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Stavudine is an antiviral medicine that is used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). Stavudine is not a cure for HIV or AIDS.
Stavudine may also be used for purposes not listed in this medication guide.
Do not take stavudine with didanosine or zidovudine, or with any other medicine that contains stavudine.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
Stavudine can also cause serious or life-threatening effects on your liver or pancreas. Call your doctor at once if you have: stomach pain or swelling, fever, nausea, vomiting, easy bruising or bleeding, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).
You should not take stavudine if you are allergic to it. Do not take this medicine with didanosine or zidovudine, or with any other medicine that contains stavudine.
Stavudine can cause severe or life-threatening effects on your liver or pancreas. Tell your doctor if you have liver disease or a history of pancreatitis.
Tell your doctor if you have ever had:
kidney disease (or if you are on dialysis);
liver disease, including hepatitis C;
diabetes (stavudine liquid may contain sucrose);
gallstones;
numbness, tingling, or pain in your hands or feet;
problems with your pancreas; or
if you drink large amounts of alcohol.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.
Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.
Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take your doses at regular intervals to keep a steady amount of the drug in your body at all times. You may take stavudine with or without food.
Shake the liquid medicine before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Stavudine doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.
You will need frequent medical tests.
Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.
Store stavudine capsules at room temperature away from moisture and heat. Keep the bottle tightly closed.
Store stavudine liquid in the refrigerator, do not freeze. Throw away any unused liquid after 30 days.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of pancreas or liver damage.
Using stavudine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.
Call your doctor at once if you have:
numbness, tingling, or pain in your hands or feet;
weakness in your legs, feet, arms, or hands;
liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
pancreatitis--fever, severe pain in your upper stomach spreading to your back, nausea and vomiting.
Stavudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:
signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
Common side effects may include:
weakness, numbness, tingling, or burning pain in your hands or feet;
nausea, vomiting, diarrhea;
rash; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your other medicines, especially:
hydroxyurea.
This list is not complete. Other drugs may affect stavudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Stavudine (www.drugs.com/mtm/stavudine.html).
Commonly reported side effects of stavudine include: increased serum alanine aminotransferase, increased serum amylase, increased serum aspartate aminotransferase, and increased serum lipase. See below for a comprehensive list of adverse effects.
Applies to stavudine: oral capsule
Oral route (Capsule; Powder for Solution)
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. Coadministration of stavudine and didanosine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine.
Along with its needed effects, stavudine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking stavudine:
More common
Incidence not known
Some side effects of stavudine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Incidence not known
Applies to stavudine: oral capsule, oral capsule extended release, oral powder for reconstitution
This drug was associated with many side effects (e.g., polyneuropathy, lactic acidosis, lipoatrophy) for which mitochondrial toxicity was a potential underlying mechanism.
In a monotherapy trial, elevated ALT (greater than 5 times the upper limit of normal [5 x ULN]), AST (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) were reported in 13%, 11%, and 2% of patients, respectively. Elevated ALT (up to 5 x ULN) and AST (up to 5 x ULN) were reported in 65% and 63% of patients, respectively.
In combination therapy trials, elevated AST (grades 3 to 4: up to 7%; all grades: up to 53%), ALT (grades 3 to 4: up to 8%; all grades: up to 50%), bilirubin (grades 3 to 4: up to 16%; all grades: up to 68%), and GGT (grades 3 to 4: up to 5%; all grades: up to 28%) were reported; grades 3 to 4 AST, ALT, and GGT elevations were greater than 5 x ULN and grades 3 to 4 bilirubin elevations were greater than 2.6 x ULN.
In clinical trials, modest elevations of hepatic transaminases not requiring dose adjustment were reported in up to 13% of patients.
Hepatosplenomegaly (up to 72%) was reported in children; this side effect was not listed for adults.
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs alone or in combination, including this drug and other antiretroviral agents.
Fatal hepatic events were reported most often in patients treated with this drug in combination with hydroxyurea and didanosine.
Very common (10% or more): Elevated bilirubin (up to 68%), elevated ALT (up to 65%), elevated AST (up to 63%), elevated GGT (up to 28%), elevated hepatic transaminases (up to 13%)
Uncommon (0.1% to 1%): Hepatitis/jaundice
Frequency not reported: Severe hepatomegaly with steatosis, fatal hepatic events, hepatosplenomegaly
Postmarketing reports: Hepatic steatosis, hepatitis, liver failure, hepatotoxicity resulting in death
In clinical trials, peripheral neuropathy requiring or leading to dose adjustment (regardless of severity) was reported in up to 24% of patients. Other peripheral neurological symptoms not requiring dose changes were reported in up to 39% of patients. Neuropathy requiring dose adjustment was reported in up to 14% of patients.
