Zidovudine

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Uses

Zidovudine 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)

Zidovudine tablet USP, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Zidovudine tablet USP is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.2)]. The indication is based on a dosing regimen that included 3 components:

antepartum therapy of HIV-1 infected mothers
intrapartum therapy of HIV-1 infected mothers
post-partum therapy of HIV-1 exposed neonate.

Points to consider prior to initiating zidovudine tablets USP in pregnant women for the prevention of maternal-fetal HIV-1 transmission include:

In most cases, zidovudine tablets USP 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 zidovudine tablets USP 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 zidovudine tablets USP 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.

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Other Information

Zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3'-azido-3'-deoxythymidine; it has the following structural formula:

Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg/mL in water at 25°C. The molecular formula is C10H13N5O4.

Zidovudine tablets USP are for oral administration. Each film-coated tablet contains 300 mg of zidovudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, polyethylene glycol, titanium dioxide, polyvinyl alcohol-part hydrolyzed, talc and lecithin soya.

Sources

Zidovudine Manufacturers

Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

•Treatment of HIV-1 infection: Adults: 600 mg/day in divided doses with other antiretroviral agents. Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (
2.1
)•Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. (
2.2
)•Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. (
2.3
)•Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (
2.4
)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 weeks to <18 years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine tablets for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology(12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

•Treatment of HIV-1 infection: Adults: 600 mg/day in divided doses with other antiretroviral agents. Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (
2.1
)•Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. (
2.2
)•Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. (
2.3
)•Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (
2.4
)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 weeks to <18 years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine tablets for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology(12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

•Treatment of HIV-1 infection: Adults: 600 mg/day in divided doses with other antiretroviral agents. Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (
2.1
)•Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. (
2.2
)•Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. (
2.3
)•Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (
2.4
)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 weeks to <18 years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine tablets for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology(12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
State Of Florida Doh Central Pharmacy

Zidovudine | State Of Florida Doh Central Pharmacy

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (6 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 6 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate. Table 1: Recommended Pediatric Dosage of Zidovudine Tablets
   Body Weight
          (kg)
      Total Daily
         Dose
   Dosage Regimen and Dose

   b.i.d.

   t.i.d.

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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA. 2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours. 2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm 3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance. 2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3) ]. 2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Rebel Distributors Corp

Zidovudine | Rebel Distributors Corp

2.1 Treatment of HIV-1 Infection
Adults:
The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (6 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 6 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.

Table 1: Recommended Pediatric Dosage of Zidovudine Tablets
   Body Weight
          (kg)
      Total Daily
         Dose
   Dosage Regimen and Dose

   b.i.d.

   t.i.d.

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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]
. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing:
2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm
3
or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed
[see Warnings and Precautions (5.1)]
. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease:
In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours
[see Clinical Pharmacology (12.3)
]
.
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Camber Pharmaceuticals

Zidovudine | Camber Pharmaceuticals

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose b.i.d t.i.d. 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2   Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonate is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
2.3     Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment:
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5    Patients With Hepatic Impairment:
There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Edenbridge Pharmaceuticals, Llc

Zidovudine | Edenbridge Pharmaceuticals, Llc

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing Zidovudine capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow a Zidovudine capsule, the Zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous Zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of Zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Cipla Limited

Zidovudine | Cipla Ltd.

2.1 Adults - Treatment of HIV-1 Infection
Oral Dosing
The recommended oral dose of zidovudine is 300 mg twice daily in combination with other antiretroviral agents.
2.2 Pediatric Patients (Aged 4 Weeks to Less than 18 Years)
Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing Zidovudine capsules, children should be assessed for the ability to swallow capsules.
The recommended 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.
Table 1: Recommended Pediatric Oral Dosage of Zidovudine

Dosage Regimen and Dose
Body Weight (kg)
Total Daily 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine 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.
2.3 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 (14.3)]. During labor and delivery, intravenous Zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously . See Table 2
Table 2. Recommended Neonatal Dosage of Zidovudine 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
2.4 Patients with Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin less than 7.5 g/dL or reduction greater than 25% of baseline) and/or significant neutropenia (granulocyte count less than 750 cells/mm3 or reduction greater than 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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.
2.5 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 dosage is 100 mg every 6 to 8 hours.
2.6 Patients with Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine in patients with impaired hepatic function or liver cirrhosis. Frequent monitoring of hematologic toxicities is advised [see Use in Specific Populations (8.7)].

