Fluoxetine Capsules USP 20mg Technical Specification:

Product Name:   Fluoxetine Capsules USP
Brand Name:Generics
Strength:10mg, 20mg, 40mg, 60mg
Dosage Form:Capsule (Hard gelatine)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidepressants, Central Nervous System
Indication: Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks).
Storage:Do not store above 30°C.Oral solution: Store in the original container to protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fluoxetine Capsules USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION

  • Fluoxetine Capsules USP 20mg
    Each Hard Gelatin capsule contains:
    Fluoxetine Hydrochloride USP
    Equivalent to Fluoxetine…………….20mg
    Excipients……………………………………q.s.
    Approved colour used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks).

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Fluoxetine Capsules USP10mg
b) Fluoxetine Capsules USP 20mg
c) Fluoxetine Capsules USP 40mg
d) Fluoxetine Capsules USP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Fluoxetine Capsules USP10mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine……………10mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.

b) Fluoxetine Capsules USP 20mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………….20mg
Excipients……………………………………q.s.
Approved colour used in empty capsule shells.


c) Fluoxetine Capsules USP 40mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………...40mg
Excipients…………………………………q.s.
Approved colour used in empty capsule shells.

d) Fluoxetine Capsules USP 60mg
Each Hard Gelatin capsule contains:
Fluoxetine Hydrochloride USP
Equivalent to Fluoxetine…………...60mg
Excipients…………………………………q.s.
Approved colour used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.