Category: neurology

zonisamide (Zonegran) Uses, Side Effects & Dosage

What is zonisamide-oral, and how does it work (mechanism of action)?

  • Scientists do not known how exactly zonisamide works in the body. Zonisamide is presumed to work on the sodium and calcium channels in the brain cells where it controls electric-currents that are responsible for seizure activity.
  • The FDA approved zonisamide in March 2000.
  • The brand name for zonisamide is Zonergran.
  • Zonisamide is available in generic form. You need a prescription to obtain zonisamide.

What is zonisamide-oral used for?

Zonisamide (Zonergan) is an anti-seizure medication. Zonisamide is primarily used to treat partial-seizures.

What are the side effects of zonisamide-oral?

Common side effects of zonisamide are:

Serious side effects of zonisamide include:

  • Psychiatric disorders such as
    schizophrenia
  • Seizures
  • Serious skin disorders such as Stevens-Johnson's
    syndrome or toxic epidermal necrolysis.




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What is the dosage for zonisamide-oral?

The recommended starting dose of zonisamide is 100 mg/day. Doses may
be increased 100 mg/day every 2 weeks. The usual dosage varies from 100 to 600
mg/day, administered in 1 to 2 divided doses.

Safe and effective use of zonisamide is not established for children under
the age of 16.

Which drugs or supplements interact with zonisamide-oral?

Zonisamide increases the risk of lactic acid build up when
combined with metformin (Glucophage). If you experience sudden weakness, heavy
breathing, and increased drowsiness, contact your healthcare professional
immediately.

Orlistat (Xenical) should be used with caution with zonisamide because it
lowers the beneficial effects of zonisamide and increases the chances of
seizures. If you experience dizziness, drowsiness, difficulty walking, nausea,
vomiting, and abnormal eye movements, contact your healthcare professional
immediately.

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Is zonisamide-oral safe to take if you are pregnant or breastfeeding?

  • There are no adequate studies done on zonisamide to determine its safe and effective use in pregnant mothers.
  • It is not known whether zonisamide is excreted in breast milk. It should be used with caution in females who are nursing.

What else should I know about zonisamide-oral?

What preparations of zonisamide-oral are available?

Capsules: 25, 50, and 100 mg.

How should I keep zonisamide-oral stored?

Store zonisamide capsules between 20 C and 25 C (68 F and 77 F).

Sympazan (clobazam) Seizure Medication Side Effects & Warnings


Generic drug: clobazam

Brand name: Sympazan

What is Sympazan (clobazam), and how does it work?

Sympazan is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut Syndrome in people 2 years of age or older.

It is not known if Sympazan is safe and effective in children less than 2 years old.

What are the side effects of Sympazan?

WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
  • Limit dosages and durations to the minimum required
  • Follow patients for signs and symptoms of respiratory depression and sedation

The most common side effects of Sympazan  include:

These are not all the possible side effects of Sympazan. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Sympazan?

Dosing Information

A daily dose of Sympazan greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability.

Each dose in Table 1 (e.g., 5 to 20 mg in 30 kg or less weight group) has been shown to be effective, although effectiveness increases with increasing dose. Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.

Table 1: Recommended Total Daily Dosing by Weight Group

30 kg or Less Body Weight
Greater than 30 kg Body Weight

Starting Dose
5 mg
10 mg

Starting Day 7
10 mg
20 mg

Starting Day 14
20 mg
40 mg

Discontinuation Or Dosage Reduction Of Sympazan

  • To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue Sympazan or reduce the dosage. Taper by decreasing the total daily dosage by 5-10 mg/day on a weekly basis until discontinued.
  • If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly.

Important Administration Instructions

  • Instruct patients and/or caregivers to read the “Instructions for Use” carefully for complete directions on how to properly dose and administer Sympazan oral films.
  • Apply Sympazan on top of the tongue where it adheres and dissolves.
  • Sympazan  oral film can be taken with or without food. Do not administer with liquids. As the film dissolves, saliva should be swallowed in a normal manner, but the patient should refrain from chewing, spitting or talking.
  • Only one oral film should be taken at a time; if a second film is needed to complete the dosage, it should not be taken until the first film has completely dissolved.

Dosage Adjustments In Geriatric Patients

  • Plasma concentrations at any given dose are generally higher in geriatric patients.
  • Therefore, the starting dosage should generally be 5 mg/day for all geriatric patients.
  • Then proceed slowly with dose escalation; titrate according to weight, but to half the dosage presented in Table 1, as tolerated. If necessary and based upon clinical response, an additional titration to the maximum dosage (20 mg/day or 40 mg/day, depending on weight) may be started on day 21.

Dosage Adjustments In CYP2C19 Poor Metabolizers

  • In CYP2C19 poor metabolizers, levels of N-desmethylclobazam, clobazam's active metabolite, will be increased.
  • Therefore, the starting dosage should be 5 mg/day in patients known to be CYP2C19 poor metabolizers.
  • Then proceed slowly with dose escalation; titrate according to weight, but to half the dosage presented in Table 1, as tolerated.
  • If necessary and based upon clinical response, an additional titration to the maximum dosage (20 mg/day or 40 mg/day, depending on weight) may be started on day 21.

Dosage Adjustments In Patients With Hepatic Impairment

  • Sympazan is hepatically metabolized; however, there are limited data to characterize the effect of hepatic impairment on the pharmacokinetics of Sympazan.
  • For patients with mild to moderate hepatic impairment (Child-Pugh score 5-9), the starting dosage should be 5 mg/day (regardless of weight).
  • Then proceed slowly with dosing escalations; titrate patients according to weight, but to half the dosage presented in Table 1, as tolerated.
  • If necessary and based upon clinical response, an additional titration to the maximum dosage (20 mg/day or 40 mg/day, depending on weight) may be started on day 21.
  • There is inadequate information about metabolism of clobazam in patients with severe hepatic impairment. Therefore, no dosing recommendation can be given for those patients.

