Clomipramine HCl Tablets 75mg Technical Specification:

Product Name:            Clomipramine HCl Tablets 75mg
Brand Name:CLOMIPRAMINE
Strength:25gm, 50mg, 75mg
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:100s, 500s.1000s
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: Clomipramine is used to treat obsessive compulsive disorder (OCD). OCD is a nervous condition wherein a person has recurring thoughts or ideas or does repetitive things because they are anxious. Clomipramine is a tricyclic antidepressant (TCA).
Storage:Do not store above 30°C.Oral solution: Store in the original container to protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT: 

  • Clomipramine HCl Tablets 75mg (Clomipramine)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clomipramine HCl Tablets USP 75mg
    Each film coated Tablet Contains:
    Clomipramine Hydrochloride……………75mg
    Excipients………………………………………q.s.
    Colour: D&C Red 27 Lake

 THERAPEUTIC INDICATIONS:

Clomipramine Tablets are indicated for the treatment of:
– the symptoms of depressive illness especially where sedation is required
– obsessional and phobic states
– adjunctive treatment of cataplexy associated with narcolepsy.

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) Clomipramine HCl Tablets 25gm (Clomipramine)
B) Clomipramine HCl Tablets 50mg (Clomipramine)
C) Clomipramine HCl Tablets 75mg (Clomipramine)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Clomipramine HCl Tablets USP 25gm
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………...25mg
Excipients………………………………………q.s.
Colour: Ponceau 4R

B) Clomipramine HCl Tablets USP 50mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………...50mg
Excipients………………………………………q.s.
Colour: Iron Oxide Red

C) Clomipramine HCl Tablets USP 75mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………75mg
Excipients………………………………………q.s.
Colour: D&C Red 27 Lake


THERAPEUTIC INDICATIONS:

Clomipramine Tablets are indicated for the treatment of:
– the symptoms of depressive illness especially where sedation is required
– obsessional and phobic states
– adjunctive treatment of cataplexy associated with narcolepsy.

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.