Afalino 25 Tablet
Cenobamate
25 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 20's Pack |
|---|---|
| Unite Price | 35.00 BDT |
Indications
Afalino 25 Tablet is used for:
Partial-onset Seizures
Adult Dose
Partial-onset Seizures
Indicated for treatment of partial-onset seizures as either monotherapy or adjunctive therapy
Dose and titration schedule
Do not exceed recommended dosage and titration, owing to potential for serious adverse reactions
Weeks 1-2: 12.5 mg PO qDay initially
Titration dose
Weeks 3-4: 25 mg PO qDay
Weeks 5-6: 50 mg PO qDay
Weeks 7-8: 100 mg PO qDay
Weeks 9-10 150 mg PO qDay
Maintenance dose
Week 11 and thereafter: 200 mg PO qDay
Maximum dose
Based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg/day q2week to 400 mg PO qDay if needed
Hepatic impairment
Mild-to-moderate (Child-Pugh 5-9): Not to exceed 200 mg/day; additional dosage reduction may be necessary
Severe: Not recommended
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Mild, moderate, or severe: Caution advised; consider dosage reduction
End-stage renal disease: Not recommended
Administration
Administer at any time with or without food
Swallow tablet whole with liquid; do not crush or chew
Contra Indications
Hypersensitivity
Familial short QT syndrome (SQTS)
Precautions
Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multiorgan hypersensitivity, reported; DRESS has occurred, including 1 fatality, when cenobamate was titrated rapidly (weekly or faster titration)
Antiepileptic drugs (AEDs), including cenobamate, increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
Similar to most AEDs, discontinue cenobamate gradually, owing to risk of increased seizure frequency and status epilepticus; may consider rapid discontinuation because of a serious adverse event
Neurological adverse reactions
Dose-dependent increases in somnolence and fatigue-related adverse reactions (somnolence, fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy) observed in approximately one third of patients during clinical trials
Dose-dependent adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance, abnormal coordination) observed in up to ~50% of patients observed in clinical trials
Cognitive dysfunction (ie, memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorders, slowness of thought, disorientation, psychomotor retardation) observed
Visual changes (eg, diplopia, blurred vision, and impaired vision) observed
Warn patients against engaging in hazardous activities requiring mental alertness until the effects of cenobamate are known
Pregnancy-Lactation
Pregnancy
Data are unavailable on the developmental risk associated with use of cenobamate in pregnant women
Animal studies
Administration during pregnancy or throughout pregnancy and lactation resulted in adverse effects on development (increased embryofetal mortality, decreased fetal and offspring body weights, neurobehavioral and reproductive impairment in offspring) at clinically relevant drug exposures
Contraception
Cenobamate may decrease plasma concentrations of oral contraceptives
Women of reproductive potential concomitantly using oral contraceptives should use additional or alternative nonhormonal birth control
Lactation
Data are unavailable on the presence in human milk, effects on breastfed infants, or effects on milk production
Interactions
CNS depressants and alcohol
Coadministration with other CNS depressants, including alcohol, may increase risk of neurological adverse reactions, including sedation and somnolence
Effect of cenobamate on other drugs
Lamotrigine or carbamazepine: Plasma levels decreased; potential for reduced efficacy of these drugs; increase dosage of lamotrigine or carbamazepine, as needed
Phenytoin: Plasma levels increased; owing to potential 2-fold increase in phenytoin levels, gradually decrease phenytoin dosage by up to 50% as cenobamate is being titrated
Phenobarbital, clobazam (ie, desmethyl-clobazam active metabolite): Plasma levels increased; potential for increased adverse reactions from these drugs; consider dose reduction of phenobarbital or clobazam, as clinically appropriate
Oral contraceptives: Plasma levels decreased; potential for reduced efficacy of oral contraceptives; women should use additional contraceptive or a nonhormonal birth control method while taking cenobamate
Side Effects
Side effects of Cenobamate :
Mode of Action
Exact mechanism of action unknown
It is thought to work by reducing repetitive neuronal firing by inhibiting voltage-gated sodium currents; it is also a positive allosteric modulator of the GABA ion channel
Note
Afalino 25 25 mg Tablet generic name is Cenobamate. Afalino 25 25 mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Afalino 25 is availble in all over Bangladesh.
Mes BD drug index information on Afalino 25 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.