RETROVIR 10 mg/mL
zidovudine · SOLUTION · ViiV Healthcare Company
RETROVIR is a solution containing zidovudine at 10 mg/mL, taken oral. Manufactured by ViiV Healthcare Company.
Key Facts
- Brand Name
- RETROVIR
- Generic Name
- zidovudine
- NDC Code (Product)
49702-212- Manufacturer
- ViiV Healthcare Company
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA019910
- Drug Class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Marketing Start
- 10/28/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: • Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 1.1 Treatment of HIV-1 RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission RETROVIR is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3 )]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV‑1–infected mothers 2. intrapartum therapy of HIV‑1–infected mothers 3. post-partum therapy of HIV‑1–exposed neonate Points to consider prior to initiating RETROVIR in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: • In most cases, RETROVIR for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs. • Prevention of HIV-1 transmission in women who have received RETROVIR for a p…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Treatment of HIV-1 infection: Adults: Recommended oral dosage is 300 mg twice a day with other antiretroviral agents. For patients who are unable to take the oral formulations, the recommended intravenous dose is 1 mg per kg infused over 1 hour every 4 hours. ( 2.1 ) Pediatric patients (aged 4 weeks to less than 18 years): Dosage should be calculated based on body weight not to exceed adult dose. ( 2.2 ) • Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. ( 2.3 ) • Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. ( 2.4 ) • Renal impairment: Recommended oral dosage in hemodialysis or peritoneal dialysis or in patients with creatinine clearance (CrCl) less than 15 mL per minute is 100 mg every 6 to 8 hours. Equivalent intravenous dosing is approximately 1 mg per kg every 6 to 8 hours. ( 2.5 ) 2.1 Adults – Treatment of HIV-1 Infection Oral Dosing The recommended oral dose of RETROVIR is 300 mg twice daily in combination with other antiretroviral agents. Intravenous (IV) Dosing The recommended intravenous dose is 1 mg per kg infused at a constant rate over 1 hour every …
Contraindications
4 CONTRAINDICATIONS RETROVIR is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Avoid use with stavudine. ( 7.1 ) • Avoid use with doxorubicin. ( 7.2 ) • Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine. ( 7.3 ) 7.1 Antiretroviral Agents Stavudine Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro. Nucleoside Analogues Affecting DNA Replication Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of RETROVIR against HIV-1; concomitant use of such drugs should be avoided. 7.2 Doxorubicin Concomitant use of zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro. 7.3 Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration of ganciclovir, interferon alfa, ribavirin, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine.
Adverse Reactions
6 ADVERSE REACTIONS 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 ( 5.1 )]. • Symptomatic myopathy [see Boxed Warning , Warnings and Precautions ( 5. 2)]. • Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions ( 5. 3)]. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions ( 5. 4)]. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in adult HIV-1 clinical trials were headache, malaise, nausea, anorexia, and vomiting. ( 6.1 ) • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in pediatric HIV-1 clinical trials were fever and cough. ( 6.1 ) • Most commonly reported adverse reactions in neonates (incidence greater than or equal to 15%) in the prevention of maternal-fetal transmission of HIV-1 clinical trial were anemia and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwa…
Frequently Asked Questions
What is RETROVIR used for?
RETROVIR contains zidovudine. It is a solution taken oral. Consult your doctor for specific uses.
Is RETROVIR a controlled substance?
RETROVIR is not classified as a controlled substance by the DEA.
What is the generic name for RETROVIR?
The generic name for RETROVIR is zidovudine. There are 5 other brand versions of zidovudine.
What is the NDC code for RETROVIR 10 mg/mL?
The NDC (National Drug Code) for RETROVIR 10 mg/mL is 49702-212, listed by ViiV Healthcare Company.