Retrovir

Do not take this medication if you have ever had an allergic reaction to Retrovir or any medicine that contains zidovudine, including Combivir or Trizivir.

Do not take Retrovir with any other medicine that contains zidovudine or stavudine, including: Combivir, Trizivir, or Zerit.

Some people develop a life-threatening condition called lactic acidosis while taking zidovudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Zidovudine can also cause severe or life-threatening effects on your liver. Tell your doctor if you have liver disease, especially hepatitis C.

To make sure you can safely take zidovudine, tell your doctor if you have any of these other conditions:

• kidney disease;
• anemia (low red blood cell count);
• an active infection;
• bone marrow suppression; or
• if you have used an HIV medication in the past, such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Complera, Emtriva, Truvada), lamivudine (Combivir, Epivir, Epzicom, Trizivir), stavudine (Zerit), tenofovir (Viread), or zidovudine (Retrovir).

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of zidovudine on the baby.

FDA pregnancy category C. It is not known whether zidovudine will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection.

You should not breast-feed while you are using zidovudine. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Symptomatic myopathy [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The frequency and severity of adverse reactions associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.

Table 3 summarizes adverse reactions reported at a statistically significant greater incidence for subjects receiving oral RETROVIR in a monotherapy trial.

Table 3: Percentage (%) of Subjects with Adverse Reactions (Greater than or Equal to 5% Frequency) in Asymptomatic HIV-1 Infection (ACTG 019)

In addition to the adverse reactions listed in Table 3, adverse reactions observed at an incidence of greater than or equal to 5% in any treatment arm in clinical trials (NUCA3001, NUCA3002, NUCB3001, and NUCB3002) were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, insomnia, musculoskeletal pain, myalgia, and neuropathy. Additionally, in these trials hyperbilirubinemia was reported at an incidence of less than or equal to 0.8%.

Selected laboratory abnormalities observed during a clinical trial of monotherapy with oral RETROVIR are shown in Table 4.

Table 4: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Subjects with Asymptomatic HIV-1 Infection (ACTG 019)

The adverse reactions reported during IV administration of RETROVIR injection are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term IV administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse reactions. Local reaction, pain, and slight irritation during IV administration occur infrequently.

The clinical adverse reactions reported among adult recipients of RETROVIR may also occur in pediatric patients.

Trial ACTG 300: Selected clinical adverse reactions and physical findings with a greater than or equal to 5% frequency during therapy with EPIVIR® (lamivudine) oral suspension 4 mg per kg twice daily plus RETROVIR 160 mg per m² 3 times daily compared with didanosine in therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 5.

Table 5: Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG 300

Selected laboratory abnormalities experienced by therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 6.

Table 6: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Subjects in Trial ACTG 300

Macrocytosis was reported in the majority of pediatric subjects receiving RETROVIR 180 mg per m² every 6 hours in open-label trials. Additionally, adverse reactions reported at an incidence of less than 6% in these trials were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, nervousness/irritability, and weight loss.

In a randomized, double-blind, placebo-controlled trial in HIV-1-infected women and their neonates conducted to determine the utility of RETROVIR for the prevention of maternal-fetal HIV-1 transmission, RETROVIR syrup at 2 mg per kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. The most commonly reported adverse reactions were anemia (hemoglobin less than 9.0 g per dL) and neutropenia (less than 1,000 cells per mm³). Anemia occurred in 22% of the neonates who received RETROVIR and in 12% of the neonates who received placebo. The mean difference in hemoglobin values was less than 1.0 g per dL for neonates receiving RETROVIR compared with neonates receiving placebo. No neonates with anemia required transfusion and all hemoglobin values spontaneously returned to normal within 6 weeks after completion of therapy with RETROVIR. Neutropenia in neonates was reported with similar frequency in the group that received RETROVIR (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to RETROVIR are unknown.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RETROVIR. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole

Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Cardiovascular

Cardiomyopathy, syncope.

Eye

Macular edema.

Gastrointestinal

Constipation, dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer.

General

Sensitization reactions including anaphylaxis and angioedema, vasculitis.

Hematologic

Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.

Hepatobiliary

Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.

Musculoskeletal

Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV-1 disease), rhabdomyolysis, tremor.

Nervous

Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.

Reproductive System and Breast

Gynecomastia.

Respiratory

Dyspnea, rhinitis, sinusitis.

Skin and Subcutaneous Tissue

Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweating, urticaria.

Special Senses

Amblyopia, hearing loss, photophobia, taste perversion.

