Levamisole (Oral)

Levamisole is used together with another cancer medicine (fluorouracil) to help it be more effective against colon cancer.

Levamisole is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to look for any unwanted effects.

In deciding to use a medicine, the risks of taking the medicine must be compared to the benefits it provides. This decision will be made between you and your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies on this medicine have only been conducted in adult patients, and there is no specific information about the use of levamisole in children compared to other age groups.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together, in other situations two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may modify the dose or frequency of one or both medicines.

• Capecitabine
• Doxifluridine
• Fluorouracil
• Tegafur
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

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

Along with its needed effects, Levamisole (Oral) 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 any of 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

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 Levamisole (Oral). 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

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

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.

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 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.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

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.