Technology-II Assignment

Fluoxetine HCL
Fluoxetine, sold under the brand names Prozac and Sarafem, among
others, is an antidepressant of the selective serotonin reuptake
inhibitor (SSRI) class.
DOSAGE FORMS AND STRENGTHS:

• 10 mg Pulvule is an opaque green cap and opaque green body, imprinted
with DISTA 3104 on the cap and Prozac 10 mg on the body.
• 20 mg Pulvule is an opaque green cap and opaque yellow body, imprinted

• 40 mg Pulvule is an opaque green cap and opaque orange body, imprinted

• 90 mg Prozac Weekly Capsule is an opaque green cap and clear body

containing discretely visible white pellets through the clear body of the
capsule, imprinted with Lilly on the cap and 3004 and 90 mg on the body.
Introduction
Fluoxetine was discovered by Eli Lilly and Company in 1972, and
entered medical use in 1986. It is on the World Health Organization's
List of Essential Medicines. It is available as a generic medication. In
2020, it was the 25th most commonly prescribed medication in the
United States, with more than 23 million prescriptions. Lilly also
markets fluoxetine in a fixed-dose combination with olanzapine as
olanzapine/fluoxetine (Symbyax).
Indications & Uses

PROZAC is indicated for the treatment of:
• Acute and maintenance treatment of Major Depressive Disorder.
• Acute and maintenance treatment of obsessions and compulsions

in patients with Obsessive Compulsive Disorder (OCD).
• Acute and maintenance treatment of binge-eating and vomiting

behaviors in patients with moderate to severe Bulimia Nervosa.
• Acute treatment of Panic Disorder, with or without agoraphobia.
PROZAC and Olanzapine in Combination is indicated for the

treatment of:
• Acute treatment of depressive episodes associated with Bipolar I

Disorder.
• Treatment resistant depression (Major Depressive Disorder in

patients, who do not respond to 2 separate trials of different
antidepressants of adequate dose and duration in the current
episode).
 PROZAC monotherapy is not indicated for the treatment of

depressive episodes associated with Bipolar I Disorder or the
treatment of treatment resistant depression.
Mechanism of action
Fluoxetine is an antidepressant intended for oral administration.
Fluoxetine is a selective inhibitor of serotonin reuptake, its presumed
mechanism of action. Fluoxetine has practically no affinity to other
receptors such as α1-, α2- and ß-adrenergic; serotonergic;
dopaminergic; histaminergic; muscarinic; and GABA receptors.
Side Effects
Fluoxetine may cause side effects. Tell your doctor if any of these
symptoms are severe or do not go away:
 nervousness
 anxiety
 difficulty falling asleep or staying asleep
 nausea
 diarrhea
 dry mouth
 heartburn
 yawning
 weakness
 uncontrollable shaking of a part of the body
 loss of appetite
 weight loss
 unusual dreams
 stuffy nose
 sexual problems in males; decreased sex drive, inability to get
or keep an erection, or delayed or absent ejaculation
 sexual problems in females; decreased sex drive, or delayed
orgasm or unable to have an orgasm
 excessive sweating
 headache, confusion, weakness, difficulty concentrating, or
memory problems
Some side effects can be serious. If you experience any of the

following symptoms or those listed in the IMPORTANT WARNING
or SPECIAL PRECAUTIONS section, call your doctor immediately:
 rash
 hives or blisters
 itching
 fever
 joint pain
 swelling of the face, throat, tongue, lips, eyes, hands, feet,
ankles, or lower legs
 difficulty breathing or swallowing
 agitation, fever, sweating, confusion, fast or irregular
heartbeat, shivering, severe muscle stiffness or twitching,
hallucinations, loss of coordination, nausea, vomiting, or
diarrhea
 fast, slow, or irregular heartbeat
 shortness of breath
 dizziness or fainting
 seizures
 abnormal bleeding or bruising
Drug Interactions
• Monoamine Oxidase Inhibitors (MAOIs).
• Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of
CYP2D6 enzyme pathway.
• Tricyclic Antidepressants (TCAs): Monitor TCA levels during
coadministration with PROZAC or when PROZAC has been recently
discontinued.
• CNS Acting Drugs: Caution should be used when taken in
combination with other centrally acting drugs.
• Benzodiazepines: Diazepam – increased t½, alprazolam – further
psychomotor performance decrement due to increased levels.
• Antipsychotics: Potential for elevation of haloperidol and clozapine
levels.
• Anticonvulsants: Potential for elevated phenytoin and
carbamazepine levels and clinical anticonvulsant toxicity.
• Serotonergic Drugs
• Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin,
Warfarin): May potentiate the risk of bleeding.
• Drugs Tightly Bound to Plasma Proteins: May cause a shift in
plasma concentrations.
• Olanzapine: When used in combination with PROZAC, also refer to
the Drug Interactions section of the package insert for Symbyax.
• Drugs that Prolong the QT Interval: Do not use Prozac with
thioridazine or pimozide. Use with caution in combination with other
drugs that prolong the QT interval.
Pharmaceutical Particulars
 List of excipients:
o The capsule also contains; pregelatinised maize starch
anhydrous colloidal silica magnesium stearate talc.
o The capsule shell contains: quinoline yellow E104, erythrosine

