PROZAC- fluoxetine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fluoxetine hydrochloride (UNII: I9W7N6B1KJ) (Fluoxetine - UNII:01K63SUP8D)

Available from:

Stat Rx USA

INN (International Name):

Fluoxetine hydrochloride

Composition:

Fluoxetine hydrochloride 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prozac is indicated for the treatment of major depressive disorder. Adult — The efficacy of Prozac was established in 5– and 6–week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM–III (currently DSM–IV) category of major depressive disorder (see CLINICAL TRIALS). A major depressive episode (DSM–IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of Prozac in hospitalized depressed patients have not been adequately studied. The efficacy of Prozac 20

Authorization status:

New Drug Application

Patient Information leaflet

PROZAC - FLUOXETINE HYDROCHLORIDE CAPSULE
Stat Rx USA
----------
Medication Guide
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic–
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or worry you:
•
thoughts abo

Summary of Product characteristics

PROZAC - FLUOXETINE HYDROCHLORIDE CAPSULE
STAT RX USA
----------
PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE
CLINICAL PHARMACOLOGYPharmacodynamics
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 α –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.
Absorption, Distribution, Metabolism, and Excretion
SYSTEMIC BIOAVAILABILITY — In man, following a single oral 40–mg
dose, peak plasma concentrations of
fluoxetine from 15 to 55 ng/mL are observed after 6 to 8 hours.
The Pulvule, oral solution, and Prozac Weekly capsule dosage forms of
fluoxetine are bioequivalent.
Food does not appear to affect the systemic bioavailability of
fluoxetine, although it may delay its
absorption by 1 to 2 hours, which is probably not clinically
significant. Thus, fluoxetine may be
administered with or without food. Prozac Weekly capsules, a
delayed–release formulation, contain
enteric–coated pellets that resist dissolution until reaching a
segment of the gastrointestinal tract where
the pH exceeds 5.5. The enteric coating delays the onset of absorption
of fluoxetine 1 to 2 hours
relative to the immediate–release formulations.
PROTEIN BINDING — Over the concentration range from 200 to 1000
ng/mL, approximately 94.5% of
fluoxetine is bound in vitro to human serum proteins, including
albumin and α –glycoprotein. The
interaction between fluoxetine and other highly pr