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tamoxifen citrate

(ta mox' i fen)


Apo-Tamox (CAN), Nolvadex, Novo-Tamoxifen (CAN), Tamofen (CAN),
Tamone (CAN)

Pregnancy Category D

Drug class
Antiestrogen

Therapeutic actions
Potent antiestrogenic effects: Competes with estrogen for binding sites in target tissues,
such as the breast.

Indications
• Treatment of metastatic breast cancer in women and men; in premenopausal
women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy
or ovarian irradiation
• Treatment of node-positive breast cancer in postmenopausal women following
total mastectomy or segmental mastectomy, axillary dissection, and breast
irradiation
• Treatment of axillary node-negative breast cancer in women following total
mastectomy or segmental mastectomy, axillary dissection, and breast irradiation
• Reduction in risk of invasive breast cancer in women with ductal carcinoma in
situ (DCIS) following breast surgery and radiation
• Reduction in occurrence of contralateral breast cancer in patients receiving
adjuvant tamoxifen therapy for breast cancer
• Reduction in incidence of breast cancer in women at high risk for breast cancer
• Unlabeled uses: Treatment of mastalgia; useful for decreasing size and pain of
gynecomastia; treatment of McCune–Albright syndrome and precocious puberty
in female patients 2–10 yr

Contraindications and cautions


• Contraindicated with allergy to tamoxifen, pregnancy, lactation, women who
require concomitant coumarin-type anticoagulation therapy or in women with a
history of DVT or PE.
• Use cautiously in women with a history of thromboembolic events.

Available forms
Tablets—10, 20 mg

Dosages
ADULTS
• Breast cancer: 20–40 mg/day PO for 5 yr. Dosages > 20 mg/day should be given
in divided doses, morning and evening.
• Reduction in breast cancer incidence: 20 mg/day PO for 5 yr.
• DCIS: 20 mg/day PO for 5 yr.

Pharmacokinetics
Route Onset Peak
Oral Varies 4–7 hr

Metabolism: Hepatic; T1/2: 7–14 days


Distribution: Crosses placenta; may enter breast milk
Excretion: Feces

Adverse effects
• CNS: Depression, light-headedness, dizziness, headache, corneal opacity,
decreased visual acuity, retinopathy, stroke
• Dermatologic: Hot flashes, rash, Stevens-Johnson syndrome
• GI: Nausea, vomiting, food distaste, alterations in liver enzymes
• GU: Vaginal bleeding, vaginal discharge, menstrual irregularities, pruritus
vulvae, endometrial cancer, uterine sarcoma
• Hematologic: Hypercalcemia, especially with bone metastases,
thrombocytopenia, leukopenia, anemia, DVT
• Other: Peripheral edema; increased bone and tumor pain and local disease
(initially seen with a good tumor response, usually subsides); cancer in animal
studies, changes in LFTs, PE

Interactions
Drug-drug
• Increased risk of bleeding with oral anticoagulants
• Increased serum levels with bromocriptine
• Increased risk of thromboembolic events if given with cytotoxic agents
Drug-food
• Decreased metabolism and risk of toxic effects if combined with grapefruit juice;
avoid this combination
Drug-lab test
• Possible increase in calcium levels, T4 levels without hyperthyroidism

Nursing considerations
Assessment
• History: Allergy to tamoxifen; pregnancy, lactation, previous DVT or PE
• Physical: Skin lesions, color, turgor; pelvic exam; orientation, affect, reflexes;
ophthalmologic exam; peripheral pulses, edema; liver function tests, CBC and
differential, estrogen receptor evaluation of tumor cells

Interventions
• Administer bid, in the morning and the evening.
• Arrange for periodic blood counts.
• Arrange for initial ophthalmologic exam and periodic exams if visual changes
occur.
• Counsel patient to use contraception while taking this drug; inform patient that
serious fetal harm could occur.
• Decrease dosage if adverse effects become severe.

Teaching points
• For doses greater than 20 mg, take the drug twice a day, in the morning and
evening. Do not drink grapefruit juice while using this drug.
• This drug can cause serious fetal harm and must not be taken during pregnancy.
Contraceptive measures should be used. If you become pregnant or decide that
you would like to become pregnant, consult with your health care provider
immediately.
• Have regular gynecologic exams during therapy.
• These side effects may occur: Bone pain; hot flashes (staying in cool temperatures
may help); nausea, vomiting (eat frequent small meals); weight gain; menstrual
irregularities; dizziness, headache, light-headedness (use caution if driving or
performing tasks that require alertness).
• Report marked weakness, sleepiness, mental confusion, pain or swelling of the
legs, shortness of breath, blurred vision.

Adverse effects in Italic are most common; those in Bold are life-threatening.