ANXETIN 20/MG CAP 20/CAP

Indications

Approved Uses

Major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, bulimia nervosa, premenstrual dysphoric disorder (PMDD), bipolar depression (as adjunct with olanzapine)

Off-Label Uses

Common off-label uses include generalized anxiety disorder, PTSD, social anxiety disorder, binge-eating disorder, and premature ejaculation.

Dosage & Administration

Dosing by Condition

Major depressive disorder: start 20 mg once daily; typical range 20-60 mg/day; max 80 mg/day. OCD: start 20 mg/day; typical range 20-60 mg/day; max 80 mg/day. Panic disorder: start 10 mg/day then increase to 20 mg/day; max 60 mg/day. Bulimia nervosa: 60 mg/day. PMDD: 20 mg/day either continuously or intermittently (luteal-phase dosing).

Initial Dose

20 mg once daily in the morning.

Maintenance Dose

20-60mg once daily

Maximum Dose

80 mg per day for depression and OCD; 60 mg per day for panic disorder and bulimia.

Children's Dosage

OCD (ages 7-17): Initial 10mg/day, may increase to 20-60mg/day. MDD (ages 8-18): Initial 10mg/day, may increase to 20mg/day after 1 week. Lower weight children: 10-20mg/day. Not approved for children under 7 years

Dose Adjustment Notes

If response is inadequate, increase gradually after several weeks; use lower or less frequent dosing in hepatic impairment and consider lower dosing in the elderly; when switching with MAOIs: wait at least 14 days after stopping an MAOI before starting fluoxetine, and wait at least 5 weeks after stopping fluoxetine before starting an MAOI.

How to Take

Swallow the capsule whole with water; may be taken with or without food; usually taken once daily in the morning (if activating/insomnia occurs, avoid late-day dosing).

Side Effects

Common Side Effects

Nausea, headache, insomnia, somnolence/drowsiness, diarrhea, dry mouth, anxiety/nervousness, tremor, sweating, decreased appetite/weight loss, fatigue/weakness, and sexual dysfunction (e.g., decreased libido, delayed ejaculation/anorgasmia).

Side Effect Frequency

Very common (≥10%): nausea, headache, insomnia, diarrhea; sexual dysfunction is common to very common depending on definition/study. Common (1-10%): anxiety/nervousness, decreased appetite/anorexia, tremor, dizziness, dry mouth, dyspepsia, sweating, abnormal dreams, fatigue/somnolence. Rare/serious: hyponatremia/SIADH, seizures, mania/hypomania, serotonin syndrome, abnormal bleeding, angle-closure glaucoma; QT prolongation is uncommon/rare and not a typical frequent effect at usual doses.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of MAOIs or within 14 days of stopping an MAOI, and do not start an MAOI within 5 weeks of stopping fluoxetine; (2) concomitant use with thioridazine; (3) concomitant use with pimozide; (4) known hypersensitivity to fluoxetine.

Warnings & Precautions

Key warnings/precautions: monitor for clinical worsening/suicidality (especially children/adolescents/young adults) during initiation and dose changes; risk of serotonin syndrome with serotonergic drugs; screen for bipolar disorder and monitor for mania/hypomania; increased bleeding risk with NSAIDs/antiplatelets/anticoagulants; hyponatremia/SIADH risk (higher in elderly/diuretics); seizure risk (use caution in seizure disorders); consider QT prolongation risk and avoid interacting QT-prolonging agents; use lower/less frequent dosing in hepatic impairment; taper when discontinuing when feasible.

Age Restriction

Not approved for MDD in children under 8 years or for OCD in children under 7 years

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions include: MAOIs (contraindicated; serotonin syndrome), linezolid or IV methylene blue (avoid/contraindicated due to serotonin syndrome risk), thioridazine and pimozide (contraindicated; QT prolongation/arrhythmia), other serotonergic agents (e.g., triptans, tramadol, lithium, other SSRIs/SNRIs/TCAs, St John’s wort-serotonin syndrome), anticoagulants/antiplatelets/NSAIDs (increased bleeding), and CYP2D6 substrates with narrow therapeutic index (fluoxetine is a strong CYP2D6 inhibitor-can increase levels of TCAs and some antipsychotics).

Interaction Severity

MAJOR/contraindicated: 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 agents (e.g., tramadol, triptans, TCAs, lithium, St. John’s wort) and anticoagulants/antiplatelets/NSAIDs (increased bleeding risk); CYP2D6 substrates with narrow therapeutic index (e.g., TCAs, some antipsychotics) may have increased levels.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Children

OCD (ages 7-17): Initial 10mg/day, may increase to 20-60mg/day. MDD (ages 8-18): Initial 10mg/day, may increase to 20mg/day after 1 week. Lower weight children: 10-20mg/day. Not approved for children under 7 years

Elderly

Start at lower dose (10mg/day), titrate slowly. Monitor for hyponatremia, falls, and drug interactions. Reduced clearance may necessitate lower maintenance doses.

Kidney Impairment

No routine dose adjustment is generally required in renal impairment; use caution and clinical monitoring in severe renal dysfunction.

Liver Impairment

Use a lower dose or less frequent dosing (e.g., reduced dose and/or longer dosing interval such as every other day) in hepatic impairment; use extra caution in severe hepatic disease.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly without medical advice; tapering is generally recommended, although fluoxetine’s long half-life makes discontinuation symptoms less likely/severe than many other SSRIs.

Overdose

Overdose may cause nausea/vomiting, agitation/CNS excitation, tremor, seizures, tachycardia/arrhythmias (including QT prolongation), somnolence, and serotonin syndrome; management is supportive (airway/breathing/circulation, consider activated charcoal if appropriate, treat seizures, and cardiac/ECG monitoring) and requires urgent emergency evaluation.

Patient Counseling

Take exactly as prescribed (usually once daily in the morning); may take several weeks to feel full benefit; do not stop abruptly without clinician advice; report suicidal thoughts, worsening mood, or unusual behavior changes; avoid combining with other serotonergic products (including St. John’s wort) unless advised and seek urgent care for serotonin syndrome symptoms; use caution with driving if drowsy; limit alcohol; report unusual bleeding/bruising and rash.

Monitoring Requirements

Monitor for worsening depression/suicidal ideation especially at initiation and dose changes; monitor for serotonin syndrome when combined with serotonergic drugs; monitor sodium (hyponatremia/SIADH) in older adults or at-risk patients; monitor weight/appetite; consider bleeding risk when used with NSAIDs/anticoagulants and monitor glucose in diabetics as clinically indicated.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic serotonin (5‑HT) reuptake, increasing synaptic serotonin; minimal direct affinity for muscarinic, histaminic, or adrenergic receptors compared with TCAs.

Onset of Action

Initial symptom improvement may be seen in 1-2 weeks; full antidepressant effect typically requires 4-6 weeks.

Metabolism

Hepatic metabolism to active norfluoxetine primarily via CYP2D6; other CYPs (notably CYP2C9 and CYP3A4) also contribute.

Excretion

Excreted mainly in urine as metabolites (≈60%); the remainder is excreted in feces (≈15%) with minimal unchanged drug.

Product Information

Available Dosage Forms

For this SFDA product: oral capsule (20 mg). In general fluoxetine is also available in tablets/capsules and oral solution; a delayed-release capsule formulation is not a standard fluoxetine dosage form (that is typical of some other SSRIs).

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

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.