zidovudine

REMS

HIV infection (in combination with other antiretrovirals).
Reduction of maternal/fetal transmission of HIV.

Unlabeled Use:

Chemoprophylaxis after occupational exposure to HIV.

Following intracellular conversion to its active form, inhibits viral RNA synthesis by inhibiting the enzyme DNA polymerase (reverse transcriptase).
Prevents viral replication.

Therapeutic Effects:

Virustatic action against selected retroviruses.
Slowed progression and decreased sequelae of HIV infection.
Decreased viral load and improved CD4 cell counts.
Decreased transmission of HIV to infants born to HIV-infected mothers.

Absorption: Well absorbed following oral administration.

Distribution: Widely distributed; enters the CNS. Crosses the placenta.

Metabolism/Excretion: Mostly (75%) metabolized by the liver; 15–20% excreted unchanged by the kidneys.

Half-life: 1 hr.

Contraindicated in:

Hypersensitivity
Lactation: Breastfeeding not recommended in mothers with HIV.

Use Cautiously in:

↓bone marrow reserve (dose ↓ required for anemia or granulocytopenia)
Women and obese patients (↑ risk of lactic acidosis and severe hepatomegaly)
Severe hepatic or renal disease (dose modification may be required)
Latex allergy (IV only)
Geri: Select dose carefully due to potential for age-related ↓ in hepatic, renal, or cardiac function.

Derm: nail pigmentation.

Endo: gynecomastia, lipoatrophy.

F and E: LACTIC ACIDOSIS.

GI: HEPATOMEGALY (WITH STEATOSIS), PANCREATITIS, abdominal pain, diarrhea, nausea, anorexia, dyspepsia, oral mucosa pigmentation, vomiting.

Hemat: anemia, granulocytopenia, pure red-cell aplasia, thrombocytosis.

MS: back pain, myopathy.

Neuro: tremor , SEIZURES, headache, weakness, anxiety, confusion, ↓ mental acuity, dizziness, insomnia, mental depression, restlessness, syncope.

Misc: immune reconstitution syndrome.

Drug-Drug:

↑bone marrow depression with other agents having bone marrow–depressing properties, antineoplastics, radiation therapy, or ganciclovir.
↑neurotoxicity may occur with acyclovir.
Toxicity may be ↑ by concurrent administration of probenecid or fluconazole.
Levels are ↓ by clarithromycin.

Management of HIV Infection

PO (Adults): 100 mg every 4 hr while awake or 200 mg 3 times daily or 300 mg twice daily (depends on combination and clinical situation).
PO (Children 4 wk–<18 yr): 4–8.9 kg — 12 mg/kg twice daily or 8 mg/kg 3 times daily; 9–29.9 kg — 9 mg/kg twice daily or 6 mg/kg 3 times daily; 30 kg — 300 mg twice daily or 200 mg 3 times daily.
IV (Adults and Children >12 yr): 1 mg/kg every 4 hr. Change to oral therapy as soon as possible.
IV (Children): 120 mg/m² every 6 hr (not to exceed 160 mg/dose) or 20 mg/m²/hr as a continuous infusion.

Prevention of Maternal/Fetal Transmission of HIV Infection

PO (Adults >14 wk Pregnant): 100 mg 5 times daily until onset of labor.
IV (Adults during Labor and Delivery): 2 mg/kg over 1 hr, then continuous infusion of 1 mg/kg/hr until umbilical cord is clamped.
PO (Neonates): 2 mg/kg every 6 hr until 6 wk of age.
IV (Neonates): 1.5 mg/kg every 6 hr until 6 wk of age.

Do not confuse Retrovir (zidovudine) with ritonavir.
PO: Administer doses around the clock.
- For neonates, use a syringe with 0.1-mL graduations to ensure accurate dosing of the syrup.
IV: Patient should receive the IV infusion only until oral therapy can be administered.

