LAMOTRIGINE Kit (Page 11 of 12)

14.2 Bipolar Disorder

Adults

The effectiveness of lamotrigine in the maintenance treatment of bipolar I disorder was established in 2 multicenter, double-blind, placebo-controlled trials in adult patients (aged 18 to 82 years) who met DSM-IV criteria for bipolar I disorder. Trial 1 enrolled patients with a current or recent (within 60 days) depressive episode as defined by DSM-IV and Trial 2 included patients with a current or recent (within 60 days) episode of mania or hypomania as defined by DSM-IV. Both trials included a cohort of patients (30% of 404 subjects in Trial 1 and 28% of 171 patients in Trial 2) with rapid cycling bipolar disorder (4 to 6 episodes per year).

In both trials, patients were titrated to a target dose of 200 mg of lamotrigine as add-on therapy or as monotherapy with gradual withdrawal of any psychotropic medications during an 8- to 16-week open-label period. Overall 81% of 1,305 patients participating in the open-label period were receiving 1 or more other psychotropic medications, including benzodiazepines, selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics (including olanzapine), valproate, or lithium, during titration of lamotrigine. Patients with a CGI-severity score of 3 or less maintained for at least 4 continuous weeks, including at least the final week on monotherapy with lamotrigine, were randomized to a placebo-controlled, double-blind treatment period for up to 18 months. The primary endpoint was TIME (time to intervention for a mood episode or one that was emerging, time to discontinuation for either an adverse event that was judged to be related to bipolar disorder, or for lack of efficacy). The mood episode could be depression, mania, hypomania, or a mixed episode.

In Trial 1, patients received double-blind monotherapy with lamotrigine 50 mg/day (n = 50), lamotrigine 200 mg/day (n = 124), lamotrigine 400 mg/day (n = 47), or placebo (n = 121). Lamotrigine (200- and 400-mg/day treatment groups combined) was superior to placebo in delaying the time to occurrence of a mood episode (Figure 1). Separate analyses of the 200- and 400-mg/day dose groups revealed no added benefit from the higher dose.

In Trial 2, patients received double-blind monotherapy with lamotrigine (100 to 400 mg/day, n = 59), or placebo (n = 70). Lamotrigine was superior to placebo in delaying time to occurrence of a mood episode (Figure 2). The mean dose of lamotrigine was about 211 mg/day.

Although these trials were not designed to separately evaluate time to the occurrence of depression or mania, a combined analysis for the 2 trials revealed a statistically significant benefit for lamotrigine over placebo in delaying the time to occurrence of both depression and mania, although the finding was more robust for depression.

Figure 1: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 1)

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(click image for full-size original)

Figure 2: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Mood Episode (Trial 2)

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(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Lamotrigine Tablets, USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange Kit).

25 mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with “45″ on one side and break line on other side.

100 mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with “1047″ on one side and break line on other side.

Blister pack of 42, 25-mg tablets and 7, 100-mg tablets NDC-69102-137-10

Lamotrigine Tablets, USP Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green Kit).

25 mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with “45″ on one side and break line on other side.

100 mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with “1047″ on one side and break line on other side.

Blister pack of 84, 25-mg tablets and 14, 100-mg tablets NDC-69102-359-11

Lamotrigine Tablets, USP Starter Kit for Patients Taking Valproate (Blue Kit).

25 mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with “45″ on one side and break line on other side.

Blister pack of 35 tablets NDC-69102-639-09

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, 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 healthcare providers immediately.

Hemophagocytic Lymphohistiocytosis

Prior to initiation of treatment with lamotrigine, inform patients that excessive immune activation may occur with lamotrigine 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. Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Instruct patients to contact their healthcare providers 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 lamotrigine, 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 lamotrigine 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 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 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 in combination with these medications.

Discontinuing Lamotrigine

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

Aseptic Meningitis

Inform patients that lamotrigine 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.

