Zerit

Zerit is used in combination with other anti-virus medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Zerit will not cure or prevent HIV infection or AIDS. It helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease.

Zerit will not keep you or your child from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Capsule
• Powder for Suspension
• Powder for Solution

Before using Zerit, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of stavudine in children.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of stavudine in the elderly. However, elderly patients are more likely to have age-related kidney problems which may require an adjustment in the dose for patients receiving stavudine.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Didanosine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Hydroxyurea
• Ribavirin
• Zidovudine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methadone

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, active or history of
• Gallstones, active or history of
• Liver disease (includes hepatitis) 
• Obesity (being overweight) 
• Pancreatitis (inflammation of the pancreas), history of 
• Peripheral neuropathy (nerve disorder), history of 
• Use of other HIV medicines for a long period of time—May causes side effects to become worse
• Diabetes—The oral liquid contains sucrose (sugar), which can make this condition worse
• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body

Proper usage of Zerit requires strict adherence to your doctor’s orders. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

Keep taking stavudine for the full time of treatment , even if you begin to feel better. Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

The capsule should be swallowed whole. Do not chew, crush or dissolve. You may take this medicine with or without food. Shake the oral liquid before use. Use a specially marked measuring cup or another device to measure each dose accurately.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow the instructions in the guide or leaflet carefully. Talk to your doctor if you have any questions.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or oral solution):

For treatment of HIV infection:

• Adults and teenagers weighing 60 kilograms (kg) or more—40 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
• Adults and teenagers weighing up to 60 kg—30 mg every 12 hours. Your doctor may adjust your dose if needed.
• Children weighing 30 kg or more—30 mg every 12 hours.
• Infants and children at least 14 days old and weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight every 12 hours.
• Infants from birth to 13 days old—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight every 12 hours.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 30 days, but do not throw it in the trash. Flush it down the toilet or take it to a community take-back program when available. Ask your doctor how to dispose of any capsules you do not use.

Before using Zerit, there are some precautions you must take. It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take any other medicines without checking first with your doctor. To do so may increase the chance of side effects from stavudine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”).

Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break.

Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus.

If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time.

Stop taking the medicine and call your doctor right away if you or your child have more than one of these symptoms:

• abdominal discomfort or cramping
• dark urine
• decreased appetite
• diarrhea
• a general feeling of discomfort
• light-colored stools
• muscle cramping or pain
• nausea
• unusual tiredness or weakness
• trouble breathing
• vomiting
• yellow eyes or skin

Stop using this medicine and check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy. Pancreatitis may occur while you are using this medicine.

Tell your doctor right away if you or your child have:

• sudden and severe stomach pain
• chills
• constipation
• nausea
• vomiting
• fever
• lightheadedness

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area.

You might also lose fat from your legs, arms, or face. When you or your child start taking HIV medicines, your immune system may get stronger.

If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away. Avoid drinking alcohol or alcoholic beverages while taking this medicine.

As with many medications, there are several potential side effects associated with Zerit. 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:

More common:

• Burning, numbness, tingling, or painful sensations
• chills with fever
• tingling, burning, numbness, or pain in the hands or feet
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Less common:

• Cough
• the difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• joint pain
• muscle pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Rare:

• Nausea and vomiting
• stomach pain (severe)

Incidence not known:

• Abdominal or stomach discomfort or pain
• black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• blurred vision
• chest pain
• constipation
• darkened urine
• decreased appetite
• diarrhea
• the difficulty with moving
• dry mouth
• fast, shallow breathing
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort
• general tiredness and weakness
• increased hunger
• increased thirst
• increased urination
• indigestion
• light-colored stools
• loss of appetite
• loss of consciousness
• muscle cramping, pains, or stiffness
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
• sleepiness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• swollen joints
• troubled breathing
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• yellow eyes or skin

Some side effects 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:

• headache
• loss of appetite
• weight loss

Less common:

• difficulty with sleeping
• lack of strength or energy
• stomach pain (mild)

Incidence not known:

• gaining weight around your neck, upper back, breast, face, or waist
• sleeplessness
• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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