Antiepileptics: Increased Risk of Suicidal Behavior or Ideation - Updated: December 2008

Topiramate martindale Hal

The U.S. Food and Drug Administration (FDA) has issued an update following the completion of
its analysis concerning the risk of suicidality (suicidal behavior or ideation) observed during
clinical trials of various antiepileptic drugs (compared to placebo) in the treatment of epilepsy,
psychiatric disorders, and other conditions. The pooled analysis of 199 clinical trials involving
11 antiepileptic drugs (carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine,
levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, zonisamide) as either
monotherapy or as adjuvant therapy showed that patients receiving an antiepileptic had a 0.43%
risk of suicidal behavior/ideation compared to 0.24% of patients receiving placebo. As a result of
the findings, the FDA will require that the product labeling of the entire class of antiepileptics
include a warning concerning the risk of suicidality, and a medication guide be developed
informing patients of this risk.

Additional information may be found at

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

Medication Safety Issues

Sound-alike/look-alike issues:

Topamax may be confused with Tegretol, Tegretol-XR, Toprol-XL

Pronunciation

(toe PYRE a mate)

U.S. Brand Names

Topamax

Canadian Brand Names

Apo-Topiramate; Co-Topiramate; Dom-Topiramate; Gen-Topiramate; Novo-Topiramate; PHL-

Topiramate; PMS-Topiramate; ratio-Topiramate; Sandoz-Topiramate; Topamax
 Pharmacologic Category

Anticonvulsant, Miscellaneous

Use: Labeled Indications

Monotherapy or adjunctive therapy for partial onset seizures and primary generalized tonic-
clonic seizures; adjunctive treatment of seizures associated with Lennox-Gastaut syndrome;
prophylaxis of migraine headache

Use: Unlabeled/Investigational

Infantile spasms, neuropathic pain, cluster headache

Dosing: Adults

Note: Do not abruptly discontinue therapy; taper dosage gradually to prevent rebound effects. (In
clinical trials, adult doses were withdrawn by decreasing in weekly intervals of 50-100 mg/day
gradually over 2-8 weeks for seizure treatment, and by decreasing in weekly intervals by 25-50
mg/day for migraine prophylaxis.)

Partial onset seizure (monotherapy) and primary generalized tonic-clonic seizure

(monotherapy): Oral: Initial: 25 mg twice daily; may increase weekly by 50 mg/day up to
100 mg twice daily (week 4 dose); thereafter, may further increase weekly by 100 mg/day
up to the recommended maximum of 200 mg twice daily.

Migraine prophylaxis: Oral: Initial: 25 mg/day (in the evening), titrated at weekly intervals in
25 mg increments, up to the recommended total daily dose of 100 mg/day given in 2
divided doses

Partial onset seizures (adjunctive therapy): Oral: Initial: 25-50 mg/day (given in 2 divided
doses) for 1 week; increase at weekly intervals by 25-50 mg/day until response; usual
maintenance dose: 100-200 mg twice daily. Doses >1600 mg/day have not been studied.

Primary generalized tonic-clonic seizures (adjunctive therapy): Oral: Use initial dose as
listed above for partial onset seizures, but use slower initial titration rate; titrate upwards to
recommended dose by the end of 8 weeks; usual maintenance dose: 200 mg twice daily.
Doses >1600 mg/day have not been studied.

Cluster headache (unlabeled use): Oral: Initial: 25 mg/day, titrated at weekly intervals in 25
mg increments, up to 200 mg/day
Neuropathic pain (unlabeled use): Oral: Initial: 25 mg/day, titrated at weekly intervals in 25-50
mg increments to target dose of 400 mg daily in 2 divided doses. Reported dosage range
studied: 25-800 mg/day

Dosing: Elderly

Most older adults have creatinine clearances <70 mL/min; obtain a serum creatinine and
calculate creatinine clearance prior to initiation of therapy. An initial dose of 25 mg/day may be
recommended, followed by incremental increases of 25 mg at weekly intervals until an effective
dose is reached; refer to adult dosing for titration schedule.

