Tamoxifen citrate

What is Tamoxifen citrate?

• Tamoxifen citrate (Soltamox) is an estrogen agonist/antagonist used to treat Breast cancer and Ductal carcinoma in situ.
• Tamoxifen citrate is also used to prevent Breast cancer in women who are at high risk for the cancer.

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What are the uses of this medicine?

Tamoxifen citrate (Soltamox) is used:

• to treat adults with estrogen receptor-positive breast cancer that has spread to other parts of the body (metastatic)
• to treat adults with early stage estrogen receptor positive breast cancer after surgery and radiation for breast cancer
• to reduce the chance of developing breast cancer in the other breast in adults after surgery and radiation for breast cancer
• to reduce the risk of invasive breast cancer in adult women with Ductal carcinoma in situ (DCIS), after breast surgery and radiation treatment
• to reduce the risk of getting breast cancer in women with a high risk of getting breast cancer

How does this medicine work?

• Tamoxifen competitively inhibits the binding of estradiol to estrogen receptors, thereby preventing the receptor from binding to the estrogen-response element on DNA.
• The result is a reduction in DNA synthesis and cellular response to estrogen.
• In addition, tamoxifen up-regulates the production of transforming growth factor B (TGFb), a factor that inhibits tumor cell growth, and down-regulates insulin-like growth factor 1 (IGF-1), a factor that stimulates breast cancer cell growth.
• Tamoxifen also down-regulates protein kinase C (PKC) expression in a dose-dependant manner, inhibiting signal transduction and producing an antiproliferative effect in tumors such as malignant glioma and other cancers that overexpress PKC.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to tamoxifen or any other ingredient in Soltamox.
• have Ductal carcinoma in situ (DCIS) or a high-risk of breast cancer, and you need to take the blood thinner medicine warfarin, or have a history of a blood clot in your veins or lungs

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention any of the following:

• aminoglutethimide (Cytadren)
• anastrozole (Arimidex), bromocriptine (Parlodel)
• cancer chemotherapy medication such as cyclophosphamide (Cytoxan, Neosar) letrozole (Femara)
• medroxyprogesterone (Depo-Provera, Provera, in Prempro)
• phenobarbital
• rifampin (Rifadin, Rimactane)

Is this medicine FDA approved?

• Tamoxifen was approved for use in the United States in 1977 and is still widely used, being considered a first line adjuvant therapy for breast cancer.

How should this medicine be used?

Recommended dosage: Metastatic Breast Cancer:

• For patients with breast cancer, the recommended daily dose of Soltamox is 20 to 40 mg. Doses greater than 20 mg per day should be given in divided doses (morning and evening).

Adjuvant Treatment of Breast Cancer:

• For use in the adjuvant setting, the recommended dose of Soltamox is 20 mg daily for 5-10 years.

Ductal Carcinoma in Situ:

• For patients with DCIS, the recommended dose of Soltamox is 20 mg daily for 5 years.

Reduction in Breast Cancer Incidence in Women at High Risk:

• In the risk reduction setting, the recommended dose of Soltamox is 20 mg daily for 5 years.

Administration:

• Your healthcare provider will tell you how much Soltamox to take and when to take it.
• Your healthcare provider will decide how long you should continue to take Soltamox, depending on your medical condition.
• Do not stop taking Soltamox without first talking with your healthcare provider.
• Use the dosing cup that comes with Soltamox to measure the correct amount for each dose. Ask your healthcare provider or pharmacist if you are not sure how to measure your dose.
• If you forget a dose of Soltamox, take it when you remember, then take the next dose at your usual time. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral solution: Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate.

This medicine is available in fallowing brand namesː

• Soltamox

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flashes
• mood changes
• vaginal discharge
• vaginal bleeding
• nausea
• swelling (fluid retention)

Soltamox can cause serious side effects, including:

• Uterine cancer
• Blood clots in your veins or lungs
• Stroke
• Liver problems, including liver cancer
• Other cancers
• hypercalcemia
• Decreased blood cell counts
• Eye problems

What special precautions should I follow?

• An increased incidence of uterine malignancies (endometrial adenocarcinoma and uterine sarcoma), including fatal cases, has been reported with tamoxifen treatment.
• There is an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy.
• Tamoxifen can cause fetal harm when administered to a pregnant woman.
• Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing.
• As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported. If hypercalcemia occurs, treat as appropriate; if the hypercalcemia is severe, discontinue tamoxifen.
• Decreases in platelet counts, usually to 50,000-100,000/mm3, infrequently lower, have been reported in patients taking tamoxifen for breast cancer. Leukopenia has been observed, sometimes in association with anemia and/or thrombocytopenia. Perform periodic complete blood counts, including platelet counts.
• Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, and retinopathy have been reported in patients receiving tamoxifen. Patients should be advised to seek medical attention if they experience any visual disturbance.
• Perform periodic complete blood counts, including platelet counts, and periodic liver function tests during therapy with Soltamox. Periodic monitoring of plasma triglycerides and cholesterol may be indicated in patients with preexisting hyperlipidemias.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• tremor
• hyperreflexia
• unsteady gait
• dizziness
• prolongation of the QT interval

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Soltamox can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The safety and effectiveness of Soltamox in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tamoxifen citrate
• Inactive ingredients: ethanol, glycerol, propylene glycol, sorbitol solution, licorice flavor, aniseed flavor, purified water.

Who manufactures and distributes this medicine?

Distributed by:

• Mayne Pharma
• Greenville, NC

What should I know about storage and disposal of this medication?

• Store Soltamox at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze or refrigerate.
• Keep Soltamox in the original bottle to protect it from light.
• Keep the bottle tightly closed.
• Use within 3 months of opening. Throw away any Soltamox remaining in the bottle after 3 months.

• Dailymed label info on Tamoxifen citrate
• FDA Tamoxifen citrate

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