PAI Holdings, LLC dba PAI Pharma

Levetiracetam

Generic

ID: 00121239740

NaN

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LEVETIRACETAM 1500 MG 15ML SOLUTION 0121239740

📜 Prescription Required

FORM

Solution

STRENGTH

1500 mg/15mL

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TL;DR — Quick Summary

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RECENT MAJOR CHANGES SECTION 1 INDICATIONS AND USAGE 1.1 Partial-Onset Seizures 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy 1.3 Primary Generalized Tonic-Clonic Seizures

🩺What it's for

Levetiracetam Oral Solution USP is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam Oral Solution USP is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)

💊How to take it

Use the oral solution for pediatric patients with body weight 20 kg (2.1) For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1) Partial-Onset Seizures (monotherapy or adjunctive therapy) 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily (2.2) 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice…

ℹ️Common side effects

The following adverse reactions are discussed in more details in other sections of labeling: Behavior Abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Somnolence and Fatigue [see Warnings and Precautions (5.3) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.4) ] Serious Dermatological Reactions [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms…

⚠️Serious risks

Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms (5.1) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (5.2) Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam…

📦Storage & missed dose

Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

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The effectiveness of levetiracetam for the treatment of partial-onset seizures in pediatric patients was established in one multicenter, randomized double-blind, placebo-controlled study (Study 5), conducted at 62 sites in North America, South America, and Europe in pediatric patients 1 month to less than 4 years of age with partial seizures, uncontrolled by standard epileptic drugs (AEDs). Eligible patients on a stable dose of 1-2 AEDs, who experienced at least 2 partial-onset seizures during the 48-hour baseline video EEG were randomized to receive either levetiracetam or placebo. The enrolled population included 116 patients (levetiracetam N=60, placebo N=56) with refractory partial-onset seizures, whether or not secondarily generalized. Randomization was stratified by age range as follows: 1 month to less than 6 months of age (N=4 treated with levetiracetam), 6 months to less than 1 year of age (N=8 treated with levetiracetam), 1 year to less than 2 years of age (N=20 treated with levetiracetam), and 2 years to less than 4 years of age (N=28 treated with levetiracetam). The study consisted of a 5-day evaluation period which included a 1-day titration period followed by a 4-day maintenance period. Levetiracetam dosing was determined by age and weight as follows: children 1 month to less than 6 months old were randomized to a target dose of 40 mg/kg/day, and children 6 months to less than 4 years old were randomized to a target dose of 50 mg/kg/day. The primary measure of effectiveness was the responder rate (percent of patients with 50% reduction from baseline in average daily partial-onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG performed during the last two days of the 4-day maintenance period. A total of 109 patients were included in the efficacy analysis. A statistically significant difference between levetiracetam and placebo was observed (see Figure 5). The treatment effect associated with levetiracetam was consistent across age groups. Figure 5: Responder Rate for All Patients Ages 1 Month to < 4 Years ( 50% Reduction from Baseline) in Study 5

Antiepileptic drugs (AEDs), including levetiracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs. Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing levetiracetam or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

The safety and effectiveness of levetiracetam for the treatment of partial-onset seizures in patients 1 month to 16 years of age have been established [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ]. The dosing recommendation in these pediatric patients varies according to age group and is weight-based [see Dosage and Administration (2.2) ]. The safety and effectiveness of levetiracetam as adjunctive therapy for the treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see Clinical Studies (14.2) ]. The safety and effectiveness of levetiracetam as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see Clinical Studies (14.3) ]. Safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 1 month; adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years; and adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam N=64, placebo N=34) pediatric patients, ages 4 to 16 years old, with partial seizures that were inadequately controlled. The target dose was 60 mg/kg/day. Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which measures various aspects of a child s memory and attention. Although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo. The Achenbach Child Behavior Checklist (CBCL/6-18), a standardized validated tool used to assess a child s competencies and behavioral/emotional problems, was also assessed in this study. An analysis of the CBCL/6-18 indicated on average a worsening in levetiracetam-treated patients in aggressive behavior, one of the eight syndrome scores [see Warnings and Precautions (5.1) ].