Dosing: Pediatric

Note: Do not abruptly discontinue therapy; taper dosage gradually to prevent rebound effects.

Monotherapy:Partial onset seizure and primary generalized tonic-clonic seizure: Children

10 years: Oral: Refer to adult dosing.

Adjunctive therapy:

Partial onset seizure or seizure associated with Lennox-Gastaut syndrome: Children 2-

16 years: Oral: Initial dose titration should begin at 25 mg (or less, based on a range of
1-3 mg/kg/day) nightly for the first week; dosage may be increased in increments of 1-
3 mg/kg/day (administered in 2 divided doses) at 1- or 2-week intervals to a total daily
dose of 5-9 mg/kg/day

Adolescents 17 years: Refer to adult dosing.

Primary generalized tonic-clonic seizure: Children 2-16 years: Oral: Use initial dose
listed above, but use slower initial titration rate; titrate to recommended
maintenance dose by the end of 8 weeks

Adolescents 17 years: Refer to adult dosing.

Dosing: Renal Impairment

Clcr <70 mL/minute: Administer 50% dose and titrate more slowly.

Hemodialysis: Supplemental dose may be needed during hemodialysis

Dialyzable: ~30%

Dosing: Hepatic Impairment

Clearance may be reduced.

Calculations

Creatinine Clearance: Adults

Creatinine Clearance: Pediatrics

Administration: Oral

May be administered without regard to meals

Capsule sprinkles: May be swallowed whole or opened to sprinkle the contents on soft food
(drug/food mixture should not be chewed).

Tablet: Because of bitter taste, tablets should not be broken.

Storage

Store at room temperature of 15C to 30C (59F to 86F). Protect from moisture.

Contraindications

Hypersensitivity to topiramate or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

CNS effects: Cognitive dysfunction, psychiatric disturbances (mood disorders), and

sedation (somnolence or fatigue) may occur with use; incidence may be related to
rapid titration and higher doses. May also cause paresthesia, dizziness, and ataxia.

Glaucoma: Has been associated with acute myopia and secondary angle-closure
glaucoma in adults and children, typically within 1 month of initiation; discontinue in
patients with acute onset of decreased visual acuity or ocular pain.

Hyperthermia: May be associated (rarely) with severe oligohydrosis and hyperthermia,

most frequently in children; use caution and monitor closely during strenuous exercise,
during exposure to high environmental temperature, or in patients receiving drugs with
anticholinergic activity.
 Metabolic acidosis (hyperchloremic, nonanion gap): May decrease serum bicarbonate
concentrations, due to inhibition of carbonic anhydrase and increased renal bicarbonate
loss. Decreases in serum bicarbonate are relatively common (7% to 67%) but usually
mild to moderate (average decrease of 4 mEq/L at dose of 400 mg/day in adults and 6
mg/kg/day in children). Treatment-emergent metabolic acidosis is less common;
however, risk may be increased in patients with a predisposing condition (renal,
respiratory and/or hepatic impairment), ketogenic diet, or concurrent treatment with
other drugs which may cause acidosis. Metabolic acidosis may occur at dosages as low
as 50 mg/day. Serum bicarbonate should be monitored, as well as potential
complications of chronic acidosis (nephrolithiasis, osteomalacia, and reduced growth
rates in children). Dose reduction or discontinuation (by tapering dose) should be
considered in patients with persistent or severe metabolic acidosis. If treatment is
continued, alkali supplementation should be considered.

Renal calculus: Topiramate exhibits carbonic anhydrase properties and the risk of
kidney stones is about 2-4 times that of the untreated population. Kidney stones have
been reported in children and adults. The risk of stones may be reduced by increasing
fluid intake.

Disease-related concerns:

Hepatic impairment: Use with caution in patients with hepatic impairment; dosage
adjustment may be required.

