Indications, posology and method of administration
THERAPEUTIC INDICATIONS Emtricitabine is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over.
This indication is based on studies in treatment-naï ve patients and treatment-experienced patients with stable virological control. There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate. POSOLOGYAND METHOD OF ADMINISTRATION Posology: - Adults: 200 mg once daily.
If a patient misses a dose of emtricitabine within 12 hours of the time it is usually taken, the patient should take emtricitabine with or without food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of emtricitabine by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking emtricitabine, another dose should be taken. If the patient vomits more than 1 hour after taking emtricitabine they do not need to take another dose. - Elderly: There are no safety and efficacy data available in patients over the age of 65 years. However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency. - Renal insufficiency:
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency.
Dose or dose interval adjustment is required in all patients with creatinine clearance < 50 ml/min.
Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency. The safety and efficacy of the dose interval adjustments have not been clinically evaluated. Therefore, the clinical response to treatment and renal function should be closely monitored in these patients.
Table 1: Dose interval guidelines adjusted according to creatinine clearance
Creatinine clearance(CLcr) (ml/min)
≥ 50
30 – 49
15 – 29
< 15 (requiring haemodialysis)
Recommended dose interval for 200 mg hard capsules
One 200 mg hard capsule every 24 hours
One 200 mg hard capsule every 48 hours
One 200 mg hard capsule every 72 hours
One 200 mg hard capsule every 96 hours
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made. - Hepatic insufficiency:
No data are available on which to make a dose recommendation for patients with hepatic insufficiency. However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency.
If emtricitabine is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis. - Paediatric population:
The recommended dose of emtricitabine for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, once daily.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age. Therefore emtricitabine is not recommended for use in those aged less than 4 months.
No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency. Method of administration:
Emtricitabine 200 mg hard capsules should be taken once daily, orally with or without food. CONTRAINDICATIONS
Hypersensitivity to the active substance or to a
This information is for reference only. Please read the leaflet inside.
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