Trifluoperazine Tablets USP 2mg

Trifluoperazine Tablets USP 2mg
Product Name:Trifluoperazine Tablets USP
Brand Name:Generic
Strength:1mg, 2mg, 5mg
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:Antipsychotic, Anti-anxiety, Antidepressant
Indication:Trifluoperazine is indicated in low dosages for the treatment of anxiety and depression and in high dosages for the treatment of schizophrenia and other paranoid psychoses.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Trifluoperazine Tablets USP 1mg
    Each film-coated tablet contains:
    Trifluoperazine hydrochloride USP
    Equivalent to Trifluoperazine 2mg
    Colour: Ferric Oxide Yellow
  • Trifluoperazine Tablets USP 2mg
    Each film-coated tablet contains:
    Trifluoperazine hydrochloride USP
    Equivalent to Trifluoperazine 2mg
    Colour: Carmoisine
  • Trifluoperazine Tablets USP 5mg
    Each film-coated tablet contains:
    Trifluoperazine hydrochloride USP
    Equivalent to Trifluoperazine 5mg
    Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Low dosage: ‘Trifluoperazine’ is indicated as an adjunct in the short-term management of anxiety states, depressive symptoms secondary to anxiety, and agitation. It is also indicated in the symptomatic treatment of nausea and vomiting.
High dosage: ‘Trifluoperazine’ is indicated for the treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. It may also be used as an adjunct in the short-term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
Dosage: As directed by the Physician.

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