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RX ITEM-Lamictal ODT 25 50 100 Dose Pack 35 By Glaxosmithkline

NDC 00173-0778-00 UPC/GTIN No.3-01730-77800-2 Mfg.Part No.77800BRAND: LAMICTAL  NDC: 00173-0778-00,173077800 UPC: 3-01730-77800-2,301730778002 Glaxosmithkline/KdcOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Lamictal ODT 25 50 100 Dose Pack 35 By Glaxosmithkline

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item No.:RX271288 NDC No.173077800 UPC No.:301730778002 NDC No. 00173-0778-00 UPC/GTIN No. 3-01730-77800-2 MPN 77800 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx271288 Lamictal ODT 25/50/100 Dose Pack 35 by Glaxosmithkline Item No. 3271288 NDC No. 00173077800 UPC No. 301730778002 Other Name L

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LAMICTAL- lamotrigine tablet
LAMICTAL- lamotrigine tablet, chewable
LAMICTAL ODT- lamotrigine tablet, orally disintegrating
LAMICTAL- lamotrigine
LAMICTAL ODT- lamotrigine
GlaxoSmithKline LLC

WARNING: SERIOUS SKIN RASHES

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 [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Epilepsy
Adjunctive Therapy

LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:


partial-onset seizures.

primary generalized tonic-clonic (PGTC) seizures.

generalized seizures of Lennox-Gastaut syndrome.
Monotherapy

LAMICTAL is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Safety and effectiveness of LAMICTAL have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

1.2 Bipolar Disorder
LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.1)].

NDC 00173-0778-00 UPC/GTIN No.3-01730-77800-2 Mfg.Part No.77800
RX ITEM-Lamictal ODT 25 50 100 Dose Pac
NDC 00173-0778-00 UPC/GTIN No.3-01730-77800-2 Mfg.Part No.77800

BRAND: LAMICTAL  NDC: 00173-0778-00,173077800 UPC: 3-01730-77800-2,301730778002 Glaxosmithkline/Kdc
Lamictal ODT 25 50 100 Dose Pack 35 By
BRAND: LAMICTAL NDC: 00173-0778-00,173077800 UPC: 3-01730-77800-2,301730778002 Glaxosmithkline/Kdc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
LAMOTRIGINE ORAL TB RD DS
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.