Renal impairment: Use with caution in patients with renal impairment; dosage
adjustment may be required.

Concurrent drug therapy issues:

Sedatives: Effects with other sedative drugs or ethanol may be potentiated.

Valproate: Hyperammonemia with or without encephalopathy may occur and has been
documented in patients who have tolerated each drug alone. Risk may be increased in
patients with inborn errors of metabolism or decreased hepatic mitochondrial activity.
Monitor for lethargy, vomiting, or unexplained changes in mental status.

Special populations:

Pediatrics: Safety and efficacy have not been established in children <2 years of age for
adjunctive treatment of seizures and <10 years of age for monotherapy treatment of
seizures. Safety and efficacy have not been established in children for migraine
prophylaxis.

Other warnings/precautions:
 Withdrawal: Anticonvulsants should not be discontinued abruptly because of the
possibility of increasing seizure frequency; therapy should be withdrawn gradually to
minimize the potential of increased seizure frequency, unless safety concerns require a
more rapid withdrawal. Doses were also gradually withdrawn in migraine prophylaxis
studies (decreased in weekly intervals by 25-50 mg/day).

Geriatric Considerations

This drug may not be a drug of choice in the elderly until all other therapies for seizures have
been exhausted. Follow the recommended titration schedule and adjust time intervals to meet
patient's needs. Since most elderly will have a Clcr <70 mL/minute, it is important to either
measure or estimate by calculation the Clcr prior to initiating therapy.

Pregnancy Risk Factor

Pregnancy Considerations

Topiramate was found to be teratogenic in animal studies; however, there is limited information
in pregnant women; use only if benefit to the mother outweighs the risk to the fetus. Based on
limited data, topiramate was found to cross the placenta. Postmarketing experience includes
reports of hypospadias following in vitro exposure to topiramate.

Lactation

Enters breast milk/not recommended

Breast-Feeding Considerations

Based on limited data, topiramate was found in breast milk; low concentrations were detected in
nursing infants.

Adverse Reactions
Adverse events are reported for placebo-controlled trials of adjunctive therapy in adult and
pediatric patients. Unless otherwise noted, the percentages refer to incidence in epilepsy trials.
Note: A wide range of dosages were studied; incidence of adverse events was frequently lower in
the pediatric population studied.

>10%:
 Central nervous system: Dizziness (4% to 32%), ataxia (6% to 16%), somnolence (15% to
29%), psychomotor slowing (3% to 21%), nervousness (9% to 19%), memory
difficulties (2% to 14%), speech problems (2% to 13%), fatigue (9% to 30%),
difficulty concentrating (5% to 14%), depression (9% to 13%), confusion (4% to 14%)

Endocrine & metabolic: Serum bicarbonate decreased (dose-related: 7% to 67%; marked

reductions [to <17 mEq/L] 1% to 11%)

Gastrointestinal: Nausea (6% to 12%; migraine trial: 14%), weight loss (8% to 13%),
anorexia (4% to 24%)

Neuromuscular & skeletal: Paresthesia (1% to 19%; migraine trial: 35% to 51%)

Ocular: Nystagmus (10% to 11%), abnormal vision (<1% to 13%)

Respiratory: Upper respiratory infection (migraine trial: 12% to 13%)

Miscellaneous: Injury (6% to 14%)

1% to 10%:

Cardiovascular: Chest pain (2% to 4%), edema (1% to 2%), bradycardia (1%), pallor (up to
1%), hypertension (1% to 2%)

Central nervous system: Abnormal coordination (4%), hypoesthesia (1% to 2%; migraine
trial: 8%), convulsions (1%), depersonalization (1% to 2%), apathy (1% to 3%),
cognitive problems (3%), emotional lability (3%), agitation (3%), aggressive reactions
(2% to 9%), tremor (3% to 9%), stupor (1% to 2%), mood problems (4% to 9%),
anxiety (2% to 10%), insomnia (4% to 8%), fever (migraine trial: 1% to 2%), vertigo
(1% to 2%), neurosis (1%)