Renal and Urinary

Urinary frequency, urinary hesitancy.

Read the entire FDA prescribing information for Retrovir (Zidovudine)

​Oral/Injectable:

Common side effects include headache, tiredness, nausea, anorexia, and vomiting.

Common side effects in children include fever, cough, and digestive disorders. 

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen
• acyclovir (Zovirax)
• aspirin
• cimetidine (Tagamet)
• fluconazole (Diflucan)
• foscarnet (Foscavir)
• ganciclovir (Cytovene)
• indomethacin (Indocin)
• interferon
• lorazepam (Ativan)
• oxazepam (Serax)
• probenecid (Benemid)
• valproic acid (Depakene, Depakote)
• vitamins

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before taking Retrovir,

• tell your doctor and pharmacist if you are allergic to Retrovir or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking.
• tell your doctor if you have or have ever had liver or kidney disease, any disease or swelling of the muscle, anemia, a history of alcohol abuse, or bleeding or other blood problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Retrovir, call your doctor.
• tell your doctor if you drink alcohol.

Avoid drinking alcohol. It may increase your risk of liver damage or lactic acidosis.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Treatment of HIV Infection

Treatment of HIV-1 infection in adults, adolescents, and pediatric patients; used in conjunction with other antiretrovirals.1 200 201 231

Used with another NRTI (dual NRTIs) in conjunction with an HIV integrase strand transfer inhibitor (INSTI), HIV nonnucleoside reverse transcriptase inhibitor (NNRTI), or HIV protease inhibitor (PI) in INSTI-, NNRTI-, or PI-based regimens.200 201

Dual NRTI option of zidovudine and lamivudine not usually recommended for initial treatment regimens in nonpregnant HIV-infected adults and adolescents, but is one of several preferred dual NRTI options for initial treatment regimens in antiretroviral-naive pregnant women.200 202

For initial treatment in antiretroviral-naive pediatric patients, experts state that preferred dual NRTI options for use in NNRTI- or PI-based regimens are zidovudine and either lamivudine or emtricitabine (use in pediatric patients of any age) or abacavir and either lamivudine or emtricitabine (use only in those ≥3 months of age negative for HLA-B*5701).201 For adolescents at Tanner stage 4 or 5, experts recommend the dual NRTI options of abacavir and either lamivudine or emtricitabine (use only in those negative for HLA-B*5701), tenofovir DF and either lamivudine or emtricitabine, or zidovudine and either lamivudine or emtricitabine.201

Dual NRTI option of zidovudine and stavudine not recommended at any time because of antagonistic antiretroviral effects.200 201

Lamivudine/zidovudine fixed combination (Combivir) can be used in adults, adolescents, and pediatric patients weighing ≥30 kg when dual NRTI option of zidovudine and lamivudine is indicated;227 used in conjunction with other antiretrovirals.227

Abacavir/lamivudine/zidovudine fixed combination (Trizivir) can be used in adults and adolescents weighing ≥40 kg;229 used alone as a complete treatment regimen or in conjunction with other antiretrovirals.229 Intended only for regimens that require all 3 drugs; data limited regarding use in patients with baseline viral loads >100,000 copies/mL.229

Triple NRTI regimen of abacavir, lamivudine, and zidovudine not recommended for initial treatment in antiretroviral-naive patients because of inferior antiretroviral activity.200 201

Prevention of Perinatal HIV Transmission

Prevention of maternal-fetal transmission of HIV.1 202 231 Maternal and neonatal regimens recommended for prevention of perinatal HIV transmission in the US may differ from those used in other countries (e.g., resource-limited countries).202

Multiple-drug antiretroviral regimens considered the standard of care in the US for treatment of HIV infection in pregnant women and for prevention of perinatal HIV transmission.202 Zidovudine used alone during pregnancy for prevention of perinatal HIV transmission is not optimal, but may be an option in some HIV-infected pregnant women not currently receiving antiretroviral therapy who have plasma HIV-1 RNA levels <1000 copies/mL and wish to minimize fetal exposure to antiretrovirals.202

In addition, to decrease risk of perinatal HIV transmission, pregnant HIV-infected women in the US with plasma HIV-1 RNA levels >1000 copies/mL (or unknown HIV-1 RNA levels) near delivery should receive an intrapartum IV zidovudine prophylaxis regimen initiated at onset of labor and continued until delivery and all neonates born to HIV-infected women (HIV-exposed neonates) should receive oral or IV zidovudine prophylaxis initiated as soon as possible after birth (within 6–12 hours) and continued through 4–6 weeks of age.202 In certain situations (e.g., infant born to woman who did not receive antepartum or intrapartum antiretrovirals or received only intrapartum antiretrovirals), a 3-dose nevirapine prophylaxis regimen is recommended in the neonate in addition to usual neonatal zidovudine prophylaxis regimen.202

