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USP DI Vol. II - ZALCITABINE (Systemic)

ZALCITABINE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • HIVID

In Canada?

  • HIVID

Another commonly used name is ddC.


Category

  • Antiviral, systemic

Description

Zalcitabine (zal-SITE-a-been) (also known as ddC)is used in the treatment of the infection caused by the human immunodeficiencyvirus (HIV). HIV is the virus that causes acquired immune deficiency syndrome(AIDS).

Zalcitabine (ddC) will not cure or prevent HIV infection or AIDS; however,it helps keep HIV from reproducing and appears to slow down the destructionof the immune system. This may help delay the development of problems usuallyrelated to AIDS or HIV disease. Zalcitabine will not keep you from spreadingHIV to other people. People who receive this medicine may continue to haveother problems usually related to AIDS or HIV disease.

Zalcitabine may cause some serious side effects, including peripheral neuropathy(a problem involving the nerves). Symptoms of peripheral neuropathy includetingling, burning, numbness, or pain in the hands or feet. Zalcitabine mayalso cause pancreatitis (inflammation of the pancreas). Symptoms of pancreatitisinclude stomach pain, and nausea and vomiting. Checkwith your doctor if any new health problems or symptoms occur while you aretaking zalcitabine.

Zalcitabine is available only with your doctor's prescription, in the followingdosage form:

    Oral
  • Tablets (U.S. and Canada)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For zalcitabine, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to zalcitabine. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Zalcitabine has not been studied in pregnant women.However, studies in animals have shown that zalcitabine causes birth defectswhen given in very high doses. Before taking this medicine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether zalcitabine passes intothe breast milk. However, if your baby does not already have the AIDS virus,there is a chance that you could pass it to your baby by breast-feeding. Talkto your doctor first if you are thinking about breast-feeding your baby.

Children?Zalcitabine can cause serious side effects in anypatient. Therefore, it is especially important that you discuss with yourchild's doctor the good that this medicine may do as well as the risks ofusing it. Your child must be seen frequently and your child's progress carefullyfollowed by the doctor while the child is taking zalcitabine.

Older adults?Zalcitabine has not been studied specifically inolder people. Therefore, it is not known whether it causes different sideeffects or problems in the elderly than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingzalcitabine, it is especially important that your health care professionalknow if you are taking any of the following:

  • Alcohol or
  • Asparaginase (e.g., Elspar) or
  • Azathioprine (e.g., Imuran) or
  • Estrogens (female hormones) or
  • Furosemide (e.g., Lasix) or
  • Methyldopa (e.g., Aldomet) or
  • Pentamidine by injection (e.g., Pentam, Pentacarinat) or
  • Sulfonamides (e.g., Bactrim, Septra) or
  • Sulindac (e.g., Clinoril) or
  • Tetracyclines or
  • Thiazide diuretics (water pills) (e.g., Diuril, Hydrodiuril) or
  • Valproic acid (e.g., Depakote)?Use of these medicines withzalcitabine may increase the chance of pancreatitis (inflammation of the pancreas)
  • Aminoglycosides by injection (amikacin [e.g., Amikin], gentamicin[e.g., Garamycin], kanamycin [e.g., Kantrex], neomycin [e.g., Mycifradin],netilmicin [e.g., Netromycin], streptomycin, tobramycin [e.g., Nebcin]) or
  • Amphotericin B (e.g., Fungizone) or
  • Foscarnet (e.g., Foscavir)?Use of these medicines with zalcitabinemay increase the chance of side effects
  • Antacids, aluminum- and/or magnesium-containing (e.g., Maalox, Mylanta)?Useof antacids with zalcitabine may decrease the absorption of zalcitabine; antacidsand zalcitabine should not be taken at the same time
  • Chloramphenicol (e.g., Chloromycetin) or
  • Cisplatin (e.g., Platinol) or
  • Dapsone (e.g., Avlosulfon) or
  • Didanosine (e.g., Videx, ddI) or
  • Disulfiram (e.g., Antabuse) or
  • Ethionamide (e.g., Trecator-SC) or
  • Glutethimide or
  • Gold (arthritis medicine) or
  • Hydralazine (e.g., Apresoline) or
  • Iodoquinol (e.g., Dinquinol, Yodoxin) or
  • Isoniazid (e.g., Nydrazid) or
  • Metronidazole (e.g., Flagyl) or
  • Phenytoin (e.g., Dilantin) or
  • Ribavirin (e.g., Virazole) or
  • Stavudine (e.g., Zerit, d4T) or
  • Vincristine (e.g., Oncovin)?Use of these medicines with zalcitabinemay increase the chance of peripheral neuropathy (tingling, burning, numbness,or pain in your hands or feet)
  • Cimetidine (e.g., Tagamet) or
  • Probenecid (e.g., Benemid)?Use of these medicines with zalcitabinemay increase the chance of side effects of zalcitabine
  • Doxorubicin (e.g., Adriamycin or Rubex) or
  • Lamivudine (e.g., 3TC, Epivir, Heptovir)?Use of these medicineswith zalcitabine may make zalcitabine not work well
  • Nitrofurantoin (e.g., Furadantin, Macrodantin)?Use of nitrofurantoinwith zalcitabine may increase the chance of side effects, including peripheralneuropathy (tingling, burning, numbness, or pain in your hands or feet) andpancreatitis (inflammation of the pancreas)

