Wellbutrin SR
El Wellbutrin Genérico de Liberación Sostenida es un antidepresivo. Funciona en el cerebro para tratar la depresión. No se sabe exactamente cómo funciona.
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€ 0.74
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
WELLBUTRIN SR safely and effectively. See full prescribing
information for WELLBUTRIN SR.
WELLBUTRIN SR (bupropion hydrochloride) sustained-release tablets,
for oral use
Initial U.S. Approval: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
- Increased risk of suicidal thinking and behavior in children,
adolescents and young adults taking antidepressants. (5.1) - Monitor for worsening and emergence of suicidal thoughts and
behaviors. (5.1)
————————— INDICATIONS AND USAGE—————————-
WELLBUTRIN SR is an aminoketone antidepressant, indicated for the
treatment of major depressive disorder (MDD). (1)
———————–DOSAGE AND ADMINISTRATION ———————– - Starting dose: 150 mg/day. (2.1)
- General: Increase dose gradually to reduce seizure risk. (2.1, 5.3)
- After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice
daily at an interval of at least 8 hours. (2.1) - Usual target dose: 300 mg/day as 150 mg twice daily. (2.1)
- Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients
not responding to 300 mg/day. (2.1) - Periodically reassess the dose and need for maintenance treatment. (2.1)
- Moderate to severe hepatic impairment: 100 mg daily or 150 mg every
other day. (2.2, 8.7) - Mild hepatic impairment: Consider reducing the dose and/or frequency of
dosing. (2.2, 8.7) - Renal impairment: Consider reducing the dose and/or frequency. (2.3,
8.6)
——————— DOSAGE FORMS AND STRENGTHS———————-
Tablets: 100 mg, 150 mg, 200 mg. (3)
—————————— CONTRAINDICATIONS —————————— - Seizure disorder. (4, 5.3)
- Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3)
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates,
antiepileptic drugs. (4, 5.3) - Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to
treat psychiatric disorders with WELLBUTRIN SR or within 14 days of
stopping treatment with WELLBUTRIN SR. Do not use WELLBUTRIN
SR within 14 days of stopping an MAOI intended to treat psychiatric
disorders. In addition, do not start WELLBUTRIN SR in a patient who is
being treated with linezolid or intravenous methylene blue. (4, 7.6) - Known hypersensitivity to bupropion or other ingredients of
WELLBUTRIN SR. (4, 5.8)
———————– WARNINGS AND PRECAUTIONS———————— - Neuropsychiatric adverse events during smoking cessation: Postmarketing
reports of serious or clinically significant neuropsychiatric adverse events
have included changes in mood (including depression and mania),
psychosis, hallucinations, paranoia, delusions, homicidal ideation,
aggression, hostility, agitation, anxiety, and panic, as well as suicidal
ideation, suicide attempt, and completed suicide. Observe patients
attempting to quit smoking with bupropion for the occurrence of such
symptoms and instruct them to discontinue bupropion and contact a
healthcare provider if they experience such adverse events. (5.2) - Seizure risk: The risk is dose-related. Can minimize risk by gradually
increasing the dose and limiting daily dose to 400 mg. Discontinue if
seizure occurs. (4, 5.3, 7.3) - Hypertension: WELLBUTRIN SR can increase blood pressure. Monitor
blood pressure before initiating treatment and periodically during
treatment. (5.4) - Activation of mania/hypomania: Screen patients for bipolar disorder and
monitor for these symptoms. (5.5) - Psychosis and other neuropsychiatric reactions: Instruct patients to
contact a healthcare professional if such reactions occur. (5.6) - Angle-closure glaucoma: Angle-closure glaucoma has occurred in
patients with untreated anatomically narrow angles treated with
antidepressants. (5.7)
—————————— ADVERSE REACTIONS ——————————
Most common adverse reactions (incidence ≥5% and ≥2% more than placebo
rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis,
constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation,
myalgia, sweating, rash, and anorexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact
GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
—————————— DRUG INTERACTIONS——————————- - CYP2B6 inducers: Dose increase may be necessary if coadministered
with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz,
carbamazepine, phenobarbital, and phenytoin) based on clinical response,
but should not exceed the maximum recommended dose. (7.1) - Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can
increase concentrations of: antidepressants (e.g., venlafaxine,
nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline),
antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers
(e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone,
flecainide). Consider dose reduction when using with bupropion. (7.2) - Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
(7.2) - Drugs that lower seizure threshold: Dose WELLBUTRIN SR with
caution. (5.3, 7.3) - Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur
when used concomitantly with WELLBUTRIN SR. (7.4) - MAOIs: Increased risk of hypertensive reactions can occur when used
concomitantly with WELLBUTRIN SR. (7.6) - Drug-laboratory test interactions: WELLBUTRIN SR can cause false-