Intrapartum IV zidovudine regimen not required in women who have been receiving a multiple-drug antiretroviral regimen and have plasma HIV-1 RNA levels that have consistently been ≤1000 copies/mL during late pregnancy and/or near delivery, provided there are no concerns about adherence to or tolerance of the antiretroviral regimen.202

Decisions to include additional antiretrovirals for prophylaxis with the recommended intrapartum and postpartum zidovudine prophylaxis regimens should be made in consultation with a pediatric HIV specialist.202

Clinicians can consult National Perinatal HIV Hotline at 888-448-8765 for information regarding antiretroviral treatment of pregnant HIV-infected women and their infants and prevention of perinatal HIV transmission.202

Postexposure Prophylaxis following Occupational Exposure to HIV

Postexposure prophylaxis of HIV infection following occupational exposure† (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV.96 97 98 149 194 199 337 338 339 340 341 342 343 344 418 465 531

USPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV.199 Several alternative regimens that include an INSTI, NNRTI, or PI and 2 NRTIs (dual NRTIs) also recommended.199 Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF (may be given as emtricitabine/tenofovir DF; Truvada); alternative dual NRTIs are tenofovir DF and lamivudine, lamivudine and zidovudine (may be given as lamivudine/zidovudine; Combivir), or zidovudine and emtricitabine.199

Management of occupational exposures to HIV is complex and evolving; consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible.199 Do not delay initiation of PEP while waiting for expert consultation.199

Postexposure Prophylaxis following Nonoccupational Exposure to HIV

Postexposure prophylaxis of HIV infection following nonoccupational exposure† (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.198 Used in conjunction with other antiretrovirals.198

Contraindications

• Zidovudine, lamivudine/zidovudine, abacavir/lamivudine/zidovudine: History of potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to zidovudine or any ingredient in the formulation.1 227 229 231

• Abacavir/lamivudine/zidovudine: Hepatic impairment.229

Warnings/Precautions

Warnings

Hematologic toxicity (including neutropenia and severe anemia) reported, especially in patients with advanced HIV-1 disease.1 2 3 29 30 38 62 64 65 82 106 107 134 139 231 260 332 Pancytopenia reported; pancytopenia usually reversible following discontinuation of zidovudine.1 231

Blood cell counts and indices of anemia (e.g., hemoglobin, mean corpuscular volume) should be determined prior to and monitored during zidovudine therapy.1 50 64 181 231 332 Patients with advanced HIV disease or low baseline blood cell counts and indices of anemia should be monitored frequently1 231 (at least every 2 weeks);181 231 periodic monitoring1 231 (once monthly for the first 3 months and then, if stable, once every 3 months) recommended for patients with asymptomatic or early symptomatic HIV infection.181

Substantial anemia (hemoglobin <7.5 g/dL or >25% reduction from baseline) and/or neutropenia (granulocyte count <750/mm3 or >50% reduction from baseline) may require dose interruption until there is evidence of bone marrow recovery.1 231 Dose interruption does not necessarily eliminate need for transfusion.1 231 If bone marrow recovery occurs following dose interruption, reinitiation may be appropriate using adjunctive measures (e.g., epoetin alfa), depending on hematologic indices and patient tolerance.1 231

Myopathy and myositis with pathologic changes, similar to that produced by HIV-1 disease, associated with long-term zidovudine use.1 231

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving HIV NRTIs (including zidovudine) alone or in conjunction with other antiretrovirals.1 227 229 Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.1 227 229 Has been reported in patients with no known risk factors.1 227 229

Use particular caution in patients with known risk factors for liver disease.1 227 229

Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of markedly increased serum aminotransferase concentrations).1 227 229

Exacerbation of anemia reported in patients coinfected with HIV and HCV receiving zidovudine, interferon alfa, and ribavirin concomitantly.1 (See Specific Drugs under Interactions.)

Hepatic decompensation, sometimes fatal, reported in patients coinfected with HIV and HCV receiving antiretroviral therapy concomitantly with interferon alfa (or peginterferon alfa) with or without ribavirin.1 231 298 (See Specific Drugs under Interactions.)

