Buy Zerit Online

Zerit (stavudine)

BOXED WARNING

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues. Fatal lactic acidosis reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents; use with caution. Fatal and nonfatal pancreatitis reported when used as part of a combination regimen that included didanosine.

THERAPEUTIC CLASS

Nucleoside reverse transcriptase inhibitor (NRTI)

DEA CLASS

RX

INDICATIONS

Treatment of HIV-1 infection in combination with other antiretroviral agents.

ADULT DOSAGE

HIV-1 Infection

Combination with Other Antiretrovirals:
<60kg: 30mg q12h
≥60kg: 40mg q12h

PEDIATRIC DOSAGE

HIV-1 Infection

Combination with Other Antiretrovirals:
Birth-13 Days of Age:
0.5mg/kg q12h

≥14 Days of Age:
<30kg: 1mg/kg q12h
≥30kg: Use adult dose

DOSING CONSIDERATIONS

Renal Impairment
CrCl 26-50mL/min:
<60kg: 15mg q12h
≥60kg: 20mg q12h

CrCl 10-25mL/min or on Hemodialysis:

<60kg: 15mg q24h
≥60kg: 20mg q24h

Administer after completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days

ADMINISTRATION

Oral route

Take with or without food
Shake oral sol vigorously prior to measuring each dose

HOW SUPPLIED

Cap: 15mg, 20mg, 30mg, 40mg; Sol: 1mg/mL [200mL]

WARNINGS/PRECAUTIONS

Female gender, obesity, and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly with steatosis. Caution in patients with known risk factors for liver disease. Suspend treatment if findings suggestive of symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity develop; consider permanent discontinuation with confirmed lactic acidosis. Increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events in patients with preexisting liver dysfunction; monitor accordingly and consider interruption or discontinuation if worsening of liver disease is evident. Motor weakness reported rarely; d/c if this develops. Dose-related peripheral sensory neuropathy reported; occurs more frequently in patients with advanced HIV-1 disease, history of peripheral neuropathy, or receiving other drugs associated with neuropathy (eg, didanosine). Consider permanent discontinuation if peripheral neuropathy develops. Redistribution/accumulation of body fat reported; monitor for signs/symptoms of lipoatrophy or lipodystrophy. Immune reconstitution syndrome reported. Autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) reported in the setting of immune reconstitution and can occur many months after initiation of treatment. Caution with renal impairment and in elderly.

ADVERSE REACTIONS

Lactic acidosis, severe hepatomegaly with steatosis, peripheral neurologic symptoms/neuropathy, headache, diarrhea, rash, N/V, increased AST/ALT/amylase.

DRUG INTERACTIONS

See Boxed Warning. Suspend combination of stavudine and didanosine and any other agents that are toxic to the pancreas in patients with suspected pancreatitis; caution with reinstitution of stavudine and avoid use in combination with didanosine if pancreatitis is confirmed. Avoid with zidovudine or hydroxyurea with or without didanosine. Hepatic decompensation may occur in combination with interferon and ribavirin in HIV-1/HCV coinfected patients; monitor for clinical toxicities and consider discontinuation if this occurs. Caution with doxorubicin or ribavirin.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Synthetic thymidine nucleoside analogue; inhibits activity of HIV-1 reverse transcriptase by competing with natural substrate thymidine triphosphate and by causing DNA chain termination following its incorporation into viral DNA. Inhibits cellular DNA polymerases β and gamma and markedly reduces synthesis of mitochondrial DNA.

PHARMACOKINETICS

Absorption: Rapid. Oral bioavailability (86.4%) (adults), (76.9%) (pediatrics); Cmax=536ng/mL (adults); Tmax=1 hr; AUC0-24=2568ng•hr/mL. Distribution: (IV) Vd=46L (adults), 0.73L/kg (pediatrics). Metabolism: Oxidized stavudine, glucuronide conjugates, and N-acetylcysteine conjugate (minor metabolites). Elimination: Urine (42%) (IV, adults), (34%) (pediatrics); T1/2=1.6 hrs (adults), 0.96 hr (pediatrics).

ASSESSMENT

Assess for drug hypersensitivity, risk factors for lactic acidosis or liver disease, renal/hepatic impairment, history of peripheral neuropathy, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of lactic acidosis, hepatotoxicity, worsening of liver disease, motor weakness, peripheral neuropathy, pancreatitis, fat redistribution/accumulation, lipoatrophy/lipodystrophy, immune reconstitution syndrome (eg, opportunistic infections), and autoimmune disorders.

PATIENT COUNSELING

Inform that therapy is not a cure for HIV and patients may continue to experience illnesses associated with HIV. Advise to avoid doing things that can spread HIV to others (eg, sharing needles, other inj equipment, or personal items that can have blood or body fluids on them; sex without protection; breastfeeding). Advise diabetic patients that oral sol contains 50mg of sucrose/mL. Advise to seek medical attention immediately if symptoms of hyperlactatemia or lactic acidosis syndrome (eg, unexplained weight loss, abdominal discomfort, N/V, fatigue, dyspnea, motor weakness) develop. Instruct to report symptoms of peripheral neuropathy to physician. Advise to avoid alcohol while on therapy. Inform that fat redistribution/accumulation may occur.

STORAGE

25°C (77°F); excursions permitted between 15-30°C (59-86°F). (Sol) Protect from excessive moisture. After Constitution: 2-8°C (36-46°F). Discard any unused portion after 30 days.

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