Fycompa 2mg Eisai Medicine for Supplementing Corruption (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Perampanel
Ingredient
| Composition information | Content |
| Perampanel | 2mg |
Uses
Indications
Fycompa 2mg drug is indicated in the following cases:
Perampanel is the first substance in the group (First-in-Class) selected, non-competitive antagonistic, ionotropic D-Amino-3-Hydroxy-5-Methyl-4-IsoxazoleProprionic Acid (AMPA) glutamate on the SYNAP neurosus. Glutamat is a main stimulant neurotransmitter in the central nervous system and is related to many neurological disorders caused by excessive stimulation of neurons. The AMPA receptor activation by glutamat is thought to be responsible for most rapid transmission through synap in the brain.
In In vitro studies, Perampanel is not competing with AMPA to connect with the AMPA receptor, but the cohesion of Perampanel has been pushed out by non -competitive AMPA receptor counterparts, showing that Perampanel is an non -competitive AMPA receptor counterclose. In vitro, Perampanel inhibits the increase in intracellular calcium caused by AMPA (which is not caused by NMDA). In Vivo, Perampanel significantly extends the delay of seizures in a epilepsy model caused by AMPA.
The exact mechanism for Perampanel to promote anti -epileptic effects on humans still need to be completely clarified.
pharmacokinetic
absorption
After drinking, Perampanel is easily absorbed without evidence that this substance has metabolized through the liver significantly. Food does not affect the level of absorption but slows down the absorption speed. When used with food, the peak concentration in plasma decreases and is 1 hour later than the drug when hungry.
Distribution
Data from In vitro studies show that Perampanel binds about 95% to plasma protein.
In vitro studies show that Perampanel is not a significant substrate or inhibitor of organic polypeptides (OATP) 1B1 and 1B3, organic anion agent (OAT) 1, 2, 3 and 4, Organic cation shipping (OCT) 1, 2, 3, and P-Glycoprotein and anti-cancer proteins (BCRP).
Metabolism
Perampanel is strongly metabolized through the original oxidation and glucuronids. The initial oxidation metabolism through the intermediate of CYP3A is based on the results of In vitro studies using CYP enzymes of recombinant and human liver microsom. However, this transformation has not been completely explained and other roads cannot be excluded.
After using Perampanel with radioactive markers, only a small amount of Perampanel metabolites have been observed in plasma.
Elimination
After taking a dose of Perampanel with radioactive marks for 8 healthy elderly, 30% of the recovered radiation has been found in urine and 70% in feces. In urine and feces, the recovered radioactive amount mainly includes a mixture of oxidative metabolites and conjugated metabolites. In a population pharmacokinetics analysis, it includes gross data from 19 phase 1, t1/2 studies of Perampanel's average 105 hours. When used in combination with carbamazepin is a strong CYP3A, T1/2 induction drug on average 25 hours.
Before taking Fycompa 2mg Eisai Medicine for Supplementing Corruption (4 blisters x 7 tablets)
How to use
Should take Fycompa as a single dose before going to bed. Can be used with or not with food.
Should drink whole tablet with a glass of water. Do not chew, crush or divide the pill, can not divide the pills correctly because there is no break. To ensure adequate dose, need to drink whole tablets without chewing or crushing.
Dosage
Adults and teenagers aged 12 and older
Local sperm epilepsy
Perampanel at a dose of 4mg/day to 12mg/day has been shown to be effective for local boundary epilepsy.
Should use the starting dose of Fycompa 2mg/day. It is possible to increase the dose based on clinical response and tolerance in each increase of 2mg (per week or every 2 weeks, according to the considering the sale time described below) to the maintenance dose of 4mg/day - 8mg/day.
Depending on the clinical response and the ability to tolerate each individual at a dose of 8mg/day, the dose may increase by increased by 2mg/day to 12mg/day. The patient is taking the drugs simultaneously without shortening the semi -waste time of Perampanel, so the dose is more frequent than the 2 -week distance. The patient is taking the drugs while shortening Perampanel's disposal time, so the dose is not frequent than a week.
Sexicular seizures - First -level convulsions
Perampanel with a dose of up to 8mg/day has been shown to be effective for spastic spastic seizures - a whole of the first -fledged convulsions.
Should use the starting dose of Fycompa 2mg/day. The dose can be increased based on clinical response and tolerance capacity in each increase of 2mg (per week or every 2 weeks, according to the considering the selling time is described below) to the maintenance dose of up to 8mg/day. Depending on the clinical response and the ability to tolerate each individual at a dose of 8mg/day, the dose can be increased to 12mg/day that can be effective in some patients.
