Generic Name: Stavudine Brand Name(s): Generics only. No brands available.

Uses

What is Stavudine used for?

Stavudine used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Stavudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTI).

How should I take Stavudine?

Take this medication by mouth with or without food, usually every 12 hours or as directed by your doctor.

The dosage is based on your weight, medical condition, and response to treatment.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Refill your medication before you run out.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

How do I store Stavudine?

Store stavudine capsules at room temperature away from moisture and heat. Keep the bottle tightly closed.

Store the liquid medicine in the refrigerator, do not freeze. Throw away any unused liquid after 30 days.

Throw away any unused or expired stavudine in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

There may be different brands of Stavudine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Stavudine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Stavudine?

Before taking stavudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, kidney problems, liver problems (such as hepatitis, cirrhosis), nerve problems (such as peripheral neuropathy), alcohol use, gall bladder problems (such as gallstones).

Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially the increased risk of nerve problems.

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Stavudine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Stavudine. Stavudine is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Stavudine?

Headache or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain, muscle weakness, or decreased muscle control. If you experience any of these symptoms, contact your doctor right away so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of stavudine.

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Stavudine?

Some products that may interact with this drug include: didanosine, doxorubicin, hydroxyurea, orlistat, zidovudine, drugs that can cause nerve problems (such as isoniazid, vincristine).

Stavudine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Stavudine?

Stavudine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Stavudine?

Stavudine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Stavudine.

What is the dose of Stavudine for an adult?

Usual Adult Dose for HIV Infection

Less than 60 kg: 30 mg orally every 12 hours

At least 60 kg: 40 mg orally every 12 hours

Comments:

-Some experts (including the WHO) have recommended a maximum dose of 30 mg orally twice a day, regardless of weight.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations:

-Less than 60 kg: 30 mg orally every 12 hours

-At least 60 kg: 40 mg orally every 12 hours

Duration of therapy: 28 days

Comments:

-Only with expert consultation, as part of an alternative regimen for use as nonoccupational postexposure prophylaxis of HIV infection

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:

-Less than 60 kg: 30 mg orally twice a day

-At least 60 kg: 40 mg orally twice a day

Duration of therapy: 28 days, if tolerated

Comments:

-Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis

-Prophylaxis should be started as soon as possible, preferably within hours after exposure.

-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.

-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Adult Patients:

CrCl 26 to 50 mL/min:

-Less than 60 kg: 15 mg orally every 12 hours

-At least 60 kg: 20 mg orally every 12 hours

CrCl 10 to 25 mL/min:

-Less than 60 kg: 15 mg orally every 24 hours

-At least 60 kg: 20 mg orally every 24 hours

Dialysis

Hemodialysis:

Adult Patients:

-Less than 60 kg: 15 mg orally every 24 hours

-At least 60 kg: 20 mg orally every 24 hours

Comments:

-Dose should be administered after hemodialysis on dialysis days and at the same time each day on non-dialysis days.

Administration advice:

-May administer without regard to food

-Oral solution: Shake well before measuring each dose; discard any unused portion after 30 days.

Storage requirements:

-Store in tightly-closed bottles.

-Capsules: Store at 25C (77F); excursions permitted between 15C and 30C (59F and 86F).

-Oral solution (prior to constitution): Store at 25C (77F); excursions permitted between 15C and 30C (59F and 86F); protect from excessive moisture.

-Oral solution (after constitution): Store in the refrigerator at 2C to 8C (36F to 46F) for up to 30 days.

Reconstitution/preparation techniques:

-Oral solution: The manufacturer product information should be consulted.

Monitoring:

-Hepatic: Liver function in patients with preexisting liver dysfunction (according to standard practice)

-Renal: Renal function in elderly patients (during therapy)

Patient advice:

-Read the US FDA-approved patient labeling (Medication Guide).

-Seek medical attention at once if symptoms of symptomatic hyperlactatemia or lactic acidosis syndrome (including unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, motor weakness) develop.

-Do not use this drug with didanosine and/or hydroxyurea.

-Report symptoms of peripheral neuropathy (e.g., numbness, tingling, pain in hands/feet) to physician.

-Avoid alcohol while using this drug as it may increase risk of pancreatitis or liver damage.

-If diabetic, be aware that the oral solution contains 50 mg sucrose/mL.

What is the dose of Stavudine for a child?

Usual Pediatric Dose for HIV Infection

Birth to 13 days: 0.5 mg/kg orally every 12 hours

14 days or older:

Less than 30 kg: 1 mg/kg orally every 12 hours

30 to less than 60 kg: 30 mg orally every 12 hours

At least 60 kg: 40 mg orally every 12 hours

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV Recommendations:

-Neonates/infants (birth to 13 days): 0.5 mg/kg orally twice a day

-Pediatrics (14 days or older, weighing less than 30 kg): 1 mg/kg orally twice a day

-Adolescents (at least 30 kg): 30 mg orally twice a day

Comments:

-This drug is not recommended due to higher risk of side effects associated with mitochondrial toxicity and higher rate of lipoatrophy than other NRTIs.

-Current guidelines should be consulted for additional information.

How is Stavudine available?

Stavudine is available in the following dosage forms and strengths:

  • Oral capsule,
  • Oral powder for reconstitution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Stavudine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 27, 2018 | Last Modified: April 27, 2018

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