Emtricitabine


Full Generic Medicine Info
Dosage/Direction for Use

Oral
HIV infection
Adult: In combination with other antiretrovirals: As 10 mg/mL solution: 240 mg (24 mL) once daily. As cap: 200 mg once daily.
Child: In combination with other antiretrovirals: 1-<3 months As 10 mg/mL solution: 3 mg/kg once daily; >3 months As 10 mg/mL solution: 6 mg/kg once daily. Max: 240 mg daily. In patient weighing >33 kg who are capable to swallowing capsules whole: As capsules: 200 mg once daily.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<15200 mg as cap every 96 hours or 60 mg as solution (6 mL) every 24 hours.
15-29200 mg as cap every 72 hours or 80 mg as solution (8 mL) every 24 hours.
30-49 200 mg as cap every 48 hours or 120 mg as solution (12 mL) every 24 hours.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
Patient with severe immune deficiency; chronic Hepatitis B. Renal impairment. Children. Pregnancy and lactation. Monitoring Parameters Monitor viral load, CD4, LFT, serum creatinine. Perform Hepatitis B testing prior to initiation of therapy.
Adverse Reactions
Significant: Immune reconstitution syndrome, severe acute exacerbations of Hepatitis B, hyperpigmentation (children). Blood and lymphatic system disorders: Anaemia, neutropenia. Ear and labyrinth disorders: Otitis media. Gastrointestinal disorders: Diarrhoea, vomiting, nausea, abdominal pain, gastroenteritis, dyspepsia. General disorders and administration site conditions: Weakness, fever Immune system disorders: Allergic reaction. Infections and infestations: Infection. Investigations: Increased creatine phosphokinase, increased serum triglycerides, increased amylase, increased serum transaminases. Metabolism and nutrition disorders: Hyperglycaemia. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Nervous system disorders: Dizziness, headache, paraesthesia. Psychiatric disorders: Depression, insomnia, abnormal dreams. Respiratory, thoracic and mediastinal disorders: Cough, rhinitis, pneumonia, sinusitis, upper respiratory tract infection, pharyngitis. Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Lactic acidosis, severe hepatomegaly with steatosis.
Drug Interactions
Increased serum concentration of either emtricitabine or co-administered drugs that are eliminated by active tubular secretion. May enhance the adverse effect with lamivudine. May diminish therapeutic effect of cladribine. May decrease serum concentration with orlistat.
Action
Emtricitabine, a synthetic nucleoside analogue of cytidine, is phosphorated intracellularly to form emtricitabine 5'-triphosphate, which interferes with HIV viral RNA dependent DNA polymerase thereby inhibiting viral replication.
Absorption: Rapidly and extensively absorbed from the gastrointestinal tract. Bioavailability: 93% (cap); 75% (solution). Time to peak plasma concentration: 1-2 hours.
Distribution: Crosses placenta, enters breast milk. Plasma protein binding: <4%.
Metabolism: Metabolised minimally via oxidation and glucuronide conjugation. Phosphorated intracellularly to emtricitabine 5'-triphosphate.
Excretion: Via urine (86% as unchanged drug, 13% as metabolites, 9% as oxidative metabolite, 4% as glucuronide metabolite); faeces (14%). Elimination half-life: Approx 10 hours (emtricitabine). Intracellular half-life: 39 hours (emtricitabine 5'-triphosphate).
Storage
Oral: Cap: Store at 25°C. Solution: Store between 2-8°C.
CIMS Class
Antivirals
ATC Classification
J05AF09 - emtricitabine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on emtricitabine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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