No Recall
Bryant Ranch Prepack

Zidovudine | Bryant Ranch Prepack

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) Total Daily Dose Dosage Regimen and Dose b.i.d. t.i.d. 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m 2/day in divided doses (240 mg/m 2 twice daily or 160 mg/m 2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA. 2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours. 2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm 3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance. 2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3) ]. 2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Roxane Laboratories, Inc

Zidovudine | Roxane Laboratories, Inc

2.1 Treatment of HIV-1 Infection
Adults
The recommended oral dose of zidovudine is 600 mg per day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 Weeks to <18 Years)
Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine capsules or tablets, children should be assessed for the ability to swallow capsules or tablets. If a child is unable to reliably swallow a zidovudine capsule or tablet, the zidovudine oral solution formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine oral solution should be used to provide accurate dosage when whole tablets or capsules are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine
Body Weight (kg)
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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2: Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions(5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease
In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology(12.3)].
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Cipla Limited

Zidovudine | Cipla Limited

2.1 Treatment of HIV-1 Infection
Adults:The recommended oral dose of Zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing Zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a Zidovudine tablet, the zidovudine Syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine    Body

   Weight
Total Daily
                   Dosage Regimen and Dose
   (kg)
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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of Zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous Zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered Zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
Table 2. Recommended Neonatal Dosages of Zidovudine. Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment:
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment:
There are insufficient data to recommend dose adjustment of Zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Aurobindo Pharma Limited

Zidovudine | Aurobindo Pharma Limited

2.1 Adults - Treatment of HIV-1 Infection
Oral Dosing

The recommended oral dose of zidovudine capsules is 300 mg twice daily in combination with other antiretroviral agents.
2.2 Pediatric Patients (Aged 4 Weeks to Less than 18 Years)
Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine capsules, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

Before prescribing zidovudine capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow a zidovudine capsule, the zidovudine 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. Zidovudine syrup should be used to provide accurate dosage when whole capsules are not appropriate.
Table 1: Recommended Pediatric Oral Dosage of Zidovudine Capsules Body Weight
(kg)
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 zidovudine capsules can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine capsules 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.
2.3 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 (14.3)]. During labor and delivery, intravenous zidovudine 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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine 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
2.4 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 (5.1)]. 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.
2.5 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. [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.6 Patients with Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine capsules in patients with impaired hepatic function or liver cirrhosis. Frequent monitoring of hematologic toxicities is advised [see Use in Specific Populations (8.7)].

No Recall
Aurobindo Pharma Limited

Zidovudine | Aurobindo Pharma Limited

2.1 Adults - Treatment of HIV-1 Infection
Oral Dosing

The recommended oral dose of zidovudine tablets is 300 mg twice daily in combination with other antiretroviral agents.
2.2 Pediatric Patients (Aged 4 Weeks to Less than 18 Years)
Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine 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. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Oral Dosage of Zidovudine Tablets Body Weight
(kg)
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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets 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.
2.3 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 (14.3)]. During labor and delivery, intravenous zidovudine 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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine 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
2.4 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 (5.1)]. 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.
2.5 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 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.6 Patients with Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with impaired hepatic function or liver cirrhosis. Frequent monitoring of hematologic toxicities is advised [see Use in Specific Populations (8.7)].

