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Fycompa
Overview
What is Fycompa?
FYCOMPA tablets and oral suspension contain perampanel a non-competitive AMPA receptor antagonist as a 4:3 hydrate.
The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3).
The molecular formula is CHNO • ¾HO and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure is:
Tablets
FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg).
Oral Suspension
FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water.
What does Fycompa look like?
What are the available doses of Fycompa?
Tablets
Oral Suspension
What should I talk to my health care provider before I take Fycompa?
Pregnancy: Based on animal data, may cause fetal harm ()
How should I use Fycompa?
FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
Monotherapy or Adjunctive Therapy
The recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by increments of 2 mg once daily based on individual clinical response and tolerability, no more frequently than at weekly intervals.
The recommended maintenance dose range is 8 mg to 12 mg once daily, although some patients may respond to a dose of 4 mg daily.A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions.
Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which include certain antiepileptic drugs (AEDs)
What interacts with Fycompa?
Sorry No Records found
What are the warnings of Fycompa?
Sorry No Records found
What are the precautions of Fycompa?
Sorry No Records found
What are the side effects of Fycompa?
Sorry No records found
What should I look out for while using Fycompa?
None.
What might happen if I take too much Fycompa?
There is limited clinical experience with FYCOMPA overdose. The highest reported overdose (approximately 264 mg) was intentional. This patient experienced serious adverse reactions of altered mental status, agitation, and aggressive behavior and recovered without sequelae. In general, the adverse reactions associated with overdoses were similar to the reactions at therapeutic doses with dizziness reported most frequently. There were no reported sequelae.
There is no available specific antidote to the overdose reactions of FYCOMPA. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rhythm and vital sign measurement is recommended. A certified poison control center should be contacted for updated information on the management of overdose with FYCOMPA. Due to its long half-life, the reactions caused by FYCOMPA could be prolonged.
How should I store and handle Fycompa?
Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Oral Suspension: Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Oral Suspension: Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘1’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4762-0Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4763-0Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘5’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4764-0Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘6’ on other side and they are supplied :Overbagged with 10 tablets per bag, NDC 55154-4765-0Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation.
The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown.
Non-Clinical Toxicology
None.Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.
Nafcillin in high dosage regimens, i.e., 2 grams every 4 hours, has been reported to decrease the effects of warfarin. When nafcillin and warfarin are used concomitantly, the prothrombin time should be closely monitored and the dose of warfarin adjusted as necessary. This effect may persist for up to 30 days after nafcillin has been discontinued.
Nafcillin when administered concomitantly with cyclosporine has been reported to result in subtherapeutic cyclosporine levels. The nafcillin-cyclosporine interaction was documented in a patient during two separate courses of therapy. When cyclosporine and nafcillin are used concomitantly in organ transplant patients, the cyclosporine levels should be monitored.
In the controlled partial-onset seizure clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. FYCOMPA-treated patients experienced more hostility- and aggression-related adverse reactions that were serious, severe, and led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients.
In general, in placebo-controlled partial-onset seizure clinical trials, neuropsychiatric events were reported more frequently in patients being treated with FYCOMPA than in patients taking placebo. These events included irritability, aggression, anger, and anxiety, which occurred in 2% or greater of FYCOMPA-treated patients and twice as frequently as in placebo-treated patients. Other symptoms that occurred with FYCOMPA and were more common than with placebo included belligerence, affect lability, agitation, and physical assault. Some of these events were reported as serious and life-threatening. Homicidal ideation and/or threat were exhibited in 0.1% of 4,368 FYCOMPA-treated patients in controlled and open label trials, including non-epilepsy trials Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA.
In the partial-onset seizure clinical trials, these events occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression. Some patients experienced worsening of their pre-existing psychiatric conditions. Patients with active psychotic disorders and unstable recurrent affective disorders were excluded from the clinical trials. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol .
Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.
In healthy volunteers taking FYCOMPA, observed psychiatric events included paranoia, euphoric mood, agitation, anger, mental status changes, and disorientation/confusional state.
In the non-epilepsy trials, psychiatric events that occurred in perampanel-treated patients more often than placebo-treated patients included disorientation, delusion, and paranoia.
In the postmarketing setting, there have been reports of psychosis (acute psychosis, hallucinations, delusions, paranoia) and delirium (delirium, confusional state, disorientation, memory impairment) in patients treated with FYCOMPA
Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least 1 month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Dose of FYCOMPA should be reduced if these symptoms occur. Permanently discontinue FYCOMPA for persistent severe or worsening psychiatric symptoms or behaviors and refer for psychiatric evaluation.
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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