Peripheral sensory neuropathy (generally characterized by numbness, tingling, or pain in the feet or hands) has been reported. Peripheral neuropathy (some cases severe) was dose-related and occurred more often in patients with advanced HIV disease, with history of peripheral neuropathy, or using other drugs associated with neuropathy. Symptoms generally resolved after dose reduction or interruption of this drug.
Syncope (up to 15%), encephalopathy (up to 17%), abnormal gait (up to 11%), tremor (up to 11%), hyperkinesia (up to 10%), ear disorder (up to 39%), ear pain (up to 45%), otitis media (up to 15%), and speech disorder (up to 10%) were reported in children; these side effects were not listed for adults.
Most cases of motor weakness occurred in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome. Symptoms have continued or worsened after therapy was stopped.
Very common (10% or more): Headache (up to 54%), peripheral neurologic symptoms/neuropathy (up to 52%), peripheral neuropathy (up to 24%), dizziness (up to 11%)
Common (1% to 10%): Paresthesia, peripheral neuritis, somnolence
Frequency not reported: Peripheral sensory neuropathy, ototoxicity, syncope, encephalopathy, abnormal gait, tremor, hyperkinesia, speech disorder, ear disorder, ear pain, otitis media
Postmarketing reports: Motor weakness (including severe cases)
Very common (10% or more): Nausea (up to 53%), diarrhea (up to 50%), nausea/vomiting (up to 39%), abdominal pain (up to 34%), vomiting (up to 30%), elevated amylase (up to 31%), elevated lipase (up to 26%), dyspepsia (up to 12%)
Common (1% to 10%): Pancreatitis (including fatal cases), constipation
Frequency not reported: Ulcerative stomatitis, melena, tooth caries, dysphagia, aphthous stomatitis, cheilitis, gastrointestinal disorder, glossitis
In a monotherapy trial, elevated amylase (at least 1.4 x ULN) was reported in 14% of patients.
In combination therapy trials, elevated amylase (grades 3 to 4: up to 8%; all grades: up to 31%) and lipase (grades 3 to 4: up to 6%; all grades: up to 26%) were reported; grades 3 to 4 amylase and lipase elevations were greater than 2 x ULN.
Ulcerative stomatitis (up to 45%), melena (up to 11%), tooth caries (up to 11%), dysphagia (up to 15%), aphthous stomatitis (up to 10%), cheilitis (up to 10%), gastrointestinal disorder (up to 15%), and glossitis (up to 10%) were reported in children; these side effects were not listed for adults.
Abdominal pain, elevated lipase, and pancreatitis (including fatal cases) have also been reported during postmarketing experience.
Very common (10% or more): Chills/fever (up to 50%), asthenia (up to 35%), pain (up to 21%), malaise (up to 20%)
Common (1% to 10%): Fatigue
Frequency not reported: Edema, infection, accidental injury, AIDS, death, face edema, mucous membrane disorder, enlarged abdomen, peripheral edema
Antiretroviral therapy:
-Frequency not reported: Increased weight, increased blood lipid levels
Infection (up to 95%), accidental injury (up to 80%), AIDS (up to 22%), death (up to 17%), face edema (up to 25%), mucous membrane disorder (up to 11%), peripheral edema (up to 10%), and enlarged abdomen (up to 10%) were reported in children; these side effects were not listed for adults.
Edema has been reported with use of this drug although no causal relationship has been established.
Chills/fever have also been reported during postmarketing experience.
Very common (10% or more): Rash (up to 40%), sweating (up to 18%), pruritus (up to 15%)
Common (1% to 10%): Maculopapular rash, lipoatrophy
Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Subcutaneous fat loss, progressive subcutaneous fat wasting, ecchymosis, lesions, vesiculobullous rash, dry skin, skin discoloration, seborrhea, skin disorder, fungal dermatitis, nail disorder, petechial rash, skin ulcer, herpes zoster
Postmarketing reports: Lipodystrophy
Subcutaneous fat loss was most apparent in the face, limbs, and buttocks. The incidence and severity of lipoatrophy have been linked to cumulative exposure. Often, lipoatrophy was not reversible when this drug was discontinued.