positive urine test results for amphetamines. (7.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 4/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Instructions for Use
2.2 Dose Adjustment in Patients with Hepatic Impairment
2.3 Dose Adjustment in Patients with Renal Impairment
2.4 Switching a Patient to or from a Monoamine Oxidase
Inhibitor (MAOI) Antidepressant
2.5 Use of WELLBUTRIN SR with Reversible MAOIs Such as
Linezolid or Methylene Blue
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behaviors in Children, Adolescents,
and Young Adults
5.2 Neuropsychiatric Adverse Events and Suicide Risk in
Smoking Cessation Treatment
5.3 Seizure
5.4 Hypertension
5.5 Activation of Mania/Hypomania
5.6 Psychosis and Other Neuropsychiatric Reactions
5.7 Angle-Closure Glaucoma
5.8 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Potential for Other Drugs to Affect WELLBUTRIN SR
7.2 Potential for WELLBUTRIN SR to Affect Other Drugs
7.3 Drugs that Lower Seizure Threshold
7.4 Dopaminergic Drugs (Levodopa and Amantadine)
7.5 Use with Alcohol
1
Reference ID: 5376823This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
7.6 MAO Inhibitors 10.2 Overdosage Management
7.7 Drug-Laboratory Test Interactions 11 DESCRIPTION
8 USE IN SPECIFIC POPULATIONS 12 CLINICAL PHARMACOLOGY
8.1 Pregnancy 12.1 Mechanism of Action
8.2 Lactation 12.3 Pharmacokinetics
8.4 Pediatric Use 13 NONCLINICAL TOXICOLOGY
8.5 Geriatric Use 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
8.6 Renal Impairment 14 CLINICAL STUDIES
8.7 Hepatic Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING
9 DRUG ABUSE AND DEPENDENCE 17 PATIENT COUNSELING INFORMATION
9.1 Controlled Substance *Sections or subsections omitted from the full prescribing information are not
9.2 Abuse listed. - Wellbutrin SR es un medicamento cuyo principio activo es el bupropión, un antidepresivo atípico utilizado en el tratamiento de la depresión mayor, el trastorno depresivo persistente y como apoyo en la cesación del tabaquismo. Su acción se basa en la inhibición de la recaptación de dopamina y noradrenalina (IRDN), lo que mejora el estado de ánimo, la motivación y la concentración.
- ¿Para qué sirve Wellbutrin SR?
Tratamiento de la depresión mayor y el trastorno depresivo persistente.- Mejora los síntomas de fatiga, falta de energía y desmotivación en la depresión.
- Ayuda a dejar de fumar al reducir la ansiedad y la dependencia a la nicotina.
- Alternativa en pacientes que no toleran los inhibidores selectivos de la recaptación de serotonina (ISRS) como la fluoxetina o la sertralina.
- Puede usarse en algunos casos de trastorno por déficit de atención e hiperactividad (TDAH) en adultos.
- Composición y Presentación
Principio activo: Bupropión hidrocloruro.
Presentación: Comprimidos de Wellbutrin SR 100 mg y 150 mg de liberación sostenida.
Duración de acción: Efecto prolongado que permite dos tomas al día.- Cómo tomar Wellbutrin SR
La dosis inicial suele ser de 150 mg una vez al día, aumentando a 150 mg dos veces al día según indicación médica.- Se recomienda tomarlo con o sin alimentos, pero no triturar ni partir los comprimidos.
- No debe tomarse por la noche, ya que puede causar insomnio.
- Los efectos antidepresivos pueden tardar 2 a 4 semanas en manifestarse.
- Beneficios de Wellbutrin SR
No causa aumento de peso, a diferencia de otros antidepresivos.- No afecta la libido, a diferencia de los ISRS.
- Mejora la motivación, la energía y el estado de ánimo.
- Alternativa sin efectos sedantes, ideal para pacientes con depresión y fatiga.
- Reduce la ansiedad y la compulsión por la nicotina en fumadores.
- Efectos secundarios de Wellbutrin SR
- Algunos efectos adversos pueden incluir:
- Boca seca
- Náuseas y malestar estomacal
- Insomnio o dificultades para dormir
- Mareos o dolor de cabeza
- Aumento de la ansiedad en las primeras semanas
- Palpitaciones o taquicardia
- En casos raros, puede aumentar el riesgo de convulsiones, especialmente en dosis altas o en personas con antecedentes de epilepsia.
- Precauciones y Contraindicaciones
No recomendado en pacientes con trastornos convulsivos o antecedentes de epilepsia.- Contraindicado en personas con trastornos de la alimentación como anorexia o bulimia.
- No debe combinarse con alcohol, ya que puede aumentar el riesgo de efectos adversos.
- No se recomienda en mujeres embarazadas o en período de lactancia, salvo indicación médica.
- Puede interactuar con otros antidepresivos y medicamentos para la ansiedad.
- Diferencias entre Wellbutrin SR, Wellbutrin XL y Zyban
Wellbutrin SR: Versión de liberación sostenida, con dosis de 100 mg y 150 mg, administrada dos veces al día.- Wellbutrin XL: Versión de liberación prolongada, con dosis de 150 mg y 300 mg, administrada una vez al día.
- Zyban: Misma sustancia activa (bupropión), pero indicado específicamente para dejar de fumar.
- ¿Dónde comprar Wellbutrin SR?
- Wellbutrin SR es un medicamento de venta con receta médica, disponible en farmacias y hospitales. Su precio varía según la presentación y el país de compra.
- Si buscas un tratamiento eficaz para la depresión, el TDAH o dejar de fumar, consulta a tu médico sobre Wellbutrin SR (bupropión 150 mg) y sus beneficios.
