Thông tin kê toa tóm tắt
Chỉ định/Công dụng
HIV infection w/ other antiretrovirals.
Liều dùng/Hướng dẫn sử dụng
Adult : PO Combined w/ other antiretrovirals: ≥18 yr: As 10 mg/mL soln: 240 mg once daily; As cap: 200 mg once daily.
Dosage Details
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).
<15200 mg as capsule every 96 hr or 60 mg as solution (6 ml) every 24 hr
15-29200 mg as capsule every 72 hr or 80 mg as solution (8 ml) every 24 hr
30-49200 mg as capsule every 48 hr or 120 mg as solution (12 ml) every 24 hr
Cách dùng
May be taken with or without food.
Chống chỉ định
Lactation. Not to be used with other emtricitabine or lamivudine containing preparations.
Thận trọng
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.
Phản ứng phụ
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.
Quá liều
Treatment is supportive and monitor for signs of toxicity. Haemodialysis may be useful.
Tương tác
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.
Tác dụng
Description: 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.
Bảo quản
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).
Phân loại MIMS
Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Emtricitabine từ nhiều nguồn tài liệu tham khảo và được cung cấp chỉ cho mục đích tham khảo. Việc sử dụng điều trị và thông tin kê toa có thể khác nhau giữa các quốc gia. Vui lòng tham khảo thông tin sản phẩm trong MIMS để biết thông tin kê toa cụ thể đã qua phê duyệt ở quốc gia đó. Mặc dù đã rất nỗ lực để đảm bảo nội dung được chính xác nhưng MIMS sẽ không chịu trách nhiệm hoặc nghĩa vụ pháp lý cho bất kỳ yêu cầu bồi thường hay thiệt hại nào phát sinh do việc sử dụng hoặc sử dụng sai các thông tin ở đây, về nội dung thông tin hoặc về sự thiếu sót thông tin, hoặc về thông tin khác. © 2020 MIMS. Bản quyền thuộc về MIMS. Phát triển bởi MIMS.com
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