Lamotrigine Extended Release (Page 10 of 11)

15 REFERENCES

1. French JA, Wang S, Warnock B, Temkin N. Historical control monotherapy design in the treatment of epilepsy. Epilepsia. 2010; 51 (10): 1936-1943.

16 HOW SUPPLIED

Lamotrigine Extended-Release Tablets

25 mg, round, beige, biconvex, film-coated tablet debossed with “561” on one side and “Par” on the other

30 Tablets — (NDC 49884-561-11)

100 Tablets — (NDC 49884-561-01)

500 Tablets — (NDC 49884-561-05)

50 mg, round, white, biconvex, film-coated tablet debossed with “562” on one side and “Par” on the other

30 Tablets — (NDC 49884-562-11)

100 Tablets — (NDC 49884-562-01)

500 Tablets — (NDC 49884-562-05)

100 mg, round, brown, biconvex, film-coated tablet debossed with “563” on one side and “Par” on the other

30 Tablets — (NDC 49884-563-11)

100 Tablets — (NDC 49884-563-01)

500 Tablets — (NDC 49884-563-05)

200 mg, round, yellow, biconvex, film-coated tablet debossed with “564” on one side and “Par” on the other

30 Tablets — (NDC 49884-564-11)

100 Tablets — (NDC 49884-564-01)

500 Tablets — (NDC 49884-564-05)

250 mg, round, white, biconvex, film-coated tablet debossed with “604” on one side and “Par” on the other

30 Tablets – (NDC 49884-604-11)

100 Tablets – (NDC 49884-604-01)

500 Tablets – (NDC 49884-604-05)

300 mg, round, grey, biconvex, film-coated tablet debossed with “605” on one side and “Par” on the other

30 Tablets — (NDC 49884-605-11)

100 Tablets — (NDC 49884-605-01)

500 Tablets — (NDC 49884-605-05)

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

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Rash

Prior to initiation of treatment with lamotrigine extended-release, inform patients that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and instruct them to report any such occurrence to their physician immediately.

Hemophagocytic Lymphohistiocytosis

Prior to initiation of treatment with lamotrigine extended-release, inform patients that excessive immune activation may occur with lamotrigine extended-release and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately.

Multiorgan Hypersensitivity Reactions, Blood Dyscrasias and Organ Failure

Inform patients that multiorgan hypersensitivity reactions and acute multiorgan failure may occur with lamotrigine extended release. Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Instruct patients to contact their physician immediately if they experience any signs or symptoms of these conditions [see Warnings and Precautions (5.3, 5.4)].

Suicidal Thinking and Behavior

Inform patients, their caregivers, and families that AEDs, including l amotrigine extended-release, may increase the risk of suicidal thoughts and behavior. Instruct them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior or thoughts about self-harm. Instruct them to immediately report behaviors of concern to their healthcare providers.

Worsening of Seizures

Instruct patients to notify their healthcare providers if worsening of seizure control occurs.

Central Nervous System Adverse Effects

Inform patients that l amotrigine extended-release may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, instruct them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on lamotrigine extended-release to gauge whether or not it adversely affects their mental and/or motor performance.

Pregnancy and Nursing

Instruct patients to notify their healthcare providers if they become pregnant or intend to become pregnant during therapy and if they intend to breastfeed or are breastfeeding an infant.

Encourage patients to enroll in the 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)].

Inform patients who intend to breastfeed that lamotrigine extended-release is present in breast milk and advise them to monitor their child for potential adverse effects of this drug. Discuss the benefits and risks of continuing breastfeeding.

Oral Contraceptive Use

Instruct women to notify their healthcare providers if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Starting estrogen-containing oral contraceptives may significantly decrease lamotrigine plasma levels and stopping estrogen-containing oral contraceptives (including the pill-free week) may significantly increase lamotrigine plasma levels [see Warnings and Precautions (5.8), Clinical Pharmacology (12.3)]. Also instruct women to promptly notify their healthcare providers if they experience adverse reactions or changes in menstrual pattern (e.g., break-through bleeding) while receiving lamotrigine extended-release in combination with these medications.

Discontinuing Lamotrigine Extended-Release

Instruct patients to notify their healthcare providers if they stop taking lamotrigine extended-release for any reason and not to resume lamotrigine extended-release without consulting their healthcare providers.

