who are capable to swallowing capsules whole).
Renal impairment: Haemodialysis: 200 mg as capsule every 96 hr or 60 mg as solution (6 ml) every 24 hr (For dialysis day, give dose after dialysis).
CrCl (ml/min)Dosage Recommendation
30-49200 mg as capsule every 48 hr or 120 mg as solution (12 ml) every 24 hr
15-29200 mg as capsule every 72 hr or 80 mg as solution (8 ml) every 24 hr
<15200 mg as capsule every 96 hr or 60 mg as solution (6 ml) every 24 hr
Contraindications
 Lactation. Not to be used with other emtricitabine or lamivudine containing preparations.
Warnings / Precautions
 Pregnancy. Renal impairment. Hepatomegaly, hepatic steatosis, hepatitis, hepatic impairment or at risk for liver disease. Patients co-infected with hepatitis C and HIV and on αinterferon and ribavirin therapy. Test for presence of chronic HBV before initiating therapy. If emtricitabine is discontinued in patients co-infected with HIV and HBV, monitor hepatic function for several months for acute exacerbation of hepatitis. Discontinue therapy if there is a rapid rise in aminotransferase concentrations, progressive hepatomegaly or steatosis, metabolic or lactic acidosis of unknown cause. Patient to seek medical advice if there is joint aches or stiffness or difficulty in movement. Monitor child exposed in utero to combination drug for possible mitochondrial dysfunction.
Adverse Reactions
 Diarrhoea, nausea, vomiting, dyspepsia, abdominal pain, elevated amylase, lipase, creatine kinase or LFT, anaemia, headache, insomnia, dizziness, abnormal dreams, rash, hyper-pigmentation, asthenia, pain, osteonecrosis, metabolic abnormalities (e.g. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), hyperbilirubinaemia, lipodystrophy, immune reconstitution syndrome, neutropenia, anaemia.
Potentially Fatal: Lactic acidosis and severe hepatomegaly with steatosis.
Overdose Reactions
 Treatment is supportive and monitor for signs of toxicity. Haemodialysis may be useful.
Drug Interactions
 Increased serum concentration of emtricitabine or co-administered drug if taken with drugs that are eliminated by active tubular secretion. Increased risk of peripheral neuropathy with bortezomib.
Potentially Fatal: Do not use emtricitabine with lamivudine due to similar resistance profile. Increased risk if lactic acidosis with α-interferon.
See Below for More emtricitabine Drug Interactions
Mechanism of Actions
 Emtricitabine, a synthetic nucleoside analogue of cytidine, undergoes phosphorylation intracellularly to emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate then competes with deoxycytidine 5'-triphosphate and is incorporated into viral DNA which results in chain termination. It has activity against HIV-1 and HIV-2 viruses as well as hepatitis B virus (HBV).
Absorption: Rapidly and well absorbed from GI tract; peak plasma concentrations achieved in 1-2 hours. Bioavailability: 93% (capsules); 75% (oral solution).
Distribution: Protein binding: < 4%, independent of concentration.
Metabolism: Limited metabolism.
Excretion: Excreted largely unchanged in the urine and to a lesser extent in the faeces. Plasma elimination half-life: 10 hr.
Administration
 May be taken with or without food.
Storage Conditions
 Oral: Capsule: Store between 15-30°C (59-86°F). Oral Solution: Store refrigerated, between 2-8°C (36-46°F), use within 3 mth if stored between 15-30 °C (59-86 °F).
ATC Classification
 J05AF09 - emtricitabine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Storage
 Oral: Capsule: Store between 15-30°C (59-86°F). Oral Solution: Store refrigerated, between 2-8°C (36-46°F), use within 3 mth if stored between 15-30 °C (59-86 °F).
Available As
  • Emtricitabine 200 mg

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