The effectiveness of levetiracetam as adjunctive therapy in patients 6 years of age and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic (PGTC) seizures was established in one multicenter, randomized, double-blind, placebo-controlled study (Study 7), conducted at 50 sites in 8 countries. Eligible patients on a stable dose of 1 or 2 antiepileptic drugs (AEDs) experiencing at least 3 PGTC seizures during the 8-week combined baseline period (at least one PGTC seizure during the 4 weeks prior to the prospective baseline period and at least one PGTC seizure during the 4-week prospective baseline period) were randomized to either levetiracetam or placebo. The 8-week combined baseline period is referred to as baseline in the remainder of this section. Patients were titrated over 4 weeks to a target dose of 3000 mg/day for adults or a pediatric target dose of 60 mg/kg/day and treated at a stable dose of 3000 mg/day (or 60 mg/kg/day for children) over 20 weeks (evaluation period). Study drug was given in 2 equally divided doses per day. The primary measure of effectiveness was the percent reduction from baseline in weekly PGTC seizure frequency for levetiracetam and placebo treatment groups over the treatment period (titration + evaluation periods). The population included 164 patients (levetiracetam N=80, placebo N=84) with idiopathic generalized epilepsy (predominately juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening) experiencing primary generalized tonic-clonic seizures. Each of these syndromes of idiopathic generalized epilepsy was well represented in this patient population. There was a statistically significant decrease from baseline in PGTC frequency in the levetiracetam-treated patients compared to the placebo-treated patients. Table 15: Median Percent Reduction from Baseline in PGTC Seizure Frequency per Week in Study 7 Placebo (N=84) Levetiracetam (N=78) Percent reduction in PGTC seizure frequency 44.6% 77.6%statistically significant versus placebo The percentage of patients (y-axis) who achieved 50% reduction in weekly seizure rates from baseline in PGTC seizure frequency over the entire randomized treatment period (titration + evaluation period) within the two treatment groups (x-axis) is presented in Figure 6. Figure 6: Responder Rate ( 50% Reduction from Baseline) in PGTC Seizure Frequency per Week in Study 7 *statistically significant versus placebo

Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed on www.paipharma.com or by calling 1-800-845-8210. Psychiatric Reactions and Changes in Behavior Advise patients that levetiracetam may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and psychotic symptoms [see Warnings and Precautions (5.1) ]. Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including levetiracetam, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2) ]. Effects on Driving or Operating Machinery Inform patients that levetiracetam may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.3) ]. Anaphylaxis and Angioedema Advise patients to discontinue levetiracetam and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4) ]. Dermatological Adverse Reactions Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5) ]. DRESS/Multiorgan Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately. Levetiracetam should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions (5.6) ]. Withdrawal of Levetiracetam Advise patients and caregivers not to discontinue use of levetiracetam without consulting with their healthcare provider. Levetiracetam should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.8) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant [see Use in Specific Populations (8.1) ].

