Introduction
Eslicar is a prescription medicine used to treat epilepsy (seizures). It helps to decrease the abnormal and excessive activity of the nerve cells and calms the brain.
Eslicar may be taken with or without food, preferably at the same time, each day. Take this medicine in the dose and duration as advised by your doctor. If you have missed a dose, take it as soon as you remember it. Do not skip any doses and finish the full course of treatment even if you feel better. Do not stop taking it abruptly without discussing it with your doctor, as it may increase seizure frequency.
Some of the common side effects of this medicine include blurred or double vision, headache, nausea, vomiting, fatigue and diarrhea. It may also cause dizziness and sleepiness, do not drive or do anything that requires mental focus until you know how this medicine affects you. Please consult your doctor if these side effects bother you or do not go away.
Your doctor may advice for regular monitoring of sodium levels, as it may reduce the sodium levels in your blood (hyponatremia). Inform your doctor if you are taking oral contraceptive pills as this medicine reduces their levels in the body.
Side effects of Eslicar
Common
- Sleepiness
- Blurred vision
- Nausea
- Headache
- Vomiting
- Double vision
- Fatigue
- Balance disorder (loss of balance)
- Diarrhea
- Impaired coordination
- Vertigo
- Decreased appetite
- Decreased sodium level in blood
- Dizziness
How to use Eslicar
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Eslicar may be taken with or without food, but it is better to take it at a fixed time.
How Eslicar works
Eslicar is an anti epileptic medication. It works by blocking the voltage gated sodium channels that stabilizes the hyperexcited nerve cells in the brain. In this way, it treats seizures or fits.
What if you forget to take Eslicar?
If you miss a dose of Eslicar, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Indication
Partial-onset seizures
Administration
May take with or without food
Adult Dose
Partial-Onset Seizures
Indicated for partial-onset seizures as monotherapy or adjunctive therapy
Initial
400 mg PO qDay
For some patients, treatment may be initiated at 800 mg qDay if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation
Titration & maintenance
Increase dose by weekly increments of 400-600 mg, based on clinical response and tolerability
Recommended maintenance dose is 800-1600 mg once daily
Monotherapy: Consider 800 mg/day maintenance dose in patients unable to tolerate 1200 mg/day
Adjunctive therapy: 1600 mg/day should be considered in patients who did not achieve a satisfactory response with 1200 mg/day
Hepatic impairment
Mild-to-moderate: No dosage adjustment required
Severe: Not recommended (not studied)
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Moderate-to-severe (CrCl <50 mL/min): Reduce the initial, titration, and maintenance doses by 50%; may adjust titration and maintenance doses according to clinical response
Contraindication
Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients. Second or third degree atrioventricular (AV) block.
Mode of Action
Antiepileptic drug; eslicarbazepine acetate is a prodrug that is activated to eslicarbazepine (S-licarbazepine), the major active metabolite of oxcarbazepine.
Stabilizes neuronal membranes by blocking Na+ channels; this may inhibit repetitive firing and may decrease the propagation of synaptic impulses; may also increase potassium conductance and modulate the activity of high-voltage activated calcium channels.
Precaution
Suicidal ideation
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Nervous system disorders
Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.
Oral contraceptives
Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended
Other warnings and precautions
If Eslicarbazepine is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency.
Concomitant use of eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Hyponatraemia
Hyponatraemia has been reported as an adverse reaction in 1.2% of patients treated with Eslicarbazepine. Hyponatraemia is asymptomatic in most cases, however, it may be accompanied by clinical symptoms like worsening of seizures, confusion, decreased consciousness. Frequency of hyponatraemia increased with increasing eslicarbazepine acetate dose. In patients with pre-existing renal disease leading to hyponatraemia, or in patients concomitantly treated with medicinal products which may themselves lead to hyponatraemia (e.g. diuretics, desmopressin, carbamazepine), serum sodium levels should be examined before and during treatment with eslicarbazepine acetate. Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur. Apart from this, sodium levels should be determined during routine laboratory examination. If clinically-relevant hyponatraemia develops, eslicarbazepine acetate should be discontinued.
PR interval
Prolongations in PR interval have been observed in clinical studies with eslicarbazepine acetate.
Caution should be exercised in patients with medical conditions (e.g. low levels of thyroxine, cardiac conduction abnormalities), or when taking concomitant medicinal products known to be associated with PR prolongation.
Lactation: Unknown if distributed in human breast milk
Side Effect
>10%
Dizziness (20-28%),Somnolence (11-18%),Nausea (10-16%),Headache (13-15%),Diplopia (9-11%)
1-10%
Vomiting (6-10%),Fatigue (4-7%),Blurred vision (5-6%),Ataxia (4-6%),Vertigo (2-6%),Diarrhea (2-4%),Tremor (2-4%),Balance disorder (3%),Asthenia (2-3%),Falls (1-3%),Depression (1-3%),Rash (1-3%),Constipation (2%),Abdominal pain (2%),Gait disturbance (2%),UTI (2%),Hyponatremia (2%),Insomnia (2%),Visual impairment (1-2%),Gastritis (1-2%),Peripheral edema (1-2%),Dysarthria (1-2%),Memory impairment (1-2%),Nystagmus (1-2%),Cough (1-2%),Hypertension (1-2%)
Pregnancy Category Note
Pregnancy
Limited available data with eslicarbazepine acetate use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
Advise women of reproductive potential taking eslicarbazepine acetate who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control
Eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation
Lactation
Eslicarbazepine is present in human milk; effects of eslicarbazepine acetate on the breastfed infant or on milk production are unknown