fluvoxamine maleate

fluvoxamine maleate,

an antidepressant drug with selective inhibitory action in neuronal serotonin reuptake.

indications It is prescribed in the treatment of obsessive-compulsive disorder in adult patients and has unlabeled uses for treating depression and panic attacks in adults, and anxiety in children.

contraindications It should not be given to patients with allergy to fluvoxamine maleate, patients who use monoamine oxidase inhibitors, or patients with a history of seizures, suicide attempts, or mania.

adverse effects The side effects most often reported include headache, sleepiness or insomnia, nausea, vomiting, and sexual dysfunction.

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fluvoxamine maleate (flōōvak´smēn´ mā´lēāt),

n brand name: Luvox;
drug class: antidepressant;
action: selectively inhibits reuptake of serotonin in central nervous system neurons;
uses: obsessive-compulsive disorder.

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fluvoxamine maleate

Apo-Fluvoxamine (CA), Faverin (UK), Luvox

Pharmacologic class: Selective serotonin reuptake inhibitor (SSRI)

Therapeutic class: Antidepressant, antiobsessive agent

Pregnancy risk category C

FDA Boxed Warning

• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders, especially during first few months of therapy. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.
• Drug isn't approved for use in pediatric patients except those with obsessive-compulsive disorder.

Action

Selectively inhibits serotonin reuptake in neurons. This inhibition is thought to relieve depression and reduce behaviors related to obsessive-compulsive disorder (OCD).

Availability

Tablets: 25 mg, 50 mg, 100 mg

⊘Indications and dosages

➣ OCD; depression

Adults: Initially, 50 mg P.O. daily at bedtime; may increase by 50 mg q 4 to 7 days until desired effect occurs (not to exceed 300 mg/day). If daily dosage exceeds 100 mg, give in two equally divided doses; if doses aren't equal, give larger dose at bedtime. As needed, adjust dosage periodically to maintain lowest effective dosage.

Children ages 8 to 17: Initially, 25 mg at bedtime; may increase by 25 mg/day q 4 to 7 days until desired effect occurs (up to 200 mg/day). If daily dosage exceeds 50 mg, give in divided doses, with larger dose at bedtime.

Dosage adjustment

• Hepatic impairment
• Elderly patients

Off-label uses

• Autism
• Anxiety disorders

Contraindications

• Hypersensitivity to drug or other SSRIs
• MAO inhibitor use within past 14 days

Precautions

Use cautiously in:
• cardiovascular disease, hepatic or renal impairment, mania, seizures, suicidal tendency
• elderly patients
• labor and delivery
• pregnant or breastfeeding patients.

Administration

• Give with or without food.
• Discontinue 5 weeks before MAO inhibitor therapy is set to begin.

Route	Onset	Peak	Duration
P.O.	Rapid	2-8 hr	Unknown

Adverse reactions

CNS: dizziness, drowsiness, headache, insomnia, nervousness, anxiety, apathy, manic or psychotic reactions, depression, hypokinesia or hyperkinesia, tremor, suicide or suicidal ideation (especially in child or adolescent)

CV: hypertension, orthostatic hypotension, palpitations, tachycardia

EENT: sinusitis

GI: nausea, vomiting, diarrhea, constipation, dyspepsia, flatulence, dry mouth, dysphagia, anorexia

GU: decreased libido, sexual dysfunction, anorgasmia

Musculoskeletal: hypertonia, myoclonus, twitching

Respiratory: cough, dyspnea

Skin: diaphoresis

Other: abnormal taste, tooth disorder, dental caries, edema, weight gain or loss, chills, fever, flulike symptoms, yawning, hot flashes, allergic reactions, hypersensitivity reaction

Interactions

Drug-drug. Beta-adrenergic blockers (such as propranolol), carbamazepine, lithium, L-tryptophan, methadone, some benzodiazepines, theophylline, tolbutamide, warfarin: decreased fluvoxamine metabolism, increased effects

Clozapine: increased clozapine blood level and risk of toxicity

MAO inhibitors: serotonin syndrome

Tricyclic antidepressants: increased fluvoxamine blood level

Drug-tests. Hepatic enzyme levels: increased

Drug-behaviors. Smoking: decreased fluvoxamine efficacy

Patient monitoring

☞ Watch closely for signs and symptoms of depression and suicidal ideation (especially in child or adolescent).
• Assess patient's appetite. Report weight gain or loss.
• Monitor liver function test results.
• Monitor cardiovascular status, particularly blood pressure.

Patient teaching

☞ Instruct patient or caregiver (especially with child or adolescent patient) to recognize and immediately report signs of suicidal intent or expressions of suicidal ideation.
• Inform patient that drug may take several weeks to be fully effective.
• Recommend establishing effective bedtime routine to minimize insomnia.
• Instruct female patient to notify prescriber if she becomes or intends to become pregnant. Caution her not to breastfeed.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.