Risperidone Tablets USP 2mg

Risperidone Tablets USP 2mg
Product Name:Risperidone Tablets USP
Brand Name:RESPERITAJ
Strength:1mg, 2mg, 3mg, 4mg
Dosage Form:Tablets (Film-coated)
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:Antipsychotic, Central Nervous System
Indication:It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.
Storage:Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Risperidone Tablets USP 1mg
    Each film-coated Tablet Contains:
    Risperidone…………….1mg
    Excipients……………………q.s.
    Colures: Brilliant Blue.
  • Risperidone Tablets USP 2mg
    Each film-coated Tablet Contains:
    Risperidone…………….2mg
    Excipients……………………q.s.
    Colures: Sunset Yellow.
  • Risperidone Tablets USP 3mg
    Each film-coated Tablet Contains:
    Risperidone…………….3mg
    Excipients……………………q.s.
    Colures: Iron Oxide Yellow.
  • Risperidone Tablets USP 4mg
    Each film-coated Tablet Contains:
    Risperidone………………4mg
    Excipients……………………q.s.
    Colures: Quinoline Yellow.

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Swallow whole does not chew or crush.
*Not suitable for children under 10 years.
*Treatment of moderate to severe manic episodes associated with bipolar disorders. <br>
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. <br>
If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage:  As directed by the Physician.
NOTE: Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults & adolescents aged 13-17 years.

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