Prozac - Comprehensive Usage Guide: instructions, indications, composition, side effects

• Active Ingredient: Fluoxetine hydrochloride
• Excipients: May include microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and other inactive ingredients depending on the formulation.

• Capsules: Available in various strengths, including 10 mg, 20 mg, and 40 mg capsules.
• Tablets: Available in various strengths, including 10 mg, 20 mg, and 60 mg tablets.
• Oral Solution: Available as a liquid formulation, typically in a concentration of 20 mg/5 mL.

Prozac belongs to the pharmacological group of selective serotonin reuptake inhibitors (SSRIs) (ATC code: N06AB03).

• Pharmacodynamics: Fluoxetine exerts its antidepressant effects by selectively inhibiting the reuptake of serotonin in the central nervous system, thereby increasing serotonin levels and enhancing neurotransmission.
• Pharmacokinetics: After oral administration, fluoxetine is well-absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 6 to 8 hours. It undergoes extensive hepatic metabolism via the cytochrome P450 enzyme system and has an active metabolite, norfluoxetine, with a longer half-life.

Prozac is indicated for the treatment of:

• Major depressive disorder
• Obsessive-compulsive disorder (OCD)
• Bulimia nervosa
• Panic disorder
• Premenstrual dysphoric disorder (PMDD)

Prozac is contraindicated in individuals with:

• Hypersensitivity to fluoxetine or any component of the formulation
• Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy
• Concurrent use with thioridazine due to the risk of QT prolongation and ventricular arrhythmias

Fluoxetine may interact with various medications, including:

• MAOIs
• Serotonergic drugs (e.g., serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants)
• Drugs metabolized by the CYP2D6 enzyme system (e.g., tricyclic antidepressants, beta-blockers)
• Warfarin and other anticoagulants

• Prozac capsules and tablets should be taken orally once daily in the morning or as directed by a healthcare provider, with or without food.
• The dosage should be individualized based on the patient’s response and tolerance, with initial doses typically lower for certain populations (e.g., elderly patients, patients with hepatic impairment).
• Gradual dose titration may be necessary to minimize the risk of adverse effects.
• It may take several weeks for the full therapeutic effect of Prozac to be achieved, and treatment should be continued even if symptomatic improvement is observed.

• Prozac should be used with caution during pregnancy, especially during the third trimester, due to the potential risk of neonatal complications such as persistent pulmonary hypertension of the newborn (PPHN).
• Breastfeeding is not recommended during Prozac treatment due to the excretion of fluoxetine and its metabolites in breast milk.

• The recommended starting dose for depression is 20 mg/day, with adjustments made in increments of 10 mg/day at weekly intervals, up to a maximum dose of 80 mg/day.
• For OCD, the initial dose is 20 mg/day, with adjustments up to a maximum dose of 80 mg/day.
• Bulimia nervosa and panic disorder may require higher initial doses (e.g., 60 mg/day) with adjustments made based on clinical response.
• PMDD is treated with a dose of 20 mg/day administered intermittently (e.g., daily during the luteal phase of the menstrual cycle).

In the event of Prozac overdose, supportive measures should be initiated, and symptomatic treatment may be necessary. Close monitoring of vital signs and cardiac function is essential, with particular attention to QT interval prolongation and arrhythmias.

Common side effects of Prozac may include:

• Nausea
• Insomnia
• Headache
• Somnolence
• Sexual dysfunction
• Weight changes
• Diarrhea

Serious adverse effects such as serotonin syndrome, suicidal ideation, and allergic reactions are rare but require immediate medical attention if they occur.

• Prozac capsules and tablets should be stored at room temperature (20-25°C) in a dry place, protected from light and moisture.
• The oral solution should be stored at controlled room temperature (20-25°C) and discarded 4 weeks after opening.

These comprehensive instructions provide valuable information on the composition, pharmacological properties, indications, contraindications, interactions, administration, side effects, and storage of Prozac, facilitating safe and effective antidepressant therapy. Always consult a healthcare professional for personalized medical advice.