Pemoline (Oral)

Pemoline is a medicine that belongs to a group called central nervous system (CNS) stimulants. It is used to treat children with attention-deficit hyperactivity disorder (ADHD).

Pemoline helps increase attention and reduce restlessness in children who are overly active, have trouble focusing for long periods, are easily distracted, and are emotionally unstable. This medicine is part of a complete treatment plan that also includes social, educational, and psychological support.

In rare cases, pemoline can lead to serious liver issues. You should discuss with your doctor the benefits of this medicine and the risks associated with it. You will also need to sign an informed consent form to show that you understand and accept the risk of liver problems.

This medicine is available only with a prescription from your doctor.

Your doctor should check your progress at regular visits to ensure that this medicine does not cause unwanted effects. You must also have your blood tested every other week to see if this medicine is affecting your liver.

Dark urine or yellow eyes or skin may be a sign of a serious unwanted effect on your liver. Check with your doctor immediately if you develop dark urine or yellow eyes or skin.

This medicine may cause some people to feel dizzy or less alert than usual. Make sure you know how you react to this medicine before you ride a bicycle or do anything else that could be dangerous if you are dizzy or not alert.

If you have been using this medicine for a long time and think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on pemoline are:

• a strong desire or need to continue taking the medicine.
• a need to increase the dose to receive the effects of the medicine.
• withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after the medicine is stopped.

If you take this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

There have been reports of slowed growth in children who took medicines like pemoline for a long time. Some doctors recommend taking breaks from the medicine during treatment with pemoline to help prevent slowed growth.

Pemoline may worsen behavior in children with serious mental illness.

Breast Feeding

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

Interactions with Medicines

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

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

• Iobenguane I 131

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Drug abuse or dependence (or history of)—Dependence on pemoline may develop.

• Gilles de la Tourette's syndrome or other tics or
• Liver disease or
• Severe mental illness—Pemoline may worsen the condition.

• Kidney disease—Higher blood levels of pemoline may occur, increasing the chance of side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may check for others by doing certain tests.

Pemoline may cause some serious side effects, including liver problems. Also, medicines like pemoline, when used for a long time, have been reported to slow the growth rate of children. Some doctors suggest taking breaks from the medicine during treatment with pemoline. Pemoline may also cause unwanted effects on behavior in children with severe mental illness.

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:

Rare

• Dark urine
• yellow eyes or skin

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

Rare

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• nausea and vomiting
• shortness of breath, troubled breathing, wheezing, or tightness in chest
• skin rash
• sores, ulcers, or white spots on lips or in mouth
• swollen or painful glands
• uncontrolled movements of eyes, tongue, lips, face, arms, or legs
• unusual bleeding or bruising
• unusual tiredness
• vocal sounds you cannot control

Symptoms of overdose

• Agitation
• confusion
• convulsions (seizures)—may be followed by coma
• false sense of well-being
• fast heartbeat
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache (severe)
• high blood pressure
• high fever
• large pupils
• muscle trembling or twitching
• restlessness
• sweating
• vomiting

This medicine may also cause the following side effects that your doctor will watch for:

Rare

• Liver problems
• slow growth in children

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

• Loss of appetite
• trouble in sleeping
• weight loss

Less common

• Dizziness
• drowsiness
• headache
• increased irritability
• mental depression
• stomachache

After you stop using this medicine, it may still produce some side effects that need attention. During this time, check with your doctor immediately if you notice the following side effects:

• Abdominal pain
• convulsions (seizures)
• headache
• mental depression
• nausea
• unusual behavior
• unusual tiredness or weakness
• vomiting

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.

In the U.S.

• Cylert

Chemical Class: Amphetamine Related

For patients taking the chewable tablet form of this medicine:

• These tablets must be chewed before swallowing. Do not swallow whole.

Sometimes this medicine must be taken for 3 to 4 weeks before improvement is noticed.

Take pemoline only as directed by your doctor. 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. If too much is taken, it may become habit-forming.

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 or chewable dosage forms (tablets): Children 6 years of age and over—To start, 37.5 milligrams (mg) every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 112.5 mg a day. Children up to 6 years of age—Use and dose must be determined by the doctor.

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.