Stavudine (Zerit)

Trade Name : ZERIT

E.R. Squibb & Sons, L.L.C.

CAPSULE, GELATIN COATED

Strength 20 mg/1

STAVUDINE Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Stavudine (Zerit) which is also known as ZERIT and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 20 mg/1 per ml. Read more

Stavudine (Zerit) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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 pregnantu00a0individuals who received the combination of ZERIT and didanosine with other antiretroviral agents. Coadministration of ZERIT and didanosine is contraindicated because of increased risk of serious and/or life-threatening events [see ()]. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
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 ].
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 WARNING: LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS; PANCREATITIS
See full prescribing information for complete boxed warning.

u00a0u00a0Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Fatal lactic acidosis has been reported in pregnantu00a0individuals who received the combination of ZERIT and didanosine.u00a0Coadministration of ZERIT with didanosine is contraindicated.
u00a0Fatal and nonfatal pancreatitis have occurred when ZERIT was part of a combination regimen that included didanosine. Coadministration of ZERIT with didanosine is contraindicated.

ZERIT, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see ].
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. ()

The interval between doses of ZERIT (stavudine) should be 12 hours. ZERIT may be taken with or without food.
u00a0u00a0 - less than 60 kg: 30 mg every 12 hours ()
u00a0u00a0 - at least 60 kg: 40 mg every 12 hours ()
u00a0 -u00a0 newborns from birth to 13 days old: 0.5 mg/kg every 12 hours ()
u00a0 -u00a0 at least 14 days old and weighing less than 30 kg: 1 mg/kg every 12 hours ()
u00a0 -u00a0u00a0 weighing at least 30 kg: adult dose ()

No data

ZERIT is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation.
Co-administration of ZERIT with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see n , , , ].
u2022 ZERIT is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components of this product. n u2022 Coadministration of ZERIT with didanosine is contraindicated .

No data

u00a0Hepatic toxicity: May be severe, fatal. Consider interruption or discontinuation. Avoid use in combination with hydroxyurea.u00a0 Coadministration of ZERIT with didanosine is contraindicated. Risk of hepatic decompensation exists when used in combination with interferon and ribavirin; closely monitor and consider discontinuation of stavudine. (n n
Neurologic symptoms: Motor weakness, most often seen in the setting of lactic acidosis, may mimic Guillain-Barru00e9 syndrome; discontinue treatment. Monitor for peripheral neuropathy, which can be severe; treatment discontinuation should be considered. ()
Patients may develop localized loss of body fat, monitor for signs and symptoms of lipoatrophy. Alternative antiretrovirals should be considered. ()
Patients may develop immune reconstitution syndrome. ()

The following adverse reactions are discussed in greater detail in other sections of the labeling:
When ZERIT is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when stavudine is used alone.
u2022u00a0 In adults, the most common adverse reactions are headache, diarrhea, neuropathy, rash, nausea, and vomiting. n
u2022u00a0 Adverse reactions in pediatric patients were consistent with those seen in adults. ()
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ZERIT is unlikely to interact with drugs metabolized by cytochrome P450 isoenzymes.
Hydroxyurea:
Zidovudine:
Doxorubicin: In vitro
Ribavirin: In vitro

u2022u00a0 Pregnancy: Fatal lactic acidosis has been reported in pregnantu00a0individuals who received both didanosine and stavudine with other agents. (, )
u2022u00a0 Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. n

Experience with adults treated with 12 to 24 times the recommended daily dosage revealed no acute toxicity. Complications of chronic overdosage include peripheral neuropathy and hepatic toxicity. Stavudine can be removed by hemodialysis; the mean u00b1 SD hemodialysis clearance of stavudine is 120 u00b1 18 mL/min. Whether stavudine is eliminated by peritoneal dialysis has not been studied.

ZERIT is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus type 1 (HIV-1). The chemical name for stavudine is 2u2032,3u2032-didehydro-3u2032-deoxythymidine. Stavudine has the following structural formula:
Stavudine is a white to off-white crystalline solid with the molecular formula CHNO and a molecular weight of 224.2. The solubility of stavudine at 23u00b0C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23u00b0C is 0.144.
Capsules: ZERIT is available as capsules for oral administration containing either 15, 20, 30, or 40 mg of stavudine. Each capsule also contains inactive ingredients microcrystalline cellulose, sodium starch glycolate, lactose, and magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, and iron oxides. The capsules are printed with edible inks.
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 for oral solution upon reconstitution 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.