Dermatologic: Pruritus (migraine trial: 2% to 4%), skin disorder (1% to 3%), alopecia (2%),
dermatitis (up to 2%), hypertrichosis (up to 2%), rash erythematous (up to 2%),
eczema (up to 1%), seborrhea (up to 1%), skin discoloration (up to 1%)

Endocrine & metabolic: Hot flashes (1% to 2%); metabolic acidosis (hyperchloremia,
nonanion gap), dehydration, breast pain (up to 4%), menstrual irregularities (1% to
2%), hypoglycemia (1%), libido decreased (<1% to 2%)

Gastrointestinal: Dyspepsia (2% to 7%), abdominal pain (5% to 7%), constipation (3% to
5%), xerostomia (2% to 4%), fecal incontinence (1%), gingivitis (1%), diarrhea (2%;
migraine trial: 11%), vomiting (1% to 3%), gastroenteritis (1% to 3%), GI disorder
(1%), dysgeusia (2% to 4%; migraine trial: 12% to 15%), appetite increased (1%),
dysphagia (1%), flatulence (1%), GERD (1%), glossitis (1%), gum hyperplasia (1%),
weight gain (1%)
 Genitourinary: Impotence, dysuria/incontinence (<1% to 4%), prostatic disorder (2%), UTI
(2% to 3%), premature ejaculation (migraine trial: 3%), cystitis (2%)

Hematologic: Leukopenia (1% to 2%), purpura (8%), hematoma (1%), prothrombin time
increased (1%), thrombocytopenia (1%)

Neuromuscular & skeletal: Myalgia (2%), weakness (3% to 6%), back pain (1% to 5%), leg
pain (2% to 4%), rigors (1%), hypertonia, arthralgia (1% to 7%), gait abnormal (2% to
8%), involuntary muscle contractions (2%; migraine trial: 4%), skeletal pain (1%),
hyperkinesia (up to 5%), hyporeflexia (up to 2%)

Ocular: Conjunctivitis (1%), diplopia (2% to 10%), myopia (up to 1%)

Otic: Hearing decreased (1% to 2%), tinnitus (1% to 2%), otitis media (migraine trial: 1% to
2%)

Renal: Nephrolithiasis, renal calculus (1% to 2%), hematuria (<1% to 2%)

Respiratory: Pharyngitis (3% to 6%), sinusitis (4% to 6%; migraine trial: 8% to 10%),
epistaxis (1% to 4%), rhinitis (4% to 7%), dyspnea (1% to 2%), pneumonia (5%),
cough (migraine trial: 2% to 3%), bronchitis (migraine trial: 3%)

Miscellaneous: Flu-like syndrome (3% to 7%), allergy (2% to 3%), body odor (up to 1%),
viral infection (migraine trial: 3% to 4%), infection (<1% to 2%), diaphoresis
(1%), thirst (2%)

<1% (Limited to important or life-threatening): Anemia, angina, apraxia, AV block, bone

marrow depression, deep vein thrombosis, dehydration, delirium, diabetes mellitus,
dyskinesia, electrolyte imbalance, encephalopathy (with valproate therapy), eosinophilia,
euphoria, granulocytopenia, hypokalemia, hypotension, liver enzymes increased,
lymphadenopathy, lymphopenia, manic reaction, neuropathy, pancytopenia, paranoid
reaction, photosensitivity, psychosis, pulmonary embolism, suicidal behavior, syncope,
tongue edema

Postmarketing and/or case reports: Accommodation abnormality, erythema multiforme, eye pain,
hepatic failure, hepatitis, hyperammonemia (with valproate therapy), hyperthermia (severe),
migraine aggravated, oligohydrosis, pancreatitis, pemphigus, rash, renal tubular acidosis,
Stevens-Johnson syndrome, syndrome of acute myopia/secondary angle-closure glaucoma,
toxic epidermal necrolysis

