FLOZAK 20/MG CAP 30/CAP

Indications

Approved Uses

Major depressive disorder (MDD), obsessive-compulsive disorder (OCD), bulimia nervosa, panic disorder, and premenstrual dysphoric disorder (PMDD).

Dosage & Administration

Dosing by Condition

MDD: start 20 mg once daily; usual 20-60 mg/day; max 80 mg/day. OCD: start 20 mg/day; usual 20-60 mg/day; max 80 mg/day. Bulimia nervosa: 60 mg/day. Panic disorder: start 10 mg/day for 1 week then 20 mg/day; usual 20-60 mg/day (some references cap at 60 mg/day). PMDD: 20 mg/day either continuous daily dosing or intermittent luteal-phase dosing per prescriber.

Initial Dose

20mg once daily, usually in the morning.

Maintenance Dose

20-60mg once daily

Maximum Dose

80mg per day.

Children's Dosage

OCD (8-17 years): Initial 10mg/day, may increase to 20-60mg/day. MDD (8-17 years): Initial 10mg/day, may increase to 20mg/day after 1 week. Lower-weight children: start at 10mg/day, max 20mg/day

Dose Adjustment Notes

If inadequate response, increase gradually after several weeks; use lower or less frequent dosing in hepatic impairment and consider lower doses in older adults; avoid/contraindicate with MAOIs-allow at least 14 days after stopping an MAOI before starting fluoxetine and at least 5 weeks after stopping fluoxetine before starting an MAOI.

How to Take

Swallow the hard capsule whole with water; may be taken with or without food; usually take once daily in the morning (or earlier in the day) to reduce insomnia-if higher daily doses are used, they may be given once daily or divided (morning and noon) per prescriber.

Side Effects

Common Side Effects

Common: nausea, headache, insomnia, anxiety/nervousness, diarrhea, dry mouth, decreased appetite/weight loss, tremor, sweating, fatigue/asthenia, and sexual dysfunction (e.g., decreased libido, delayed ejaculation).

Safety & Warnings

Contraindications

Contraindicated with MAOIs (concurrent or within 14 days of stopping an MAOI; and allow at least 5 weeks after stopping fluoxetine before starting an MAOI), and with thioridazine or pimozide; contraindicated in known hypersensitivity to fluoxetine. Also avoid/contraindicated with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Warnings/precautions: suicidality risk in children/adolescents/young adults-close monitoring; serotonin syndrome risk with serotonergic drugs; screen for bipolar disorder/mania risk; seizure risk; hyponatremia/SIADH (higher risk in elderly/diuretics); increased bleeding risk with NSAIDs/anticoagulants; QT prolongation risk (avoid other QT-prolonging risks); hepatic impairment-use lower/less frequent dosing; tapering generally advised though withdrawal is less common with fluoxetine.

Age Restriction

Pediatric approvals: MDD ≥8 years; OCD ≥7 years (not approved below these ages).

Drug Interactions

Interaction Severity

MAJOR/contraindicated: MAOIs (including linezolid and IV methylene blue), thioridazine, and pimozide. MODERATE/clinically significant: other serotonergic agents (e.g., triptans, tramadol, lithium, TCAs), anticoagulants/antiplatelets/NSAIDs (bleeding risk), and CYP2D6 substrates with narrow therapeutic index (fluoxetine is a strong CYP2D6 inhibitor).

Food Interaction

No restriction.

Special Populations

Children

OCD (8-17 years): Initial 10mg/day, may increase to 20-60mg/day. MDD (8-17 years): Initial 10mg/day, may increase to 20mg/day after 1 week. Lower-weight children: start at 10mg/day, max 20mg/day

Elderly

Start at lower dose (10mg/day), titrate slowly. Monitor for hyponatremia, falls, and drug interactions. Once-daily dosing preferred.

Kidney Impairment

No dose adjustment generally needed in mild-moderate renal impairment; use caution in severe impairment and consider lower/less frequent dosing based on tolerability.

Liver Impairment

Use a lower or less frequent dose in hepatic impairment (e.g., cirrhosis); consider reduced dose or alternate-day dosing.

Storage & Patient Advice

Missed Dose

Take as soon as remembered on the same day; skip the missed dose if it is almost time for the next dose. Do not double the dose.

Stopping the Medicine

Do not stop abruptly; taper is generally recommended, though discontinuation symptoms are less common with fluoxetine due to its long half-life-still consult prescriber before stopping.

Patient Counseling

Take exactly as prescribed (often once daily in the morning), with or without food; benefit may take several weeks; do not stop abruptly without medical advice; seek urgent help for suicidal thoughts, severe agitation, or symptoms of serotonin syndrome; avoid starting new serotonergic medicines (including some pain/cough or migraine medicines) without checking; increased bleeding risk with NSAIDs/aspirin/anticoagulants; may impair driving initially; sexual side effects can occur; if a dose is missed, take it the same day when remembered-do not double; store below 30°C (per SFDA product data).

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes), serotonin syndrome, and bleeding risk when combined with NSAIDs/anticoagulants; consider serum sodium (hyponatremia/SIADH) in older adults or symptomatic patients; monitor for manic switch in bipolar disorder and for sexual dysfunction/weight change as clinically indicated.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic serotonin (5‑HT) reuptake, increasing serotonergic neurotransmission in the CNS.

Onset of Action

Antidepressant effect: 2-4 weeks for initial response; full therapeutic effect may take 4-6 weeks

Product Information

Available Dosage Forms

For this SFDA product specifically: hard oral capsule, 20 mg (bottle of 30). In general fluoxetine is also available in other markets as tablets/capsules and oral solution; some markets have delayed-release formulations, but that is not applicable to this specific product record.

Composition per Dose

Each hard capsule: Fluoxetine 20mg (as fluoxetine hydrochloride)

Generic Availability

Yes

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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