Aseptic Meningitis

Inform patients that lamotrigine extended-release may cause aseptic meningitis. Instruct them to notify their healthcare providers immediately if they develop signs and symptoms of meningitis such as headache, fever, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, myalgia, chills, confusion, or drowsiness while taking lamotrigine extended-release.

Potential Medication Errors

To avoid a medication error of using the wrong drug or formulation, strongly advise patients to visually inspect their tablets to verify that they are lamotrigine extended-release each time they fill their prescription.[see Dosage Forms and Strengths (3), How Supplied/Storage and Handling (16)]. Refer the patient to the Medication Guide that provide depictions of the lamotrigine extended-release tablets.

MEDICATION GUIDE

Lamotrigine (la-MO-tri-jen) Extended-Release Tablets

What is the most important information I should know about lamotrigine extended-release tablets?

1. Lamotrigine extended-release tablets may cause a serious skin rash that may cause you to be hospitalized or even cause death.

There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with lamotrigine extended-release tablets, but is more likely to happen within the first 2 to 8 weeks of treatment. Children aged between 2 and 16 years have a higher chance of getting this serious skin rash while taking lamotrigine extended-release tablets. Lamotrigine extended-release tablets is not approved for use in children younger than 13 years.

The risk of getting a serious skin rash is higher if you:

  • take lamotrigine extended-release tablets while taking valproate (DEPAKENE® (valproic acid) or DEPAKOTE® (divalproex sodium)).
  • take a higher starting dose of lamotrigine extended-release tablet than your healthcare provider prescribed.
  • increase your dose of lamotrigine extended-release tablet faster than prescribed.

Call your healthcare provider right away if you have any of the following:

  • a skin rash
  • blistering or peeling of your skin
  • hives
  • painful sores in your mouth or around your eyes

These symptoms may be the first signs of a serious skin reaction. A healthcare provider should examine you to decide if you should continue taking lamotrigine extended-release tablets.

2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine extended-release tablets can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of these symptoms:

● fever

● frequent infections

● severe muscle pain

● swelling of your face, eyes, lips or tongue

● swollen lymph glands

● unusual bruising or bleeding

● weakness, fatigue

● yellowing of your skin or the white part of your eyes

3. Like other antiepileptic drugs, Lamotrigine extended-release tablets 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

Do not stop l amotrigine extended-release tablets without first talking to a healthcare provider.

    • Stopping lamotrigine extended-release tablets suddenly can cause serious problems.
    • 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 in myself or a family member?

  • 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.

4. Lamotrigine extended-release tablets may cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.

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

  • headache
  • fever
  • nausea
  • vomiting
  • stiff neck
  • rash
  • unusual sensitivity to light
  • muscle pains
  • chills
  • confusion
  • drowsiness

Meningitis has many causes other than lamotrigine extended-release tablets, which your doctor would check for if you developed meningitis while taking lamotrigine extended-release tablets.

Lamotrigine extended-release tablets can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section below entitled “What are the possible side effects of lamotrigine extended-release tablets?”

5. People prescribed Lamotrigine extended-release tablets have sometimes been given the wrong medicine because many medicines have names similar to Lamotrigine extended-release tablets, so always check that you receive Lamotrigine extended-release tablets.

Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine extended-release tablets:

  • Make sure you can read it clearly.
  • Talk to your pharmacist to check that you are given the correct medicine.
  • Each time you fill your prescription, check the tablets you receive against the pictures of the tablets below.

These pictures show the distinct wording, colors, and shapes of the tablets that help identify the right strength of lamotrigine extended-release tablet. Immediately call your pharmacist if you receive a lamotrigine extended-release tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

tablet images
(click image for full-size original)

25 mg: round, beige, biconvex, film-coated tablet debossed with “561” on one side and “Par” on the other

50 mg: round, white, biconvex, film-coated tablet debossed with “562” on one side and “Par” on the other

100 mg: round, brown, biconvex, film-coated tablet debossed with “563” on one side and “Par” on the other

200 mg: round, yellow, biconvex, film-coated tablet debossed with “564” on one side and “Par” on the other

250 mg: round white, biconvex, film-coated tablet debossed with “604” on one side and “Par” on the other

300 mg: round, grey, biconvex, film-coated tablet debossed with “605” on one side and “Par” on the other

What are Lamotrigine Extended-Release Tablets?