No data

In 2-year carcinogenicity studies in mice and rats, stavudine was noncarcinogenic at doses which produced exposures (AUC) 39 and 168 times, respectively, human exposure at the recommended clinical dose. Benign and malignant liver tumors in mice and rats and malignant urinary bladder tumors in male rats occurred at levels of exposure 250 (mice) and 732 (rats) times human exposure at the recommended clinical dose.
Stavudine was not mutagenic in the Ames, reverse mutation, or the CHO/HGPRT mammalian cell forward gene mutation assays, with and without metabolic activation. Stavudine produced positive results in the human lymphocyte clastogenesis and mouse fibroblast assays, and in the mouse micronucleus test. In the assays, stavudine elevated the frequency of chromosome aberrations in human lymphocytes (concentrations of 25 to 250 u00b5g/mL, without metabolic activation) and increased the frequency of transformed foci in mouse fibroblast cells (concentrations of 25 to 2500 u00b5g/mL, with and without metabolic activation). In the micronucleus assay, stavudine was clastogenic in bone marrow cells following oral stavudine administration to mice at dosages of 600 to 2000 mg/kg/day for 3 days.
No evidence of impaired fertility was seen in rats with exposures (based on AUC) up to 137 times human exposure at the RHD.

No data

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

What is the most important information I should know about ZERIT?n- ZERIT can cause serious side effects, including:
Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
Call your healthcare provider right away if you have any of the following symptoms of liver problems:
You may be more likely to get lactic acidosis or severe liver problems if you are female, are very overweight (obese), or have been taking nucleoside analogue medicines for a long time.
Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:
u00a0For more information about side effects, see u201cWhat are the possible side effects of ZERIT?u201d.
What is ZERIT?
ZERIT is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV)-1 infection.HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Do not take ZERIT if you:
Before taking ZERIT, tell your healthcare provider about all of your medical conditions, including if you:
u00a0 u00a0u00a0 u00a0u00a0 -u00a0 You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.u00a0u00a0u00a0u00a0u00a0u00a0u00a0 -u00a0 ZERIT can pass into your breast milk and it could harm your baby.
Talk with your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines that you take,n- Especially tell your healthcare provider if you take a medicine called hydroxyurea.
Some medicines interact with ZERIT. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
The most common side effects of ZERIT include:
These are not all the possible side effects of ZERIT.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev December 2018

See section for a complete list of available packages of ZERIT.
60 Capsules u00a0u00a0u00a0u00a0u00a0 NDC 0003-1964-01
ZERITn- (stavudine)n- Capsules
Rx only
15 mg
Detach and dispense theenclosed Medication Guideto each patient.

60 Capsules u00a0u00a0u00a0u00a0u00a0 NDC 0003-1965-01
ZERITn- (stavudine)n- Capsules
Rx only
20 mg
Detach and dispense theenclosed Medication Guideto each patient.

60 Capsules u00a0u00a0u00a0u00a0u00a0 NDC 0003-1966-01
ZERITn- (stavudine)n- Capsules
Rx only
30 mg
Detach and dispense theenclosed Medication Guideto each patient.

60 Capsules u00a0u00a0u00a0u00a0u00a0 NDC 0003-1967-01
ZERITn- (stavudine)n- Capsules
Rx only
40 mg
Detach and dispense theenclosed Medication Guideto each patient.

200 mL u00a0u00a0u00a0u00a0u00a0 NDC 0003-1968-01
ZERITn- (stavudine) n- for Oral Solution
Rx only
1 mg stavudine per mLn when constituted perlabel instructions
Detach and dispense theenclosed Medication Guideto each patient.

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Stavudine (Zerit)

Trade Name : ZERIT

CAPSULE, GELATIN COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Stavudine (Zerit)

Trade Name : ZERIT

CAPSULE, GELATIN COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Browse from other international pharmaceuticals

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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