Monograph Details

Infections & Infestations > Viral infections
EMTRIVA ORAL SOLUTION
Manufacturer
Gilead Sciences, Inc.
Legal Classification
Rx
Pharmacological Class
Nucleoside analogue (reverse transcriptase inhibitor).
Generic Name
Emtricitabine 10mg/mL; cotton candy flavor.
Also
EMTRIVA
Indications
HIV-1 infection.
Children
<3months: 3mg/kg once daily. 3months–17yrs: 6mg/kg [max 240mg (24mL)] once daily. >33kg: may use cap form. Renal impairment: reduce dose or prolong dosing interval (see literature).
Adults
≥18yrs: 240mg (24mL) once daily. Renal impairment: (CrCl 30–49mL/min): 120mg (12mL) once daily; (CrCl 15–29mL/min): 80mg (8mL) once daily; (CrCl <15mL/min): 60mg (6mL) once daily.
Precautions
Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Not for treating chronic hepatitis B; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Women, obesity, or prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity (eg, lactic acidosis). Renal impairment. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions
Avoid concomitant drugs that contain emtricitabine or lamivudine.
Adverse Reactions
Headache, GI upset, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, rhinitis; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, exacerbation of hepatitis B; also children: skin hyperpigmentation.
Extra Text
Note: Register pregnant patients exposed to emtricitabine by calling (800) 258-4263.
How Supplied
Caps—30
Soln—170mL
Additional Resources
Related Prescribing Note