Lamotrigine extended-release tablets are prescription medicine used:

  • together with other medicines to treat primary generalized tonic-clonic seizures and partial-onset seizures in people aged 13 years and older.
  • alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 13 years and older.

It is not known if lamotrigine extended-release tablets are safe or effective in children younger than 13 years. Other forms of lamotrigine can be used in children aged 2 to 12 years.

It is not known if lamotrigine extended-release tablets are safe or effective when used alone as the first treatment of seizures.

Do not take Lamotrigine Extended-Release Tablets?

if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine extended-release tablets. See the end of this leaflet for a complete list of ingredients in lamotrigine extended-release tablets.

Before taking lamotrigine extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have had a rash or allergic reaction to another antiseizure medicine.
  • have or have had depression, mood problems or suicidal thoughts or behavior.
  • have had aseptic meningitis after taking lamotrigine extended-release tablets.
  • are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines while you are taking lamotrigine extended-release tablets may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine extended-release tablet works.
  • are pregnant or plan to become pregnant. It is not known if lamotrigine extended-release tablets will harm your unborn baby. If you become pregnant while taking lamotrigine extended-release tablets, 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 drugs during pregnancy.
  • are breastfeeding. Lamotrigine extended-release passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine extended-release tablets, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby’s healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take lamotrigine extended-release tablets.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lamotrigine extended-release tablets and certain other medicines, interact with each other. This may cause side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Lamotrigine Extended-Release Tablets?

  • Take lamotrigine extended-release tablets exactly as prescribed.
  • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • Do not stop taking lamotrigine extended-release tablets without talking to your healthcare provider. Stopping lamotrigine extended-release tablets suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine extended-release tablets suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine extended-release tablets slowly.
  • If you miss a dose of lamotrigine extended-release tablets, 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 lamotrigine extended-release tablets, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
  • You may not feel the full effect of lamotrigine extended-release tablets for several weeks.
  • If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
  • Lamotrigine extended-release tablets can be taken with or without food.
  • Do not chew, crush, or divide lamotrigine extended-release tablets.
  • Swallow lamotrigine extended-release tablets whole.
  • If you have trouble swallowing lamotrigine extended-release tablets, tell your healthcare provider because there may be another form of lamotrigine you can take.

What should I avoid while taking Lamotrigine Extended-Release Tablets?

  • Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine extended-release tablets affects you.

What are possible side effects of Lamotrigine Extended-Release Tablets?

Lamotrigine Extended- Release Tablets can cause serious side effects.

See “What is the most important information I should know about lamotrigine extended-release tablets?”

Common side effects of lamotrigine extended-release tablets include:

  • dizziness
  • tremor
  • double vision
  • nausea
  • vomiting
  • trouble with balance and coordination
  • anxiety

Other common side effects that have been reported with another form of lamotrigine include headache, sleepiness, blurred vision, runny nose, and rash.

These are not all the possible side effects of lamotrigine extended-release tablets.

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 Lamotrigine Extended-Release Tablets?

  • Store lamotrigine extended-release tablets at room temperature between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30ºC (59° to 86°F) [see USP Controlled Room Temperature].
  • Keep lamotrigine extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of Lamotrigine Extended-Release Tablets

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

If you take a urine drug screening test, Lamotrigine Extended-Release Tablets may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking Lamotrigine Extended-Release Tablets.

You can ask your healthcare provider or pharmacist for information about lamotrigine extended-release tablets that is written for healthcare professionals.

What are the ingredients in Lamotrigine Extended-Release Tablets?

Active ingredient: Lamotrigine.

Inactive ingredients: hypromellose, lactose monohydrate; magnesium stearate; colloidal anhydrous silica (25 mg, 50 mg, 200 mg, 250 mg and 300 mg tablets only), methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium laurel sulfate, iron oxide yellow (25 mg and 100 mg tablets only), iron oxide red (25 mg and 100 mg tablets only), D&C Yellow # 10 (200 mg tablet only), FD&C Yellow # 6 (200 mg tablet only) and black iron oxide (300 mg tablet only).

For more information, go to www.parpharm.com or call 1-800-828-9393.

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

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang 317024 China

For:

Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

MADE IN CHINA

DEPAKENE® and DEPAKOTE® are registered trademarks of Abbott Laboratories.

Revised: 10/2019

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.