Zerit

DRUG DESCRIPTION

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 2',3'-didehydro-3'-deoxythymidine. Stavudine has the following structural formula:

ZERIT® (stavudine) Structural Formula Illustration

Stavudine is a white to off-white crystalline solid with the molecular formula C10H12N2O4 and a molecular weight of 224.2. The solubility of stavudine at 23°C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23°C 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.

Powder 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 oral solution upon constitution 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.

What are the possible side effects of stavudine (Zerit)?

Stop using stavudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with...

Read All Potential Side Effects and See Pictures of Zerit »

What are the precautions when taking stavudine (Zerit)?

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 gall stones).

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

This product may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in...

Read All Potential Precautions of Zerit »


Zerit Consumer (continued)

SIDE EFFECTS: See also Warning section.

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.

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 immediately 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 gall stones).

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

This product may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in your diet. Ask your doctor or pharmacist about using this product safely.

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

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

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.

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Stavudine may be part of that treatment. 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.


Zerit Patient Information Including Side Effects

Brand Names: Zerit

Generic Name: stavudine (Pronunciation: STA vue deen)

  • What is stavudine (Zerit)?
  • What are the possible side effects of stavudine (Zerit)?
  • What is the most important information I should know about stavudine (Zerit)?
  • What should I discuss with my healthcare provider before taking stavudine (Zerit)?
  • How should I take stavudine (Zerit)?
  • What happens if I miss a dose (Zerit)?
  • What happens if I overdose (Zerit)?
  • What should I avoid while taking stavudine (Zerit)?
  • What other drugs will affect stavudine (Zerit)?
  • Where can I get more information?

What is stavudine (Zerit)?

Stavudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Stavudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Stavudine is not a cure for HIV or AIDS.

Stavudine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of stavudine (Zerit)?

Stop using stavudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • high blood sugar - increased thirst, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting; or
  • any signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, or unusual weakness.

Less serious side effects may include:

  • diarrhea;
  • muscle pain;
  • headache;
  • mild skin rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about stavudine (Zerit)?

Some people have developed a life-threatening condition called lactic acidosis while taking stavudine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stavudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking stavudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking stavudine, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to stavudine in the past, such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

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