Dosulepin Tablets BP 75mg Technical Specification:

Product Name:Dosulepin Tablets BP 75mg
Brand Name:DROTHITAJ
Strength:25mg, 50mg, 75mg
Dosage Form:Tablets (Film coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 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: It is used to treat symptoms of depression (low mood) such as: Feeling sad. Feeling hopeless or worthless.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dosulepin Tablets BP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dosulepin Tablets BP 75mg
    Each film coated tablet contains:
    Dothiepin Hydrochloride BP……….75mg
    Excipients……………………………………q.s.
    Colours: Iron oxide Red

THERAPEUTIC INDICATIONS:

Dosulepin is used in the treatment of anxiety disorder and depression. It is used in patients intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Take whole tablet with water.

Read enclosed leaflet before use.

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

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight container.

Protect from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Dosulepin Tablets BP 25mg
B) Dosulepin Tablets BP 50mg
C) Dosulepin Tablets BP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Dosulepin Tablets BP 25mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP……….25mg
Excipients……………………………………q.s.
Colours: Lake brilliant blue

B) Dosulepin Tablets BP 50mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP…………50mg
Excipients……………………………………. q.s.
Colours: Indigo carmine aluminum lake

C) Dosulepin Tablets BP 75mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP………….75mg
Excipients………………………………………q.s.
Colours: Iron oxide Red


THERAPEUTIC INDICATIONS:

Dosulepin is used in the treatment of anxiety disorder and depression. It is used in patients intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.

CAUTION & WARNING:

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

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.