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Stavudine (Zerit) | HIV/AIDS Drug | Professional | AIDSinfo
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Stavudine Brand Name: ZeritOther Names: d4T
stavudine Molecular Weight: 224.2148
Patient VersionFDA Label - Capsule (gelatin coated), powder (for solution)
Several FDA-approved drug labels may be available for stavudine. AIDSinfo provides the following drug label solely as an example of the labels available for stavudine. Inclusion or absence of a drug label on the AIDSinfo site does not imply endorsement or lack thereof by AIDSinfo. Search Drugs@FDA to access more information on stavudine, including additional drug labels and any generic equivalents.+FDA Drug Label Sections
These highlights do not include all the information needed to use ZERIT safely and effectively. See full prescribing information for ZERIT.ZERIT® (stavudine) CapsulesZERIT® (stavudine) for Oral SolutionInitial U.S. Approval: 1994
WARNING: LACTIC ACIDOSIS and HEPATOMEGALY withSTEATOSIS; PANCREATITIS
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine. (5.1)
Fatal and nonfatal pancreatitis have occurred when ZERIT was part of a combination regimen that included didanosine. (5.4)
ZERIT (stavudine) is a nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection. (1)
Zerit is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components of this product. (4)
Lactic acidosis/severe hepatomegaly with steatosis: Suspend treatment with ZERIT in patients who develop clinical symptoms or signs with or without laboratory findings. (5.1)
Coadministration of ZERIT with zidovudine should be avoided. (7)
Coadministration of ZERIT and doxorubicin or ribavirin should be undertaken with caution. (7)
Pregnancy:	Fatal lactic acidosis has been reported in pregnant women who received both didanosine and stavudine with other agents. This combination should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk to the fetus. Pregnancy registry available. (8.1)
WARNING: LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS; PANCREATITIS Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Warnings and Precautions (5.1)]. Fatal and nonfatal pancreatitis have occurred during therapy when ZERIT was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression [see Warnings and Precautions (5.4)].
ZERIT® (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION The interval between doses of ZERIT (stavudine) should be 12 hours. ZERIT may be taken with or without food. 2.1 Recommended Adult Dosage
CreatinineClearance(mL/min)
Recommended ZERIT Doseby Patient Weight
Pediatric Patients: Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of ZERIT in this patient population. 2.4 Method of Preparation for Oral Solution
Prior to dispensing, the pharmacist must constitute the dry powder with purified water to a concentration of 1 mg stavudine per mL of solution, as follows: Add 202 mL of purified water to the container. Shake container vigorously until the powder dissolves completely. Constitution in this way produces 200 mL (deliverable volume) of 1 mg/mL stavudine solution. The solution may appear slightly hazy. Dispense solution in original container with measuring cup provided. Instruct patient to shake the container vigorously prior to measuring each dose and to store the tightly closed container in a refrigerator, 2°C to 8°C (36°F to 46°F). Discard any unused portion after 30 days. 3 DOSAGE FORMS AND STRENGTHS
ZERIT for oral solution is a dye-free, fruit-flavored powder that provides 1 mg of stavudine per milliliter solution after constitution. 4 CONTRAINDICATIONS
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Although relative rates of lactic acidosis have not been assessed in prospective well-controlled trials, longitudinal cohort and retrospective studies suggest that this infrequent event may be more often associated with antiretroviral combinations containing stavudine. Female gender, obesity, and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Use in Specific Populations (8.1)]. Particular caution should be exercised when administering ZERIT to any patient with known risk factors for liver disease; however, cases of lactic acidosis have also been reported in patients with no known risk factors. Generalized fatigue, digestive symptoms (nausea, vomiting, abdominal pain, and unexplained weight loss); respiratory symptoms (tachypnea and dyspnea); or neurologic symptoms, including motor weakness [see Warnings and Precautions (5.3)] might be indicative of the development of symptomatic hyperlactatemia or lactic acidosis syndrome.
Treatment with ZERIT (stavudine) should be suspended in any patient who develops clinical or laboratory findings suggestive of symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Permanent discontinuation of ZERIT should be considered for patients with confirmed lactic acidosis.
The safety and efficacy of ZERIT have not been established in HIV-infected patients with significant underlying liver disease. During combination antiretroviral therapy, 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, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Peripheral sensory neuropathy, manifested by numbness, tingling, or pain in the hands or feet, has been reported in patients receiving ZERIT therapy. Peripheral neuropathy, which can be severe, is dose related and occurs 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 [see Adverse Reactions (6)].