What drugs interact with Sympazan?

Opioids

  • The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
  • Benzodiazepines interact at GABAA sites, and opioids interact primarily at mu receptors.
  • When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
  • Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.

CNS Depressants And Alcohol

  • Concomitant use of Sympazan  with other CNS depressants may increase the risk of sedation and somnolence.
  • Alcohol, as a CNS depressant, will interact with Sympazan  in a similar way and also increases clobazam's maximum plasma exposure by approximately 50%.
  • Therefore, caution patients or their caregivers against simultaneous use with other CNS depressant drugs or alcohol, and caution that the effects of other CNS depressant drugs or alcohol may be potentiated.

Effect Of Sympazan  On Other Drugs

Hormonal Contraceptives
  • Sympazan is a weak CYP3A4 inducer. As some hormonal contraceptives are metabolized by CYP3A4, their effectiveness may be diminished when given with Sympazan.
  • Additional non-hormonal forms of contraception are recommended when using Sympazan.
Drugs Metabolized By CYP2D6
  • Sympazan inhibits CYP2D6. Dose adjustment of drugs metabolized by CYP2D6 may be necessary.

Effect Of Other Drugs On Sympazan

Strong And Moderate Inhibitors Of CYP2C19
  • Coadministration with strong or moderate inhibitors of CYP2C19 may result in increased exposure to Ndesmethylclobazam, the active metabolite of clobazam. This may increase the risk of dose-related adverse reactions
  •  Dosage adjustment of Sympazan may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole).
Effect Of Cannabidiol On Sympazan
  • Coadministration of cannabidiol, a CYP3A4 and CYP2C19 substrate and a CYP2C19 inhibitor, with clobazam may increase the risk of clobazam-related adverse reactions.
  • Consider a reduction in dosage of cannabidiol or clobazam if adverse reactions known to occur with Sympazan are experienced.





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Does Sympazan cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance
  • Sympazan contains clobazam, a Schedule IV controlled substance.
Abuse
Dependence

Physical Dependence

Acute Withdrawal Signs and Symptoms

Protracted Withdrawal Syndrome

Tolerance

  • Sympazan  is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
  • Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.
  • Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.
  • Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.
  • Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders.
  • The following adverse reactions have occurred with benzodiazepine abuse and/or misuse:
  • The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse:
  • Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).
  • The World Health Organization epidemiology database contains reports of drug abuse, misuse, and overdoses associated with clobazam.
    • Sympazan may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
    • Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening.
    • Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use.
    • To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Sympazan or reduce the dosage.
    • Acute withdrawal signs and symptoms associated with benzodiazepines have included
    • More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included
    • Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal.
    • Protracted withdrawal symptoms may last weeks to more than 12 months.
    • As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
    • Tolerance to Sympazan may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
    • Tolerance to the therapeutic effect of Sympazan may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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Is Sympazan safe to use while pregnant or breastfeeding?

  • There are no adequate and well-controlled studies of Sympazan in pregnant women.
  • Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies.
  • Although some early epidemiological studies suggested a relationship between benzodiazepine drug use in pregnancy and congenital anomalies such as cleft lip and/or palate, these studies had considerable limitations.
  • More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies.
  • There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment.
  • There are clinical considerations regarding exposure to benzodiazepines during the second and third trimester of pregnancy or immediately prior to or during childbirth.
  • These risks include decreased fetal movement and/or fetal heart rate variability, “floppy infant syndrome,” dependence, and withdrawal.
  • Sympazan should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
  • Sympazan is excreted in human milk. Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines, such as Sympazan, may have effects of lethargy, somnolence and poor sucking.
  • The effect of Sympazan on milk production is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sympazan and any potential adverse effects on the breastfed infant from Sympazan or from the underlying maternal condition.
  • If exposing a breastfed infant to Sympazan, observe for any potential adverse effects.

Vimpat (lacosamide): Epilepsy Medication Uses & Side Effects

What is Vimpat (lacosamide), and how does it work?

Vimpat is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older.

  • It is not known if Vimpat injection is safe for use in children. Children age 4 years and older should only take
    Vimpat by mouth. Vimpat injection is only for use in people 17 years of age and older.
  • It is not known if Vimpat is safe and effective in children under 4 years of age.

What are the side effects of Vimpat?

Do not stop taking Vimpat without first talking to your healthcare provider. Stopping
Vimpat suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Vimpat can cause serious side effects, including:

  1. Like other antiepileptic drugs, Vimpat may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    • thoughts about suicide or dying
    • attempt to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood

    How can I watch for early symptoms of suicidal thoughts and actions?

    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.
    • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
    • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
  2. Vimpat may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how
    Vimpat affects you.
  3. Vimpat may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you:
    • have a fast, slow, or pounding heartbeat or feel your heart skip a beat
    • have shortness of breath
    • have chest pain
    • feel lightheaded
    • fainted or if you feel like you are going to faint

    4. If you have fainted or feel like you are going to faint you should lay down with your legs raised.

Vimpat may cause other serious side effects including:

  • A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:

The most common side effects of Vimpat in adults include:

Other Adverse Reactions

The following is a list of adverse reactions reported by patients treated with
Vimpat in all clinical trials in adult patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Adverse reactions addressed in other tables or sections are not listed here.

