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Sedatives

Fluotin 20

 

Pack size:            

Box of 2 blisters x 10 capsules.

 

Composition:

Each capsule contains fluoxetine 20 mg (as fluoxetine hydrochloride)

 

Shelf-life:  

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions


Fluotin 20 is administered orally in treatment of:

  • Depression
    Adults: The usual initial dose of fluoxetine is 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).
  • 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.
  • Bulimia nervosa
    The recommended dose is 60 mg once daily.
  • 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
    A dose of 20 mg daily is used in the treatment. Intermittent dosing is also permitted: 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.
  • Fluoxetine is subject to hepatic metabolism, therefore, lower doses, such as alternate-day dosing, have been recommended in patients with significant hepatic impairment.

Or as prescribed by physicians.

 

  • Hypersensitivity to fluoxetine or any ingredient of the drug.
  • 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. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine before starting 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.
  • Metabolism and nutrition disorders: Decreased appetite.
  • Vision blurred.
  • Palpitations
  • Flushing.
  • Yawning.
  • Rash, urticaria, pruritus, hyperhidrosis.
  • Arthralgia.
  • Frequent urination.
  • Gynaecological bleeding, erectile dysfunction, ejaculation disorder.

Uncommon

  • Malaise, feeling abnormal, feeling cold, feeling hot
  • Dysphagia
  • Elevated mood, euphoric mood, thinking abnormal, orgasm abnormal, bruxism.
  • Psychomotor hyperactivity, dyskinesia, ataxia, balance disorder, myoclonus.
  • Mydriasis.
  • Hypotension.
  • Alopecia, increased tendency to bruise, cold sweat.
  • Muscle twitching.
  • Dysuria.
  • Sexual dysfunction.

Rare

  • Oesophageal pain.
  • Anaphylactic reaction, serum sickness.
  • Hyponatraemia.
  • Hypomania, mania, hallucinations, agitation, panic attacks.
  • Convulsion, akathisia, buccoglossal syndrome.
  • Vasculitis, vasodilatation.
  • Angioedema, ecchymosis, photosensitivity reaction, purpura.
  • Pharyngitis.
  • Urinary retention.
  • Galactorrhoea.

     

  • 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 ifseizures develop or when there is an increase in seizure frequency.
  • Patients with cardiac disease or a history ofbleeding disorders.
  • Patients with angle-closure glaucoma.
  • Patients with diabetes since SSRIs may alter glycaemic control.
  • Fluoxetine undergoes hepatic metabolism and should be used with caution and in reduced doses in 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.
  • Pregnancy: The safety of fluoxetine has not been established during pregnancy, and therefore its use is not recommended.
  • Lactation: Fluoxetine and its metabolites distribute into human milk. Therefore, fluoxetine should not be used in nursing women, and women should be advised to notify their physician if they plan to breast-feed.
  • Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgement or skills. Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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