Indication:
HIV infections
Adverse Reaction:
Adverse reactions-
CNS - abnormal dreams 1% asthenia 15% depressive disorders 5% dizziness 3%
headache 12% insomnia 6% neuropathy /periphral neuritis 3%
paresthesia 4%
Dermatologic - rash 15%
GI - abdominal pain 7% diarrhea 22% dyspepsia 3% nausea 16%
vomiting 8%
Lab test abnormalities - ALT 2% Bilirubin 1% creatinine kinase 10%
neutrophils 4% pancreatic amylase 1%
serum amylase 1% serum glucose 2%
triglycerides 8%
Musculoskeletal - arthalgia 2% myalgia 3%
Respiratory - increased cough 12% rhinitis 16%
Contra-Indications:
Hypersensitivity to the components
Special precautions/warnings-
Lactic acidosis/ severe hepatomegaly with steatosis- suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of
trasmsaminase elevations )
Co-infection with HIV/ and HBV - it is recommended that all patients with HIV be tested for presence of chronic HBV before initiating antiretroviral therapy
Immune reconstitution syndrome - immune redistribution syndrome has been reported in patients treated with combination of antiretroviral therapy including emtricitabine
Renal function impairment- closely monitor renal function-
Pregnancy -use emtricitabine during pregnancy only if clearly needed.
Lactation- instruct mothers not to breast feed if they are receiving emtrictabine
Children- safety and efficacy in children younger than 3 months of age have not been
established
Elderly- excecise caution in elderly patient keeping in mind the greater freqency of decreased hepatic, renal or cardiac function and of concomittant disease or other drug therapy
Monitoring- closely monitor hepatic function and laboratory follow up for at least several
months in patients who discontinue emtricitabine and or coinfected with HIV and HBV.
HIV testing is recommended.
Dosages/ Overdosage Etc:
Indications-
HIV infections
Dosage-
May be taken without regards to food.
Adults- 18 years of age and above
200mg administered once daily.
Oral solution- 240mg ( 24ml ) once daily orally
Children- 0 to 3months
Oral solution- 3mg/kg administered daily once daily orally
3months to 17 years of age-
capsules- for children weighing more than 33kg who can swallow an intact capsule,
one 200mg capsule administered once daily
oral solution- 6mg.kg up to a maximum of 240mg ( 24ml ) administered once daily
Patient Information:
1. Inform patients that some HIV medicines, including Emtrictabine may cause a rare but
serious condition called lactic acid acidosis with liver enlargement(hepatomegaly)
2. Emtricitabine is not a cure for HIV infection, and patients may continue to experience
illness associated with HIV infection, including oppurtunistic infection.
3.Patients should remain under the care of a healthcare provider when using Emtrictabine
4.Advice patients that the use of Emtrictabine has not shown to reduce the risk of
transmission of HIV to others through sexual contact or blood donation.
5.Inform patients that redistribution or body fat may occur in patients receiving
antiretroviral therapy, and the cause and long term health effects of these
conditions are not known at this time.
6. Advice patients of the importance of taking HIV medicines as prescribed
Interaction with Food:
May be taken without regards to food.
Pregnancy and lactation:
Pregnancy -
Use emtricitabine during pregnancy only if clearly needed.
Lactation-
Instruct mothers not to breast feed if they are receiving emtrictabine
Children-
Safety and efficacy in children younger than 3 months of age have not been
established
Elderly-
Excecise caution in elderly patient keeping in mind the greater freqency of decreased
hepatic, renal or cardiac function and of concomittant disease or other drug therapy
Manufacturer Details