  • Blood and lymphatic system disorders: neutropenia, anemia
  • Cardiac disorders: palpitations
  • Ear and labyrinth disorders: tinnitus
  • Gastrointestinal disorders: constipation, dyspepsia, dry mouth, oral hypoaesthesia
  • General disorders and administration site conditions: irritability, pyrexia, feeling drunk
  • Injury, poisoning, and procedural complications: fall
  • Musculoskeletal and connective tissue disorders: muscle spasms
  • Nervous system disorders: paresthesia, cognitive disorder, hypoaesthesia, dysarthria, disturbance in attention, cerebellar syndrome
  • Psychiatric disorders: confusional state, mood altered, depressed mood

Side effects of Vimpat in children are similar to those seen in adults. These are not all of the possible side effects of
Vimpat. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Does Vimpat cause addiction and withdrawal symptoms?

Vimpat is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your
Vimpat in a safe place, to protect it from theft. Never give your Vimpat to anyone else, because it may harm them. Selling or giving away this medicine is against the law.

Abuse

In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). However, the rate of euphoria reported as an adverse event in the
Vimpat development program at therapeutic doses was less than 1%.

Dependence

Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.




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What is the dosage for Vimpat?

  • Take Vimpat exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how much Vimpat to take and when to take it.
  • Your healthcare provider may change your dose if needed.
  • Do not stop Vimpat without first talking to a healthcare provider. Stopping
    Vimpat suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
  • Vimpat may be taken with or without food.
  • Swallow Vimpat tablets whole with liquid. Do not cut Vimpat tablets.
  • If your healthcare provider has prescribed Vimpat oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of
    Vimpat oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
  • If you take too much Vimpat, call your healthcare provider or local Poison Control Center right away.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how
Vimpat affects you. Vimpat may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.

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What drugs interact with Vimpat?

Strong CYP3A4 Or CYP2C9 Inhibitors

Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to
Vimpat. Dose reduction may be necessary in these patients.

Concomitant Medications That Affect Cardiac Conduction

Vimpat should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning
Vimpat, and after Vimpat is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered
Vimpat through the intravenous route.

Is Vimpat safe to take while pregnant or breastfeeding?

Before you take Vimpat, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Vimpat can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking
    Vimpat. You and your healthcare provider will decide if you should take
    Vimpat while you are pregnant.

    • If you become pregnant while taking Vimpat, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if Vimpat passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take
    Vimpat.

Viltepso (viltolarsen) for Duchenne: Side Effects & Warnings


Generic drug: viltolarsen

Brand name: Viltepso

What is Viltepso (viltolarsen), and how does it work?

Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

What are the side effects of Viltepso?

Side effects of Viltepso include:

Kidney Toxicity

Inform patients nephrotoxicity has occurred with drugs similar to Viltepso. Advise patients of the importance of monitoring for kidney toxicity by their healthcare providers during treatment with
Viltepso.

What is the dosage for Viltepso?

Monitoring To Assess Safety

  • Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio
    should be measured before starting Viltepso.
  • Consider measurement of glomerular
    filtration rate prior to initiation of Viltepso. Monitoring for kidney toxicity
    during treatment is recommended.
  • Obtain the urine samples prior to infusion of Viltepso or at least 48 hours after the most recent infusion.

Dosing Information

  • The recommended dosage of Viltepso is 80 mg/kg administered once weekly as a 60-minute intravenous infusion.
  • If a dose of Viltepso is missed, it should be administered as soon as possible after the scheduled dose time.

What drugs interact with Viltepso?

No information provided

Is Viltepso safe to use while pregnant or breastfeeding?

  • There are no human or animal data available to assess the use of
    Viltepso during pregnancy.
  • There are no human or animal data to assess the effect of Viltepso on milk production, the presence of viltolarsen in milk, or the effects of
    Viltepso on the breastfed infant.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
    Viltepso and any potential adverse effects on the breastfed infant from
    Viltepso or from the underlying maternal condition.

Roweepra (levetiracetam): Seizure Medication Side Effects & Dosage


Generic drug: levetiracetam

Brand name: Roweepra

What is Roweepra (levetiracetam), and how does it work?

Roweepra (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat:

  • partial onset seizures in people 1 month of age and older withepilepsy
  • myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

It is not known if Roweepra is safe or effective in children under 1 month of age.

This Medication Guide summarizes the most important information about Roweepra. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Roweepra that is written for health professionals. You can call 1-800-273-6729 to get information about Roweepra.

What are the side effects of Roweepra?

Roweepra can cause serious side effects.

Call your healthcare provider right away if you have any of
these symptoms:

The most common side effects seen in people who take
Roweepra include:

The most common side effects seen in children who take
Roweepra include, in addition to those listed above:

These side effects can happen at any time but happen
more often within the first 4 weeks of treatment except for
infection.

Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.

These are not all the possible side effects of Roweepra.
For more information, ask your healthcare provider or
pharmacist.

Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.




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What is the dosage for Roweepra?

Important Administration Instructions

  • Roweepra is given orally with or without food. The Roweepra dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal
    function.
  • Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.
  • When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
  • Roweepra tablets should be swallowed whole. Roweepra tablets should not be chewed or crushed.

Dosing For Partial Onset Seizures

Adults 16 Years And Older
  • Initiate treatment with a daily dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional
    every 2 weeks) to a maximum recommended daily dose of 3,000 mg. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.
Pediatric Patients

1 Month to < 6 Months

  • Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the
    recommended daily dose of 42 mg/kg (21 mg/kg twice daily).
  • In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses
    has not been studied.

