Adult Dosing
Treatment of HIV Infection
- (<60 kg): 30 mg PO bid
- (
60 kg): 40 mg PO bid
Pediatric Dosing
Treatment of HIV Infection
- Neonates (birth - 13 days): 0.5 mg/kg/dose PO bid
- (14 days and <30 kg): 1 mg/kg/dose PO bid
- (14 days and 30 kg): Use adult dosing
[Outline]
Renal Dose Adjustment (Based on CrCl)
Adults less than 60 kg
- >50 mL/min: 30 mg PO bid
- 26-50 mL/min: 15 mg PO bid
- 10-25 mL/min: 15 mg PO qd
- Hemodialysis: 15 mg PO immediately following completion of hemodialysis, and continuing at 15 mg PO q24 hrs thereafter
Adults (60 kg)
- >50 mL/min: 40 mg PO bid
- 26-50 mL/min: 20 mg PO bid
- 10-25 mL/min: 20 mg PO qd
- Hemodialysis: 20 mg PO immediately following completion of hemodialysis, and continuing 20 mg PO q24 hrs thereafter
Hepatic Dose Adjustment
- Hepatic impairment: Use with caution; Dose adjustments not defined
- Lactic acidosis and severe hepatomegaly with steatosis including fatal cases has occurred with the use of nucleoside analogues alone or in combination with other antiretrovirals [US Black Box Warning]. Female gender, obesity and prolonged nucleoside exposure are risk factors
- Fatal lactic acidosis has occurred in pregnant women who received the combination of stavudine and didanosine. Use combination of stavudine and didanosine with caution during pregnancy only if the potential benefit clearly outweighs the potential risk [US Black Box Warning]
- Exercise caution while administering to any patient with known risk factors for liver disease
- Consider suspension of therapy if clinical or laboratory findings suggests symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Permanently discontinue therapy for patients with confirmed lactic acidosis
- Safety and efficacy have not been established in HIV-infected patients with significant underlying liver disease
- Patients with preexisting liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities including severe and potentially fatal hepatic adverse events. Appropriately monitor patients. On evidence of worsening liver disease, consider interruption or discontinuation of treatment. Hepatotoxicity and hepatic failure resulting in death have occurred during postmarketing surveillance in HIV-infected patients treated with hydroxyurea and other antiretroviral agents
- Avoid combination of hydroxyurea, didanosine, and stavudine
- Fatal hepatic decompensation has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Closely monitor patients receiving interferon alfa with or without ribavirin and stavudine for treatment-associated toxicities, especially hepatic decompensation. Discontinue therapy as medically appropriate and consider reduction of dosage or discontinuation of interferon alfa, ribavirin, or both on observing worsening of clinical toxicities
- Discontinue therapy on developing motor weakness/peripheral neuropathy. Severe peripheral neuropathy has occurred more frequently in patients with advanced HIV-1 disease, a history of peripheral neuropathy, or in patients receiving other drugs that have been associated with neuropathy, including didanosine. Monitor patients for the development of peripheral neuropathy
- Fatal and nonfatal pancreatitis has occurred when used as a part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression; consider suspension of therapy in patients with suspected pancreatitis. Exercise caution while considering reinstitution of therapy after a confirmed diagnosis of pancreatitis and closely monitor patient; avoid use in combination with didanosine
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have occurred in patients
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Risk of hepatic disease
- Peripheral neuropathy
- Advanced HIV disease
- Concomitant neurotoxic agents
- History of pancreatitis
- Obesity
- Female patients
- Myelosuppression
- Prolonged nucleoside treatment
Pregnancy Category:C
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Extended antiretroviral prophylaxis has been successfully used as part of a regimen that decreases mother-to-child transmission to half but the optimal regimen and duration of prophylaxis has not yet been defined. This information is based upon LactMed database. (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 February 2011). Centers for disease control and prevention recommends mothers avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Zerit 30 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
60 mg = $416.98
180 mg = $1197.99 - Zerit 20 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
60 mg = $388.98
180 mg = $1126.01 - Stavudine 40 MG CAPS [Bottle] (CAMBER PHARMACEUTICALS)
60 mg = $129.99
180 mg = $369.97 - Zerit 1 MG/ML SOLR [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
200 ml = $87.99
600 ml = $255.97 - Zerit 40 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
60 mg = $426.97
180 mg = $1225.97 - Zerit 15 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
60 mg = $363.99
180 mg = $1050.34
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
