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Retrovir

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Retrovir

Indications
Dosage
How Supplied

INDICATIONS

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.

Prevention Of Maternal-Fetal HIV-1 Transmission

RETROVIR is indicated for the prevention of maternal-fetal HIV-1 transmission [see DOSAGE AND ADMINISTRATION]. 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 prolonged period before pregnancy has not been evaluated.
  • Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with RETROVIR during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks gestation.

DOSAGE AND ADMINISTRATION

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 4 hours. Patients should receive RETROVIR injection only until oral therapy can be administered.

  • RETROVIR injection must be diluted prior to administration. The calculated dose should be removed from the 20-mL vial and added to 5% Dextrose injection solution to achieve a concentration no greater than 4 mg per mL.
  • After dilution, the solution is physically and chemically stable for 24 hours at room temperature and 48 hours if refrigerated at 2° to 8°C (36° to 46°F). As an additional precaution, the diluted solution should be administered within 8 hours if stored at 25°C (77°F) or 24 hours if refrigerated at 2° to 8°C to minimize potential administration of a microbially contaminated solution.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit and discarded if either is observed.
  • Rapid infusion or bolus injection should be avoided. RETROVIR injection should not be given intramuscularly.

Pediatric Patients (Aged 4 Weeks to Less than 18 Years)

Healthcare professionals should pay special attention to accurate calculation of the dose of RETROVIR, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

Prescribers should calculate the appropriate dose of RETROVIR for each child based on body weight (kg) and should not exceed the recommended adult dose.

Before prescribing RETROVIR capsules or tablets, children should be assessed for the ability to swallow capsules or tablets. If a child is unable to reliably swallow a RETROVIR capsule or tablet, the RETROVIR syrup formulation should be prescribed.

The recommended oral dosage in pediatric patients aged 4 weeks to less than 18 years and weighing greater than or equal to 4 kg is provided in Table 1. RETROVIR syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.

Table 1: Recommended Pediatric Oral Dosage of RETROVIR

Body Weight (kS) Total Daily Dose Dosage Regimen and Dose
Twice Daily Three Times Daily
4 to < 9 24 mg/kg/day 12 mg/kg 8 mg/kg
≥ 9 to < 30 18 mg/kg/day 9 mg/kg 6 mg/kg
≥ 30 600 mg/day 300 mg 200 mg

Alternatively, dosing for RETROVIR can be based on body surface area (BSA) for each child. The recommended oral dose of RETROVIR is 480 mg per m² per day in divided doses (240 mg per m² twice daily or 160 mg per m² three times daily). In some cases the dose calculated by mg per kg will not be the same as that calculated by BSA.

Prevention Of Maternal-Fetal HIV-1 Transmission

The recommended dosage regimen for administration to pregnant women (greater than 14 weeks of pregnancy) and their neonates is:

Maternal Dosing

100 mg orally 5 times per day until the start of labor [see Clinical Studies]. During labor and delivery, intravenous RETROVIR should be administered at 2 mg per kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg per kg per hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing

Start neonatal dosing within 12 hours after birth and continue through 6 weeks of age. Neonates unable to receive oral dosing may be administered RETROVIR intravenously. See Table 2.

Table 2: Recommended Neonatal Dosages of RETROVIR

Route Total Daily Dose Dose and Dosage Regimen
Oral 8 mg/kg/day 2 mg/kg every 6 hours
Intravenous 6 mg/kg/day 1.5 mg/kg infused over 30 minutes, every 6 hours

Patients With Severe Anemia And/Or Neutropenia

Significant anemia (hemoglobin less than 7.5 g per dL or reduction greater than 25% of baseline) and/or significant neutropenia (granulocyte count less than 750 cells per mm³ or reduction greater than 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see WARNINGS AND PRECAUTIONS]. In patients who develop significant anemia, dose interruption does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose interruption, resumption in dose may be appropriate using adjunctive measures such as epoetin alfa at recommended doses, depending on hematologic indices such as serum erythropoietin level and patient tolerance.

Patients With Renal Impairment

In patients maintained on hemodialysis or peritoneal dialysis or with creatinine clearance (CrCl) by Cockcroft-Gault less than 15 mL per min, the recommended oral dosage is 100 mg every 6 to 8 hours. The intravenous dosing regimen equivalent to the oral administration of 100 mg every 6 to 8 hours is approximately 1 mg per kg every 6 to 8 hours [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

Patients With Hepatic Impairment

There are insufficient data to recommend dose adjustment of RETROVIR in patients with impaired hepatic function or liver cirrhosis. Frequent monitoring of hematologic toxicities is advised [see Use in Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

  • RETROVIR tablets 300 mg (biconvex, white, round, film-coated) containing 300 mg zidovudine, one side engraved “GX CW3” and “300” on the other side.
  • RETROVIR capsules 100 mg (white, opaque cap and body) containing 100 mg zidovudine and printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body.
  • RETROVIR syrup (colorless to pale yellow, strawberry-flavored) containing 10 mg zidovudine in each mL.
  • RETROVIR injection is a clear, nearly colorless, sterile aqueous solution with a pH of approximately 5.5. Each vial contains 200 mg of zidovudine in 20 mL solution (10 mg per mL).

Storage And Handling

RETROVIR 300-mg tablets are supplied as white, biconvex, round, film-coated tablets containing 300 mg zidovudine per tablet. Each tablet has one side engraved “GX CW3” and “300” on the other side.

Bottles of 60 (NDC 49702-214-18).

Store at 15° to 25°C (59° to 77°F).

RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body.

Bottles of 100 (NDC 49702-211-20).

Store at 15° to 25°C (59° to 77°F) and protect from moisture.

RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.

Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.

Store at 15° to 25°C (59° to 77°F).

RETROVIR injection, 10 mg zidovudine in each mL.

20-mL Single-use Vial (NDC 49702-213-01), Tray of 10 (NDC 49702-213-05).

Store vials at 15° to 25°C (59° to 77°F) and protect from light.

Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709. by: GlaxoSmithKline Research Triangle Park, NC 27709. Revised: Dec 2014

Last reviewed on RxList: 1/20/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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