Levetiracetam (Page 11 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Levetiracetam tablets, USP, 250 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “932” on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 76494-528-12).

Levetiracetam tablets, USP, 500 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “934” on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 76494-529-12), and 1,000 tablets (NDC 76494-529-11).

Levetiracetam tablets, USP, 750 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “935” on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 76494-530-12).

Levetiracetam tablets, USP, 1000 mg are white to off-white, modified capsules shaped, bi-convex, scored film-coated tablets debossed “HH” AND “936” on either side of the score and plain on the other side. They are supplied in containers of 60 tablets (NDC 76494-531-06).

16.2 Storage

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling (Medication Guide), separately provided.

Counsel patients on the benefits and risks of receiving Levetiracetam. Provide the Medication Guide to patients and/or caregivers, and instruct them to read the Medication Guide prior to taking Levetiracetam. Instruct patients to take Levetiracetam only as prescribed.

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.

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 in rare cases, psychotic symptoms have occurred.

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.

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.

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. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. [see Use In Specific Populations (8.1)].

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Linhai, Zhejiang, China, 317024

Distributed by:
Prinston Pharmaceuticals, Inc.Cranbury, New Jersey, USA, 08512

Revised: 02/2015

MEDICATION GUIDE

Levetiracetam (lee” ve tye ra’ se tam) Tablets, USP

Read this Medication Guide before you start taking Levetiracetam 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?

Like other antiepileptic drugs, Levetiracetam 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 without first talking to a healthcare provider.

Stopping Levetiracetam 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?

Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat:

partial onset seizures in people 4 years of age and older with epilepsy
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 is safe or effective in children under 1 month of age.

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 provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

250 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “932” on either side of the score and plain on the other side.

500 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “934” on either side of the score and plain on the other side.

750 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed “HH” AND “935” on either side of the score and plain on the other side.

1000 mg levetiracetam tablets, USP, are white to off-white, modified capsules shaped; bi-convex, scored film-coated tablets debossed “HH” AND “936” on either side of the score and plain on the other side.

What should I tell my healthcare provider before starting Levetiracetam?

Before taking Levetiracetam, 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 will harm your unborn baby. You and your healthcare provider will have to decide if you should take Levetiracetam while you are pregnant. If you become pregnant while taking Levetiracetam, 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 these registries is to collect information about the safety of Levetiracetam and other antiepileptic medicine during pregnancy.
are breast feeding. Levetiracetam can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take Levetiracetam or breast-feed; you should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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?

Take Levetiracetam exactly as prescribed.

Your healthcare provider will tell you how much Levetiracetam to take and when to take it. Levetiracetam is usually taken twice a day. Take Levetiracetam at the same times each day.
Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
Take Levetiracetam with or without food.
Swallow the tablets whole. Do not chew or crush tablets. Ask your healthcare provider for Levetiracetam oral solution if you cannot swallow tablets.
If you miss a dose of Levetiracetam, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
If you take too much Levetiracetam, call your local Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking Levetiracetam?

Do not drive, operate machinery or do other dangerous activities until you know how Levetiracetam affects you. Levetiracetam may make you dizzy or sleepy.

What are the possible side effects of Levetiracetam?

See “What is the most important information I should know about Levetiracetam?”

Levetiracetam can cause serious side effects.

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
problems with muscle coordination (problems walking and moving)
a skin rash. Serious skin rashes can happen after you start taking Levetiracetam. There is no way to tell if a mild rash will become a serious reaction.

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

sleepiness
weakness
infection
dizziness

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

tiredness
acting aggressive
nasal congestion
decreased appetite
irritability

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 Levetiracetam. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Prinston Pharmaceutical Inc. at 1- 866-257-2597 or FDA at 1-800-FDA-1088.

How should I store Levetiracetam?

Store Levetiracetam at room temperature, 59°F to 86°F (15°C to 30°C) away from heat and light.
Keep Levetiracetam and all medicines out of the reach of children.

General information about Levetiracetam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levetiracetam for a condition for which it was not prescribed. Do not give Levetiracetam to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Levetiracetam. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Levetiracetam that is written for health professionals. You can also get information about Levetiracetam by contacting Prinston Pharmaceutical Inc at 1-866-257-2597.

What are the ingredients of Levetiracetam?

Levetiracetam tablet active ingredient: Levetiracetam, USP.

Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc, and additional agents listed below:

250 mg, 500 mg, and 750 mg tablets:

Opadry II Pink 40L94198, which contains D&C Red No.27; FD&C Blue No.2; FD&C Red No. 40; FD&C Yellow No. 6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin.

1000 mg tablets:

Opadry II white Y-22-7719, which contains hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin.

Levetiracetam tablets do not contain lactose or gluten.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

This Medication Guide has been approved by the US Food and Drug Administration.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Linhai, Zhejiang, China, 317024

Distributed by:
Prinston Pharmaceutical Inc.
Cranbury, New Jersey, USA, 08512

Revised: 02/2015

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg 120 Tablet Bottle text

NDC 76494-528-12 Rx only

Levetiracetam
Tablets, USP
250 mg

Dispense accompanying Medication Guide to each patient.

120 Tablets

Prinston Pharmaceuticals Inc

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (120 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg 120 Tablet Bottle text

NDC 76494-529-12 Rx only

Levetiracetam
Tablets, USP
500 mg

Dispense accompanying Medication Guide to each patient.

120 Tablets

Prinston Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (120 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 750 mg 120 Tablet Bottle text

NDC 76494-530-12 Rx only

Levetiracetam
Tablets, USP
750 mg

Dispense accompanying Medication Guide to each patient.

120 Tablets

Prinston Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 750 mg (120 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1000 mg 60 Tablet Bottle text

NDC 76494-531-06 Rx only

Levetiracetam
Tablets, USP

1000 mg

Dispense accompanying Medication Guide to each patient.

60 Tablets

Prinston Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1000 mg (60 Tablet Bottle)
(click image for full-size original)
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76494-528
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 800
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code HH;932
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76494-528-12 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078106 09/11/2012
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76494-529
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 800
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code HH;934
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76494-529-12 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078106 09/11/2012
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76494-530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 800
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code HH;935
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76494-530-12 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078106 09/11/2012
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76494-531
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 1000 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 800
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 23mm
Flavor Imprint Code HH;936
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76494-531-06 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078106 09/11/2012
Labeler — Prinston Pharmaceutical Inc. (967289799)

Revised: 08/2020 Prinston Pharmaceutical Inc.

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