The reference site for Pemoline

Pemoline is a stimulant drug of the 4-oxazolidinone class. It was first synthesized in 1913[1] but its activity was not discovered until the 1930s.

WHAT IS Pemoline?

Pemoline belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) in children over the age of six, and used as part of a total treatment program that also includes social, educational, and psychological counseling.

The exact way that pemoline work is unknown, but scientist believe that it stimulate the brain by affecting neurotransmitters, the chemicals in the brain that nerves use to communicate with each other.

Pemoline is sold under the brand name Cylert®.

 

Brand Name(s): Cylert
CAS nº: 2152-34-3
(PEH moe leen)

 

Product Info

The sections below will provide you with more specific information and guidelines related to pemoline and its correct use. Please read them carefully.

FDA Information

Pemoline was approved by the FDA for the treatment of ADHD on January 27th 1975.

Pemoline has some advantages over other stimulants in that it does not reduce the appetite or cause dry mouth. However, in some patients pemoline is suspected of causing liver damage, so regular liver tests are performed on those treated with it.

However, since receiving FDA approval, it has been linked with 21 cases of liver failure, of which 13 resulted in liver replacement or death. As a result, Abbott Laboratories announced in March 2005 that Cylert® (pemoline) would no longer be available in the United States, and in October 2005 manufacturers of generic pemoline agreed to stop sales and marketing of these products. This action was based on advice from the FDA, who stated that the overall risk of liver toxicity with pemoline outweighs the benefits of the drug. The FDA’s withdrawl of pemoline was also due to pressure from certain public advocacy groups, including Public Citizen.

On the other hand, the patient support group Narcolepsy Network, tried to persuade the FDA not to ban it, on the grounds that some patients find all other treatments ineffective or to have dehabilitating side effects. This medication was used by an estimated 10,000 Americans afflicted with narcolepsy.

If you are currently taking pemoline, you should call your doctor to discuss switching to another treatment. Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Pemoline belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) in children over the age of six. It works by increases attention and decreases restlessness in children who are overactive, cannot concentrate for very long or are easily distracted, and tend to be emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological counseling.

Under the Convention on Psychotropic Substances, pemoline is categorized as a Schedule IV drug.

The exact way that pemoline work is unknown, but scientist believe that it stimulate the brain by affecting neurotransmitters, the chemicals in the brain that nerves use to communicate with each other.

Other uses for this medicine

Other FDA unapproved uses include narcolepsy, fatigue, and excessive daytime sleepiness. For those who do not know, narcolepsy is a chronic disease of the brain and spinal cord most commonly characterized by a recurrent, uncontrollable desire to sleep.

Nevertheless, this medication should not be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dosage and using this medicine

Pemoline comes as an orally-administered tablet.

Take this medication exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.

Pemoline is usually taken once a day in the morning, with a full glass of water. Follow your doctor’s instructions.

It may take up to three weeks to observe an effect.

In rare cases, pemoline has caused severe liver damage resulting in death or liver transplant. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage. Before taking pemoline, you will be required to discuss with your doctor the risks and benefits of this medicine and to sign an informed consent stating that you understand these risks and benefits.

Also, your doctor will need to monitor your liver function with blood tests before starting therapy with pemoline, and every two weeks thereafter.

What special precautions should I follow?

BEFORE TAKING PEMOLINE:

Tell your doctor if you have liver disease, kidney disease, seizures or epilepsy, Tourette’s syndrome, or a history of drug or alcohol abuse. You may not be able to take pemoline or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Some drugs may interact with pemoline. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Pemoline is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. However, do not take pemoline without first talking to your doctor if you are pregnant.

Additionally, it is also not known whether pemoline passes into breast milk. Do not take pemoline without first talking to your doctor if you are breast-feeding a baby.

Pemoline is not recommended for children less than 6 years since its safety and efficacy in this age group have not been established.

Furthermore, clinical experience suggests that in psychotic children, administration of pemoline may exacerbate symptoms of behavior disturbance and thought disorder.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose.

Never take a double dose of this medication.

What side effects can this medication cause?

If you experience any of the following serious side effects, stop taking pemoline and seek emergency medical attention or notify your doctor immediately:

an allergic reaction (difficulty breathing, closing of your throat, swelling of your lips, tongue, or face, or hives)
liver damage (nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine)
seizures
unusual behavior, confusion, or hallucinations
unusual movements of the tongue, lips, face, or arms and legs

Other, less serious side effects may be more likely to occur. Continue to take pemoline and talk to your doctor if you experience

insomnia (difficulty sleeping)
nervousness, headache, or drowsiness
mild depression
nausea
decreased appetite
weight loss

Note: Pemoline is habit forming and may cause drug dependence. Do not stop taking it suddenly.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What storage conditions are needed for this medicine?

Always keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Remember to throw away any medication that is outdated or no longer needed. If you have any questions, please talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of a suspected overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, please call the local emergency services immediately on 911.

Symptoms of overdose may include:

agitation
vomiting
tremors (shaking)
muscle twitches
seizures
confusion
hallucinations
sweating
flushing
headache
fast or irregular heartbeat
large pupils
dryness of the mouth and eyes

Product Images

PICTURES OF PEMOLINE PILLS

Below you will find images and specific information on the principal types of pemoline that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

Name: PEMOLINE
Strength(s): 18.75 MG
Imprint: A 197
Manufacturer: AMIDE PHARMACEUTICALS
Distributor: MALLINKRT PHARM.

Name: PEMOLINE
Strength(s): 18.75 MG
Imprint: INV 391
Manufacturer: GENEVA PHARMA

Name: PEMOLINE
Strength(s): 18.75 MG
Imprint: GG 932
Manufacturer: SANDOZ

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: A 161
Manufacturer: AMIDE PHARMACEUTICALS

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: COPLEY 524
Manufacturer: COPLEY

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: INV 392
Manufacturer: GENEVA PHARMA

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: GG 933
Manufacturer: SANDOZ

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: 93 9577
Manufacturer: TEVA USA

Name: PEMOLINE
Strength(s): 37.5 MG
Imprint: A 161
Manufacturer: AMIDE PHARMACEUTICALS

Name: CYLERT®
Strength(s): 37.5 MG
Imprint: LOGO | TI
Manufacturer: ABBOTT LABS.
Distributor: PHYSICIANS TOTALCARE INC.

Name: CYLERT®
Strength(s): 37.5 MG
Imprint: LOGO | TK
Manufacturer: ABBOTT LABS.

Name: CYLERT®
Strength(s): 75 MG
Imprint: LOGO | TJ
Manufacturer: ABBOTT LABS.
Distributor: PHYSICIANS TOTALCARE INC.

Name: PEMOLINE
Strength(s): 75 MG
Imprint: A 162
Manufacturer: AMIDE PHARMACEUTICALS

Name: PEMOLINE
Strength(s): 75 MG
Imprint: COPLEY 472
Manufacturer: COPLEY

Name: PEMOLINE
Strength(s): 75 MG
Imprint: INV 393
Manufacturer: GENEVA PHARMA

Name: PEMOLINE
Strength(s): 75 MG
Imprint: 4931 V
Manufacturer: QUALITEST PHARMA

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