Florest 50

Fluvoxamine is an SSRI antidepressant derived from an aralkylketone structure. It works by selectively inhibiting the reuptake of serotonin (5-hydroxytryptamine, 5-HT) into presynaptic nerve cells within the central nervous system.

By increasing serotonin concentrations at neuronal synapses, Fluvoxamine helps regulate mood, emotions, anxiety, and obsessive-compulsive symptoms. The enhanced serotonergic activity contributes to its antidepressant, anxiolytic, and anti-obsessional effects.

Florest 50 should be used exactly as prescribed by a registered physician.

• May be taken with or without food.
• Swallow the tablet whole with water.
• Do not crush, chew, or break the tablet.
• Take the medicine at the same time each day to maintain consistent therapeutic levels.
• Evening or bedtime administration is often preferred, particularly if drowsiness occurs.

Adults

Obsessive-Compulsive Disorder (OCD)

• Initial dose: 50 mg once daily
• Dose may be increased by 50 mg every 4–7 days according to clinical response and tolerability.
• Doses above 100 mg daily should be administered in two divided doses.
• Maximum dose: 300 mg daily

Depression

• Initial dose: 50–100 mg daily
• The dose may be gradually increased based on therapeutic response.
• Doses exceeding 150 mg daily should be administered in two or three divided doses.
• Maximum dose: 300 mg daily

Elderly Patients

• Recommended starting dose: 25 mg once daily
• Dose adjustments should be made cautiously with close clinical monitoring.

Hepatic Impairment

• Dose reduction may be necessary in patients with liver dysfunction.

Pediatric Use

Obsessive-Compulsive Disorder

Children older than 8 years:

• Initial dose: 25 mg once daily
• May be increased by 25 mg every 4–7 days if required.
• Doses exceeding 50 mg daily should be given in divided doses.
• Reassessment is recommended if no significant improvement is observed after 10 weeks of therapy.
• Maximum dose: 200 mg daily

If a dose is missed:

• Take it as soon as remembered.
• If it is nearly time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule.
• Do not take a double dose to compensate for a missed dose.

Florest 50 is contraindicated in patients with:

• Known hypersensitivity to Fluvoxamine or any component of the formulation.
• Concurrent use of monoamine oxidase inhibitors (MAOIs).
• Concomitant treatment with:
  • Thioridazine
  • Terfenadine
  • Astemizole
  • Cisapride
  • Pimozide
  • Alosetron
  • Tizanidine

Breastfeeding is generally not recommended during treatment unless specifically advised by a healthcare professional.

Use Florest 50 with caution in patients with:

• History of mania or bipolar disorder
• Seizure disorders or epilepsy
• Hepatic impairment
• Diabetes mellitus
• Glaucoma
• Cardiovascular disease
• History of suicidal thoughts or behavior

Additional precautions include:

• Increased risk of suicidal ideation and behavior in children, adolescents, and young adults under 24 years of age.
• Avoid abrupt discontinuation; taper gradually under medical supervision to minimize withdrawal symptoms.
• Exercise caution when operating machinery or driving until the drug's effects are known.
• Monitor prothrombin time when used concurrently with oral anticoagulants.
• Smokers may require additional monitoring due to potential alterations in drug metabolism.

Treatment with MAO inhibitors should not be initiated until at least 14 days after discontinuing Fluvoxamine.

Side Effects

Florest 50 is generally well tolerated; however, adverse effects may occur.

Very Common (≥10%)

• Nausea
• Headache
• Drowsiness (somnolence)
• Weakness or fatigue
• Insomnia
• Diarrhea
• Dizziness
• Dry mouth
• Reduced appetite
• Delayed or abnormal ejaculation

Common (1–10%)

• Dyspepsia
• Constipation
• Decreased libido
• Anxiety
• Tremor
• Increased sweating
• Vomiting
• Abdominal pain
• Muscle pain (myalgia)
• Taste disturbances
• Bruising
• Abnormal dreams
• Chest pain
• Palpitations
• Agitation
• Vasodilation
• Weight changes
• Elevated liver enzymes

Rare but Serious

• Mania or hypomania
• Seizures
• Significant mood changes
• Suicidal thoughts or behavior
• Serotonin syndrome

Patients should seek immediate medical attention if severe psychiatric or neurological symptoms develop.

Pregnancy

Available observational data have not demonstrated a clear association between Fluvoxamine use and major congenital malformations or miscarriage. However, untreated depression during pregnancy also carries significant maternal and fetal risks.

Use during pregnancy should be based on a careful assessment of benefits and risks by the treating physician.

Exposure to SSRIs, including Fluvoxamine, during late pregnancy has been associated with:

• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Poor neonatal adaptation syndrome
• Respiratory distress
• Feeding difficulties
• Irritability
• Tremor
• Hypoglycemia
• Seizures

Women who become pregnant while taking Florest 50 should consult their healthcare provider promptly.

Lactation

Fluvoxamine is excreted into breast milk. Although most reported cases have not identified serious adverse effects in breastfed infants, occasional reports of:

• Diarrhea
• Vomiting
• Sleep disturbances
• Agitation

have been documented.

The benefits of breastfeeding should be weighed against the mother's need for treatment and potential risks to the infant. Infants exposed through breast milk should be monitored appropriately.

Fluvoxamine has the potential to interact with numerous medications through effects on hepatic enzyme systems.

Significant interactions include:

• Carbamazepine: Increased serum concentrations and toxicity.
• Theophylline: Increased plasma levels and toxicity risk.
• Lithium: Enhanced serotonergic effects and increased risk of serotonin syndrome.
• Oral anticoagulants: May require dosage adjustment and closer monitoring.
• Diltiazem: Increased risk of bradycardia.
• Alcohol: Should be avoided because it may increase central nervous system adverse effects.

Potentially Serious Interaction

Fluvoxamine must not be used together with MAO inhibitors or within 14 days of discontinuing MAOI therapy, as this may result in life-threatening reactions, including serotonin syndrome.

Patient Counseling Information

• Take the medication regularly at the same time each day.
• Therapeutic improvement may take several weeks to become noticeable.
• Do not stop treatment abruptly without medical advice.
• Inform your physician immediately if you experience worsening depression, unusual behavioral changes, or suicidal thoughts.
• Avoid alcohol while taking Florest 50.
• Use caution when driving or operating machinery until you know how the medication affects you.
• Inform your healthcare provider about all prescription medicines, over-the-counter products, and herbal supplements you are taking.

Storage

• Store below the temperature recommended by the manufacturer.
• Protect from excessive heat, light, and moisture.
• Keep out of the reach of children.