6 Months to <4 Years

  • Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
  • Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended
    daily dose of 50 mg/kg (25 mg/kg twice daily).
  • If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily
    dose was 47 mg/kg in this age group.

4 Years to < 16 Years

  • Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the
    recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial,
    the mean daily dose was 44 mg/kg. The maximum daily dose was 3,000 mg/day.
  • For Roweepra tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily).
    Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1,500 mg (750 mg twice daily).
  • For Roweepra tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day given as twice daily dosing (500
    mg twice daily). Increase the daily dose every 2 weeks by increments of 1,000 mg/day to a maximum recommended daily dose of 3,000 mg (1,500 mg twice daily).

Levetiracetam Oral Solution, USP Weight-Based Dosing Calculation For Pediatric Patients

The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

Total daily dose (mL/day) =
Daily dose (mg/kg/day) x patient weight(kg)

100 mg/mL

Dosing For Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

  • Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1,000 mg/day every 2 weeks to the recommended
    daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been studied.

Dosing For Primary Generalized Tonic-Clonic Seizures

Adults 16 Years And Older
  • Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1,000 mg/day every 2 weeks to the recommended
    daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been adequately studied.
Pediatric Patients Ages 6 To <16 Years
  • Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10
    mg/kg twice daily). Increase the daily dose every 2 weeks by increments of
    20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily).
  • The effectiveness of doses lower than 60 mg/kg/day has not been
    adequately studied. Patients with body weight =20 kg should be dosed with
    oral solution. Patients with body weight above 20 kg can be dosed with
    either tablets or oral solution. Only whole tablets should be administered.

Dosage Adjustments In Adult Patients With Renal Impairment

  • Roweepra dosing must be individualized according to the patient’s renal function status.
  • Recommended dosage adjustments for adults are shown in Table 1.
  • In order
    to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for
    body surface area must be calculated.
  • To do this an estimate
    of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

CLcr =
[140-age (years)] x weight (kg)
72 x serum creatinine (mg/dL)
x 0.85 for female patients)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min) =
CLcr (mL/min/1.73m2)
BSA subject (m2)
x 1.73

Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment

Group
Creatinine Clearance
(mL/min/1.73m2)
Dosage (mg)
Frequency

Normal
> 80
500 to 1,500
Every 12 hours

Mild
50 – 80
500 to 1,000
Every 12 hours

Moderate
30 – 50
250 to 750
Every 12 hours

Severe
< 30
250 to 500
Every 12 hours

ESRD patients using
dialysis
–
500 to 1,0001
Every 24 hours1

1 Following dialysis, a 250 to 500 mg supplemental dose is ecommended.

What drugs interact with Roweepra?

No Information Provided

Is Roweepra safe to use while pregnant or breastfeeding?

  • There are no adequate and controlled studies in pregnant women.

    Levetiracetam is excreted in human milk.

  • Because of the potential for serious adverse reactions in nursing infants from
    Roweepra, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

What Are the Side Effects of Antiepileptic Drugs (AED)?

What are antiepileptic drugs?

Antiepileptic drugs aim to rebalance the chemo-electric activity in the brain, the dysfunction of which causes seizures.Antiepileptic drugs aim to rebalance the chemo-electric activity in the brain, the dysfunction of which causes seizures.

Antiepileptic drugs (AED) are medications given to control epileptic seizures and convulsions. Antiepileptic drugs do not cure epilepsy, but may reduce the frequency, duration, and severity of seizures. Most people must continue taking antiepileptic drugs for their entire lives.

Seizures may also be caused by high fevers and psychological distress. Antiepileptic drugs are prescribed only for seizures from epilepsy and not for other kinds of seizures.

What is epilepsy?

Epilepsy is a disorder that causes abnormal electrical activity in the brain’s nerve cells (neurons), resulting in recurrent, unprovoked seizures. Epilepsy is a spectrum disorder and may happen in people of any age, though it is more common in young children.

Epileptic seizures may be generalized, affecting the whole brain, or partial, localized to one part of the brain.  Localized epileptic seizures may or may not spread to other parts of the brain.

A seizure is a sudden burst of abnormal electrical activity in the brain, which may induce abnormal behavior and uncontrolled muscle movements in a person. A seizure may or may not be accompanied by convulsions.

What is the best antiepileptic drug?

There is no single best antiepileptic drug, and the choice of antiepileptic drug depends on factors such as:

  • The type of epilepsy
  • The age of the patient
  • Chance of pregnancy
  • Toleration of side effects
  • Other coexisting conditions
  • Lifestyle habits, such as alcohol consumption

Antiepileptic drugs may be of two kinds:

  • Narrow spectrum AEDs: Designed for specific types of seizures such as
    • Partial
    • Focal
    • Absence
    • Myoclonic
  • Broad spectrum AEDs: Treat patients who have more than one type of seizures.

A patient may respond to a single antiepileptic drug (monotherapy), or may require a combination of drugs, depending on the type of epilepsy. Antiepileptic drug regimens are usually started using just one medication in a low dosage. The dosage is increased slowly to reach the maximum therapeutic effect with the fewest side effects.




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How do antiepileptic drugs work?

