Tamoxifen Citrate Tablets USP 20mg Technical Specification:

Product Name:Tamoxifen Citrate Tablets USP 20mg
Brand Name:Tamoxifen Citrate
Strength:10mg, 20mg, 40mg
Dosage Form:uncoated Tablet
Packing:100s, 200s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tamoxifen Citrate Tablets USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tamoxifen Citrate Tablets USP 20mg 
    Each uncoated tablet contains:
    Tamoxifen Citrate USP
    Equivalent to tamoxifen…………20mg
    Excipient………………………………..q.s.

THERAPEUTIC INDICATIONS:

Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Caution: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.

Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

PRESCRIPTION ONLY MEDICINE (POM)

ANTINEOPLASTIC AGENT (NON-STEROIDAL ANTIESTROGEN)

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Dispense in a well closed, light resistant container as defines in the USP, with a child resistant closure (as required)

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Tamoxifen Citrate Tablets USP 10mg
b) Tamoxifen Citrate Tablets USP 20mg
c) Tamoxifen Citrate Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Tamoxifen Citrate Tablets USP 10mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………10mg
Excipient………………………………..q.s.

b) Tamoxifen Citrate Tablets USP 20mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………20mg
Excipient………………………………..q.s.

c) Tamoxifen Citrate Tablets USP 40mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………40mg
Excipient………………………………..q.s.

THERAPEUTIC INDICATIONS:

Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Caution: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
PRESCRIPTION ONLY MEDICINE (POM)
ANTINEOPLASTIC AGENT (NON-STEROIDAL ANTIESTROGEN)
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
Dispense in a well closed, light resistant container as defines in the USP, with a child resistant closure (as required)
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.