Fatal and nonfatal pancreatitis have occurred during therapy when ZERIT was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. The combination of ZERIT and didanosine and any other agents that are toxic to the pancreas should be suspended in patients with suspected pancreatitis. Reinstitution of ZERIT after a confirmed diagnosis of pancreatitis should be undertaken with particular caution and close patient monitoring; avoid use in combination with didanosine.
5.5 Fat Redistribution Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy.
In randomized controlled trials of treatment-naive patients, clinical lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir). Dual energy x-ray absorptiometry (DEXA) scans demonstrated overall limb fat loss in stavudine-treated patients compared to limb fat gain or no gain in patients treated with other nucleosides (abacavir, tenofovir, or zidovudine). The incidence and severity of lipoatrophy or lipodystrophy are cumulative over time with stavudine-containing regimens. In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy. Patients receiving ZERIT should be monitored for symptoms or signs of lipoatrophy or lipodystrophy and questioned about body changes related to lipoatrophy or lipodystrophy. Given the potential risks of using ZERIT including lipoatrophy or lipodystrophy, a benefit-risk assessment for each patient should be made and an alternative antiretroviral should be considered.
Table 2:	Selected Adverse Reactions in Study AI455-019a (Monotherapy)
ZERITb(40 mg twice daily)(n=412)
zidovudine(200 mg 3 times daily)(n=402)
a The incidences reported included all severity grades and all reactions regardless of causality. b Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.
Table 3:	Selected Adverse Reactionsa in START 1 and START 2b Studies (Combination Therapy)
zidovudine + lamivudine + indinavir(n=103)
a	The incidences reported included all severity grades and all reactions regardless of causality.
b	START 2 compared two triple-combination regimens in 205 treatment-naive patients. Patients received either ZERIT (40 mg twice daily) plus didanosine plus indinavir or zidovudine plus lamivudine plus indinavir.
c	Duration of stavudine therapy = 48 weeks.
Table 4:	Selected Laboratory Abnormalities in Study AI455-019a,b
a	Data presented for patients for whom laboratory evaluations were performed.
b	Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.
AST (SGOT) (>5.0 x ULN)
ALT (SGPT) (>5.0 x ULN)
Table 5:	Selected Laboratory Abnormalities in START 1 and START 2 Studies (Grades 3–4)
Table 6:	Selected Laboratory Abnormalities in START 1 and START 2 Studies (All Grades)
zidovudine + lamivudine + indinavir (n=103)
6.2 Clinical Trial Experience in Pediatric Patients Adverse reactions and serious laboratory abnormalities reported in pediatric patients from birth through adolescence during clinical trials were similar in type and frequency to those seen in adult patients. [See Use in Specific Populations (8.4).] 6.3 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of ZERIT. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to ZERIT, or a combination of these factors. Body as a Whole: abdominal pain, allergic reaction, chills/fever, and redistribution/accumulation of body fat [see Warnings and Precautions (5.5)].
Exocrine Gland Disorders: pancreatitis, including fatal cases [see Warnings and Precautions (5.4)].
Hematologic Disorders: anemia, leukopenia, thrombocytopenia, neutropenia, and macrocytosis. Liver: symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see Warnings and Precautions (5.1)], hepatitis and liver failure.
Musculoskeletal: myalgia. Nervous System: insomnia, severe motor weakness (most often reported in the setting of lactic acidosis) [see Warnings and Precautions (5.1, 5.3)].
When stavudine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when stavudine is used alone. Thus, patients treated with ZERIT in combination with didanosine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see Warnings and Precautions (5)]. The combination of ZERIT and hydroxyurea, with or without didanosine, should be avoided.
Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in nonpregnant individuals receiving nucleoside analogues [see Boxed Warning and Warnings and Precautions (5.1)]. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Healthcare providers caring for HIV-infected pregnant women receiving stavudine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome.
Use of stavudine in pediatric patients from birth through adolescence is supported by evidence from adequate and well-controlled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients [see Dosage and Administration (2.2) and Adverse Reactions (6.2)]. Adverse reactions and laboratory abnormalities reported to occur in pediatric patients in clinical studies were generally consistent with the safety profile of stavudine in adults. These studies include ACTG 240, where 105 pediatric patients ages 3 months to 6 years received ZERIT 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received ZERIT 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received ZERIT 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.
Stavudine pharmacokinetics have been evaluated in 25 HIV-1-infected pediatric patients ranging in age from 5 weeks to 15 years and in weight from 2 to 43 kg after IV or oral administration of single doses and twice-daily regimens and in 30 HIV-1-exposed or -infected newborns ranging in age from birth to 4 weeks after oral administration of twice-daily regimens [see Clinical Pharmacology (12.3, Table 9)].
