Antivirals, Reverse Transcriptase Inhibitors

Human immunodeficiency virus (HIV) infection, Mother-to-child transmission of HIV-1 infection (prophylaxis)

FDA Pregnancy Category C

Pediatrics

Zidovudine is  approved  for use in children at birth up to 12 years of age.

Geriatrics

Studies have not been performed to determine the safety and effective­ness of zidovudine in the geriatric population.

Dental

The bone marrow-depressant effects of zidovudine may result in an  increased incidence of certain microbial infections and delayed heal­ing.

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Hypersensitivity to zidovudine or any of the components of the for­mulation

Risk-benefit should be considered when the following medical problems exist:

Obesity, Prolonged nucleoside exposure or Risk factors for hepatic disease, Bone marrow depression, Folic acid deficiency, Vitamin B₁₂ deficiency, Hepatic function impairment

Drug Interactions

Atovaqune, Blood dyscrasia-causing medication, Bone marrow depressants, other, Radiation therapy, Clarithromycin, Combination drugs that contain Zidovudine, Doxorubicin, Fluconazol, Ganciclovir, Hepatic glucuronidation-metabolized medications, other, Interferon alfa, Lamivudine, Methadone, Nelfinavir, Rifampin, Ritonavir, Phenytoin, Probenecid, Ribavirin, Stavudine (d4T), Valproic acid

Human immunodefIciency virus (HIV) infection (treatment)-

Oral, 600 mg of zidovudine daily in divided doses (300 mg every twelve hours or 200 mg every eight hours).

Note: Patients with end-stage renal disease may require a reduction in dosage to 300 mg per day.

Mother-to-child transmission of HIV-1  infection (prophylaxis)-

Oral, 100 mg five times a day, 200 mg every eight hours, or 300 mg every twelve hours beginning after fourteen weeks of gestation and continuing until  the start of labor. At that time, intravenous zidovudine should be administered (see Zidovudine Injection USP).

HIV infection (treatment)-

Children up to 6 weeks of age: Oral, 2 mg per kg of body weight every six hours.

Children 6 weeks to 12 years of age: Oral, 160 mg per square meter of body surface area every eight hours.

Children 12 years of age and older: See Usual adult and adolescent dose.

Nole: Pediatric patients with granulocytopenia may require a dose re­duction to 120 mg per square meter of body surface area every six hours.

Usual pediatric prescribing limits

480 mg per square meter of body surface area per day up to a maximum of 200 mg every eight hours.

Those indicating need for medical attention

Incidence more frequent:

Anemia, leukopenia or  neutropenia

Incidence less  frequent:

Changes in platelet count

Incidence rare:

Hepatotoxicity, lactic acidosis, myopathy, neurotoxicity

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent:

Anorexia, asthenia, constipation, headache, severe, insomnia, malaise, my­algia, nausea, vomiting

Incidence less  frequent:

Changes in skin pigmentation, hyperpig­mentation of nails

Incidence unknown:

Abdominal cramps, abdominal pain, chills, dyspepsia, fatigue, hyperbilirubinemia, musculoskeletal pain, neuropathy

Those indicating need for medical attention if they occur after medication is discontinued

Bone marrow depression

Store  below 30^oC (86^oF),Protect  from light and keep the medicine in the box.

Box of 100 Zidovudine Capsules  300 mg