Lamotrigine (Lamictal)

Trade Name : LAMICTAL

GlaxoSmithKline LLC

TABLET, CHEWABLE

Strength 5 mg/1

LAMOTRIGINE Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lamotrigine (Lamictal) which is also known as LAMICTAL and Manufactured by GlaxoSmithKline LLC. It is available in strength of 5 mg/1 per ml. Read more

Lamotrigine (Lamictal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

No data

LAMICTAL can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving LAMICTAL. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking LAMICTAL as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by LAMICTAL. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.
Although benign rashes are also caused by LAMICTAL, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring .
WARNING: SERIOUS SKIN RASHES
See full prescribing information for complete boxed warning.

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug related. ()

LAMICTAL is indicated for:
Epilepsyu2014adjunctive therapy in patients aged 2 years and older:
Epilepsyu2014monotherapy in patients aged 16 years and older:
Bipolar disorder:
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

Epilepsy:
Bipolar disorder:

No data

3.1n- 16
3.2n- 16
3.3n- 16

LAMICTAL is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients .
Hypersensitivity to the drug or its ingredients. (, )

No data

Boxed Warningn- 5.1
5.7n- 16n- 17

The following serious adverse reactions are described in more detail in the section of the labeling:

Epilepsy:
Bipolar disorder:
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .

Significant drug interactions with LAMICTAL are summarized in this section.
Uridine 5u00b4-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine.
Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in . Specific dosing guidance for these drugs is provided in the Dosage and Administration section .
Additional details of these drug interaction studies are provided in the Clinical Pharmacology section .
Effect of LAMICTAL on Organic Cationic Transporter 2 Substrates
Lamotrigine is an inhibitor of renal tubular secretion via organic cationic transporter 2 (OCT2) proteins . This may result in increased plasma levels of certain drugs that are substantially excreted via this route. Coadministration of LAMICTAL with OCT2 substrates with a narrow therapeutic index (e.g., dofetilide) is not recommended.

7n- 12.3
7n- 12.3
7n- 12.3
7n- 12.3
7n- 12.3

No data

2.1n- 8.6
2.1n- 8.7

No data

LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigineu2019s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)--triazine, its molecular formula is CHNCl, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK of 5.7. Lamotrigine is very slightly soluble in water (0.17u00a0mg/mL at 25u00b0C) and slightly soluble in 0.1u00a0M HCl (4.1u00a0mg/mL at 25u00b0C). The structural formula is:
LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only).
LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2u00a0mg (white), 5u00a0mg (white), or 25u00a0mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension.
LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25u00a0mg (white to off-white), 50u00a0mg (white to off-white), 100u00a0mg (white to off-white), or 200u00a0mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose.
LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps and AdvaTab) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108u00a0healthy volunteers.

No data

No evidence of carcinogenicity was seen in mice or rats following oral administration of lamotrigine for up to 2 years at doses up to 30 mg/kg/day and 10 to 15 mg/kg/day, respectively. The highest doses tested are less than the human dose of 400u00a0mg/day on a body surface area (mg/m) basis.
Lamotrigine was negative in in vitro gene mutation (Ames and mouse lymphoma ) assays and in clastogenicity (in vitro human lymphocyte and in vivo rat bone marrow) assays.
No evidence of impaired fertility was detected in rats given oral doses of lamotrigine up to 20 mg/kg/day. The highest dose tested is less than the human dose of 400 mg/day on a mg/m basis.

No data

LAMICTAL (lamotrigine) tablets
25-mg, white, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c25u201d, bottles of 100 (NDC 0173-0633-02).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place.
100-mg, peach, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c100u201d, bottles of 100 (NDC 0173-0642-55).
150-mg, cream, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c150u201d, bottles of 60 (NDC 0173-0643-60).
200-mg, blue, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c200u201d, bottles of 60 (NDC 0173-0644-60).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place and protect from light.
LAMICTAL (lamotrigine) Starter Kit for Patients Taking Valproate (Blue Kit)
25-mg, white, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c25u201d, blister pack of 35 tablets (NDC 0173-0633-10).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place.
LAMICTAL (lamotrigine) Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green Kit)
25-mg, white, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c25u201d and 100 mg, peach, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c100u201d, blister pack of 98 tablets (84/25-mg tablets and 14/100-mg tablets) (NDC 0173-0817-28).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place and protect from light.
LAMICTAL (lamotrigine) Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange Kit)
25-mg, white, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c25u201d and 100 mg, peach, scored, shield-shaped tablets debossed with u201cLAMICTALu201d and u201c100u201d, blister pack of 49 tablets (42/25-mg tablets and 7/100-mg tablets) (NDC 0173-0594-02).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place and protect from light.
LAMICTAL (lamotrigine) tablets for oral suspension
2-mg, white to off-white, round tablets debossed with u201cLTGu201d over u201c2u201d, bottles of 30 (NDC 0173-0699-00). ORDER DIRECTLY FROM GlaxoSmithKline 1-800-334-4153.
5-mg, white to off-white, caplet-shaped tablets debossed with u201cGX CL2u201d, bottles of 100 (NDC 0173-0526-00).
25-mg, white, super elliptical-shaped tablets debossed with u201cGX CL5u201d, bottles of 100 (NDC 0173-0527-00).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature] in a dry place.
LAMICTAL ODT (lamotrigine) orally disintegrating tablets
25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c25u201d on the other, Maintenance Packs of 30 (NDC 0173-0772-02).
50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c50u201d on the other, Maintenance Packs of 30 (NDC 0173-0774-02).
100-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLAMICTALu201d on one side and u201c100u201d on the other, Maintenance Packs of 30 (NDC 0173-0776-02).
200-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLAMICTALu201d on one side and u201c200u201d on the other, Maintenance Packs of 30 (NDC 0173-0777-02).
Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); with excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F).
LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Valproate (Blue ODT Kit)
25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c25u201d on the other, and 50u00a0mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c50u201d on the other, blister pack of 28 tablets (21/25-mg tablets and 7/50-mg tablets) (NDC 0173-0779-00).
Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); with excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F).
LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green ODT Kit)
50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c50u201d on the other, and 100u00a0mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLAMICTALu201d on one side and u201c100u201d on the other, blister pack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (NDC 0173-0780-00).
Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); with excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F).
LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange ODT Kit)
25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c25u201d on the other, 50u00a0mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLMTu201d on one side and u201c50u201d on the other, and 100u00a0mg, white to off-white, round, flat-faced, radius-edged tablets debossed with u201cLAMICTALu201d on one side and u201c100u201d on the other, blister pack of 35 (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (NDC 0173-0778-00).
Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); with excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F).
Blister Packs
If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.