Different classes of antiepileptic drugs use different mechanisms to prevent a seizure, some of which are not clearly understood. Some of the primary ways antiepileptic drugs work are:

  • Sodium channel blockers alter the electrical state of the neuron by blocking the sodium ion channels, to prevent them from firing electrical signals.
  • Calcium channel blockers stop the transmission of electrical signals between neurons by calcium ion channels, by blocking the release of chemicals which transmit the signals (neurotransmitters).
  • GABA (Gamma-aminobutyric acid) enhancers: GABA is the brain’s natural neurotransmitter that stops transmission of electrical signals. GABA enhancers work by
    • Increasing GABA production
    • Reducing GABA metabolic breakdown
    • Increasing the transmission of GABA between neurons
  • Glutamate blockers block the action of glutamate, a neurotransmitter that promotes the brain’s electrical activity by facilitating the flow of sodium, calcium, and potassium ions through a neuron. Much like a battery has a positive and negative charge, this ion balance maintains the electrical polarity of the nerve cell.

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What are the side effects of antiepileptic drugs?

The first-generation antiepileptic drugs can have severe side effects and are known to cause liver damage. People taking these AEDs require regular blood tests to monitor kidney and liver functions. Some antiepileptic drugs may also adversely interact with other drugs.

Though side effects cannot be eliminated, newer drugs have been developed with:

  • Better efficacy
  • Fewer side effects
  • Less toxicity

If given during pregnancy, many of the antiepileptic drugs can cause birth defects in the child, such as:

Some of the common antiepileptic drugs and their main possible side effects are listed below.

Brivaracetam (Briviact) 

Adjunct or monotherapy for partial-onset seizures.

Side effects include:  

Cannabidiol (Epidiolex) 

For seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

Side effects include:  

Carbamazepine (Carbatrol or Tegretol) 

For partial, and generalized tonic-clonic seizures.

Side effects include:  

Cenobamate (Xcopri) 

Adjunct therapy to reduce seizure frequency.

Side effects include:  

Clobazam (Onfi) 

For partial and generalized epilepsy and as intermittent and preventive treatment.

Side effects include:  

Clonazepam (Klonopin) 

For myoclonic seizures and emergency treatment.

Side effects include:  

Children may have hyperactivity and drooling.

Diazepam (Valium) 

For short-term treatment of frequent, acute repetitive seizures.

Side effects include:  

  • Ataxia, 
  • loss of appetite, 
  • restlessness, 
  • depression, 
  • cardiovascular or respiratory depression. 

Children may have hyperactivity and drooling.

Eslicarbazepine (Aptiom) 

For partial-onset seizures.

Side effects include:  

Ethosuximide (Zarontin) 

Treatment for absence seizures.

Side effects include:  

Ezogabine (Potiga) 

Adjunct therapy for uncontrolled partial-onset seizures.

Side effects include:  

  • Drowsiness, 
  • dizziness, 
  • memory problems, 
  • fatigue, 
  • weakness, and 
  • trouble concentrating.

Felbamate (Felbatol) 

Restricted to treatment of severe uncontrolled partial epilepsy or Lennox-Gastaut syndrome, because of potentially fatal toxic side effects.

Side effects include:  

Fosphenytoin (Cerebyx) 

For short term administration via injection or IV.

Side effects include:  

  • Nausea,
  • vomiting, 
  • headache, 
  • dizziness, 
  • fatigue, 
  • slurred speech, 
  • acne, 
  • rash, 
  • increased hair growth, 
  • involuntary eye movements (nystagmus), and 
  • osteoporosis if taken over a long time.

Gabapentin (Neurontin) 

For partial and secondary generalized tonic-clonic seizures.

Side effects include:  

  • Drowsiness, 
  • dizziness, 
  • ataxia, 
  • nystagmus, 
  • headache, 
  • tremor, 
  • fatigue, 
  • diplopia, 
  • rhinitis, 
  • nausea, and 
  • vomiting.

Lacosamide (Vimpat) 

Adjunct and monotherapy for partial onset seizures in adults and adolescents over 17 years old.

Side effects include:  

  • Dizziness, 
  • fatigue, 
  • nausea, and 
  • diplopia.

Lamotrigine (Lamictal) 

Inhibits release of glutamate and used as an adjunct therapy for partial onset and secondary generalized tonic-clonic seizures, transition to monotherapy and Lennox-Gastaut syndrome. Used during pregnancy because of fewer side effects.

Side effects include:  

  • Dizziness, 
  • insomnia, 
  • headache, 
  • ataxia, 
  • diplopia, 
  • tremor, 
  • hypersensitivity and, 
  • potentially fatal Stevens-Johnson rash in children.

Levetiracetam (Keppra) 

Adjunct treatment for primary generalized tonic-clonic seizures, partial onset seizures, and myoclonic seizures.

Side effects include:  

Midazolam (Nayzilam) 

For short-term treatment of frequent, acute, repetitive seizures.

Side effects include:  

  • Drowsiness, 
  • dizziness headache, 
  • nose pain, 
  • runny nose and 
  • throat irritation.

Oxcarbazepine (Oxtellar XR, Trileptal) 

For partial seizures.

Side effects include:  

Perampanel (Fycompa) 

For partial onset seizures and primary generalized tonic-clonic seizures in 12 years and older patients.

Side effects include:  

  • Aggression, 
  • hostility, 
  • irritability, 
  • anger, 
  • paranoia, 
  • euphoric mood, 
  • agitation, and 
  • mood swings.

Phenobarbital 

Low-cost broad-spectrum drug effective for many types of seizures and first-line treatment for continuous seizures (status epilepticus).

Side effects include:  

  • Cognitive and behavior changes, 
  • sleepiness, 
  • poor concentration, 
  • irritability, 
  • ataxia, and 
  • decreased libido. 

Long-term use may cause vitamin D and folate deficiency.

Phenytoin (Dilantin) 

For partial and secondary generalized seizures, controls spread of seizures.

