Lamivudine + Zidovudine


Concise Prescribing Info
Indications/Uses
HIV infection.
Dosage/Direction for Use
Adult : PO Each tab contains lamivudine 150 mg and zidovudine 300 mg: >30 kg: 1 tab bid.
Dosage Details
Oral
HIV infection
Adult: Each tab contains lamivudine 150 mg and zidovudine 300 mg: >30 kg: 1 tab bid.
Child: 14-21 kg: One-half tab bid; 22-30 kg: One-half tab in the morning, 1 tab at night, or one-half tab tid; >30 kg: 1 tab bid.
Renal Impairment
CrCl (mL/min) Dosage
≤50 Not recommended, use separate preparations.
Hepatic Impairment
Severe: Not recommended, use separate preparations.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Abnormally low neutrophil counts (<0.75 x 109/L) or Hb levels (<7.5 g/dL or 4.65 mmol/L). Lactation. Concomitant use w/ interferon alfa (w/ or w/o ribavirin) in HIV and hepatitis B or C virus co-infected patients.
Special Precautions
Patient w/ poor bone marrow reserve prior to treatment; obese women w/ hepatomegaly, hepatitis or other risk factors for liver disease and hepatic steatosis; hepatitis B or C virus co-infection; history or risk factors for pancreatitis. Renal and severe hepatic impairment. Childn. Pregnancy.
Adverse Reactions
Abdominal pain, nausea, vomiting, diarrhoea, dizziness, headache, fever, rash, alopecia, malaise, myalgia, insomnia, cough, nasal symptoms, arthralgia, musculoskeletal pain, immune reconstitution syndrome, lipodystrophy, metabolic abnormalities (e.g. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), mitochondrial dysfunction (e.g. abnormal behaviour, anaemia, convulsions, hyperlipasaemia, hypertonia, neutropenia), osteonecrosis; increased creatine phosphokinase, liver enzymes, bilirubin and serum amylase; symptomatic myopathy and myositis. Rarely, rhabdomyolysis, pancreatitis, cardiomyopathy.
Potentially Fatal: Lactic acidosis, hepatomegaly w/ steatosis; haematologic toxicity (severe anaemia, neutropenia).
MonitoringParameters
Monitor haematological parameters (e.g. CBC w/ platelet count); observe for appearance of opportunistic infections and signs and symptoms of pancreatitis. Periodically monitor LFTs and for several mth following discontinuation of therapy for patients co-infected w/ hepatitis B virus and HIV.
Drug Interactions
Cross-resistance may develop when given w/ emtricitabine. Exacerbation of anaemia w/ concomitant use of zidovudine w/ ribavirin. Increased adverse effects to zidovudine w/ nephrotoxic or myelosuppressive drugs (e.g. systemic pentamide, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine, doxorubicin). Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Antagonistic effect when zidovudine is used concomitantly w/ stavudine or doxorubicin.
Potentially Fatal: Risk of hepatic decompensation when used concomitantly w/ interferon alfa (w/ or w/o ribavirin) in HIV and hepatitis B or C virus co-infected patients.
Action
Description: Lamivudine and zidovudine synergistically reduce viral resistance and inhibit reverse transcriptase via DNA chain termination and delay the emergence of mutations conferring resistance.
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Delayed absorption w/ food. Bioavailability: 80-87% (lamivudine); approx 60-70% (zidovudine). Time to peak plasma concentration: Approx 1 hr.
Distribution: Crosses the blood-brain barrier and placenta; enters breast milk. Detected in semen (zidovudine). Volume of distribution: 1.3 L/kg (lamivudine); 1-2.2 L/kg (zidovudine). Plasma protein binding: Up to 36% (lamivudine); 34-38% (zidovudine).
Metabolism: Both are metabolised intracellularly to the active triphosphate form. Zidovudine undergoes hepatic metabolism, mainly to the inactive glucuronide.
Excretion: Via urine, mainly as unchanged drug. Elimination half-life: 5-7 hr (lamivudine); 0.5-3 hr (zidovudine).
Chemical Structure

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Click on icon to see table/diagram/image
Storage
Store between 2-30°C.
MIMS Class
ATC Classification
J05AR01 - zidovudine and lamivudine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Disclaimer: This information is independently developed by MIMS based on Lamivudine + Zidovudine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Lamivudine & Zidovudine DHA
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