Quetiapine fumarate Tablets USP 25mg Technical Specification:

Product Name:                 Quetiapine fumarate Tablets USP 25mg
Brand Name:Generics
Strength:25mg, 50mg, 100mg, 150mg, 200mg, 300mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:60s, 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:Anticonvulsant, Antipsychotic
Indication: Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers.
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Quetiapine fumarate Tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Quetiapine fumarate Tablets USP 25mg
    Each film-coated tablet contains:
    Quetiapine fumarate USP
    Equivalent to Quetiapine………….25mg
    Excipients……………………………q.s.
    Colours: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Quetiapine oral tablet is used to treat the symptoms of schizophrenia, bipolar disorder, or depression.

Quetiapine can be used to treat symptoms in adults who have depressive episodes or manic episodes caused by bipolar I disorder. For major depression, quetiapine is used as an add-on treatment for people already taking antidepressant drugs.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Avoid while taking quetiapine: Quetiapine Interactions with Food and Herbs

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

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place. 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. Quetiapine fumarate Tablets USP 25mg
B. Quetiapine fumarate Tablets USP 50mg
C. Quetiapine fumarate Tablets USP 100mg
D. Quetiapine fumarate Tablets USP 150mg
E. Quetiapine fumarate Tablets USP 200mg
F. Quetiapine fumarate Tablets USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Quetiapine fumarate Tablets USP 25mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….25mg
Excipients……………………………q.s.
Colours: Iron Oxide Red


B. Quetiapine fumarate Tablets USP 50mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….50mg
Excipients……………………………q.s.
Colours: Quinoline Yellow

C. Quetiapine fumarate Tablets USP 100mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….100mg
Excipients……………………………q.s.
Colours: D&C Orange 4

D. Quetiapine fumarate Tablets USP 150mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….150mg
Excipients……………………………q.s.
Colours: Erythrosine Lake

E. Quetiapine fumarate Tablets USP 200mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….200mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide

F. Quetiapine fumarate Tablets USP 300mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….300mg
Excipients……………………………q.s.
Colours: Iron oxide Red

THERAPEUTIC INDICATIONS:

Quetiapine oral tablet is used to treat the symptoms of schizophrenia, bipolar disorder, or depression.
Quetiapine can be used to treat symptoms in adults who have depressive episodes or manic episodes caused by bipolar I disorder. For major depression, quetiapine is used as an add-on treatment for people already taking antidepressant drugs.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Avoid while taking quetiapine: Quetiapine Interactions with Food and Herbs
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. 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.