E127 indigo carmine El32 titanium dioxide E171 gelatin.
o The printing ink Opacode S-1-17823 black contains: Black iron

oxide (El72) Shellac Glaze Propylene Glycol (E1520)
Ammonium hydroxide (E527)
 Special precautions for storage:
o AL/PVC Blister; Do not store above 25°C. Store in the original

package.
o HDPE Bottle: Do not store above 25°C Keep the bottle tightly
closed.
 Nature and contents of container:
o Al/PVC blisters. Pack size 28 or 30 capsules

o Al-PVC/PVDC blisters: Pack size 28 or 30 capsules
o HDPE bottle with white LDPE snap on cap. Pack size 28 or 30
capsules.
o Not all pack sizes may be marketed.
 Available Brand Names & Unit Price:
Brand Dosage Strength Company Pack Size & Price

Name Form
Beximco Unit price: $ 2.98
Modipran Capsule 20 mg Pharmaceutical
s Ltd.
Capsule General Unit price: $ 2.81
Nodep 20 mg pharmaceutical
s Ltd.
Kemiko Unit price: $ 2.60
Nodepress Capsule 20 mg Pharmaceutical
s Ltd.
Decent Pharma Unit price: $ 2.90
Oxetin Capsule 20 mg Laboratories
Ltd.
Sun Unit price: $ 3.01
Prodep Capsule 20 mg Pharmaceutical
Ltd.
Square Unit price: $ 3.01
Prolert Capsule 20 mg Pharmaceutical
s Ltd.
Square 100 ml bottle:$ 60
Prolert Oral 20 mg/5 Pharmaceutical
Suspension ml s Ltd.
Sonear Unit price: $ 2.87
Seren Capsule 20 mg Laboratories
Ltd.
WARNING: SUICIDAL THOUGHTS AND
BEHAVIORS
• Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and young adults in short-term studies. These
studies did not show an increase in the risk of suicidal thoughts and
behavior with antidepressant use in patients over age 24; there was a
reduction in risk with antidepressant use in patients aged 65 and older.
• In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening and for emergence of suicidal thoughts
and behaviors. Advise families and caregivers of the need for close
observation and communication with the prescriber.
• PROZAC is not approved for use in children less than 7 years of
age.
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Fluoxetine HCL

DOSAGE FORMS AND STRENGTHS:

• 20 mg Pulvule is an opaque green cap and opaque yellow body, imprinted

• 40 mg Pulvule is an opaque green cap and opaque orange body, imprinted

• 90 mg Prozac Weekly Capsule is an opaque green cap and clear body

Indications & Uses

• Acute and maintenance treatment of Major Depressive Disorder.

• Acute and maintenance treatment of obsessions and compulsions

• Acute and maintenance treatment of binge-eating and vomiting

• Acute treatment of Panic Disorder, with or without agoraphobia.

PROZAC and Olanzapine in Combination is indicated for the

• Acute treatment of depressive episodes associated with Bipolar I

• Treatment resistant depression (Major Depressive Disorder in

 PROZAC monotherapy is not indicated for the treatment of

Some side effects can be serious. If you experience any of the

o The capsule shell contains: quinoline yellow E104, erythrosine

o The printing ink Opacode S-1-17823 black contains: Black iron

 Special precautions for storage:

o AL/PVC Blister; Do not store above 25°C. Store in the original

 Nature and contents of container:

o Al/PVC blisters. Pack size 28 or 30 capsules

Brand Dosage Strength Company Pack Size & Price

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