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 03/2024 MEDICATION GUIDE Levetiracetam Oral Solution USP (LEE ve tye RA se tam) Read this Medication Guide before you start taking Levetiracetam Oral Solution USP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about Levetiracetam Oral Solution USP? Like other antiepileptic drugs, Levetiracetam Oral Solution USP may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. 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 attempts 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 Do not stop Levetiracetam Oral Solution USP without first talking to a healthcare provider. Stopping Levetiracetam Oral Solution USP suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). 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. 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. What is Levetiracetam Oral Solution USP? Levetiracetam Oral Solution USP is a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 1 month of age and older. Levetiracetam Oral Solution USP is a prescription medicine taken by mouth that is used with other medicines to treat: 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 Levetiracetam Oral Solution USP is safe or effective in children under: 1 month of age to treat partial-onset seizures 12 years of age to treat myoclonic seizures 6 years of age to treat primary generalized tonic-clonic seizures Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of Levetiracetam Oral Solution USP provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine. Who should not take Levetiracetam Oral Solution USP? Do not take Levetiracetam Oral Solution USP if you are allergic to levetiracetam. What should I tell my healthcare provider before starting Levetiracetam Oral Solution USP? Before taking Levetiracetam Oral Solution USP, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems or suicidal thoughts or behavior. have kidney problems. are pregnant or planning to become pregnant. It is not known if Levetiracetam Oral Solution USP will harm your unborn baby. You and your healthcare provider will have to decide if you should take Levetiracetam Oral Solution USP while you are pregnant. If you become pregnant while taking Levetiracetam Oral Solution USP, 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 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of Levetiracetam Oral Solution USP and other antiepileptic medicine during pregnancy. are breastfeeding or plan to breastfeed. Levetiracetam Oral Solution USP can pass into your breast milk. It is not known if the Levetiracetam Oral Solution USP that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive Levetiracetam Oral Solution USP. Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How should I take Levetiracetam Oral Solution USP? Take Levetiracetam Oral Solution USP exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Levetiracetam Oral Solution USP to take and when to take it. Levetiracetam Oral Solution USP is usually taken 2 times each day. Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider. Take Levetiracetam Oral Solution USP with or without food. If your healthcare provider has prescribed Levetiracetam Oral Solution USP, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of Levetiracetam Oral Solution USP. 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 Levetiracetam Oral Solution USP, call your local Poison Control Center or go to the nearest emergency room right away. What should I avoid while taking Levetiracetam Oral Solution USP? Do not drive, operate machinery or do other dangerous activities until you know how Levetiracetam Oral Solution USP affects you. Levetiracetam Oral Solution USP may make you dizzy or sleepy. What are the possible side effects of Levetiracetam Oral Solution USP? Levetiracetam Oral Solution USP can cause serious side effects including: See " What is the most important information I should know about Levetiracetam Oral Solution USP?" Call your healthcare provider right away if you have any of these symptoms: mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior. extreme sleepiness, tiredness, and weakness allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives. a skin rash. Serious skin rashes can happen after you start taking Levetiracetam Oral Solution USP. There is no way to tell if a mild rash will become a serious reaction. a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Call your healthcare provider right away if you have: a skin rash fever or swollen glands that do not go away swelling of your face shortness of breath dark urine yellowing of the skin or whites of the eyes problems with muscle coordination (problems walking and moving) The most common side effects seen in people who take Levetiracetam Oral Solution USP include: sleepiness infection weakness dizziness The most common side effects seen in children who take Levetiracetam Oral Solution USP include, in addition to those listed above include: tiredness decreased appetite irritability acting aggressive nasal congestion 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 Levetiracetam Oral Solution USP. 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. How should I store Levetiracetam Oral Solution USP? Store Levetiracetam Oral Solution USP at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature] away from heat and light. Keep Levetiracetam Oral Solution USP and all medicines out of the reach of children. General information about the safe and effective use of Levetiracetam Oral Solution USP. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levetiracetam Oral Solution USP for a condition for which it was not prescribed. Do not give Levetiracetam Oral Solution USP to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider information about Levetiracetam Oral Solution USP that is written for health professionals. What are the ingredients of Levetiracetam Oral Solution USP? Levetiracetam oral solution active ingredient: levetiracetam inactive ingredients: acesulfame potassium, artificial grape flavor, citric acid anhydrous, glycerin, maltitol solution, methylparaben, propylparaben, purified water, and sodium citrate dihydrate. Levetiracetam Oral Solution USP does not contain lactose or gluten. Levetiracetam Oral Solution USP does contain carbohydrates. The liquid is dye-free. MANUFACTURED AND DISTRIBUTED BY PAI Pharma Greenville, SC 29605 For more information, go to www.paipharma.com or call 1-800-845-8210.