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Fluotin 20
Rx

Fluotin 20 contains fluoxetine that is a selective serotonin reuptake inhibitor (SSRI). The antidepressant, antiobsessive compulsive, and antibulimic actions of fluoxetine are presumed to be linked to its inhibition of central nervous system neuronal uptake of serotonin.

Pack size Box of 14 capsules, 28 capsules, 20 capsules. Bottle of 50 capsules, 100 capsules
Shelf-life 36 months
Composition Fluoxetine
Dosage forms and strengths Hard-gelatin capsule: 20 mg
Product code :

PRESCRIBING INFORMATION

Indications

  • Depression,
  • Bulimia nervosa,
  • Obsessive-compulsive disorder,
  • Panic disorder,
  • Premenstrual dysphoric disorder.

Dosage

Depression

  • Adults:
    20 mg once daily in the morning.
    If no clinical response is seen after several weeks, the daily dose may be gradually increased, up to a maximum of 80 mg daily (60 mg in the elderly).
    Doses above 20 mg daily may be given in 2 divided doses, for example in the morning and at noon, or as a once daily dose.
  • Children aged 8 years and over:
    Initial doses of 10 mg should be increased to 20 mg daily after 1 week (except in low-weight children when such increases should not be made for several weeks, and then only if the clinical response is insufficient).

Bulimia nervosa:

  • 60 mg once daily.

Obsessive-compulsive disorder:

  • Adults:
    The initial dose of fluoxetine is 20 mg once daily increased after several weeks if there is no response to up to 60 mg daily. Up to 80 mg daily has been used, sometimes divided into 2 doses.
  • Children aged 7 years and over:
    The starting dose is 10 mg daily; in low weight children this is increased after several weeks to 20 to 30 mg daily, if required. Adolescents and heavier children may be increased to 20 mg daily after 2 weeks; further increases to 60 mg daily may be made after several weeks, as necessary.

Panic disorder:

  • The initial dose is 10 mg once daily.
  • After a week the dose should be increased to 20 mg daily; further increases to 60 mg daily may be considered after several weeks if no improvement is seen.

Premenstrual dysphoric disorder:

  • 20 mg daily.
  • For each new cycle, fluoxetine should be started 14 days before the onset of menstruation and continued until the first full day of menstruation.
  • Treatment may be continued for 6 months; benefit should then be reassessed before continuing further.

Elderly patients:

  • A lower or less frequent dosage is recommended.

Usage

  • Orally administered.
  • Hypersensitivity to fluoxetine or any of its excipients.
  • Monoamine oxidase inhibitors (MAOI): Fluoxetine should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI.
  • Concomitant use in patients taking pimozide is contraindicated.
  • Thioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued.

Very common

  • Fatigue,
  • Diarrhoea,
  • Nausea,
  • Insomnia,
  • Headache.

Common

  • Feeling jittery, chills,
  • Vomiting, dyspepsia, dry mouth,
  • Anxiety, nervousness, restlessness, tension, libido decreased, sleep disorder, abnormal dreams.
  • Dizziness, dysgeusia, lethargy, somnolence, tremor.
  • Decreased appetite,
  • Vision blurred,
  • Palpitations,
  • Flushing,
  • Yawning,
  • Rash, urticaria, pruritus, hyperhidrosis.
  • Arthralgia,
  • Frequent urination,
  • Gynaecological bleeding, erectile dysfunction, ejaculation disorder.

Because of their epileptogenic effect SSRIs should be used with caution in patients with epilepsy or a history of such disorders. Treatment should be stopped if seizures develop or when there is an increase in seizure frequency.

Caution should be exercised when use Fluotin 20 for:

  • Patients with cardiac disease or a history of bleeding disorders.
  • Patients with angle-closure glaucoma.
  • Patients with diabetes since SSRIs may alter glycaemic control.
  • Patients with impaired hepatic function.

Patients should be closely monitored during early therapy until significant improvement in depression is observed because suicide is an inherent risk in depressed patients.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Fluotin 20.

Fluotin 20 is not recommended in pregnant and nursing women.

Patients should be advised to avoid driving a car or operating hazardous machinery.