Metabolism/Transport Effects

Inhibits CYP2C19 (weak); Induces CYP3A4 (weak)

 Drug Interactions

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl).
Risk C: Monitor therapy

CarBAMazepine: May decrease the serum concentration of Topiramate. Risk D: Consider

therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C:
Monitor therapy

Ketorolac: May diminish the therapeutic effect of Anticonvulsants. Risk C: Monitor therapy

Maraviroc: CYP3A4 Inducers may decrease the serum concentration of Maraviroc. Risk D:
Consider therapy modification

Mefloquine: May diminish the therapeutic effect of Anticonvulsants. Mefloquine may decrease
the serum concentration of Anticonvulsants. Management: Mefloquine is contraindicated in
persons with a history of convulsions. If anticonvulsant is being used for another indication
monitor response to treatment closely, as concurrent mefloquine may decrease response to
treatment. Risk D: Consider therapy modification

Oral Contraceptive (Estrogens): Topiramate may decrease the serum concentration of Oral
Contraceptive (Estrogens). Contraceptive failure is possible. Risk D: Consider therapy
modification

Phenytoin: Topiramate may decrease the metabolism of Phenytoin. Phenytoin may increase the
metabolism of Topiramate. Risk C: Monitor therapy

Valproic Acid: Topiramate may enhance the hepatotoxic effect of Valproic Acid. Risk C:
Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Food: Ketogenic diet may increase the possibility of acidosis and/or kidney stones.

Herb/Nutraceutical: Avoid evening primrose (seizure threshold decreased).

Monitoring Parameters

Seizure frequency, hydration status; electrolytes (recommended monitoring includes serum

bicarbonate at baseline and periodically during treatment), serum creatinine; monitor for
symptoms of acute acidosis and complications of long-term acidosis (nephrolithiasis,
osteomalacia, and reduced growth rates in children); ammonia level in patients with unexplained
lethargy, vomiting, or mental status changes; intraocular pressure, symptoms of secondary angle
closure glaucoma

Nursing: Physical Assessment/Monitoring

Assess effectiveness and interactions of other medications patient may be taking. Monitor
therapeutic effectiveness (seizure activity, force, type, duration), laboratory values, and adverse
reactions at beginning of therapy and periodically with long-term use. Taper dosage slowly when
discontinuing. May cause weight loss; monitor weight periodically. Assess knowledge/teach
patient appropriate use, seizure safety precautions, interventions to reduce side effects, and
adverse symptoms to report..

Monitoring: Lab Tests

Recommended monitoring includes serum bicarbonate (baseline and periodically during

treatment) and serum creatinine. Ammonia level in patients with unexplained lethargy, vomiting,
or mental status changes.

Patient Education

Take exactly as directed; do not increase dose or frequency or discontinue without consulting
prescriber. While using this medication, do not use alcohol and other prescription or OTC
medications (especially pain medications, sedatives, antihistamines, or hypnotics) without
consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to
restrict fluid intake; possibly to prevent the development of kidney stones and dehydration. You
may be at risk for decreased sweating and increased body temperature, especially in hot weather.
You may experience drowsiness, dizziness, disturbed concentration, memory changes, or blurred
vision (use caution when driving or engaging in tasks requiring alertness until response to drug is
known); or mouth sores, nausea, vomiting, or loss of appetite (small frequent meals, frequent
mouth care, chewing gum, or sucking lozenges may help). Wear identification of epileptic status
and medications. Report behavioral or CNS changes, suicidal ideation, or depression; skin rash;
muscle cramping, numbness in extremities, weakness, tremors, changes in gait; chest pain,
irregular heartbeat, or palpitations; hearing loss; cough or respiratory difficulty; or worsening of
seizure activity or loss of seizure control. Seek immediate medical evaluation if you experience
sudden vision changes, periorbital pain, flank pain, or blood in urine. Pregnancy/breast-feeding
precautions: Inform prescriber if you are pregnant or intend to become pregnant. Breast-feeding
is not recommended.

Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult
specific product labeling.

Capsule, sprinkle:

Topamax: 15 mg, 25 mg

Tablet:

Topamax: 25 mg, 50 mg, 100 mg, 200 mg

Generic Available

No

Manufacturer

Ortho-McNeil Pharmaceutical, Inc

Pricing: U.S. (www.drugstore.com)

Tablets (Topamax)

25 mg (60): $148.51

50 mg (60): $278.81

100 mg (60): $395.39

200 mg (60): $457.08

Mechanism of Action

Anticonvulsant activity may be due to a combination of potential mechanisms: Blocks neuronal

voltage-dependent sodium channels, enhances GABA(A) activity, antagonizes AMPA/kainate
glutamate receptors, and weakly inhibits carbonic anhydrase.

Pharmacodynamics/Kinetics

Absorption: Good, rapid; unaffected by food

Protein binding: 15% to 41% (inversely related to plasma concentrations)

Metabolism: Hepatic via P450 enzymes

Bioavailability: 80%

Half-life elimination: Mean: Adults: Normal renal function: 21 hours; shorter in pediatric
patients; clearance is 50% higher in pediatric patients; Elderly: ~24 hours

Time to peak, serum: ~1-4 hours

Excretion: Urine (~70% to 80% as unchanged drug)

Dialyzable: ~30%

Related Information

Anticonvulsants by Seizure Type

Pharmacotherapy Pearls

May be associated with weight loss in some patients

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Gingivitis, dysphagia, glossitis, gum
hyperplasia, and xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health Comment

Large double-blind studies have failed to differentiate this drug from placebo when used for
bipolar disorder.

References

Bar-Oz B, Nulman I, Koren G, et al, Anticonvulsants and Breast Feeding: A Critical

Review, Paediatr Drugs, 2000, 2(2):113-26. [PubMed 10937463]
Carroll DG, Kline KM, and Malnar KF, "Role of Topiramate for the Treatment of Painful
Diabetic Peripheral Neuropathy," Pharmacotherapy, 2004, 24(9):1186-93.[PubMed 15460179]

Chong MS and Libretto SE, " The Rationale and Use of Topiramate for Treating Neuropathic
Pain," Clin J Pain, 2003, 19(1):59-68.[PubMed 12514458]

Dib JG, "Focus on Topiramate in Neuropathic Pain," Curr Med Res Opin, 2004, 20(12):1857-
61.[PubMed 15701203]

Doose DR, Walker SA, Gisclon LG, et al, Single-Dose Pharmacokinetics and Effect of Food
on the Bioavailability of Topiramate, a Novel Antiepileptic Drug, J Clin Pharmacol, 1996,
36(10):884-91. [PubMed 8930774]

Glauser TA, Preliminary Observations on Topiramate in Pediatric Epilepsies, Epilepsia,

1997, 38(Suppl 1):37-41.

Glauser TA, Topiramate Use in Pediatric Patients, Can J Neurol Sci, 1998, 25(3):S8-12.
[PubMed 9706734]

Glauser TA, Clark PO, and Strawsburg R, A Pilot Study of Topiramate in the Treatment of
Infantile Spasms, Epilepsia, 1998, 39(12):1324-8. [PubMed 9860068]

Hershey AD, Powers SW, Vockell AL, et al, Effectiveness of Topiramate in the Prevention
of Childhood Headaches, Headache, 42(8):810-18.

