DOSAGE AND ADMINISTRATION
Major
depression: The maintenance dosage is 20 mg daily administered in the morning.
Although symptomatic relief may be apparent within the first 1-3 weeks of
fluoxetine therapy, optimum anti-depressant effect usually requires at least
4 weeks or more of therapy with the drug. A dose increase may be considered
after several weeks if no clinical improvement is observed. Doses above 20
mg/day may be administered on a once-a-day (morning) or on a b.i.d. schedule
(i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day.
Obsessive-Compulsive Disorder:A dose of 20 mg/day administered in the morning
is recommended as the initial dose. A dose increase may be considered after
several weeks if insufficient clinical improvement is observed. The full therapeutic
effect may be delayed until 5 weeks of treatment or longer.
Doses above 20 mg/day may be administered on a once-a-day (morning) schedule
or on a twice a day schedule (i.e. morning and noon) not exceeding 80 mg/day.
2. THERAPEUTIC / DIAGNOSTIC CLAIMS
Health
2000 Fluoxetine 20 mg is indicated for the treatment of symptoms of major
depression and obsessive compulsive disorders. Fluoxetine also is used occasionally
to treat alcoholism, some eating disorders, attention-deficit disorders, borderline
personality disorders, sleep disorders, headaches, premenstrual syndrome,
irregular heartbeat, schizophrenia, Tourette's syndrome, anxiety, and phobias
3. DESCRIPTION OF DOSAGE FORM
Fluoxetine an antidepressant (mood elevator), is used to treat depression, obsessive-compulsive disorders, and some eating disorders. Fluoxetine is used to treat premenstrual dysphoric disorder.Fluoxetine comes as a capsule, tablet, and liquid to take by mouth. It is usually taken once or twice a day and may be taken with or without food.
4. CONTRAINDICATIONS
Hypersensitivity
to the drug.
WARNING AND PRECAUTIONS
Precaution has to be taken-
-if one has glaucoma, an enlarged prostate, difficulty urinating, seizures,
diabetes, an overactive thyroid gland, or liver or heart disease.
-one should know that this drug may make you drowsy. Do not drive a car or
operate machinery until one knows how this drug affects .
-alcohol can add to the drowsiness caused by this drug.
-If tobacco products are used. Cigarette smoking may decrease the effectiveness
of this drug.
DRUG
INTERACTION
Precaution has to be taken if drugs are taken within the last 2 weeks of fluoxetine
administration , especially anticoagulants [warfarin]; antidepressants; antihistamines;
antipsychotics such as haloperidol or clozapine ; buspirone; carbamazepine;
cyclosporine ; levodopa; lithium; MAO inhibitors [phenelzine; medication for
anxiety, diabetes, high blood pressure, seizures, Parkinson's disease, asthma,
colds, or allergies; muscle relaxants; phenytoin ; phentermine; pimozide;
sedatives; sleeping pills; sumatriptan; thioridazine; thyroid medications;
tranylcypromine]; tranquilizers; tryptophan; and vitamins. You should not
take phenelzine, tranylcypromine, or thioridazine until at least 5 weeks after
you stop taking fluoxetine.
PREGNANCY
AND NURSING MOTHERS
The safety of fluoxetine in pregnancy and lactating women has not been established.
Hence it should be used in this group of patients only when clearly needed.
PAEDIATRIC
USE
Safety and effectiveness in children have not been established.
IN
RENAL IMPAIRMENT
Fluoxetine should not be administered to patients with severe renal failure
(GFR<10 ml/min) since accumulation may occur.
IN
HEPATIC IMPAIRMENT
A lower o less frequent dose should be used in patients with cirrhois of the
liver.
5.
SIDE EFFECTS
Side effects from fluoxetine are common:
-upset stomach
-drowsiness
-weakness or tiredness
-excitement or anxiety
-insomnia
-nightmares
-dry mouth
-skin more sensitive to sunlight than usual
-changes in appetite or weight
6. TOXIC EFFECTS
MUTAGENICITY, CARCINOGENICITY AND TERATOGENICITY
In animal
studies, fluoxetine has not demonstrated teratogenic effects or fetotoxicty
but studies were limited by maternal toxicity. In humans, the number of exposed
pregnancies is too low to conclude. Therefore, as a precautionary measure,
fluoxetine use is not recommended during pregnancy.Fertility studies conducted
in rats at dose levels of up to 9 to 12.5 mg/kg/day showed that fluoxetine
had no adverse effects on fertility but that neonatal survival rate was slightly
decreased (probably associated with depressed maternal food consumption and
suppressed weight gain).
Fluoxetine did not show evidence of mutagenicity or carcinogenicity in animal
studies.