LAMICTAL (Page 13 of 13)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Rash
Prior to initiation of treatment with LAMICTAL, 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 LAMICTAL, inform patients that excessive immune activation may occur with LAMICTAL 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 LAMICTAL. 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, 5.5)].
Cardiac Rhythm and Conduction Abnormalities
Inform patients that, due to its mechanism of action, LAMICTAL could lead to irregular or slowed heart rhythm. This risk is increased in patients with underlying cardiac disease or heart conduction problems or who are taking other medications that affect heart conduction. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lie down with raised legs and contact their healthcare provider [see Warnings and Precautions (5.4)].
Suicidal Thinking and Behavior
Inform patients, their caregivers, and families that AEDs, including LAMICTAL, 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 LAMICTAL 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 LAMICTAL 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 LAMICTAL 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 (5.9), 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 LAMICTAL in combination with these medications.
Discontinuing LAMICTAL
Instruct patients to notify their healthcare providers if they stop taking LAMICTAL for any reason and not to resume LAMICTAL without consulting their healthcare providers.
Aseptic Meningitis
Inform patients that LAMICTAL 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 LAMICTAL.
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 LAMICTAL, as well as the correct formulation of LAMICTAL, each time they fill their prescription [see Dosage Forms and Strengths (3.1, 3.2, 3.3), How Supplied/Storage and Handling (16)]. Refer the patient to the Medication Guide that provides depictions of the LAMICTAL tablets, tablets for oral suspension, and orally disintegrating tablets.
LAMICTAL and LAMICTAL ODT are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
Distributed by
GlaxoSmithKline
Research Triangle Park, NC 27709
©2022 GSK group of companies or its licensor.
LMT:25PI
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: October 2020
PRINCIPAL DISPLAY PANEL
NDC 0173-0642-55
LAM ICTAL®
(LAMOTRIGINE)
TABLETS
100 mg
CAUTION: Verify Product Dispensed
100 Tablets
Dispense the accompanying Medication Guide to each patient.
Each scored tablet contains 100 mg of lamotrigine.
See Prescribing Information for dosage information.
Store at 25o C (77o F); excursions 15 to 30o C (59 to 86o F) [see USP Controlled Room Temperature] in a dry place and protect from light.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0643-60
LAM ICTAL®
(LAMOTRIGINE)
TABLETS
150 mg
CAUTION: Verify Product Dispensed
60 Tablets
Dispense the accompanying Medication Guide to each patient.
Each scored tablet contains 150 mg of lamotrigine.
See Prescribing Information for dosage information.
Store at 25o C (77o F); excursions 15-30o C (59-86o F) [see USP Controlled Room Temperature] in a dry place and protect from light.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0644-60
LAM ICTAL®
(LAMOTRIGINE)
TABLETS
200 mg
CAUTION: Verify Product Dispensed
60 Tablets
Dispense the accompanying Medication Guide to each patient.
Each scored tablet contains 200 mg of lamotrigine.
See Prescribing Information for dosage information.
Store at 25o C (77o F); excursions 15 to 30o C (59 to 86o F) [see USP Controlled Room Temperature] in a dry place and protect from light.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0633-10
LAMICTAL®
(LAMOTRIGINE)
TABLETS
RX ONLY
For patients TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL.
STARTER KIT
Contains: 35 25-mg Tablets
Weeks | Tablets per day |
1&2 | Take 1 (25 mg) tablet every OTHER day |
3&4 | Take 1 (25 mg) tablets once a day |
5 | Take 2 (25 mg) tablet once a day |
Please check with your physician about proper maintenance dose before week 5.
Dispense the enclosed Medication Guide to each patient.
Each LAMICTAL 25 tablet contains 25 mg of lamotrigine
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0817-28
LAMICTAL®
(LAMOTRIGINE)
TABLETS
RX ONLY
For patients TAKING carbamazepine, phenytoin, phenobarbital, or primidone and NOT TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL.
STARTER KIT
Contains: 84 25-mg Tablets
14 100-mg Tablets
Weeks | Tablets per day |
1&2 | Take 2 (25 mg) tablets once a day |
3&4 | Take 2 (25 mg) tablets twice a day |
5 | Take 1 (100 mg) tablet twice a day |
Please check with your physician about proper maintenance dose before week 5.
Dispense the enclosed Medication Guide to each patient.