Patients who are taking drugs simultaneously do not shorten the sale time of Perampanel's discharges, so the titration is not frequent than at a distance of 2 weeks. The patient is taking the drugs and shortens Perampanel's disposal time, so the benchmark is not frequent than at a distance of 1 week.
When stopping fycompa, the dose should be slowly reduced.
Elderly (65 years and older)
Clinical studies on fycompa in epilepsy have not included enough subjects 65 and older to determine whether they have a different response than younger subjects. Analysis of safety information on 905 elderly people treated with Perampanel (in double blind studies conducted on non -epileptic expenses) shows no age difference in safety data. Combined with no age difference in the use of Perampanel, the results showed that it was not necessary to adjust the dose in the elderly. Perampanel needs to be used cautiously in the elderly due to the ability to interact with drugs in patients who use a lot of drugs.
Patients with renal failure
Unsurting dose adjustment in mild renal impairment patients. It is not recommended to use in patients with average renal impairment or severe renal failure or patients who are being bloody.
Patients with liver failure
Increasing dose in patients with mild and medium liver failure should be based on clinical response and tolerance. For patients with mild or medium liver failure, the dose may be started at a dose of 2mg. The dose should be adjusted at 2mg, not faster every 2 weeks based on tolerance and efficiency.
Perampanel dose for patients with mild liver failure and on average must not exceed 8mg. Do not recommend use in severe liver failure.
Group of children's patients
The safety and effectiveness of Perampanel in children under 12 years of age has not been determined. There is no data.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Overdose due to intentional may have led to a dose of up to 264mg, a patient who has encountered events of changing mental state, agitated, aggressive and recovered without sequelae.
There is currently no specific antidote to the effect of Perampanel. General support for patients includes monitoring of survival signs and observing the patient's clinical status. Due to the long selling time of the drug, the effects caused by Perampanel can last. Due to low kidney clearance, special interventions such as mandatory diuretic, hemolysis or uncertainty blood transfusion.
What to do when forgetting a dose?
If you forget more than 1 dose, for a period of less than 5 semi -waste cycles (3 weeks for patients who do not use anti -epileptic drugs that cause perampanel metabolism, 1 week for patients using anti -epilepsy drugs that cause perampanel metabolism), should consider the base to start treating the treatment from the final dose.
If the patient has stopped using Perampanel for a continuous time of more than 5 semi -waste cycles, it is recommended to comply with the recommendations on the starting dose mentioned above.
Side Effects
When using Fycompa 2mg, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Mental disorders: aggression, anger, anxiety, a state of confusion. Central nervous system disorders: dizziness, drowsiness, loss of air conditioning, vanity, balance disorders, easily stimulated. Digestive disorders: Nausea. Uncommon, 1/1000 Instructions on how to handle ADR Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Fycompa 2mg drug is contraindicated in the following cases: Hypersensitivity to active ingredients or any excipients.
Precautions when using
suicide thoughts
suicide thoughts and suicidal behavior have been reported in patients treated with anti -epileptic drugs in some indications. A comprehensive analysis of random tests that are controlled to placebo on anti -epileptic drugs has also shown a slight increase in the risk of suicide thoughts and suicide behavior. The mechanism of this risk is unknown and existing data does not exclude the possibility of increasing risk to Perampanel.
Therefore, it is necessary to monitor patients on signs of suicide thoughts, suicide behavior and need to consider appropriate treatment, should advise patients (and patient care) to find medical advice if signs of suicide thoughts or suicide behavior.
Central nervous system disorders
Perampanel can cause dizziness and drowsiness, so it can affect the ability to drive or operate machinery.
Oral contraceptives
At 12mg/day, Fycompa may reduce the effectiveness of hormone contraceptives containing progesterone, in this case, it is recommended to use additional methods of contraception without hormones when using Fycompa.
End of treatment
recommend that the stopping of the drug should be done slowly to minimize the possibility of responding seizures. However, due to the long -term semi -discharged time and plasma concentrations decreased slowly later, it is possible to stop Perampanel when it is really necessary.
falls
may increase the risk of falling, especially in the elderly, unknown reasons.
aggression
Acting and hostile behavior has been reported in patients treated with Perampanel. In patients treated with Perampanel in clinical trials, aggression, anger and discomfort that have been reported more often at higher doses. Most of the unwanted effects are reported to be mild or medium levels and patients recover or do the dose adjustments.
However, the thought of harming others, physical attacks or threatening behaviors have been observed in some patients (
Abuse of drugs
Be careful in patients with a history of drug abuse and need to monitor patients on Perampanel abuse symptoms.
