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Fluoxetine information from DrugsUpdate  

See Available Brands of Fluoxetine in India

P - Caution when used during pregnancy
L - Contraindicated in Lactation

Fluoxetine (trade name Prozac) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Fluoxetine is approved for the treatment of major depression (including pediatric depression), obsessive-compulsive disorder (in both adult and pediatric populations), bulimia nervosa, anorexia nervosa, panic disorder and premenstrual dysphoric disorder. Despite the availability of newer agents, it remains extremely popular. Over 22.2 million prescriptions for generic formulations of fluoxetine were filled in the United States in 2007, making it the third most prescribed antidepressant.

Pharmacodynamics

The antidepressant, antiobsessive compulsive, and antibulimic actions of Fluoxetine are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Studies at clinically relevant doses in man have demonstrated that Fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that Fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine.

Antagonism of muscarinic, histaminergic, and α1-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs.

Pharmacokinetics

Fluoxetine is a potent and highly selective inhibitor of serotonin (5-HT) re-uptake. No affinity for adrenoceptors or histamine, GABA-B, or muscarinic receptors.

Absorption
Oral admin: Readily absorbed from the GI tract; peak plasma concentrations after 6-8 hr.

Distribution
Widely distributed; enters breast milk. Protein-binding: 95%.

Metabolism
Extensively hepatic by demethylation to norfluoxetine.

Excretion
Urine. Elimination half-life: 1-3 days (fluoxetine), 4-16 days (norfluoxetine).

Fluoxetine Indications / Fluoxetine Uses

Information Not Available

Fluoxetine Adverse Reactions / Fluoxetine Side Effects

Nervousness, insomnia, anxiety, headache, tremor, drowsiness, dry mouth, nausea, vomiting, sweating, diarrhoea. Seizures, mania, hypomania or mixed manic states reported. Hyponatraemia; elevation of hepatic enzymes.

Potentially Fatal: Rarely, systemic events possibly related to vasculitis have been reported in patients with rash but may be serious involving lungs, kidney and liver.

Precautions

Information Not Available

Special Precautions

Unstable epilepsy, liver and renal impairment, cardiac disease, diabetes, electroconvulsive therapy, bleeding disorders, closed-angle glaucoma; pregnancy. May impair performace of skilled tasks; withdraw gradually. Close monitoring of clinical worsening and behavioural changes during the 1st few mth of treatment or when there are dose changes.

Other Drug Interactions

May cause transient shift in plasma conc of tightly protein bound drugs e.g. warfarin and digoxin, resulting in adverse effects. T1/2 of diazepam is prolonged. Avoid concurrent use with clopidogrel.

Potentially Fatal: Serious reactions when combined with MAOIs; at least 14 days should elapse after MAOIs withdrawal before starting fluoxetine treatment or at least 5 wk should elapse after fluoxetine treatment before starting MAOIs therapy. Two-fold increase in plasma levels of other antidepressants when combined with fluoxetine. Monitor lithium levels when combined.

Other Interactions

Information Not Available

Dosage

Oral
Depression
Adult: 20-40 mg daily. Max: 80 mg daily.
Child: 8-18 yr: 10-20 mg daily; initiate at 10 mg daily for lower-wt children, may increase to 20 mg/day after 1 wk if necessary.
Elderly: Initially, 10 mg daily, may increase by 10-20 mg every few wk as tolerated.
Max Dosage:
Hepatic impairment: Dose adjustments may be needed.

Oral
Bulimia nervosa
Adult: 60 mg daily.
Hepatic impairment: Dose adjustments may be needed.

Oral
Obsessive compulsive disorder
Adult: Initially, 20 mg daily increased up to 60 mg daily after several wk if unresponsive. Max: 80 mg daily.
Child: 7-18 yr: Initially, 10 mg daily; may increase to 20 mg daily after 2 wk in adolescents and higher-wt children. Usual range: 10-60 mg daily.
Hepatic impairment: Dose adjustments may be needed.

Oral
Premenstrual dysmorphic disorder
Adult: 20 mg daily continuously. Alternatively, 20 mg daily, to be started 14 days before onset of menstruation and continue until 1st day of menses. May repeat with each cycle, if needed.
Hepatic impairment: Dose adjustments may be needed.

Oral
Panic disorder
Adult: Initial dose: 10 mg daily, may increase to 20 mg daily after a wk. May increase to 60 mg daily after a few wk, if needed.
Hepatic impairment: Dose adjustments may be needed.

Food(before/after)

May be taken with or without food

List of Contraindications

Fluoxetine and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Fluoxetine and Lactation

Contraindicated in lactation

Fluoxetine and Children

Information Not Available

Fluoxetine and Geriatic

Information Not Available

Fluoxetine and Other Contraindications

Severe renal or hepatic failure; hypersensitivity; lactation; concomitant MAOIs or within 2 weeks of MAOI withdrawal.

Storage

Oral
Store at 15-30°C

Lab interference

Oral
Store at 15-30°C

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