দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Solco healthcare U.S., LLC
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset in patients 12 years of age and older. Levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam extended-release tablets, during pregnancy. Encourage women who are taking levetiracetam extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Prolonged experience with levetiracetam tablets in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registri
Levetiracetam extended-release 500 mg tablets, USP, are white, oval, biconvex film-coated extended-release tablets debossed with "HH" on one side and “172” on the other side. They are supplied in white HDPE bottles as follows: NDC 43547-345-06: bottles of 60 NDC 43547-345-50: bottles of 500 Levetiracetam extended-release 750 mg tablets, USP, are white, oval, biconvex film-coated extended-release tablets debossed with "HH" on one side and “173” on the other side. They are supplied in white HDPE bottles as follows: NDC 43547-346-06: bottles of 60 NDC 43547-346-50: bottles of 500 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE Solco healthcare U.S., LLC ---------- MEDICATION GUIDE Levetiracetam Extended-Release Tablets USP, for oral use (LEE-ve-tye-RA-se-tam) Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/levetiracetam-er- tablets.pdf Read this Medication Guide before you start taking levetiracetam extended-release tablets 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 extended-release tablets? Like other antiepileptic drugs, levetiracetam extended-release tablets 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 extended-release tablets without first talking to a healthcare provider. • Stopping levetiracetam extended-release tablets 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 follo সম্পূর্ণ নথি পড়ুন
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE SOLCO HEALTHCARE U.S., LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Indications and Usage (1) 10/2019 Dosage and Administration (2.1, 2.3) 10/2019 INDICATIONS AND USAGE Levetiracetam extended-release tablets is indicated for the treatment of partial-onset in patients 12 years of age and older (1) DOSAGE AND ADMINISTRATION Initiate treatment with a dose of 1,000 mg once daily; increase by 1,000 mg every 2 weeks to a maximum recommended dose of 3,000 mg once daily (2) See full prescribing information for use in patients with impaired renal function (2.1) DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US, LLC AT 1-866-257- 2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH USE IN SPECIFIC POPULATIONS • SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 6/2023 500 mg white, film-coated extended-release tablet (3) 750 mg white, film-coated extended-release tablet (3) Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred (4, 5.4) 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 extended-release tablets (5 সম্পূর্ণ নথি পড়ুন