Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 200 mg - tablet, chewable - excipient ingredients: magnesium stearate; colloidal anhydrous silica; aspartame; purified talc; povidone; crospovidone; microcrystalline cellulose; hyprolose; calcium carbonate; maltodextrin; flavour - lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as "add-on" therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 100 mg - tablet, chewable - excipient ingredients: microcrystalline cellulose; hyprolose; povidone; purified talc; crospovidone; magnesium stearate; colloidal anhydrous silica; aspartame; calcium carbonate; maltodextrin; flavour - lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as "add-on" therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 50 mg - tablet, chewable - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; hyprolose; povidone; aspartame; purified talc; calcium carbonate; maltodextrin; flavour - lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as "add-on" therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 25 mg - tablet, chewable - excipient ingredients: crospovidone; hyprolose; microcrystalline cellulose; aspartame; colloidal anhydrous silica; povidone; purified talc; magnesium stearate; calcium carbonate; maltodextrin; flavour - lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as "add-on" therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: lamotrigine 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 lamotrigine 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. lamotrigine 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 adults (aged 18 years and older) treated for acute mood episodes with standard therapy [see clinical studies (14.1)] . limitations of use treatment of acute manic or mixed episod

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

mylan institutional inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine tablets, usp are 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. lamotrigine tablets are 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 lamotrigine tablets has 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 two or more concomitant aeds. lamotrigine tablets, usp are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in pat

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 50 mg - lamotrigine extended-release is indicated as adjunctive therapy for primary generalized tonic-clonic (pgtc) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. lamotrigine extended-release is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (aed). safety and effectiveness of lamotrigine extended-release have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant aeds. safety and effectiveness of lamotrigine extended-release for use in patients younger than 13 years have not been established. lamotrigine extended-release is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions ( 5.1, 5.2)] . as w

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 5 mg - adjunctive therapy lamotrigine tablets for oral suspension (chewable dispersible tablets) are 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 lamotrigine tablets for oral suspension (chewable dispersible tablets) are 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 lamotrigine tablets for oral suspension (chewable dispersible tablets) 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. lamotrigi

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

hikma pharmaceutical - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - teratogenic effects: pregnancy category c. no evidence of teratogenicity was found in mice, rats, or rabbits when lamotrigine was orally administered to pregnant animals during the period of organogenesis at doses up to 1.2, 0.5, and 1.1 times, respectively, on a mg/m2 basis, the highest usual human maintenance dose (i.e., 500 mg/day). however, maternal toxicity and secondary fetal toxicity producing reduced fetal weight and/or delayed ossification were seen in mice and rats, but not in rabbits at these doses. teratology studies were also conducted using bolus intravenous administration of the isethionate salt of lamotrigine in rats and rabbits. in rat dams administered an intravenous dose at 0.6 times the highest usual human maintenance dose, the incidence of intrauterine death without signs of teratogenicity was increased. a behavioral teratology study was conducted in rats dosed during the period of organogenesis. at day 21 postpartum, offspring of dams receiving 5 mg/kg/day or higher displayed a signifi

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 150 mg - adjunctive therapy lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: monotherapy lamotrigine tablets are 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 lamotrigine 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. lamotrigine tablets are 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)]. limitation of use