IV Administration:

Intermittent Infusion: Retrovir vial stoppers contain latex; may cause allergic reactions in latex-sensitive individuals.
Rate: Infuse at a constant rate over 1 hr or over 30 min in neonates. Avoid rapid infusion or bolus injection.
Continuous Infusion: Has also been administered via continuous infusion.
Y-Site Compatibility:
- acyclovir
- alemtuzumab
- allopurinol
- amifostine
- amikacin
- aminocaproic acid
- amiodarone
- amphotericin B deoxycholate
- amphotericin B lipid complex
- amphotericin B liposome
- anidulafungin
- argatroban
- arsenic trioxide
- azithromycin
- aztreonam
- bivalirudin
- bleomycin
- carboplatin
- carmustine
- caspofungin
- cefepime
- ceftazidime
- ceftriaxone
- cisatracurium
- cisplatin
- clindamycin
- cyclophosphamide
- cytarabine
- dactinomycin
- daptomycin
- daunorubicin hydrochloride
- dexamethasone
- dexmedetomidine
- diltiazem
- dobutamine
- docetaxel
- dopamine
- doxorubicin hydrochloride
- doxorubicin liposome
- epirubicin
- eptifibatide
- ertapenem
- erythromycin lactobionate
- etoposide
- etoposide phosphate
- fenoldopam
- filgrastim
- fluconazole
- fludarabine
- fluorouracil
- foscarnet
- fosphenytoin
- gemcitabine
- gentamicin
- granisetron
- heparin
- hetastarch
- hydromorphone
- idarubicin
- ifosfamide
- imipenem/cilastatin
- irinotecan
- leucovorin calcium
- levofloxacin
- linezolid
- lorazepam
- melphalan
- meperidine
- meropenem
- mesna
- methadone
- methotrexate
- metoclopramide
- metronidazole
- milrinone
- mitoxantrone
- morphine
- mycophenolate
- nafcillin
- nicardipine
- octreotide
- ondansetron
- oxacillin
- oxaliplatin
- oxytocin
- paclitaxel
- palonosetron
- pamidronate
- pancuronium
- pantoprazole
- pemetrexed
- pentamidine
- phenylephrine
- piperacillin/tazobactam
- potassium acetate
- potassium chloride
- quinapristin/dalfopristin
- remifentanil
- rituxumab
- rocuronium
- sargramostim
- sodium acetate
- tacrolimus
- thiotepa
- tigecycline
- tirofiban
- tobramycin
- topotecan
- trastuzumab
- trimethoprim/sulfamethoxazole
- vancomycin
- vasopressin
- vecuronium
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- zoledronic acid
Y-Site Incompatibility:
- dexrazoxane
- gentuzumab ozogamicin
Additive Incompatibility: blood products or protein solutions,
- dexrazoxane.

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

(Generic available)

Capsules: 100 mg;
Oral solution: 50 mg/5 mL;
Solution for injection: 10 mg/mL;
Tablets: 300 mg;
In combination with: lamivudine (Combivir); abacavir and lamivudine (Trizivir); see Appendix [not included in this PDA edition].

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	0.5–1.5 hr	4 hr
IV	rapid	end of infusion	4 hr

Assess patient for change in severity of symptoms of HIV and for symptoms of opportunistic infections during therapy.

Lab Test Considerations:

Monitor viral load and CD4 counts prior to and periodically during therapy.
- Monitor CBC every 2 wk during the first 8 wk of therapy in patients with advanced HIV disease, and decrease to every 4 wk after the first 2 mo if zidovudine is well tolerated or monthly during the first 3 mo and every 3 mo thereafter unless indicated in patients who are asymptomatic or have early symptoms. Commonly causes granulocytopenia and anemia. Anemia may occur 2–4 wk after initiation of therapy. Anemia may respond to epoetin administration (see epoetin monograph). Granulocytopenia usually occurs after 6–8 wk of therapy. Consider dose reduction, discontinuation of therapy, or blood transfusions if hemoglobin <7.5 g/dL or reduction of >25% from baseline and/or granulocyte count <750/mm³ or reduction of >50% from baseline. Therapy may be gradually resumed when bone marrow recovery is evident.
- May cause ↑ serum AST, ALT, and alkaline phosphatase levels.Lactic acidosis may occur with hepatic toxicity, causing hepatic steatosis; may be fatal, especially in women.
- Monitor serum amylase, lipase, and triglycerides periodically during therapy. Elevated serum levels may indicate pancreatitis and require discontinuation.