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, as well as the correct formulation of lamotrigine, each time they fill their prescription [see Dosage Forms and Strengths (3.1), How Supplied/Storage and Handling (16)]. Refer the patient to the Medication Guide that provides depictions of the lamotrigine tablets.

image description

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392 130, INDIA

Manufactured For:

OWP Pharmaceuticals, Inc., 400 E. Diehl Road, Suite 400, Naperville, IL 60563

8070373 Revised: October 2019

OWOSLAMPI1019

MEDICATION GUIDE

Lamotrigine (la-MOE-tri-jeen) Tablets, USP

What is the most important information I should know about lamotrigine?

1. Lamotrigine 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, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine.

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

  • take lamotrigine while taking valproate [DEPAKENE(valproic acid) or DEPAKOTE(divalproex sodium)].
  • take a higher starting dose of lamotrigine than your healthcare provider prescribed.
  • increase your dose of lamotrigine 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.

2.Other serious reactions, including serious blood problems or liver problems. Lamotrigine 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 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 lamotrigine without first talking to a healthcare provider.

  • Stopping lamotrigine 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 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, which your doctor would check for if you developed meningitis while taking lamotrigine.

Lamotrigine can cause 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?”

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

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

  • 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 to identify the right strength of lamotrigine tablets, USP. Immediately call your pharmacist if you receive a lamotrigine tablet, USP that does not look like one of the tablets shown below, as you may have received the wrong medication.

Shape
(click image for full-size original)

What is lamotrigine?

Lamotrigine is a prescription medicine used:

  • together with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people aged 2 years and older.
  • alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.
  • for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people who have been treated for mood episodes with other medicine.

It is not known if lamotrigine is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.

It is not known if lamotrigine is safe or effective when used alone as the first treatment of seizures.

It is not known if lamotrigine is safe or effective for people with mood episodes who have not already been treated with other medicines.

Lamotrigine should not be used for acute treatment of manic or mixed mood episodes.

Do not take lamotrigine:

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

Before taking lamotrigine, tell your healthcare provider about all of your health 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.
  • 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 may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine works.
  • are pregnant or plan to become pregnant. It is not known if lamotrigine will harm your unborn baby. If you become pregnant while taking lamotrigine, 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 passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine, 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.

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

  • Take lamotrigine 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 without talking to your healthcare provider. Stopping lamotrigine suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine slowly.
  • If you miss a dose of lamotrigine, 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 2 doses at the same time.
  • If you take too much lamotrigine, 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 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.
  • Swallow lamotrigine tablets whole.
  • If you have trouble swallowing lamotrigine tablets, tell your healthcare provider because there may be another form of lamotrigine you can take.
  • If you receive lamotrigine in a blister pack, examine the blister pack before use. Do not use if blisters are torn, broken, or missing.

What should I avoid while taking lamotrigine?

Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine affects you.

What are the possible side effects of lamotrigine?

Lamotrigine can cause serious side effects.

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

Common side effects of lamotrigine include:

  • dizziness
  • tremor
  • headache
  • rash
  • blurred or double vision
  • fever
  • lack of coordination
  • abdominal pain
  • infections, including seasonal flu
  • sleepiness
  • back pain
  • nausea, vomiting
  • diarrhea
  • tiredness
  • insomnia
  • dry mouth
  • stuffy nose
  • sore throat

These are not all the possible side effects of lamotrigine.

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?

  • Store lamotrigine 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].
  • Keep lamotrigine and all medicines out of the reach of children.

General information about the safe and effective use of lamotrigine.

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

If you take a urine drug screening test, lamotrigine 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.

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

For more information, call 1-800-273-6729.

What are the ingredients in lamotrigine ?

Lamotrigine tablets, USP

Active ingredient: lamotrigine, USP.

Inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate.

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

Trademarks are the property of their respective owners.

image description

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392 130, INDIA.

Manufactured For:

OWP Pharmaceuticals, Inc., 400 E. Diehl Road, Suite 400, Naperville, IL 60563.

8070374 Revised: October 2019

OWOSLAMMGI1019

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