Powder for Oral Solution: ZERIT is available as a dye-free, fruit-flavored powder in bottles with child-resistant closures providing 200 mL of a 1 mg/mL stavudine oral solution upon constitution with water per label instructions. The powder for oral solution contains the following inactive ingredients: methylparaben, propylparaben, sodium carboxymethylcellulose, sucrose, and antifoaming and flavoring agents.
Stavudine is an antiviral drug [see Clinical Pharmacology (12.4)]. 12.3 Pharmacokinetics
Table 7:	Steady-State Pharmacokinetic Parameters of ZERIT in HIV-1-Infected Adults
ZERIT 40 mg BIDMean ± SD (n=8)
Metabolism plays a limited role in the clearance of stavudine. Unchanged stavudine was the major drug-related component circulating in plasma after an 80-mg dose of 14C-stavudine, while metabolites constituted minor components of the circulating radioactivity. Minor metabolites include oxidized stavudine, glucuronide conjugates of stavudine and its oxidized metabolite, and an N‑acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.
Table 8:	Pharmacokinetic Parameters of Stavudine in HIV-1-Infected Adults: Bioavailability, Distribution, and Clearance
a	Following 1-hour IV infusion.
b	Following single oral dose.
c	Assuming a body weight of 70 kg.
d	Over 12–24 hours.
Table 9:	Pharmacokinetic Parameters (Mean ± SD) of Stavudine in HIV-1-Exposed or -Infected Pediatric Patients
b	At median time of 2.5 hours (range 2–3 hours) following multiple oral doses.
c	Following single oral dose.
d	Over 8 hours.
1.59 ± 0.29	30
Data from two studies in adults indicated that the apparent oral clearance of stavudine decreased and the terminal elimination half-life increased as creatinine clearance decreased (see Table 10). Cmax and Tmax were not significantly altered by renal impairment. The mean ± SD hemodialysis clearance value of stavudine was 120 ± 18 mL/min (n=12); the mean ± SD percentage of the stavudine dose recovered in the dialysate, timed to occur between 2–6 hours post-dose, was 31 ± 5%. Based on these observations, it is recommended that ZERIT (stavudine) dosage be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis [see Dosage and Administration (2.3)].
Table 10:	Mean ± SD Pharmacokinetic Parameter Values of ZERITa in Adults with Varying Degrees of Renal Function
HemodialysisPatientsb(n=11)
>50 mL/min(n=10)
9–25 mL/min(n=5)
a	Single 40-mg oral dose.
b	Determined while patients were off dialysis.
Apparent oral clearance (mL/min)	335 ± 57
Stavudine pharmacokinetics were not altered in five non-HIV-infected patients with hepatic impairment secondary to cirrhosis (Child-Pugh classification B or C) following the administration of a single 40-mg dose. Geriatric
Tables 11 and 12 summarize the effects on AUC and Cmax, with a 95% confidence interval (CI) when available, following coadministration of ZERIT with didanosine, lamivudine, and nelfinavir. No clinically significant pharmacokinetic interactions were observed. Table 11:	Results of Drug Interaction Studies with ZERIT: Effects of Coadministered Drug on Stavudine Plasma AUC and Cmax Values
Cmax of Stavudine (95% CI)
↑	Indicates increase.
a	HIV-1-infected patients.
40 mg singledose	18
Table 12:	Results of Drug Interaction Studies with ZERIT: Effects of Stavudine on Coadministered Drug Plasma AUC and Cmax Values
Cmax of CoadministeredDrug(95% CI)
40 mg single dose	18
8	↔
Stavudine, a nucleoside analogue of thymidine, is phosphorylated by cellular kinases to the active metabolite stavudine triphosphate. Stavudine triphosphate inhibits the activity of HIV-1 reverse transcriptase (RT) by competing with the natural substrate thymidine triphosphate (Ki=0.0083 to 0.032 µM) and by causing DNA chain termination following its incorporation into viral DNA. Stavudine triphosphate inhibits cellular DNA polymerases β and γ and markedly reduces the synthesis of mitochondrial DNA. Antiviral Activity in Cell Culture
The cell culture antiviral activity of stavudine was measured in peripheral blood mononuclear cells, monocytic cells, and lymphoblastoid cell lines. The concentration of drug necessary to inhibit HIV-1 replication by 50% (EC50) ranged from 0.009 to 4 µM against laboratory and clinical isolates of HIV-1. In cell culture, stavudine exhibited additive to antagonistic activity in combination with zidovudine. Stavudine in combination with either abacavir, didanosine, tenofovir, or zalcitabine exhibited additive to synergistic anti-HIV-1 activity. Ribavirin, at the 9–45 µM concentrations tested, reduced the anti-HIV-1 activity of stavudine by 2.5- to 5-fold. The relationship between cell culture susceptibility of HIV-1 to stavudine and the inhibition of HIV-1 replication in humans has not been established. Resistance
Cross-resistance among HIV-1 reverse transcriptase inhibitors has been observed. Several studies have demonstrated that prolonged stavudine treatment can select and/or maintain thymidine analogue mutations (TAMs; M41L, D67N, K70R, L210W, T215Y/F, K219Q/E) associated with zidovudine resistance. HIV-1 isolates with one or more TAMs exhibited reduced susceptibility to stavudine in cell culture. These TAMs are seen at a similar frequency with stavudine and zidovudine in virological treatment. The clinical relevance of these findings suggests that stavudine should be avoided in the presence of thymidine analogue mutations.