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Treatment of HIV-1 infection:
Adults: 600 mg/day in divided doses with other antiretroviral agents.
Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (2.1)
Prevention of maternal-fetal HIV-1 transmission:
Specific dosage instructions for mother and infant. (2.2) Patients with severe anemia and/or neutropenia:
Dosage interruption may be necessary. (2.3) Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (2.4)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Treatment of HIV-1 infection:
Adults: 600 mg/day in divided doses with other antiretroviral agents.
Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (2.1)
Prevention of maternal-fetal HIV-1 transmission:
Specific dosage instructions for mother and infant. (2.2) Patients with severe anemia and/or neutropenia:
Dosage interruption may be necessary. (2.3) Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (2.4)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Treatment of HIV-1 infection:
Adults: 600 mg/day in divided doses with other antiretroviral agents.
Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (2.1)
Prevention of maternal-fetal HIV-1 transmission:
Specific dosage instructions for mother and infant. (2.2) Patients with severe anemia and/or neutropenia:
Dosage interruption may be necessary. (2.3) Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (2.4)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Treatment of HIV-1 infection:
Adults: 600 mg/day in divided doses with other antiretroviral agents.
Pediatric patients (aged 4 weeks to <18 years): Dosage should be calculated based on body weight not to exceed adult dose. (2.1)
Prevention of maternal-fetal HIV-1 transmission:
Specific dosage instructions for mother and infant. (2.2) Patients with severe anemia and/or neutropenia:
Dosage interruption may be necessary. (2.3) Renal Impairment: Recommended dosage in hemodialysis or peritoneal dialysis patients is 100 mg every 6 to 8 hours. (2.4)

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose b.i.d t.i.d. 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonate is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
American Health Packaging

Zidovudine | American Health Packaging

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine capsules is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine capsules, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole capsules are not appropriate.
Table 1. Recommended Pediatric Dosage of Zidovudine Capsules
Body Weight
(kg)
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 zidovudine capsules can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine capsules is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing: Start neonatal dosing within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine capsules in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Gen-source Rx

Zidovudine | Gen-source Rx

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine capsules is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine capsules, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole capsules are not appropriate.

Table 1: Recommended Pediatric Dosage of Zidovudine Capsules Body Weight
(kg)
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 zidovudine capsules can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine capsules is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.

Neonatal Dosing: Start neonatal dosing within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously. See Table 2.

Table 2. Recommended Neonatal Dosages of Zidovudine Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours

2.3 Patients With Severe Anemia and/or Neutropenia

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment

There are insufficient data to recommend dose adjustment of zidovudine capsules in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Gen-source Rx

Zidovudine | Gen-source Rx

2.1 Treatment of HIV-1 Infection

Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.

Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission

The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.

Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment

There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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Boca Pharmacal, Llc

Zidovudine | Boca Pharmacal, Llc

2.1    Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of Zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing Zidovudine capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow a Zidovudine capsule, the Zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine
Body Weight (kg) 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2    Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route Total Daily Dose Dose and Dosage Regimen Oral 8 mg/kg/day 2 mg/kg every 6 hours IV 6 mg/kg/day 1.5 mg/kg infused over 30 minutes, every 6 hours 2.3    Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4    Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5    Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
American Health Packaging

Zidovudine | American Health Packaging

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.

Pediatric Patients (Aged 4 Weeks to <18 Years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.

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

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

The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine Route Total Daily Dose Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
Lannett Company, Inc.

Zidovudine | Lannett Company, Inc.

2.1 Treatment of HIV-1 Infection
Adults: The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 weeks to <18 years): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine tablets for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight (kg) 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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (>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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/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 zidovudine intravenously. See Table 2.
Table 2. Recommended Neonatal Dosages of Zidovudine
Route
Total Daily Dose
Dose and Dosage Regimen
Oral
8 mg/kg/day
2 mg/kg every 6 hours
IV
6 mg/kg/day
1.5 mg/kg infused over 30 minutes, every 6 hours
2.3 Patients With Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients With Renal Impairment
End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology(12.3)].
2.5 Patients With Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

No Recall
State Of Florida Doh Central Pharmacy

Zidovudine | State Of Florida Doh Central Pharmacy

2.1 Treatment of HIV-1 Infection Adults
The recommended oral dose of zidovudine tablets is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (Aged 4 Weeks to <18 Years)
Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine tablets, transcription of the medication order, dispensing information and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine tablets for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥ 4 kg is provided in Table 1. Zidovudine syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Tablets Body Weight
(kg)
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 zidovudine tablets can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine tablets is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.
2.2 Prevention of Maternal-Fetal HIV-1 Transmission
The recommended dosage regimen for administration to pregnant women (> 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 (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing
2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.
2.3 Patients with Severe Anemia and/or Neutropenia
Significant anemia (hemoglobin < 7.5 g/dL or reduction > 25% of baseline) and/or significant neutropenia (granulocyte count < 750 cells/mm3 or reduction > 50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.
2.4 Patients with Renal Impairment End-Stage Renal Disease
In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].
2.5 Patients with Hepatic Impairment
There are insufficient data to recommend dose adjustment of zidovudine tablets in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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Mylan Pharmaceuticals Inc.

