STAV-yoo-deen

• HIV infection unresponsive or intolerant to conventional therapy.

• Converted intracellularly to stavudine triphosphate, which inhibits viral DNA synthesis and replication.

• Virustatic action against HIV.
• Decreased viral load and increased cell count.
• Not curative, but may slow progression of HIV infection and decrease the incidence and severity of its sequelae.

Absorption: Well absorbed after oral administration (78–80% bioavailability). XR formulation produces less fluctuation in levels.

Distribution: Crosses the blood-brain barrier; enters RBCs and plasma equally.

Metabolism/Excretion: Converted intracellularly to stavudine triphosphate, which is the active drug; 40% excreted unchanged in urine; 50% nonrenally eliminated.

Half-life: Adults — 1–1.6 hr; children — 0.9–1.1 hr; adults with renal impairment — 4.8 hr; intracellular half-life — 3.5 hr.

Contraindicated in:

• Hypersensitivity
• Concurrent use of didanosine.
• Lactation: Avoid breastfeeding in patients with HIV.

Use Cautiously in:

• History of alcohol abuse
• Hepatic impairment
• Renal impairment (dose ↓ and/or ↑ dosing interval recommended if CCr <50 mL/min)
• History of peripheral neuropathy
• OB: Safety not established; concurrent use with didanosine during pregnancy may ↑ the risk of fetal lactic acidosis.

Endo: lipoatrophy.

F and E: LACTIC ACIDOSIS.

GI: HEPATOMEGALY (WITH STEATOSIS), HEPATOTOXICITY, PANCREATITIS, anorexia, diarrhea.

Hemat: anemia.

MS: arthralgia, myalgia.

Neuro: peripheral neuropathy , headache, insomnia, weakness.

Misc: immune reconstitution syndrome.

Drug-Drug:

• Concurrent use with didanosine may ↑ risk of lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis; concurrent use contraindicated.
• Use cautiously with drugs causing peripheral neuropathy (chloramphenicol, cisplatin, dapsone, didanosine, ethambutol, ethionamide, hydralazine, isoniazid, lithium, metronidazole, nitrofurantoin, phenytoin, or vincristine).
• Concurrent use with hydroxyurea may ↑ risk of hepatotoxicity; avoid concurrent use.
• Concurrent use with zidovudine is not recommended because of possible antiretroviral antagonism.

• PO (Adults 60 kg): 40 mg every 12 hr.
• PO (Adults <60 kg): 30 mg every 12 hr.
• PO (Children 30 kg): 30 mg every 12 hr.
• PO (Children at least 14 days old and <30 kg): 1 mg/kg every 12 hr (not to exceed 40 mg every 12 hr).
• PO (Infants birth–13 days): 0.5 mg/kg every 12 hr.

• High Alert:Do not confuse stavudine with cetirizine. Do not confuse Zerit with Zyrtec (cetirizine).
• PO: May be administered without regard to food.

Zerit

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

(Generic available)

• Capsules: 15 mg; 20 mg; 30 mg; 40 mg;

(blood levels)

• Assess patient for change in severity of symptoms of HIV infection and for symptoms of opportunistic infection during therapy.
• Monitor patient for signs and symptoms of peripheral neuropathy (tingling, burning, numbness, or pain in hands or feet); may be difficult to differentiate from peripheral neuropathy of severe HIV disease or lactic acidosis. May resolve if stavudine therapy is discontinued promptly or may temporarily worsen after discontinuation of therapy.
• Assess patient for signs of pancreatitis (nausea, vomiting, abdominal pain) periodically throughout therapy. Occurs rarely, but may require discontinuation of therapy.

• Monitor viral load CD4 counts before and regularly during therapy.
  • Monitor liver function. May cause ↑ levels of AST, ALT, and alkaline phosphatase, which usually resolve after interruption of therapy. Lactic acidosis may occur with hepatic toxicity causing hepatic steatosis; may be fatal, especially in women.
  • May cause ↑ serum amylase and lipase levels.

• Risk for infection (Indications).

• Instruct patient to take stavudine as directed. Emphasize the importance of adherence with therapy, not taking more than the prescribed amount, and not discontinuing without consulting health care professional. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Caution patient not to share medication with others.
• Inform patient that stavudine does not cure HIV disease or prevent associated or opportunistic infections. Stavudine may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to avoid sexual contact or to use a condom, and to avoid sharing needles or donating blood to prevent spreading HIV to others.
• Encourage patient to maintain adequate hydration by drinking at least 1.5 L/day.
• Instruct patient to notify health care professional promptly if signs of lactic acidosis (unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, motor weakness), signs of Immune Reconstitution Syndrome (signs and symptoms of an infection), peripheral neuropathy, or pancreatitis occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
• Rep: Advise patient taking oral contraceptives to use a nonhormonal method of birth control during stavudine therapy. If pregnancy is suspected notify health care professional promptly. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1–800–258–4263. Advise female patient to avoid breastfeeding during therapy; breast milk may transmit virus.
• Emphasize the importance of regular follow-up exams and blood tests to determine progress and monitor for side effects.

• Decrease in viral load and improvement in CD4 counts in patients with advanced HIV infection.

NDC Code^*

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-1965- ZERIT
    • 0003-1965-01- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0003-1965-01)

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-1966- ZERIT
    • 0003-1966-01- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0003-1966-01)

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-1967- ZERIT
    • 0003-1967-01- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0003-1967-01)

• 53104- Cipla Ltd.
  • 53104-0111- stavudine
    • 53104-0111-5- 200 mL in 1 BOTTLE (53104-0111-5)

• 53808- State of Florida DOH Central Pharmacy
  • 53808-0852- Stavudine
    • 53808-0852-1- 30 CAPSULE in 1 BLISTER PACK (53808-0852-1)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-354- Stavudine
    • 64980-354-06- 60 CAPSULE in 1 BOTTLE (64980-354-06)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-355- Stavudine
    • 64980-355-06- 60 CAPSULE in 1 BOTTLE (64980-355-06)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-356- Stavudine
    • 64980-356-06- 60 CAPSULE in 1 BOTTLE (64980-356-06)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-357- Stavudine
    • 64980-357-06- 60 CAPSULE in 1 BOTTLE (64980-357-06)

• 65862- Aurobindo Pharma Limited
  • 65862-046- Stavudine
    • 65862-046-60- 60 CAPSULE in 1 BOTTLE (65862-046-60)

• 65862- Aurobindo Pharma Limited
  • 65862-047- Stavudine
    • 65862-047-60- 60 CAPSULE in 1 BOTTLE (65862-047-60)

• 65862- Aurobindo Pharma Limited
  • 65862-111- Stavudine
    • 65862-111-60- 60 CAPSULE in 1 BOTTLE (65862-111-60)

• 65862- Aurobindo Pharma Limited
  • 65862-112- Stavudine
    • 65862-112-60- 60 CAPSULE in 1 BOTTLE (65862-112-60)