Buy Retrovir Online

Zidovudine (zidovudine)

BOXED WARNING

Associated w/ hematologic toxicity (eg, neutropenia, severe anemia), particularly w/ advanced HIV-1 disease. Symptomatic myopathy associated w/ prolonged use. Lactic acidosis and severe hepatomegaly w/ steatosis, including fatal cases, reported w/ nucleoside analogues; suspend treatment if lactic acidosis or pronounced hepatotoxicity occurs.

View FDA-Approved Full Prescribing Information for Retrovir

OTHER BRAND NAMES

Retrovir

THERAPEUTIC CLASS

Nucleoside reverse transcriptase inhibitor (NRTI)

DEA CLASS

RX

INDICATIONS

Treatment of HIV-1 infection in combination w/ other antiretrovirals. Prevention of maternal-fetal HIV-1 transmission.

ADULT DOSAGE

Prevention of Maternal-Fetal HIV Transmission

>14 Weeks of Pregnancy:
PO:
100mg 5X/day until start of labor
During Labor and Delivery:
IV:
2mg/kg over 1 hr followed by continuous infusion of 1mg/kg/hr until clamping of umbilical cord

HIV-1 Infection

Combination w/ Other Antiretrovirals:
PO:
300mg bid

IV:
1mg/kg at a constant rate over 1 hr q4h

PEDIATRIC DOSAGE

HIV-1 Infection

Combination w/ Other Antiretrovirals:
4 Weeks-<18 Years:
Weight Based:
4-<9kg: 12mg/kg bid or 8mg/kg tid (24mg/kg/day)
≥9-<30kg: 9mg/kg bid or 6mg/kg tid (18mg/kg/day)
≥30kg: 300mg bid or 200mg tid (600mg/day)

BSA Based:
240mg/m2 bid or 160mg/m2 tid (480mg/m2/day)

Prevention of Maternal-Fetal HIV Transmission

Neonates:
Start w/in 12 hrs after birth and continue through 6 weeks of age
PO: 2mg/kg q6h (8mg/kg/day)
IV: 1.5mg/kg over 30 min q6h (6mg/kg/day)

DOSING CONSIDERATIONS

Renal Impairment
Hemodialysis/Peritoneal Dialysis/CrCl <15mL/min:
PO: 100mg q6-8h
IV: 1mg/kg q6-8h

Adverse Reactions
Significant Anemia (Hgb <7.5g/dL or Reduction >25% of Baseline)/Neutropenia (Granulocyte Count <750 cells/mm3 or Reduction >50% from Baseline):
May require dose interruption until evidence of marrow recovery occurs; if marrow recovery occurs following dose interruption, may resume dose using adjunctive measures (eg, epoetin alfa), depending on hematologic indices and patient tolerance

ADMINISTRATION

Oral/IV route

Administer IV infusion only until oral therapy can be administered

PO
Take w/ or w/o food

IV
Avoid rapid infusion and bolus inj
Infusion must be diluted prior to administration                                                                                                                              

Dilution Instructions
1. Remove calculated dose from the 20mL vial and add to D5 inj sol to a concentration ≤4mg/mL
2. Administer diluted sol w/in 8 hrs if stored at 25°C (77°F) or 24 hrs if stored at 2-8°C (36-46°F), to minimize contamination

HOW SUPPLIED

Tab: 300mg; (Retrovir) Cap: 100mg; Inj: 10mg/mL [20mL]; Syrup: 10mg/mL [240mL]

WARNINGS/PRECAUTIONS

Caution w/ granulocyte count <1000 cells/mm3 or Hgb <9.5g/dL; monitor blood counts frequently in patients w/ poor bone marrow reserve, particularly w/ advanced HIV-1 disease and periodically w/ other HIV-infected patients and w/ asymptomatic/early HIV-1 disease. Vial stoppers for inj contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals. Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly w/ steatosis. Caution w/ any known risk factors for liver disease and in elderly. Pancytopenia and immune reconstitution syndrome reported. Autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) reported to occur in the setting of immune reconstitution and can occur many months after initiation of treatment. May cause redistribution/accumulation of body fat.

ADVERSE REACTIONS

Hematologic toxicity, myopathy, lactic acidosis, severe hepatomegaly w/ steatosis, headache, N/V, malaise, anorexia, asthenia, constipation, abdominal pain/cramps, arthralgia, chills.

DRUG INTERACTIONS

Avoid w/ stavudine, nucleoside analogues affecting DNA replication (eg, ribavirin), doxorubicin, and other combination products containing zidovudine. Hepatic decompensation may occur in HIV/hepatitis C virus (HCV) coinfected patients receiving interferon alfa w/ or w/o ribavirin; closely monitor for treatment-associated toxicities. May increase risk of hematologic toxicities w/ ganciclovir, interferon alfa, ribavirin, and other bone marrow suppressive or cytotoxic agents.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Synthetic nucleoside analogue; inhibits reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue.

PHARMACOKINETICS

Absorption: (Oral) Rapid. Bioavailability (64%); Tmax=0.5-1.5 hrs. (IV) Cmax=1.1mcg/mL. Distribution: Vd=1.6L/kg; plasma protein binding (<38%); crosses the placenta; found in breast milk. Metabolism: Hepatic. 3'-azido-3'-deoxy-5'-O-β-D-glucopyranuronosylthymidine (major metabolite). Elimination: Urine (14% unchanged, 74% metabolite [oral]; 18% unchanged, 60% metabolite [IV]); T1/2=0.5-3 hrs. Refer to PI for pediatric patients and patients w/ renal impairment pharmacokinetic parameters.

ASSESSMENT

Assess for previous hypersensitivity reaction to the drug, advanced HIV disease, latex sensitivity, risk factors for lactic acidosis/liver disease, bone marrow compromise, renal/hepatic impairment, pregnancy/nursing status, and possible drug interactions. (Oral) Assess ability to swallow cap/tab in children.

MONITORING

Monitor for signs/symptoms of hematologic toxicity, lactic acidosis, hepatomegaly w/ steatosis, myopathy, immune reconstitution syndrome, autoimmune disorders, fat redistribution/accumulation, and other adverse reactions. Monitor blood counts/hematologic indices periodically and the need for dosage adjustment.

PATIENT COUNSELING

Inform that potentially life-threatening hypersensitivity reactions can occur; instruct to immediately contact physician if rash develops. Inform about risk for hematologic toxicities and advise on importance of close blood count monitoring while on therapy. Counsel about the possible occurrence of myopathy and myositis w/ pathological changes during prolonged use and that therapy may cause a rare but serious condition called lactic acidosis w/ liver enlargement (hepatomegaly). Inform that hepatic decompensation has occurred in HIV-1/HCV coinfected patients receiving combination antiretroviral therapy and interferon alfa w/ or w/o ribavirin. Inform that immune reconstitution syndrome may occur; advise to inform physician immediately of any symptoms of infection. Inform that redistribution/accumulation of body fat may occur. Instruct to report any other adverse events that occur. Instruct not to breastfeed to prevent postnatal transmission. Inform that drug is not a cure for HIV-1 infection and that illness associated w/ HIV-1 may still be experienced. Inform to take all HIV medications exactly as prescribed. Advise to avoid doing things that can spread HIV-1 infection to others; instruct to continue to practice safe sex.

STORAGE

(Tab) 20-25°C (68-77°F). (Retrovir) 15-25°C (59-77°F). (Cap) Protect from moisture. (Inj) Protect from light. Diluted Sol: Stable for 24 hrs at room temperature and for 48 hrs if refrigerated at 2-8°C (36-46°F).

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