Zidovudine | Trustees Of The University Of Pennsylvania

Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)].
2.1 Recommended Dose for Adults
Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.
2.2 Recommended Dose for Pediatric Patients
Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)].
2.3 Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug's injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia. 2.4 Radiation Dosimetry
The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injectiona.
aMIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the bio-distribution based on data from Gallagher et al.1 and Jones et al.2 The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.
*LLI = lower large intestine; **ULI = upper large intestine
Organ Newborn
(3.4kg) 1-year old
(9.8kg) 5-year old
(19kg) 10-year
old (32kg) 15-year
old (57kg) Adult
(70kg) Bladder wall 4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.8 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall* 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gall bladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall** 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle 0.058 0.25 0.13 0.078 0.049 0.039 Bone surface 0.57 0.24 0.12 0.079 0.052 0.041 Breast 0.54 0.22 0.11 0.068 0.043 0.034 Skin 0.49 0.20 0.10 0.060 0.037 0.030 Brain 0.29 0.13 0.09 0.078 0.072 0.070 Other tissues 0.59 0.25 0.13 0.083 0.052 0.042 2.5 Radiation Safety – Drug Handling Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. The dose of Fludeoxyglucose F18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. 2.6 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F18 Injection from its container. Inspect Fludeoxyglucose F18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS. 2.7 Imaging Guidelines Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration. Acquire static emission images 30 – 100 minutes from the time of injection.

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Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose b.i.d t.i.d. 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonate is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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Remedyrepack Inc.

Zidovudine | Remedyrepack Inc.

Adults: The recommended oral dose of zidovudine is 600 mg/day in divided doses in combination with other antiretroviral agents.
Pediatric Patients (4 weeks to <18 years of age): Healthcare professionals should pay special attention to accurate calculation of the dose of zidovudine, transcription of the medication order, dispensing information, and dosing instructions to minimize risk for medication dosing errors.
Prescribers should calculate the appropriate dose of zidovudine for each child based on body weight (kg) and should not exceed the recommended adult dose.
Before prescribing zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a zidovudine tablet, the zidovudine syrup formulation should be prescribed.
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. Zidovudine Syrup should be used to provide accurate dosage when whole tablets are not appropriate.
Table 1: Recommended Pediatric Dosage of Zidovudine Body Weight (kg) Total Daily Dose Dosage Regimen and Dose b.i.d t.i.d. 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 zidovudine can be based on body surface area (BSA) for each child. The recommended oral dose of zidovudine is 480 mg/m2/day in divided doses (240 mg/m2 twice daily or 160 mg/m2 three times daily). In some cases the dose calculated by mg/kg will not be the same as that calculated by BSA.

The recommended dosage regimen for administration to pregnant women (>14 weeks of pregnancy) and their neonate is:
Maternal Dosing: 100 mg orally 5 times per day until the start of labor [see Clinical Studies (14.3)]. During labor and delivery, intravenous zidovudine should be administered at 2 mg/kg (total body weight) over 1 hour followed by a continuous intravenous infusion of 1 mg/kg/hour (total body weight) until clamping of the umbilical cord.
Neonatal Dosing: 2 mg/kg orally every 6 hours starting within 12 hours after birth and continuing through 6 weeks of age. Neonates unable to receive oral dosing may be administered zidovudine intravenously at 1.5 mg/kg, infused over 30 minutes, every 6 hours.

Significant anemia (hemoglobin <7.5 g/dL or reduction >25% of baseline) and/or significant neutropenia (granulocyte count <750 cells/mm3 or reduction >50% from baseline) may require a dose interruption until evidence of marrow recovery is observed [see Warnings and Precautions (5.1)]. 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 erythropoetin level and patient tolerance.

End-Stage Renal Disease: In patients maintained on hemodialysis or peritoneal dialysis, the recommended dosage is 100 mg every 6 to 8 hours [see Clinical Pharmacology (12.3)].

There are insufficient data to recommend dose adjustment of zidovudine in patients with mild to moderate impaired hepatic function or liver cirrhosis.

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