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FLUTIN CAP.

Composition
Each capsule contains:
Fluoxetine hydrochloride (equivalent to Fluoxetine base) 20 mg

Properties and Mode of Action

FLUTIN is an antidepressant belonging to the group of Selective Serotonin Reuptake Inhibitors (SSRIs), which exerts its
action by inhibiting C.N.S. neuronal uptake of serotonin.
FLUTIN, unlike tricyclic and tetracyclic antidepressants, has limited antimuscarinic side effect and is less cardiotoxic.
FLUTIN is readily absorbed from the gastrointestinal tract with peak plasma concentrations appearing about 6 - 8 hours
after oral administration. The systemic bioavailability does not appear to be affected by food.
It is extensively metabolised by demethylation in the liver to its primary active metabolite norfluoxetine.
Excretion is mainly via the urine.
FLUTIN has a relatively long elimination half-life of about 1 - 3 days. That of its metabolite norfluoxetine is even longer
being about 4 - 16 days. Steady state plasma concentrations will only be attained after several weeks.
Additionally, when dosing is stopped, active drug substance will persist in the body for weeks. This should be borne in
mind when starting or stopping treatment.
Both fluoxetine and norfluoxetine are excreted in breast milk.

Indications
Depression.
Obsessive - Compulsive Disorder (OCD).
Also it has been investigated in the treatment of obesity and bulimia nervosa.

Dosage and Administration

For Adults Only.
Depression:
Recommended initial dose is 20 mg/day in the morning.
Consider a dose increase after several weeks if there is no clinical improvement, up to 80 mg/day which is the maximum
daily dose.
Obsessive Compulsive Disorder (OCD):
Recommended initial dose is 20 mg/day in the morning.
Consider a dose increase after several weeks if there is no clinical improvement, up to 60 mg/day.
Obesity and Bulimia:
FLUTIN has been investigated in the treatment of obesity and bulimia nervosa at a dose of 20 - 60 mg/day.
FLUTIN should be given in a lower dose e.g.: alternate day dosing in patients with significant hepatic dysfunction or mild
to moderate renal failure.

Precautions
FLUTIN should be used with caution in patients with epilepsy and should be discontinued in any patient who develops
seizures.
FLUTIN may alter glycaemic control.Hypoglycaemia may occur during therapy with FLUTIN and hyperglycaemia may
occur following discontinuation. Insulin and/or oral hypoglycaemic dosage may need to be adjusted when FLUTIN is
started or discontinued.
FLUTIN should be avoided during pregnancy and lactation. Studies on pregnant or nursing mothers have not yet been
established, so it is used only if clearly needed.

Drug Interactions
At least 2 weeks should elapse between discontinuation of a MAOI and initiation of therapy with FLUTIN. Also 5 weeks
should elapse between discontinuation of FLUTIN and initiation of therapy with MAOIs.
Concurrent use of FLUTIN with tricyclic antidepressants and trazodone results in increase in their plasma concentrations.
Concurrent use of FLUTIN and lithium may increase lithium level with possible neurotoxicity. Lithium level should be
monitored.

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Concurrent use of FLUTIN and dextromethorphan may result in hallucinations. The half-life of concurrently-administered
diazepam with FLUTIN can be prolonged. Also FLUTIN has been reported to increase alprazolam plasma concentration
which may be accompanied by increased psychomotor impairment.
As FLUTIN metabolism involves the hepatic cytochrome P-450 2D6, concomitant therapy with drugs also metabolized by
this enzyme results in increase in their serum concentrations and their dose should be adjusted when beginning or
discontinuing FLUTIN treatment e.g. as with antipsychotics, beta-blockers: metoprolol and Type 1C antiarrhythmics:
propafenone, flecanide and encainide.

Contra_indications
Hypersensitivity to fluoxetine. Cases of severe hepatic or renal function impairment.

Side effects
FLUTIN as an SSRIs is generally well-tolerated, but the following adverse effects may occur: nausea, dyspepsia,
anorexia, weight loss, anxiety, insomnia, restlessness, excessive sweating, skin rash, urticaria, hyponatraemia, fatigue,
headache, tremors, dizziness, convulsions, decreased libido, delayed ejaculation, impotence, and anorgasmia.

Presentation
Box of 2 blisters of 7 capsules each.

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