Anti -epilepsy drug causes CYP 3A touch simultaneously
The response ratio after additional perampanel at a fixed dose is less when the patient is taken with anti -epileptic drugs that cause enzyme CYP3A (carbamazepin, phenytoin, oxcarbazepine) simultaneously when compared to the response ratio in patients using anti -epileptic drugs that do not cause enzyme induction simultaneously, need to monitor the patient's response from anti -energy -proof drugs that can be used from non -enzyme -proof drugs At the same time, the anti -epileptic drug causes enzyme induction and vice versa. Depending on the clinical response and the ability to tolerate each individual, the dose may increase or decrease by 2 mg at a time.
Other drugs that cause induction or inhibition of Cytochrom P450 are simultaneously used (in addition to anti -epileptic drugs)
Patients need to be closely monitored for their ability to tolerate and clinically respond when extra or eliminate induction or Cytochrom P450 inhibitors, because Perampanel concentration in plasma may decrease or increase, may need to adjust the perampanel dose of the corresponding.
Fycompa contains lactose, so patients with rare genetic problems are galactose intolerance, lactase deficiency or glucose-galactose absorption should not be taken.
The ability to drive and operate machinery
Fycompa has a moderate effect on the ability to drive and operate machinery.
Perampanel can cause dizziness and drowsiness, so it can affect the ability to drive or operate machinery. It is necessary to advise patients not to drive, operate complicated machines or participate in other dangerous activities until they know how Perampanel affects their ability to perform these jobs.
Pregnancy
It is not recommended to use fycompa in women who are likely to get pregnant without using contraception unless they are really necessary.
Do not recommend using Fycompa during pregnancy.
Breastfeeding period
It is unclear whether Perampanel will be excreted in breast milk. Can not rule out the risk for infants/young children. Must decide to stop breastfeeding or stop/avoid treatment with Fycompa, consider the benefits of breastfeeding with children and the benefits of treatment for the mother.
Medicinal interaction
Oral contraceptives
In healthy women using 12mg Fycompa (not 4mg/day or 8mg/day) for 21 days simultaneously with a oral contraceptive pills, Fycompa has shown to reduce the level of levonorgestrel (CMAX values (the highest concentration in plasma) and AUC (area under the curve) average each type decreased by 40%). The AUC of EthinyleLestradiol is not affected by Fycompa 12mg while CMAX decreased by 18%. Therefore, it is advisable to consider the ability to reduce the effectiveness of oral contraceptives containing progestatif for women who need to use Fycompa 12mg/day and should use a reliable contraceptive additional method (uterine equipment (IUD), condoms).
The work between Fycompa and other anti -epileptic drugs
lamotrigin
phenytoin 7 TD>
Valproic Acid
Effect of Perampanel on substrates of CYP3A
In healthy subjects, Fycompa (6mg once a day for 20 days) has reduced the AUC of Midazolam by 13%. Midazolam concentration is not eliminated (or other sensitive CYP3A4 substrates) with higher fycompa dose.
The effect of the drug causing Cytochroin P450 on Perampanel's pharmacokinetics
Strong drugs Cytochrom P450, like Rifampicin and Hypericum, are expected to reduce Perampanel's concentration. Felbamat has been shown to reduce the concentration of some drugs and can also reduce Perampanel's concentration.
The effect of Cytochrom P450 inhibitors on Perampanel's pharmacokinetics in healthy objects, ketoconazole (400mg once a day in 10 days) is a CYP3A4 inhibitor that increases the AUC of Perampanel 20% and extends the semi -waste time of Perampanel 15% (67.8 hours compared to 58.4 hours). It is impossible to eliminate greater effects when Perampanel is combined with a CYP3A inhibitor with a longer selling time than ketoconazole or when the inhibitor is used during longer treatment. Strong inhibitors of other ISOforms of Cytochrom P450 may also be likely to increase Perampanel levels.
levodopa
In healthy subjects, Fycompa (4mg once a day for 19 days) does not affect the CMAX or AUC of Levodopa.
alcohol
A study of pharmacokinetic interaction in healthy subjects has shown the impact of Perampanel on jobs related to alertness and vigilance as the ability to drive is a combination or co -effect with the impact of alcohol. Use multi -dose Perampanel 12mg/day to increase the level of anger, confusion and depression as evaluated by using the data of the 5 -point assessment of the mood state. These effects can also be observed when Fycompa is used to meet with other antidepressants on the central nervous system (CNS).
Group of children's patients
Research on drug interaction is only done in adults.
In a population pharmacokinetic analysis in teenagers in phase 3 clinical studies, there is no noticeable difference between this group of patients and the general group.
Storage
Store no more than 30 ° C.
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