Cylert (Oral)

Pemoline is part of a group of medicines 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 overactive, have difficulty concentrating for long periods, are easily distracted, and have emotional instability. This medicine should be used as part of a complete treatment program that includes social, educational, and psychological support.

Rarely, pemoline has caused serious liver problems. You and your doctor should discuss the benefits of this medicine along with the risks associated with it. You will also need to sign an informed consent form, which shows 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. Additionally, you must 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 signs of a serious unwanted effect on your liver. Contact 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 riding a bicycle or doing 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, consult 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 achieve the effects of the medicine.
• withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after stopping the medicine.

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, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, please consider the following:

Allergies

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

Pediatric

There have been reports of slowed growth in children who used medicines like pemoline for a long time. Some doctors suggest 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 sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while 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. If you are using this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected based on their potential importance and may not include all possible interactions.

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

• Iobenguane I 131

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell 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 risk 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 look for other side effects 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 having medicine-free periods 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 happen, if they do occur, they may need medical attention.

Check with your doctor right away 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, trouble 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 monitor:

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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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 sleeping
• weight loss

Less common

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

After you stop using this medicine, it may still cause some side effects that need attention. During this time, check with your doctor right away 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.