Krymchantowski AV, Bigal ME, and Moreira PR, New and Emerging Prophylactic Agents
for Migraine, CNS Drugs, 2002, 16(9):611-34. [PubMed 12153333]

Mathew NT, Kailasam J, and Meadors L, Prophylaxis of Migraine, Transformed Migraine,

and Cluster Headache With Topiramate, Headache, 2002, 42(8):796-803. [PubMed
12390644]

Ohman I, Vitols S, Luef G, et al, Topiramate Kinetics During Delivery, Lactation, and in the
Neonate: Preliminary Observations, Epilepsia, 2002, 43(10):1157-60. [PubMed 12366729]

Silberstein SD and Goadsby PJ, Migraine: Preventataive Treatment, Cephalalgia, 2002,

22(7):491-512. [PubMed 12230591]

Sachdeo RC, Topiramate. Clinical Profile in Epilepsy, Clin Pharmacokinet, 1998,

34(5):335-46. [PubMed 9592618]

Story JR, Calder CS, Hart DE, et al, Topiramate in Migraine Prevention: A Double-Blind,
Placebo-Controlled Study, Headache, 2001, 41(10):968-75. [PubMed 11903524]

Young WB, Hopkins MM, Shechter AL, et al, Topiramate: A Case Series Study in Migraine
Prophylaxis, Cephalalgia, 2002, 22(8):659-63.[PubMed 12383061]
 International Brand Names

Epilramate (TW); Epitomax (FI, FR); Epitop (KP); Gabatopa (KP); Topamac (AR, CO, EC, IN,
PE, PY, UY); Topamax (AE, AT, AU, BE, BG, BH, BR, CH, CL, CN, CY, CZ, DE, EE, EG,
ES, FI, GB, HK, HN, IE, IL, IQ, IR, IT, JM, JO, KW, LB, LY, MX, MY, NI, NL, OM, PH, PK,
PL, PT, QA, SA, SG, SY, TH, TW, VE, YE, ZA); Topamax Sprinkle (HK, IL, KP, NZ);
Topimax (DK, NO, SE); Topinmate (TW); Topirid (KP); Topitrim (IL); Topomac (GR)

Copyright (c) Lexi-Comp, Inc. 1978-2009 All Rights Reserved.

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Langsung Ke Lapangan (Pilih Nama Bidang) Administrasi: Reaksi Negatif Lurus Pertimbangan Menyusui
Perhitungan Nama Merek Kanada Kontraindikasi Kesehatan Gigi: Efek pada Perawatan Dental Kesehatan
Gigi: Vasokonstriktor / Tindakan Pencegahan Anestesi Lokal Bentuk Dosis Dosis: Dewasa Dosis: Dosis
Lansia: Dosis Hepatik Dosis : Dosis Pediatrik: Kelainan Ginjal Interaksi Obat Etanol / Nutrisi / Interaksi
Herb Pertimbangan Geriatrik Generik Nama Merek Internasional Produsen Laktasi Mekanisme Tindakan
Pengobatan Isu Keselamatan Kesehatan Mental Komentar Metabolisme / Metana Transportasi
Parameter Monitoring Pemantauan: Tes Laboratorium Perawatan: Penilaian / Pemantauan Fisik
Pendidikan Pasien Farmakodinamik / Kinetika Kategori Farmakologi Farmakoterapi Mutiara Kehamilan
Pertimbangan Kehamilan Faktor Risiko Harga: US (www.drugstore.com) Pengucapan Referensi Informasi
Terkait Penyimpanan Peringatan Khusus Nama Merek AS Gunakan: Indikasi Berlabel Penggunaan: Tidak
Dilabelkan / Berinvestasi Peringatan / tindakan pencegahan

atas Special Alerts

Antiepilepsi: Meningkatnya Risiko Perilaku Suaka atau Ideasi - Diperbarui: Desember 2008

Food and Drug Administration (FDA) AS telah mengeluarkan sebuah update setelah selesainya
analisisnya mengenai risiko bunuh diri (perilaku bunuh diri atau ideasi) yang diamati selama uji klinis
berbagai obat antiepilepsi (dibandingkan dengan plasebo) dalam pengobatan epilepsi, psikiatri
gangguan, dan kondisi lainnya. Analisis gabungan dari 199 uji klinis yang melibatkan 11 obat antiepilepsi
(karbamazepin, natrium divalproex, felbamate, gabapentin, lamotrigin, levetiracetam, oxcarbazepine,
pregabalin, tiagabine, topiramate, zonisamide) sebagai monoterapi atau terapi adjuvant menunjukkan
bahwa pasien yang menerima antiepilepsi memiliki 0,43% risiko perilaku / ide bunuh diri dibandingkan
dengan 0,24% pasien yang menerima plasebo. Sebagai hasil dari temuan tersebut, FDA akan
mewajibkan pelabelan produk dari seluruh kelas antiepilepsi termasuk peringatan mengenai risiko
bunuh diri, dan panduan pengobatan dikembangkan untuk menginformasikan pasien tentang risiko ini.

