FELBAMATE PACKAGE INSERT PDF

See package insert. How to take and store Felbamate? Follow your doctor’s directions. Call if you have any questions. Usually, your doctor will tell you to start by. Felbatol is the brand name used in the United States for felbamate. Read the black box warning in the Package Insert to your patient and obtain any necessary . Felbamate, also known as Felbatol, has been approved by the Food and Drug about all potential risks before using this drug and read the package insert.

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According to the manufacturer, felbamate is excreted into breast milk, but its effects on the infant are unknown.

Shake the oral suspension well before using. Minor The metabolism of dapsone may be accelerated when administered concurrently with felbamate, a known inducer of CYP3A4.

The effect of food on GI absorption from the oral suspension has not been evaluated. Coadministration may increase cannabidiol plasma concentrations increasing the risk of adverse reactions.

It should be noted that results of a population pharmacokinetic analysis showed that concurrent use felbamahe felbamate and inwert did not significantly alter the kinetics of clobazam or its active metabolite at steady-state.

Time to peak serum concentration is 1—6 hours. Major Avoid concurrent use of felbamate with bedaquiline. Hydroxychloroquine can lower the seizure threshold; therefore, the activity pacoage antiepileptic drugs may be impaired with concomitant use. Although this interaction has not been studied by the manufacturer, and published literature suggests the potential for interactions to be low, taking these drugs together may alter the systemic exposure of terbinafine.

Major Estrogens and progestins are both susceptible to drug interactions with hepatic enzyme inducing drugs. Patients must call to fflbamate in the registry.

Moderate Trazodone can lower the seizure threshold of anticonvulsants, although the overall risk is low at therapeutic psckage. If not possible, closely monitor for increased side effects of doxorubicin including myelosuppression and cardiotoxicity.

Predictions about the interaction can be made based on the metabolic pathways of both drugs. Additionally, patients taking non-oral combination contraceptives or estrogens or progestins for hormone replacement therapy may also experience reduced clinical efficacy; dosage adjustments may be necessary.

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In addition, seizures have been reported during the use of molindone, which is of particular significance in patients with a seizure disorder receiving anticonvulsants.

According to the Beers Criteria, anticonvulsants such as felbamate are considered potentially inappropriate medications PIMs in geriatric patients with a history of falls or fractures and should be avoided in these patient populations, with the exception of treating seizure and mood disorders, since anticonvulsants can produce ataxia, impaired psychomotor function, syncope, and additional falls.

Clinical signs and symptoms may include infection, bleeding, or anemia. Major Maprotiline, when used concomitantly with anticonvulsants, can increase CNS depression and may also lower the seizure threshold, leading to pharmacodynamic interactions.

Felbatol (felbamate) dose, indications, adverse effects, interactions from

Other reported clinical experience has not identified differences in responses. The serious toxicities of flebamate, such as aplastic anemia, would also warrant that felbamate be used during pregnancy only if clearly needed. Monitor for decreased clinical effects of tretinoin, ATRA while receiving concomitant therapy. Major Coadministration of felbamate and clarithromycin may decrease clarithromycin serum concentrations due to CYP3A4 enzyme induction.

There are no inserf in pregnant women to determine the effect of felbamate on the fetus. The half-life of the drug is prolonged and clearance reduced.

Obtaining serum medication concentrations may assist in identifying toxicity. Anticonvulsants such as paciage should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. The cause of the increase in normethsuximide concentrations is not known.

The safety and efficacy of felbamate in children, other than those with Lennox-Gastaut syndrome, have not been studied. In rats, there was a decrease in pup weight and an increase in pup deaths during lactation; the reason for the deaths is not determined.

While the OH-clarithromycin active metabolite concentrations are increased, this metabolite has different antimicrobial activity compared to clarithromycin. Too little is known about felbamate-induced aplastic anemia to determine fatality percentages or which patients are more at risk for this serious adverse reaction.

Felbamate causes a decrease in the steady-state inserr concentration of carbamazepine but increases concentrations of carbamazepine epoxide, a carbamazepine metabolite. Oral anticonvulsant agent chemically similar to meprobamate, but does not possess muscle-relaxant activity. Extrapolation from pharmacogenomic data indicates that concurrent use of clobazam with moderate or potent inhibitors of CYP2C19 may result in up to a 5-fold increase in exposure to N-desmethylclobazam.

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Plasma concentrations of atazanavir may be reduced padkage these drugs are administered concurrently, leading to a reduction of antiretroviral efficacy and the potential development of viral resistance. It is also not known if concurrent therapies may influence this risk. Patients who are discontinued off the drug therefore remain at risk for aplastic anemia for an unknown time after drug discontinuation.

Moderate Use lacosamide with caution felbaate patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants e. Among felbamate-treated patients, aplastic anemia occurs at an incidence that may be more than fold greater than that seen in the untreated population e.

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packafe Agents that induce CYP3A4 may increase the insetr of vincristine and decrease the efficacy of drug, including felbamate. Monitor patients on anticonvulsants carefully when a TCA is used concurrently. Oral dosage-Conversion to Monotherapy. In addition, monitor patients receiving lacosamide via the intravenous route closely.

Monitoring should include baseline liver function tests i. Moderate Tricyclic antidepressants, when used concomitantly with anticonvulsants, can increase CNS depression and may also lower the seizure threshold, leading to pharmacodynamic interactions. The binding of glycine to the NMDA receptor causes an increase in the frequency of NMDA receptor-mediated channel opening, which is important in the initiation and propagation of seizures.

Routine laboratory testing of the blood cannot be reliably used to reduce the incidence of aplastic anemia. Therefore, use of praziquantel with innsert, a CYP3A4 inducer, should be done with caution as concomitant use may produce therapeutically ineffective concentrations of praziquantel. Patients receiving these drugs concurrently with gelbamate should be monitored for possible loss of vincristine efficacy. Major Concurrent administration of felbamate with dasabuvir; ombitasvir; paritaprevir; ritonavir may result in decreased plasma concentrations of dasabuvir, paritaprevir, and ritonavir.

Major Coadministration of felbamate with elvitegravir is not recommended. An alternate or additional form of contraception should be used during concomitant treatment.

Felbamate is a CYP3A4 inducer, which may result in decreased bedaquiline systemic exposure AUC and possibly reduced therapeutic effect.