Side effects include:  

  • Nausea, 
  • vomiting, 
  • headache, 
  • dizziness, 
  • fatigue, 
  • slurred speech, 
  • acne, 
  • rash, 
  • vitamin K and folate deficiency, 
  • loss of libido, 
  • hormonal dysfunction, 
  • bone marrow hyperplasia and osteoporosis if taken over a long time

Pregabalin (Lyrica) 

Adjunct therapy for partial-onset seizures in adults and children over one month old.

Side effects include:  

Primidone (Mysoline) 

For partial onset and secondary generalized seizures.

Side effects include: 

  • Sleepiness, 
  • dizziness, 
  • nausea, 
  • cognitive and 
  • behavior changes.

Rufinamide (Banzel) 

Adjunct therapy for Lennox-Gastaut syndrome.

Side effects include:  

  • Drowsiness, 
  • dizziness, 
  • lack of coordination, 
  • trouble walking, 
  • fatigue, 
  • headache, 
  • nausea, 
  • vomiting, 
  • loss of appetite, and 
  • double/blurred vision.

Stiripentol (Diacomit) 

Adjunct therapy for Dravet syndrome.

Side effects include:  

  • Sleepiness, 
  • loss of appetite, 
  • weight loss, 
  • ataxia, 
  • agitation, 
  • nausea, 
  • tremor, 
  • low muscle tone, and 
  • speech difficulties.

Tiagabine (Gabitril)

Adjunct treatment for refractory partial seizures.

Side effects include:  

  • Dizziness, 
  • sleepiness, 
  • fatigue, 
  • weakness, 
  • irritability, 
  • anxiety, 
  • depression, 
  • mood swings, 
  • psychosis, 
  • confusion, 
  • tremor, 
  • diarrhea, 
  • abdominal pain, 
  • headache, 
  • ataxia, 
  • pharyngitis, and 
  • rash.

Topiramate (Topamax)

For partial onset and secondary generalized tonic-clonic seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome.

Side effects include: 

  • Ataxia, 
  • lack of concentration, 
  • confusion, 
  • dizziness, 
  • fatigue, 
  • tingling (paresthesia) in the extremities, 
  • sleepiness, 
  • memory problems, 
  • depression, 
  • agitation, and 
  • slowness of speech.

Valproate, valproic acid (Depakene, Depakote) 

For primary generalized seizures, photosensitive epilepsy, Lennox-Gastaut syndrome and partial seizures. Not to be used if pregnant.

Side effects include: 

  • Dizziness, 
  • nausea, 
  • vomiting, 
  • tremor, 
  • hair loss, 
  • weight gain, 
  • depression in adults, 
  • irritability in children and slowness in thinking. 

Long-term use can cause bone thinning, ankle swelling and menstrual irregularity. 

Hearing loss, liver damage, pancreatitis and low platelet counts are more dangerous but rare side effects. 

Vigabatrin (Sabril, Vigadrone) 

Adjunct therapy for adults and children over 2 years with refractory complex partial seizures and monotherapy for infantile spasms in children under 2 years of age.

Side effects include: 

  • Drowsiness, 
  • dizziness, 
  • difficulty concentrating, 
  • nausea, 
  • vomiting, 
  • diarrhea, 
  • headache, 
  • fatigue, 
  • weight gain, and 
  • vision loss.

Zonisamide (Zonegran) 

Adjunct therapy for partial seizures in patients who are over 12 years old.

Side effects include: 

  • Dizziness, 
  • drowsiness, 
  • fatigue, 
  • anorexia, 
  • headache, 
  • ataxia, 
  • speech abnormalities, 
  • irritability, 
  • mental slowing, 
  • weight gain, 
  • kidney stones and 
  • Stevens-Johnson rash.

Xcopri (cenobamate) Seizure Treatment: Side Effects, Addiction & Withdrawal

What is Xcopri, and how does it work?

Xcopri is a prescription medicine used to treat partial-onset seizures in adults.

It is not known if
Xcopri is safe and effective in children.

What are the side effects of Xcopri?

Xcopri may cause serious side effects, including:

  • problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.
  • nervous system problems.
    Xcopri may cause problems that can affect your nervous system. Symptoms of nervous system problems include:

    • dizziness
    • trouble walking or with coordination
    • feeling sleepy and tired
    • trouble concentrating, remembering, and thinking clearly
    • vision problems

The most common side effects of
Xcopri include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of
Xcopri.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Does Xcopri cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

Xcopri contains cenobamate and is listed as a Schedule V controlled substance.

Abuse
  • Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study conducted in recreational sedative abusers (n=39), single doses of
    Xcopri (200 mg and 400 mg) were compared to placebo.
  • Xcopri at single doses of 400 mg produced responses on positive subjective measures such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” that were statistically greater than the responses produced on these measures by placebo.
  • In this study, euphoric mood occurred at greater extent with
    Xcopri (400 mg) (8%) than with placebo (0%).
  • Phase 1 multiple ascending dose studies in healthy subjects showed rates of euphoria and feeling drunk of about 3% and disturbance in attention of about 5% in subjects who received supratherapeutic doses of cenobamate, but these adverse events were absent in the placebo group.
  • In Phase 2 and 3 studies in subjects with epilepsy, euphoric mood, confusional state, and sedation occurred at low rates in subjects who received
    Xcopri (0.5-2.5%).
Dependence
  • Physical dependence is a state that develops as a result of physiological
    adaptation in response to repeated drug use, manifested by withdrawal signs and
    symptoms after abrupt discontinuation or a significant dose reduction of a drug.
  • Clinical studies in healthy subjects indicate that Xcopri may cause physical
    dependence and lead to a withdrawal syndrome characterized by insomnia,
    decreased appetite, depressed mood, tremor, and amnesia. Xcopri should be
    withdrawn gradually.