ZERIT® (stavudine) Capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures: Table 13:	Capsule Strength/Configuration
ProductStrength
ZERIT® (stavudine) for Oral Solution is a dye-free, fruit-flavored powder that provides 1 mg of stavudine per mL of solution upon constitution with water. Directions for solution preparation are included on the product label and in the Dosage and Administration (2) section of this insert. ZERIT for Oral Solution (NDC No. 0003-1968-01) is available in child-resistant containers that provide 200 mL of solution after constitution with water. 16.3 Storage
Patients should be advised that ZERIT is not a cure for HIV-1 infection, and that they may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should be advised to remain under the care of a physician when using ZERIT and the importance of adherence to any antiretroviral regimen including those that contain ZERIT.
Do not breastfeed. It is not known if ZERIT can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.
Patients should be informed that when ZERIT is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when ZERIT is used alone. Patients should be instructed that if they miss a dose, to take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule.
Patients should be instructed if they take too much ZERIT, they should contact a poison control center or emergency room right away.
Patients with diabetes should be aware that ZERIT for Oral Solution contains 50 mg of sucrose (sugar) per mL.
Patients should be informed of the importance of early recognition of symptoms of symptomatic hyperlactatemia or lactic acidosis syndrome, which include unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, and motor weakness. Patients in whom these symptoms develop should seek medical attention immediately. Discontinuation of ZERIT therapy may be required. 17.3 Hepatic Toxicity
Patients should be informed that an increased risk of hepatotoxicity, which may be fatal, may occur in patients treated with ZERIT in combination with didanosine and hydroxyurea. This combination should be avoided.
Patients should be informed that an important toxicity of ZERIT (stavudine) is peripheral neuropathy. Patients should be aware that peripheral neuropathy is manifested by numbness, tingling, or pain in hands or feet, and that these symptoms should be reported to their physicians. Patients should be counseled that peripheral neuropathy occurs with greatest frequency in patients who have advanced HIV-1 disease or a history of peripheral neuropathy, and discontinuation of ZERIT may be required if toxicity develops.
Caregivers of young children receiving ZERIT therapy should be instructed regarding detection and reporting of peripheral neuropathy. 17.5 Pancreatitis
Patients should be informed that an increased risk of pancreatitis, which may be fatal, may occur in patients treated with the combination of ZERIT and didanosine. This combination should be avoided. Patients should be closely monitored for symptoms of pancreatitis. The patient should be instructed to avoid alcohol while taking ZERIT. Alcohol may increase the patient’s risk of pancreatitis or liver damage.
17.6 Fat Redistribution Patients should be informed that redistribution or accumulation of body fat may occur in individuals receiving antiretroviral therapy including ZERIT. Patients receiving ZERIT should be monitored for clinical signs and symptoms of lipoatrophy/lipodystrophy. Patients should be routinely questioned about body changes related to lipoatrophy/lipodystrophy.