Informasi tambahan dapat ditemukan di

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic
Atas Masalah Keselamatan Kesehatan

Isu serupa / serupa:

Topamax mungkin bingung dengan Tegretol, Tegretol-XR, Toprol-XL

atas Pengucapan (toe PYRE a mate)

simbol suara

atas Nama Merek A.S.Topamax

atas nama merek KanadaApo-topiramate; Co-Topiramate; Dom-Topiramate; Gen-Topiramate; Novo-

Topiramate; PHL-Topiramate; PMS-Topiramate; rasio-topiramate; Sandoz-Topiramate; Topamax

atas Pharmacologic KategoriAnticonvulsant, Miscellaneous

Penggunaan teratas: Indikasi berlabel Terapi tambahan atau terapi tambahan untuk serangan onset
parsial dan kejang tonik-klonik umum primer; Pengobatan tambahan untuk kejang yang berhubungan
dengan sindrom Lennox-Gastaut; profilaksis sakit kepala migrain

Penggunaan atas: Tidak diberi label / Investigasi Kecelakaan maniak, nyeri neuropatik, sakit kepala
cluster

Dosis teratas: Dewasa Catatan: Jangan hentikan terapi secara tiba-tiba; Dosis lancip secara bertahap
untuk mencegah efek rebound. (Dalam uji klinis, dosis dewasa ditarik dengan penurunan interval
mingguan 50-100 mg / hari secara bertahap selama 2-8 minggu untuk pengobatan kejang, dan dengan
penurunan interval mingguan 25-25 mg / hari untuk profilaksis migrain.)

Kejang onset parsial (monoterapi) dan kejang tonik klonik umum umum (monoterapi): Oral: Awal: 25 mg
dua kali sehari; dapat meningkat mingguan hingga 50 mg / hari sampai 100 mg dua kali sehari (minggu
ke 4 dosis); Setelah itu, mungkin akan meningkat setiap minggu dengan 100 mg / hari sampai maksimum
yang disarankan 200 mg dua kali sehari.

Profilaksis migrain: Oral: Awal: 25 mg / hari (di malam hari), dititrasi pada interval mingguan dengan
penambahan 25 mg, sampai dosis harian yang direkomendasikan 100 mg / hari diberikan dalam 2 dosis
terbagi

Serangan onset parsial (terapi adjunctive): Oral: Awal: 25-50 mg / hari (diberikan dalam 2 dosis terbagi)
selama 1 minggu; meningkat pada interval mingguan 25-50 mg / hari sampai respon; Dosis perawatan
biasa: 100-200 mg dua kali sehari. Dosis> 1600 mg / hari belum dipelajari.

Kejang klonik klonik umum primer (terapi tambahan): Oral: Gunakan dosis awal seperti yang tercantum
di atas untuk serangan onset parsial, namun gunakan laju titrasi awal yang lebih lambat; titrasi ke atas
ke dosis yang dianjurkan pada akhir 8 minggu; Dosis perawatan biasa: 200 mg dua kali sehari. Dosis>
1600 mg / hari belum dipelajari.

Sakit kepala cluster (penggunaan tanpa label): Oral: Awal: 25 mg / hari, dititrasi pada interval mingguan
dengan penambahan 25 mg, sampai 200 mg / hari.

Nyeri neuropatik (penggunaan tanpa label): Oral: Awal: 25 mg / hari,