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 .
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 .
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 . 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 . 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
u00a92020 GSK group of companies or its licensor.
LMT:22PI

This Medication Guide has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: February 2020

PRINCIPAL DISPLAY PANEL
NDC 0173-0642-55
LAMn
(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 25C (77F); excursions 15 to 30C (59 to 86F) [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
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0643-60
LAMn
(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 25C (77F); excursions 15-30C (59-86F) [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
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0644-60
LAMn
(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 25C (77F); excursions 15 to 30C (59 to 86F) [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
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0633-10
LAMICTALn
(LAMOTRIGINE)
TABLETS
R ONLY
For patients TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL.
Arrayn- STARTER KIT
Contains: 25-mg Tablets
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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0817-28
LAMICTALn
(LAMOTRIGINE)
TABLETS
R 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.
Arrayn- STARTER KIT
Contains: 25-mg Tablets
14
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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0594-02
LAMICTALn
(LAMOTRIGINE)
TABLETS
R ONLY
For patients NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, or valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL.
Arrayn- STARTER KIT
Contains: 25-mg Tablets
7
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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0699-00
LAMn
(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.u00a0 Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.u00a0
Store at 25u00b0C (77u00b0F);u00a0excursions permitted tou00a015 to 30u00b0C (59 to 86u00b0F) [see USP Controlled Room Temperature] in au00a0dry place.u00a0
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistant container as defined in the USP.u00a0
Distributed by
GlaxoSmithKline, RTP, NC 27709u00a0
Made in India
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0526-00
LAMn
(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.u00a0 Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.u00a0
Store at 25u00b0C (77u00b0F);u00a0excursions permitted to 15 to 30u00b0C (59 to 86u00b0F) [see USP Controlled Room Temperature] in au00a0dry place.u00a0
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistantu00a0container as defined in the USP.u00a0
Distributed by
GlaxoSmithKline, RTP, NC 27709u00a0
Made in India
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0527-00
LAMn
(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.u00a0 Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.
See Prescribing Information for dosage information.u00a0
Store at 25u00b0C (77u00b0F);u00a0excursions permitted tou00a015 to 30u00b0C (59 to 86u00b0F) [see USP Controlled Room Temperature] in a dry place.u00a0
Do not accept if printed seal under cap is missing or broken.
Dispense in a tight, light-resistantu00a0container asu00a0defined in the USP.u00a0
Distributed by
GlaxoSmithKline, RTP, NC 27709u00a0
Made in India
R only

PRINCIPAL DISPLAY PANEL
NDC 0173-0772-02
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R only
Maintenance Pack
25 mg
30 Tablets
This 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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0774-02
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R only
Maintenance Pack
50 mg
30 Tablets
This 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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0776-02
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R only
Arrayn- Maintenance Pack
100 mg
30 Tablets
This 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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0777-02
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R only
Arrayn- Maintenance Pack
200 mg
30 Tablets
This 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
u00a92017 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0779-00
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R only
Patient Titration Kit
For patients TAKING valproate*
*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.
KIT CONTAINS:
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
u00a92017 the GSK group of companies
Rev. 7/17
10000000146500

PRINCIPAL DISPLAY PANEL
NDC 0173-0780-00
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R 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:
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
u00a92017 the GSK group of companies
Rev. 7/17
10000000146535

PRINCIPAL DISPLAY PANEL
NDC 0173-0778-00
LAMICTAL ODTn
(LAMOTRIGINE)
ORALLY DISINTEGRATING TABLETS
R 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:
Dispense the accompanying Medication Guide to each patient.
CAUTION: Verify Product Dispensed
Do not use if blisters are torn, broken, or missing.
u00a92017 the GSK group of companies
Rev. 7/17
10000000146499

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Lamotrigine (Lamictal)

Trade Name : LAMICTAL

TABLET, CHEWABLE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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