ZERIT® Capsules and
ZERIT® for Oral Solution
Read this Medication Guide before you start taking ZERIT and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. You and your healthcare provider should talk about your treatment with ZERIT before you start taking it and at regular check-ups. You should stay under your healthcare provider’s care when taking ZERIT.
feel weak or tired have unusual (not normal) muscle pain have trouble breathing have stomach pain with nausea and vomiting
2. Liver problems. Some people (including pregnant women) who have taken ZERIT have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and death due to liver problems. Your healthcare provider should check your liver function while you are taking ZERIT. You should be especially careful if you have a history of heavy alcohol use or liver problems. Use of ZERIT with VIDEX EC or VIDEX (didanosine) may increase your risk for liver damage. It is important to call your healthcare provider right away if you have: yellowing of your skin or the white of your eyes (jaundice)
dark urine pain on the right side of your stomach swelling of your stomach easy bruising or bleeding loss of appetite
3. Swelling of the pancreas (pancreatitis) that may cause death has occurred when ZERIT was used with VIDEX EC or VIDEX (didanosine). Pancreatitis can happen at any time during your treatment with ZERIT. It is important to call your healthcare provider right away if you have:
ZERIT is a prescription medicine used with other HIV medicines to treat human immunodeficiency virus (HIV) infection in children and adults. ZERIT belongs to a class of drugs called nucleoside analogues. ZERIT will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking ZERIT, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your healthcare provider regularly and report any medical problems that occur.
Who should not take ZERIT? Do not take ZERIT if you:
What should I tell my healthcare provider before taking ZERIT?
have or had liver problems (such as hepatitis) have or had problems with your pancreas (pancreatitis)
are pregnant or plan to become pregnant. It is not known if ZERIT will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ZERIT. You and your healthcare provider will decide if you should take ZERIT while you are pregnant.Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, or herbal supplements. ZERIT may affect the way other medicines work, and other medicines may affect how ZERIT works. Especially tell your healthcare provider if you take:
Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Some medicines may require your healthcare provider to monitor your therapy or change your therapy. Check with your healthcare provider.
If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take ZERIT. Your healthcare provider may also lower your dosage of ZERIT if your kidneys are not working well.
Alcohol. You should avoid drinking alcohol while taking ZERIT. Alcohol may increase your risk of getting pain and swelling of your pancreas (pancreatitis) or may damage your liver.
What are the possible side effects of ZERIT? ZERIT can cause serious side effects including:
ZERIT can cause lactic acidosis, liver problems, and pancreatitis. See “What is the most important information I should know about ZERIT?”
Neurologic symptoms. Symptoms include: weakness of your legs, feet, arms, or hands (motor weakness) and numbness or tingling in your hands or feet (neuropathy). These problems can happen more often in people who have advanced HIV disease, have a history of peripheral neuropathy, or in people who take other medicines that also are associated with neuropathy including didanosine. In some cases, neuropathy may temporarily worsen after you stop taking ZERIT. Neuropathy can be difficult to notice in children who take ZERIT. Ask your child’s healthcare provider for the signs and symptoms of peripheral neuropathy in children.
It is important to call your healthcare provider right away if you have: numbness in your hands or feet
Changes in body fat (fat redistribution). Changes in body fat (lipoatrophy or lipodystrophy) have been seen in some people taking HIV medicines including ZERIT. Loss of body fat (lipoatrophy) happens more often in people who take ZERIT than in people who take other similar HIV medicines.
How should I store ZERIT?
Store ZERIT capsules in a tightly closed container at room temperature at 59°F to 86°F (15°C to 30°C).
Store ZERIT oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
General Information about the safe and effective use of ZERIT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZERIT for a condition for which it was not prescribed. Do not give ZERIT to other people, even if they have the same symptoms as you have. It may harm them. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place ZERIT in an unrecognizable closed container in the household trash.
This Medication Guide summarizes the most important information about ZERIT. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZERIT that is written for health professionals. For more information, go to http://www.bms.com/products/Pages/prescribing.aspx or call 1‑800‑321‑1335. What are the ingredients in ZERIT?
Inactive Ingredients: ZERIT Capsules: microcrystalline cellulose, sodium starch glycolate, lactose, and magnesium stearate.
ZERIT for Oral Solution: methylparaben, propylparaben, sodium carboxymethylcellulose, sucrose, and antifoaming and flavoring agents.
ZERIT®, VIDEX®, VIDEX EC®, HYDREA®, and DROXIA® are registered trademarks of Bristol-Myers Squibb Company. All other trademarks are the property of their respective owners.Distributed by:Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USAThis Medication Guide has been approved by the U.S. Food and Drug Administration.1286696A5MF#0152-07
ZERIT®(stavudine)
1 mg stavudine per mLwhen constituted perlabel instructions
ZERIT stavudine capsule, gelatin coated
YELLOW (light yellow) , RED (dark red) Score
60 CAPSULE, GELATIN COATED in 1 BOTTLE
ORANGE (light orange & dark orange) Score
ORANGE (dark orange) Score
ZERIT stavudine powder, for solution
Revised: 12/2012 E.R. Squibb & Sons, L.L.C.