In Canada—

• Antineoplastic adjunct
• Biological response modifier

Levamisole ( lee-VAM-i-sole) is used with another cancer medicine (fluorouracil) to help make it work better against cancer of the colon.

Levamisole is available only with your doctor's prescription in the following dosage form:

Oral
• Tablets (Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to levamisole or to any other medicines.

Pregnancy—Levamisole has not been studied in pregnant women. However, studies in rats and rabbits have not shown that levamisole causes birth defects or other problems.

Breast-feeding—It is not known whether levamisole passes into the breast milk in humans, although it passes into cows' milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of levamisole in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of levamisole in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Infection—Levamisole may decrease your body's ability to fight infection

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

If you vomit shortly after taking a dose of levamisole, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing—

The dose of levamisole will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for and whether or not other medicines are also being taken. If you are taking levamisole at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of levamisole, ask your doctor.

Missed dose—

If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

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 other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Along with its needed effects, a medicine 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:

• Less common
  • Fever or chills;  unusual feeling of discomfort or weakness 
  
  

• Rare
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness;  lower back or side pain;  painful or difficult urination ;  pinpoint red spots on skin;  unusual bleeding or bruising 
  
  

Check with your doctor as soon as possible if the following side effects occur:

• Less common
  • Sores in mouth and on lips 
  
  

• Rare
  • Blurred vision;  confusion;  convulsions (seizures);  lip smacking or puffing;  numbness, tingling, or pain in face, hands, or feet;  paranoia (feelings of persecution) ;  puffing of cheeks;  rapid or worm-like movements of tongue;  trembling or shaking ;  trouble in walking;  uncontrolled movements of arms and legs 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  metallic taste;  nausea 
  
  

• Less common
  • Anxiety or nervousness;  dizziness;  headache;  mental depression;  nightmares;  pain in joints or muscles ;  skin rash or itching;  trouble in sleeping;  unusual tiredness or sleepiness ;  vomiting 
  
  

Levamisole may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return.

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