What is the dosage for Xcopri?

Important Administration Instructions

  • Xcopri may be taken any time with or without food. Swallow tablets whole with liquid.
  • Do not crush or chew.

General Dosing Recommendations

Monotherapy And Adjunctive Therapy
  • Xcopri is administered orally once daily.
  • The recommended dosage and titration,
    which should not be exceeded because of the potential for serious adverse
    reactions, is included in Table 1.

Table 1: Recommended Dosage for Partial-Onset Seizures in Adults

Initial DosageWeek 1 and 212.5 mg once dailyTitration RegimenWeek 3 and 425 mg once dailyWeek 5 and 650 mg once dailyWeek 7 and 8100 mg once dailyWeek 9 and 10150 mg once dailyMaintenance DosageWeek 11 and thereafter200 mg once dailyMaximum DosageIf needed based on clinical response and tolerability, dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to 400 mg.400 mg once daily

Dosage Modifications In Patients With Hepatic Impairment

  • For patients with mild to moderate (5-9 points on Child-Pugh assessment) hepatic
    impairment, the maximum recommended dosage is 200 mg once daily.
  • Xcopri is not
    recommended for use in patients with severe hepatic impairment.

Discontinuation Of Xcopri

  • If Xcopri is discontinued, the dosage should be gradually reduced over a period
    of at least 2 weeks, unless safety concerns require abrupt withdrawal.




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What drugs interact with Xcopri?

Effect Of Xcopri On Other Drugs

Table 5 summarizes the effect of
Xcopri on other drugs.

Table 5: Pharmacokinetic Drug Interactions

Drug or Substrate TypeEffect of
Xcopri on Drug or SubstrateClinical RecommendationAntiepileptic Drugslamotrigine↓ plasma concentrationsBecause of a potential for reduced efficacy of these drugs, increase the dosage of lamotrigine or carbamazepine, as needed, when used concomitantly with
Xcopri.carbamazepine↓ plasma concentrationsphenytoin↑plasma concentrationsBecause of a potential 2-fold increase in phenytoin levels, gradually decrease phenytoin dosage by up to 50% as
Xcopri is being titrated.phenobarbital↑ plasma concentrationsBecause of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of phenobarbital or clobazam, as clinically appropriate, when used concomitantly with
Xcopri.desmethylclobazam, the active metabolite of clobazam↑plasma concentrationsCYP2B6 Substrates↓ plasma concentrationsBecause of a potential for reduced efficacy of these drugs, increase the dosage of CYP2B6 or CYP3 A4 substrates, as needed, when used concomitantly with
Xcopri.CYP3A Substrates↓ plasma concentrationsOral contraceptives↓ plasma concentrationsBecause of the potential for reduced efficacy of oral contraceptives, women should use additional or alternative non-hormonal birth control while taking
Xcopri.CYP2C19 Substrates↑ plasma concentrationsBecause of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of CYP2C19 substrates, as clinically appropriate, when used concomitantly with
Xcopri.

Drug That Shorten The QT Interval

  • Xcopri can shorten the QT interval; therefore, caution should be used when
    administering Xcopri and other drugs that shorten the QT interval.

CNS Depressants And Alcohol

  • Concomitant use of
    Xcopri with other CNS depressants, including alcohol, may
    increase the risk of neurological adverse reactions, including sedation and
    somnolence.

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Is Xcopri safe to use while pregnant or breastfeeding?

  • There are no adequate data on the developmental risk associated with the use of Xcopri in pregnant women.
  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Xcopri, during pregnancy.
  • Encourage women who are taking Xcopri during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.

Seizalam (midazolam) Seizure Medication Side Effects & Dosage


Generic drug: midazolam

Brand name: Seizalam

What is Seizalam, and how does it work?

Seizalam (midazolam) Injection is a benzodiazepine used to treat status epilepticus in adults.

What are the side effects of Seizalam?

WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation.

What are side effects of Seizalam?

Side effects of Seizalam include:

  • upper airway obstruction,
  • agitation,
  • fever, and
  • decreased tidal volume and/or decreased respiratory rate.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam.

What is the dosage for Seizalam?

Recommended Dose

The recommended dose of Seizalam is 10 mg, administered by intramuscular injection.

Important Administration Instructions

  • Seizalam should be administered by a healthcare professional who has had adequate training in the recognition and treatment of status epilepticus.
  • Seizalam is for intramuscular use only. Inject in the mid-outer thigh (vastus lateralis muscle).
  • Parenteral drug products should be inspected visually for particulate matter and
    discoloration prior to administration, whenever solution and container permit.

Monitoring

  • After administration of Seizalam, continuous monitoring of respiratory and
    cardiac function is recommended until the patient is stabilized. Serious and
    life-threatening cardiorespiratory adverse reactions, such as hypoventilation,
    airway obstruction, apnea, and hypotension have been reported with the use of
    midazolam.
  • Patients should be monitored in a setting that allows for immediate
    access to resuscitative drugs. Appropriate resuscitation equipment and personnel
    trained in their use and skilled in airway management should be available.
  • Observation for signs of cardiorespiratory depression is particularly important in patients with chronic obstructive pulmonary disease (COPD), patients 60 or more years of age, and patients who have received concomitant narcotics or other central nervous system (CNS) depressants.

What drugs interact with Seizalam?

Effect Of Concomitant Use Of Benzodiazepines And Opioids

  • The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
  • Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.
  • When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
  • Limit dosage and duration of concomitant use of benzodiazepines and opioids. Monitor patients closely for respiratory depression and sedation.