Instruct patient to take zidovudine as directed, around the clock, even if sleep is interrupted. Emphasize the importance of compliance with therapy, not taking more than prescribed amount, and not discontinuing without consulting health care professional. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Inform patient that long-term effects of zidovudine are unknown at this time.
Instruct patient that zidovudine should not be shared with others.
Zidovudine may cause dizziness or fainting. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Inform patient that zidovudine does not cure HIV and may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and avoid sharing needles or donating blood to prevent spreading the AIDS virus to others.
Instruct patient to notify health care professional promptly if signs of pancreatitis (nausea, vomiting, abdominal pain), lactic acidosis (feel very weak or tired; feel cold, especially in arms and legs; unusual muscle pain; feel dizzy or lightheaded; trouble breathing; fast or irregular heartbeat; stomach pain with nausea and vomiting), liver problems (yellowing of skin or white part of eyes; loss of appetite; nausea; dark or “tea-colored” urine; pain, aching, or tenderness on right side of abdomen; light-colored stools) or immune reconstitution syndrome (signs and symptoms of an infection, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, tuberculosis) occur.
Instruct patient to notify health care professional promptly if fever, sore throat, signs of infection, muscle weakness, or shortness of breath occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush, to use caution when using toothpicks or dental floss, and to have dental work done prior to therapy or deferred until blood counts return to normal.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patient taking oral contraceptives to use a nonhormonal method of birth control during therapy. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine during pregnancy. Enroll patients in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Decrease in viral load and increase in CD4 counts in patients with HIV.
Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
Reduction of maternal/fetal transmission of HIV.

NDC Code^*

0378- Mylan Pharmaceuticals Inc.
0378-6106- Zidovudine 0378-6106-91- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6106-91)

0527- Lannett Company, Inc.
0527-1905- Zidovudine 0527-1905-06- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1905-06)

31722- Camber Pharmaceuticals, Inc.
31722-509- Zidovudine 31722-509-60- 12 BOTTLE in 1 CASE (31722-509-60) > 60 TABLET in 1 BOTTLE

49702- ViiV Healthcare Company
49702-211- RETROVIR 49702-211-20- 100 CAPSULE in 1 BOTTLE (49702-211-20)

49702- ViiV Healthcare Company
49702-212- RETROVIR 49702-212-48- 240 mL in 1 BOTTLE (49702-212-48)

49702- ViiV Healthcare Company
49702-213- RETROVIR 49702-213-26- 5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) > 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)

52343- ACETRIS HEALTH, LLC
52343-044- Zidovudine 52343-044-01- 100 CAPSULE in 1 BOTTLE (52343-044-01)

52343- ACETRIS HEALTH, LLC
52343-045- Zidovudine 52343-045-60- 60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60)

53104- Cipla Ltd.
53104-0100- Zidovudine 53104-0100-4- 100 CAPSULE in 1 BOTTLE (53104-0100-4)

53104- Cipla Ltd.
53104-0100- Zidovudine 53104-0100-6- 1000 CAPSULE in 1 BOTTLE (53104-0100-6)

53104- Cipla Ltd.
53104-0101- Zidovudine 53104-0101-2- 60 TABLET, FILM COATED in 1 BOTTLE (53104-0101-2)

53104- Cipla Ltd.
53104-0101- Zidovudine 53104-0101-6- 1000 TABLET, FILM COATED in 1 BOTTLE (53104-0101-6)

53104- Cipla Ltd.
53104-0101- Zidovudine 53104-0101-9- 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (53104-0101-9)

53104- Cipla Ltd.
53104-0105- zidovudine 53104-0105-9- 240 mL in 1 BOTTLE (53104-0105-9)

53808- DOH CENTRAL PHARMACY
53808-0812- Zidovudine 53808-0812-1- 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0812-1)

53808- State of Florida DOH Central Pharmacy
53808-0878- Zidovudine 53808-0878-2- 60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0878-2)

65862- Aurobindo Pharma Limited
65862-024- Zidovudine 65862-024-10- 6 BLISTER PACK in 1 CARTON (65862-024-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

65862- Aurobindo Pharma Limited
65862-024- Zidovudine 65862-024-60- 60 TABLET, FILM COATED in 1 BOTTLE (65862-024-60)

65862- Aurobindo Pharma Limited
65862-048- Zidovudine 65862-048-24- 240 mL in 1 BOTTLE (65862-048-24)

65862- Aurobindo Pharma Limited
65862-107- Zidovudine 65862-107-01- 100 CAPSULE in 1 BOTTLE (65862-107-01)

65862- Aurobindo Pharma Limited
65862-107- Zidovudine 65862-107-10- 10 BLISTER PACK in 1 CARTON (65862-107-10) > 10 CAPSULE in 1 BLISTER PACK

70518- REMEDYREPACK INC.
70518-1656- Zidovudine 70518-1656-0- 30 TABLET in 1 BLISTER PACK (70518-1656-0)

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Pronunciation ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Implementation ⬆ ⬇

US Brand Names ⬆ ⬇

Classifications ⬆ ⬇

Availability ⬆ ⬇

Time/Action Profile ⬆ ⬇

Assessment ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

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