SALIPAX 30 CAP

Indications

Approved Uses

Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, Panic Disorder, Premenstrual Dysphoric Disorder (PMDD).

Dosage & Administration

Dosing by Condition

Major depressive disorder (adults): 20 mg once daily initially; may increase after several weeks; usual 20-60 mg/day; maximum 80 mg/day.
Obsessive-compulsive disorder: 20 mg once daily initially; usual 20-60 mg/day; maximum 80 mg/day.
Bulimia nervosa: 60 mg/day (typically once daily).
Panic disorder: 10 mg once daily initially; increase to 20 mg/day after ~1 week if tolerated; usual 20-60 mg/day; maximum 60 mg/day.
PMDD: 20 mg/day either continuously or intermittently (e.g., during the luteal phase).

Initial Dose

20mg once daily in the morning for Major Depressive Disorder.

Maintenance Dose

20-60mg once daily.

Maximum Dose

80mg per day.

Children's Dosage

OCD (children ≥7 years and adolescents): initial 10mg/day, may increase to 20-60mg/day. Lower-weight children: initial 10mg/day, max 30mg/day. MDD (adolescents ≥8 years): initial 10mg/day, may increase to 20mg/day after 1 week

Dose Adjustment Notes

If inadequate response, increase gradually after several weeks; use lower or less frequent dosing in hepatic impairment and consider lower starting doses in older adults; no routine adjustment is needed in mild-moderate renal impairment, but use caution in severe renal dysfunction; avoid late-day dosing if insomnia occurs.

How to Take

Swallow the capsule whole with water; may be taken with or without food; usually take once daily in the morning (or earlier in the day if activating/insomnia occurs).

Side Effects

Common Side Effects

Nausea, headache, insomnia, somnolence/drowsiness, diarrhea, dry mouth, decreased appetite/weight loss, anxiety/nervousness, tremor, sweating, fatigue/asthenia, dizziness, and sexual dysfunction.

Side Effect Frequency

Most common (≥5% and at least twice placebo): abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, yawn. Rare/serious: hyponatremia/SIADH, seizures,

Safety & Warnings

Contraindications

Contraindicated with MAOIs (and 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 patients with hypersensitivity to fluoxetine. Also avoid/contraindicated with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Key warnings/precautions: monitor for suicidality/clinical worsening (especially early and in <25); serotonin syndrome risk with serotonergic agents; screen for bipolar disorder/mania activation; increased bleeding risk with NSAIDs/anticoagulants; hyponatremia/SIADH (higher risk in elderly/diuretics); seizure risk; QT prolongation risk with interacting drugs; long half-life means interactions can persist after stopping; tapering generally advised though discontinuation symptoms are less common.

Age Restriction

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

Drug Interactions

Drug Interactions

Major/contraindicated: MAOIs; thioridazine; pimozide; avoid/contraindicated: linezolid and IV methylene blue. Clinically important: other serotonergic drugs (e.g., triptans, tramadol, other antidepressants, lithium) → serotonin syndrome risk; NSAIDs/aspirin/anticoagulants (incl. warfarin) → bleeding risk; strong CYP2D6 inhibition by fluoxetine → increased levels of CYP2D6 substrates (e.g., TCAs, some antipsychotics); QT-prolonging drugs → additive QT risk; phenytoin/carbamazepine levels may be affected.

Interaction Severity

"Contraindicated/Major: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; thioridazine and pimozide due to QT prolongation/arrhythmia risk.
Moderate/Clinically significant: Other serotonergic drugs (e.g., tramadol, triptans, lithium, St. John’s wort) → serotonin syndrome risk; anticoagulants/antiplatelets/NSAIDs → bleeding risk; CYP2D6 substrates with narrow therapeutic index (e.g., TCAs, some antipsychotics such as risperidone) → increased concentrations/toxicity risk.
Other notable: Warfarin-monitor INR/bleeding; alcohol-additive CNS effects (counsel to limit/avoid)."

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

OCD (children ≥7 years and adolescents): initial 10mg/day, may increase to 20-60mg/day. Lower-weight children: initial 10mg/day, max 30mg/day. MDD (adolescents ≥8 years): initial 10mg/day, may increase to 20mg/day after 1 week

Elderly

Start at lower dose (10mg/day), titrate slowly. Monitor for hyponatremia, falls, and drug interactions. Standard adult maximum doses apply but lower maintenance doses are often sufficient

Kidney Impairment

No routine dose adjustment in renal impairment; use caution in severe renal impairment due to limited data/accumulation potential.

Liver Impairment

Hepatic impairment: use a lower dose or less frequent dosing (e.g., ~50% reduction or alternate-day dosing), especially in significant hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper when feasible-withdrawal is less common/severe than with shorter-acting SSRIs due to long half-life, but can still occur.

Patient Counseling

Take once daily (often in the morning) with or without food; expect gradual benefit over several weeks; do not stop abruptly without prescriber advice; report suicidal thoughts/behavior changes, symptoms of serotonin syndrome, or unusual bleeding/bruising; avoid or limit alcohol and use caution with driving until effects are known; inform clinicians about all medicines (especially other serotonergic agents, NSAIDs, anticoagulants); discuss use in pregnancy/breastfeeding.

Monitoring Requirements

Monitor for clinical worsening/suicidal ideation (especially early and after dose changes), serotonin syndrome, bleeding risk when combined with NSAIDs/anticoagulants, hyponatremia (especially older adults/diuretics), weight/appetite, and overall therapeutic response/tolerability.

Pharmacology

Mechanism of Action

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

Duration of Effect

Clinical effect from a given dose is sustained for at least 24 hours; due to long half-lives (fluoxetine ~2-4 days; norfluoxetine ~7-15 days), pharmacologic effects may persist for 1-2+ weeks after discontinuation.

Half-Life

Fluoxetine: 1-3 days (acute), 4-6 days (chronic). Norfluoxetine (active metabolite): 4-16 days

Bioavailability

Approximately 60-80% (commonly cited around ~70%); not clinically significantly affected by food.

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 to active norfluoxetine; additional pathways include CYP2C9 and CYP2C19 (and to a lesser extent CYP3A4). Fluoxetine is a strong CYP2D6 inhibitor and also inhibits CYP2C19 (moderate) and CYP3A4 (weak-moderate).

Excretion

Eliminated mainly via hepatic metabolism; primarily in urine as metabolites

Protein Binding

Approximately 94-95% (about 94.5%) protein bound.

Product Information

Available Dosage Forms

For fluoxetine in general: capsule, tablet, oral solution; additionally, a delayed-release capsule formulation exists in some markets (fluoxetine weekly). For this SFDA product: capsule (oral), 20 mg.

Composition per Dose

Each capsule: 20mg fluoxetine (as fluoxetine hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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