Ecchymosis (up to 30%), lesions (up to 55%), vesiculobullous rash (up to 25%), dry skin (up to 35%), skin discoloration (up to 20%), seborrhea (up to 11%), skin disorder (up to 15%), fungal dermatitis (up to 15%), nail disorder (up to 15%), petechial rash (up to 15%), skin ulcer (up to 10%), and herpes zoster (up to 15%) were reported in children; these side effects were not listed for adults.
Lipoatrophy has also been reported during postmarketing experience.
Arthrosis (up to 11%) was reported in children; this side effect was not listed for adults.
Myalgia has also been reported during postmarketing experience.
Very common (10% or more): Myalgia (up to 32%), arthralgia (up to 23%), back pain (up to 19%)
Frequency not reported: Osteonecrosis, muscle weakness, decreased bone mineral density, arthrosis
Very common (10% or more): Insomnia (up to 29%), depression (up to 24%), anxiety (up to 22%), nervousness (up to 12%)
Common (1% to 10%): Abnormal dreams, abnormal thinking
Uncommon (0.1% to 1%): Emotional lability
Frequency not reported: Personality disorder
Personality disorder (up to 11%) was reported in children; this side effect was not listed for adults.
Insomnia has also been reported during postmarketing experience.
In a monotherapy trial, decreased neutrophils (less than 750/mm3) and platelets (less than 50,000/mm3) were reported in 5% and 3% of patients, respectively.
Low hemoglobin (less than 8 g/dL) was reported in less than 1% of patients
Very common (10% or more): Lymphadenopathy (up to 20%)
Common (1% to 10%): Decreased neutrophils, decreased platelets, low hemoglobin
Postmarketing reports: Anemia, leukopenia, neutropenia, macrocytosis, thrombocytopenia
Very common (10% or more): Anorexia (up to 19%)
Common (1% to 10%): Asymptomatic hyperlactatemia
Uncommon (0.1% to 1%): Lactic acidosis (some cases involved motor weakness)
Frequency not reported: Hyperlipidemia, cachexia, dehydration
Postmarketing reports: Symptomatic hyperlactatemia, diabetes mellitus, hyperglycemia, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Antiretroviral therapy:
-Frequency not reported: Increased glucose levels
Cachexia (up to 15%) and dehydration (up to 10%) were reported in children; these side effects were not listed for adults.
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received this drug plus didanosine with other antiretroviral agents.
Anorexia and lactic acidosis have also been reported during postmarketing experience.
Cough (up to 95%), rhinitis (up to 100%), pharyngitis (up to 56%), respiratory disorder (up to 60%), lung disorder (up to 44%), asthma (up to 45%), epistaxis (up to 28%), hypoventilation (up to 22%), pneumonia (up to 22%), hyperventilation (up to 15%), voice alteration (up to 25%), sinusitis (up to 10%), and stridor (up to 20%) were reported in children; these side effects were not listed for adults.
Very common (10% or more): Influenza syndrome (up to 15%), dyspnea (up to 15%)
Frequency not reported: Cough, rhinitis, pharyngitis, respiratory disorder, lung disorder, asthma, epistaxis, hypoventilation, pneumonia, hyperventilation, voice alteration, sinusitis, stridor
Tachycardia (up to 10%) and vasodilation (up to 15%) were reported in children; these side effects were not listed for adults.
Very common (10% or more): Chest pain (up to 11%)
Frequency not reported: Tachycardia, vasodilation
Common (1% to 10%): Allergic reactions
Allergic reaction has also been reported during postmarketing experience.
Common (1% to 10%): Neoplasms, benign skin neoplasm
Uncommon (0.1% to 1%): Gynecomastia
Conjunctivitis (up to 44%), eye disorder (up to 17%), abnormal vision (up to 11%), and conjunctival edema (up to 20%) were reported in children; these side effects were not listed for adults.
Frequency not reported: Conjunctivitis, eye disorder, abnormal vision, conjunctival edema
Frequency not reported: Genital pain, urinary incontinence
Genital pain (up to 17%) and urinary incontinence (up to 11%) were reported in children; these side effects were not listed for adults.
Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Frequency not reported: Fanconi syndrome
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Stavudine (www.drugs.com/mtm/stavudine.html).
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