ration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated (7.2). Tryptophan: Severe vomiting with coadministration (7.2). Diltiazem: Bradycardia with coadministration (7.3). Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously (7.3).
USE IN SPECIFIC POPULATIONS
Specific populations not discussed in Dosage and Administration or Warnings and Precautions include:
• Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN) (2.7, 8.1).
• Nursing mothers: Fluvoxamine is secreted in human breast milk (8.3).
• Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy (2.3, 8.5).
• Smokers: Smokers had a 25% increase in fluvoxamine metabolism (7.4).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
Suicidality and Antidepressant Drugs
1 INDICATIONS AND USAGE
1.1 Obsessive Compulsive Disorder 2 DOSAGE AND ADMINISTRATION
2.1 OCD (Obsessive Compulsive Disorder) 2.2 Pediatric Patients Naïve to Fluvoxamine Maleate 2.3 Dosage for Elderly or Hepatically Impaired Patients 2.4 Maintenance/Continuation of Extended Treatment 2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders 2.6 Use of LUVOX CR Capsules with Other MAOIs such as Linezolid or Methylene Blue 2.7 Discontinuation of Treatment with LUVOX CR Capsules 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Monoamine Oxidase Inhibitors (MAOIs) 5 WARNINGS AND PRECAUTIONS
5.1 Clinical Worsening and Suicide Risk 5.2 Serotonin Syndrome 5.3 Angle Closure Glaucoma 5.4 Potential Thioridazine Interaction 5.5 Potential Tizanidine Interaction 5.6 Potential Pimozide Interaction 5.7 Potential Alosetron Interaction 5.8 Potential Ramelteon Interaction 5.9 Other Potentially Important Drug Interactions 5.10 Discontinuation of Treatment 5.11 Abnormal Bleeding 5.12 Activation of Mania/Hypomania 5.13 Seizures 5.14 Hyponatremia 5.15 Use in Patients with Concomitant Illness 5.16 Laboratory Tests 6 ADVERSE REACTIONS
6.1 Clinical Trial Data Sources 6.2 Adverse Reactions Observed in Controlled Trials 6.3 Other Adverse Reactions in OCD Pediatric Population 6.4 Male and Female Sexual Dysfunction with SSRIs 6.5 Weight and Vital Sign Changes 6.6 Laboratory Changes 6.7 ECG Changes 6.8 Other Reactions Observed During the Premarketing eva luation of Fluvoxamine 6.9 Postmarketing Reports 7 DRUG INTERACTIONS
7.1 Potential Interactions with Drugs that Inhibit or are Metabolized by Cytochrome P450 Isoenzymes 7.2 CNS Active Drugs 7.3 Other Drugs 7.4 Effects of Smoking on Fluvoxamine Metabolism 7.5 Electroconvulsive Therapy (ECT) 7.6 Monoamine Oxidase Inhibitors (MAOIs) Serotonergic Drugs 7.7 Serotonergic Drugs 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance 9.2 Physical and Psychological Dependence 10 OVERDOSAGE
10.1 Human Experience 10.2 Management of Overdosage 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12 |