Other medical problems?The presence of other medicalproblems may affect the use of zalcitabine. Make sure you tell your doctorif you have any other medical problems, especially:

  • Alcohol abuse or
  • Increased amylase (or a history of ) or
  • Increased blood triglycerides (or a history of) or
  • Pancreatitis (or a history of, or at risk for)
  • Receiving nutrition in your veins?Patients with these medicalproblems may be at increased risk of pancreatitis (inflammation of the pancreas)
  • Abnormal liver function, or
  • Alcohol abuse, history of, or
  • At risk for liver disease, or
  • Hepatitis, or
  • Liver disease, or
  • Obesity, or
  • Taking medicines called nucleosides for a long time?Zalcitabinemay make liver disease worse in patients with liver disease or a history ofalcohol abuse
  • Allergy to zalcitabine, or
  • Allergy to any part of the medicine?Serious allergic reactionscan occur
  • Bone marrow disease?Patients with this condition may developsevere blood problems when taking zalcitabine
  • Heart problems, or
  • Congestive heart failure?Zalcitabine may make these conditionsworse.
  • Kidney disease?Patients with kidney disease may have an increasedchance of side effects
  • Low CD4 cell count?Zalcitabine may cause serious side effectsin patients with very low CD4 cell counts.
  • Peripheral neuropathy or at risk of developing peripheral neuropathy,or
  • Diabetes, or
  • Low CD4 cell count, or
  • Weight loss?Zalcitabine may increase your chance of developingneuropathy or worsening neuropathy.

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor. Do not takemore of it, do not take it more often, and do not take it for a longer timethan your doctor ordered. Also, do not stop taking this medicine without checkingwith your doctor first.

Keep taking zalcitabine for the full time of treatment, even if you begin to feel better.

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 health care professional.

Only take medicine that your doctor has prescribed specifically for you.Do not share your medicine with others.

Dosing?The dose of zalcitabine will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of zalcitabine. Your dose may be different if you have kidneydisease. If your dose is different, do not change it unless your doctor tells you to do so:

  • For oral dosage form (tablets):
    • For treatment of HIV infection:
      • Adults and children 12 years of age and older?0.75 milligrams(mg)
      • Children up to 12 years of age?Use and dose must be determinedby your doctor.

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

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits.

Do not take any other medicines without checking withyour doctor first. To do so may increase the chance of side effectsfrom zalcitabine.

HIV may be acquired from or spread to other people through infected bodyfluids, including blood, vaginal fluid, or semen. Ifyou are infected, it is best to avoid any sexual activity involving an exchangeof 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 timeyou have vaginal, anal, or oral sex. The use of a spermicide (suchas nonoxynol-9) may also help prevent transmission of HIV if it is not irritatingto the vagina, rectum, or mouth. Spermicides have been shown to kill HIV inlab tests. Do not use oil-based jelly, cold cream, baby oil, or shorteningas a lubricant?these products can cause the condom to break. Lubricantswithout oil, such as K-Y Jelly, are recommended.Women may wish to carry their own condoms. Birth control pills and diaphragmswill help protect against pregnancy, but they will not prevent someone fromgiving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipmentwith 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 anyquestions about this, check with your health care professional.


Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 ofthe following side effects occur:

    More common

      Lab results that show problems with liver; tingling, burning, numbness, or pain in the hands, arms, feet, or legs

    Less common

      Fever; joint pain; muscle pain; nausea and vomiting; seizures; skin rash; stomachpain (severe); ulcers in the mouth and throat

    Rare

      Discouragement, feeling sad or empty, irritability, lack of appetite,loss of interest or pleasure, tiredness, trouble concentrating, trouble sleeping; fever and sore throat; yellow eyes or skin

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    Less common

      Constipation; diarrhea; headache; hives or welts; itching skin; swelling or inflammationof the mouth

Other sideeffects not listed above may also occur in some patients. If you notice anyother effects, check with your doctor.


Revised: 01/06/2004