Each LAMICTAL 25 tablet contains 25 mg of lamotrigine
Each LAMICTAL 100 tablet contains 100 mg of lamotrigine
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0594-02
LAMICTAL®
(LAMOTRIGINE)
TABLETS
RX ONLY
For patients NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, or valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL.
STARTER KIT
Contains: 42 25-mg Tablets
7 100-mg Tablets
Weeks | Tablets per day |
1&2 | Take 1 (25 mg) tablet once a day |
3&4 | Take 2 (25 mg) tablets once a day |
5 | Take 1 (100 mg) tablet once a day |
Please check with your physician about proper maintenance dose before week 5.
Dispense the enclosed Medication Guide to each patient.
Each LAMICTAL 25 tablet contains 25 mg of lamotrigine
Each LAMICTAL 100 tablet contains 100 mg of lamotrigine
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0699-00
LAMICTAL
(LAMOTRIGINE)
TABLETS FOR ORAL SUSPENSION
2 mg
CAUTION: Verify Product Dispensed
30 Tablets
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 2 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline, RTP, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0526-00
LAMICTAL
(LAMOTRIGINE)
TABLETS FOR ORAL SUSPENSION
5 mg
CAUTION: Verify Product Dispensed
100 Tablets
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 5 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline, RTP, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0527-00
LAMICTAL
(LAMOTRIGINE)
TABLETS FOR ORAL SUSPENSION
25 mg
CAUTION: Verify Product Dispensed
100 Tablets
Dispense the accompanying Medication Guide to each patient.
Each tablet contains 25 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.
Distributed by
GlaxoSmithKline, RTP, NC 27709
Made in India
Rx only
PRINCIPAL DISPLAY PANEL
NDC 0173-0772-02
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
Rx only
Maintenance Pack
25 mg
30 Tablets
This Maintenance Pack is intended for patients already taking LAMICTAL.
NOT for initial titration.
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0774-02
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
Rx only
Maintenance Pack
50 mg
30 Tablets
This Maintenance Pack is intended for patients already taking LAMICTAL.
NOT for initial titration.
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0776-02
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
Rx only
Maintenance Pack
100 mg
30 Tablets
This Maintenance Pack is intended for patients already taking LAMICTAL.
NOT for initial titration.
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0777-02
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
Rx only
Maintenance Pack
200 mg
30 Tablets
This Maintenance Pack is intended for patients already taking LAMICTAL.
NOT for initial titration.
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Made in India
©2017 the GSK group of companies
PRINCIPAL DISPLAY PANEL
NDC 0173-0779-00
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
RX only
Patient Titration Kit
For patients TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.
KIT CONTAINS:
21 | 25 mg Tablets |
7 | 50 mg Tablets |
WEEKS | TABLETS PER DAY |
1&2 | Take 1 (25 mg) tablet every OTHER day |
3&4 | Take 1 (25 mg) tablet ONCE a day |
5 | Take 1 (50 mg) tablet ONCE a day |
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
©2017 the GSK group of companies
Rev. 7/17
10000000146500
PRINCIPAL DISPLAY PANEL
NDC 0173-0780-00
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
RX only
Patient Titration Kit
For patients TAKING carbamazepine, phenytoin, phenobarbital, or primidone, and NOT TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.
KIT CONTAINS:
42 | 50 mg Tablets |
14 | 100 mg Tablets |
WEEKS | TABLETS PER DAY |
1&2 | Take 1 (50 mg) tablet ONCE a day |
3&4 | Take 1 (50 mg) tablet TWICE a day |
5 | Take 1 (100 mg) tablet TWICE a day |
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
©2017 the GSK group of companies
Rev. 7/17
10000000146535
PRINCIPAL DISPLAY PANEL
NDC 0173-0778-00
LAMICTAL ODT ®
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
RX ONLY
Patient Titration Kit
For patients NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, or valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.
KIT CONTAINS:
14 | 25 mg Tablets |
14 | 50 mg Tablets |
7 | 100 mg Tablets |
WEEKS | TABLETS PER DAY |
1&2 | Take 1 (25 mg) tablet ONCE a day |
3&4 | Take 1 (50 mg) tablet ONCE a day |
5 | Take 1 (100 mg) tablet ONCE a day |
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
©2017 the GSK group of companies
Rev. 7/17
10000000146499
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Labeler — GlaxoSmithKline LLC (167380711) |
Revised: 04/2022 GlaxoSmithKline LLC
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.