Other CNS Depressants And Alcohol

  • The sedative effect of Seizalam is accentuated by concomitantly
    administered medication that depresses the central nervous system,
    particularly opioids (e.g., morphine, meperidine, and fentanyl),
    secobarbital, and droperidol, and also by alcohol.

Cytochrome P450-3A4 Inhibitors

Is Seizalam safe to use while pregnant or breastfeeding?

  • There are no adequate and well-controlled studies of Seizalam in pregnant women.
  • Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies.
  • Although some early epidemiological studies suggested a relationship between benzodiazepine use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations.
  • More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies.
  • There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment.
  • Midazolam is excreted in human milk. Studies assessing the effects of midazolam in breastfed children or on milk production/excretion have not been performed.
  • Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines, such as Seizalam, may have effects of lethargy, somnolence and poor sucking.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for midazolam and any potential adverse effects on the breastfed child from midazolam or from the underlying maternal condition.

levetiracetam (Keppra, Keppra XR) Side Effects in Children & Adults

What is levetiracetam?

Brand name(s): Keppra, Keppra XR

Levetiracetam (Keppra, Keppra XR) is an antiseizure medication used in combination with other antiseizure medications to treat myoclonic, partial onset, or tonic seizures in children and adults. (The safety and effectiveness in patients younger than 4 years of age has not been established.)

Common side effects are:

Keppra has few drug interactions, and it should be used during pregnancy and breastfeeding only if the potential benefits of the drug justifies the potential risk to the fetus and infant. The abuse and potential dependence on this drug hasn't been studied in humans.

While there are no known incidences of overdose with Keppra, signs and symptoms of overdose are sleepiness, agitation, aggression, a depressed level of consciousness, respiratory depression, and coma. Discuss any concerns about this drug with your doctor, pharmacist, or other health-care professional.

Read the entire levetiracetam (Keppra) drug consumer monograph >>

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Health Canada at 1-866-234-2345.

What are the side effects of levetiracetam?

Common side effects associated with levetiracetam include:

In some patients Keppra causes behavioral abnormalities such as:

Other side effects include:

  • Steven-Johnson syndrome and toxic epidermal necrolysis (severe skin reactions) in children and adults
  • High blood pressure

Like other antiseizure medications, levetiracetam should not be discontinued suddenly because of the risk of increased seizure activity.

Antiepileptic medications have been associated with increased risk of suicidal thinking and behavior. Anyone considering the use of antiepileptic drugs must balance this risk of suicide with the clinical need. Patients who are started on therapy should be closely observed for clinical worsening, suicidal thoughts, or unusual changes in behavior.

If you notice other effects not listed above, contact your doctor or pharmacist. In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire levetiracetam (Keppra) drug consumer monograph >>

Other consumer levetiracetam (Keppra) side effects*

SIDE EFFECTS: Drowsiness, dizziness, and weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur:

  • loss of coordination (such as difficulty walking and controlling muscles),
  • mental/mood changes (such as irritability, aggression, agitation, anger, anxiety).

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems.

Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

evetiracetam can cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire levetiracetam – oral, Keppra side effects, uses, interaction, overdose and precautions >>

* Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Vumerity (diroximel): Medication for Relapsing Multiple Sclerosis

What is Vumerity (diroximel), and how does it work?

  • Vumerity (diroximel) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
  • It is not known if Vumerity is safe and effective in children.

What are the side effects of Vumerity?

Vumerity may cause serious side effects including:

  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking Vumerity and get emergency medical help right away if you get any of these symptoms.
  • PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your doctor right away if you get any of these symptoms of PML:
    • weakness on one side of the body that gets worse
    • vision problems
    • confusion
    • clumsiness in your arms or legs
    • changes in thinking and memory
    • personality changes
  • herpes zoster infections (shingles), including central nervous system infections.
  • other serious infections
  • decreases in your white blood cell count. Your doctor should do a blood test to check your white blood cell count before you start treatment with Vumerity and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.
  • liver problems. Your doctor should do blood tests to check your liver function before you start taking Vumerity and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment.
    • severe tiredness
    • loss of appetite
    • pain on the right side of your stomach
    • have dark or brown (tea color) urine
    • yellowing of your skin or the white part of your eyes

The most common side effects of Vumerity include:

  • flushing, redness, itching, or rash
  • nausea, vomiting, diarrhea, stomach pain, or indigestion
  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking Vumerity with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking Vumerity may reduce flushing.

These are not all the possible side effects of Vumerity. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information go to dailymed.nlm.nih.gov

What is the dosage for Vumerity?

  • Take Vumerity exactly as your doctor tells you to take it.
  • The recommended starting dose on days 1 to 7 is one capsule by mouth 2 times a day. After 7 days, the recommended dose is 2 capsules by mouth 2 times a day.
  • If taken with food, avoid taking Vumerity with a high-fat, high-calorie meal or snack.
    • Your meal or snack should contain no more than 700 calories and no more than 30 g of fat.
  • Swallow Vumerity whole. Do not crush, chew, or sprinkle capsule contents on food.
  • If you take too much Vumerity, call your doctor or go to the nearest hospital emergency room right away.

What drugs interact with Vumerity?

  • Do not drink alcohol at the time you take a Vumerity dose.

Concomitant Dimethyl Fumarate

Vumerity is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. Vumerity may be initiated the day following discontinuation of dimethyl fumarate

Is Vumerity safe to take while pregnant or breastfeeding?

Before taking and while you take Vumerity, tell your doctor about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Vumerity will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Vumerity passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Vumerity.