Other Warnings and Precautions

Lamivudine/zidovudine, abacavir/lamivudine/zidovudine: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination.227 229 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, pediatric patients, geriatric patients) for each drug.227 229

Because antiretrovirals contained in lamivudine/zidovudine and abacavir/lamivudine/zidovudine also are available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated when a fixed combination is used in conjunction with other antiretrovirals.227 229

Do not use multiple zidovudine-containing preparations concomitantly.1 227 229

Do not use lamivudine/zidovudine or abacavir/lamivudine/zidovudine concomitantly with any preparation containing emtricitabine.227 229

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.1 Mechanisms and long-term consequences of adipogenic effects unknown;1 causal relationship not established.1

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii]); this may necessitate further evaluation and treatment.1

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) reported in the setting of immune reconstitution; time to onset is more variable and can occur many months after initiation of antiretroviral therapy.1 231

Specific Populations

Zidovudine: Category C.1

Lamivudine/zidovudine (Combivir), abacavir/lamivudine/zidovudine (Trizivir): Category C.231

Antiretroviral Pregnancy Registry at 800-258-4263 or .1 202 231

Zidovudine and lamivudine is one of several preferred dual NRTI options for initial treatment regimens in antiretroviral-naive pregnant women.202

Pregnancy registry data indicate no increased risk for congenital abnormalities among infants born to women who receive zidovudine during pregnancy compared with general population.202 453

Zidovudine distributed into human milk.1 231

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202

Well tolerated in neonates and children.1 91 92 114 163 231 244 245 458 However, usual zidovudine dosage used in full-term neonates may be excessive in premature neonates.201 530 (See Pediatric Dosage under Dosage and Administration.)

Major adverse effects reported in children are similar to those reported in adults1 91 92 114 163 244 245 and include bone marrow toxicity resulting in anemia and/or neutropenia.1 91 92 114 155 231 244 245

Lamivudine/zidovudine (Combivir): Do not use in children or adolescents weighing <30 kg.227

Abacavir/lamivudine/zidovudine (Trizivir): Do not use in pediatric patients or in adolescents weighing <40 kg.229

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.1 231 No substantial differences in response relative to younger adults identified.1 231

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1 231

Possibility of increased risk of hematologic toxicity in patients with severe hepatic impairment.1 231

Zidovudine: Use with caution in patients with known risk factors for liver disease.1 231

Lamivudine/zidovudine (Combivir), abacavir/lamivudine/zidovudine (Trizivir): Do not use in patients with impaired hepatic function.227 229

Zidovudine: Dosage adjustments recommended in patients with severe renal impairment (Clcr <15 mL/minute).1 231 (See Renal Impairment under Dosage and Administration.)

Lamivudine/zidovudine (Combivir), abacavir/lamivudine/zidovudine (Trizivir): Do not use in patients with Clcr <50 mL/minute.227 229

Common Adverse Effects

Headache, malaise, fever, cough, GI effects (anorexia, nausea, vomiting).1 231

The following drug interactions are based on studies using zidovudine.1 Drug interaction studies not performed using lamivudine/zidovudine or abacavir/lamivudine/zidovudine.227 229 When fixed combinations are used, consider interactions associated with each drug in the fixed combination.227 229

Specific Drugs

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of zidovudine in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving zidovudine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clarithromycin
• Dapsone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Flucytosine
• Orlistat
• Pyrazinamide
• Pyrimethamine
• Ribavirin
• Stavudine
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetaminophen
• Fluconazole
• Interferon Beta-1a
• Methadone
• Nelfinavir
• Probenecid
• Rifabutin
• Rifampin
• Rifapentine
• Tipranavir
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., anemia, neutropenia) or
• Muscle problems or
• Obesity (overweight)—Use with caution. Zidovudine may make these conditions worse.

• Kidney disease or
• Liver disease (including hepatitis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Low amounts of folic acid or vitamin B12 in the blood—Zidovudine may worsen anemia caused by a decrease of folic acid or vitamin B12.

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Zidovudine may cause blood problems. These problems may result in a greater chance of certain infections and slow healing. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks not to damage your gums. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Zidovudine may cause some serious side effects, including bone marrow problems. Symptoms of bone marrow problems include fever, chills, or sore throat; pale skin; and unusual tiredness or weakness. These problems may require blood transfusions or temporarily stopping treatment with zidovudine. Check with your doctor if any new health problems or symptoms occur while you or your child are taking zidovudine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles with anyone. In some cities, more than half of the drug users are infected, and sharing even one needle can spread the virus. If you have any questions about this, check with your doctor.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

LactMed Record Number

649

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.