Soltamox

DRUG DESCRIPTION

SOLTAMOX™ (tamoxifen citrate) solution, a nonsteroidal antiestrogen, is for oral administration. Each 5 mL solution contains 15.2 mg tamoxifen citrate, equivalent to 10 mg tamoxifen and the following inactive ingredients: ethanol, glycerol, propylene glycol, sorbitol solution, licorice flavor, aniseed flavor, purified water.

The chemical name is (Z)2-[4-(1,2-diphenyl-l-butenyl) phenoxy]-N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are:

SOLTAMOX Structural Formula Illustration

Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.

What are the possible side effects of tamoxifen (Soltamox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamoxifen and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, shortness of breath, or coughing up blood;
  • pain or swelling in one or both legs;
  • ...

Read All Potential Side Effects and See Pictures of Soltamox »

What are the precautions when taking tamoxifen citrate (Soltamox)?

Before taking tamoxifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have cancer limited to the milk ducts, or if you are taking this medication to prevent breast cancer, then this medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of blood clots (e.g., deep vein thrombosis, pulmonary embolism, stroke), conditions that require treatment with a "blood thinner" (such as warfarin).

If you have breast cancer and a history of blood clots/stroke, you may or may not be able to take...

Read All Potential Precautions of Soltamox »


Soltamox Consumer (continued)

SIDE EFFECTS: See also Warning section.

Hot flashes, nausea, leg cramps, hair thinning, or headache may occur. A loss of sexual ability/interest may occur in men. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (e.g., blurred vision), eye pain, easy bruising/bleeding, mental/mood changes, swelling of ankles/feet, unusual tiredness.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, dark urine, yellowing eyes/skin, signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tamoxifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have cancer limited to the milk ducts, or if you are taking this medication to prevent breast cancer, then this medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of blood clots (e.g., deep vein thrombosis, pulmonary embolism, stroke), conditions that require treatment with a "blood thinner" (such as warfarin).

If you have breast cancer and a history of blood clots/stroke, you may or may not be able to take tamoxifen. Discuss the risks and benefits with your doctor.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol/triglycerides, limited or no ability to walk (immobility), diabetes, high blood pressure, smoking, cataracts, liver disease.

This medication is not recommended for use during pregnancy because it may harm an unborn baby. Consult your doctor for more details. Women of childbearing age should start tamoxifen during their periods or get a negative pregnancy test before starting the medication.

It is recommended that men and women using this medication use two effective non-hormonal forms of birth control (e.g., condoms and diaphragms with spermicide) while taking this medication and for 2 months after stopping the medication. Consult your doctor.

It is not known if this medication passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Soltamox Patient Information Including Side Effects

Brand Names: Soltamox

Generic Name: tamoxifen (Pronunciation: ta MOX i fen)

  • What is tamoxifen (Soltamox)?
  • What are the possible side effects of tamoxifen (Soltamox)?
  • What is the most important information I should know about tamoxifen (Soltamox)?
  • What should I discuss with my healthcare provider before taking tamoxifen (Soltamox)?
  • How should I take tamoxifen (Soltamox)?
  • What happens if I miss a dose (Soltamox)?
  • What happens if I overdose (Soltamox)?
  • What should I avoid while taking tamoxifen (Soltamox)?
  • What other drugs will affect tamoxifen (Soltamox)?
  • Where can I get more information?

What is tamoxifen (Soltamox)?

Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Tamoxifen is used to treat and prevent some types of breast cancer.

Tamoxifen may also be used for other purposes not listed in this medication guide.

What are the possible side effects of tamoxifen (Soltamox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamoxifen and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, shortness of breath, or coughing up blood;
  • pain or swelling in one or both legs;
  • unusual vaginal bleeding or discharge;
  • irregular menstrual periods;
  • pain or pressure in your pelvic area;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • new breast lumps; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • hot flashes, warmth or tingly feeling under your skin;
  • bone, joint, or tumor pain;
  • redness or skin changes;
  • swelling in your hands or feet;
  • vaginal itching or dryness;
  • depressed mood, weakness;
  • weight loss;
  • nausea;
  • cough, sore throat;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • headache, dizziness; or
  • thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tamoxifen (Soltamox)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using tamoxifen, tell your doctor if you are allergic to any drugs, or if you have liver disease, high triglycerides (fatty acids) in your blood, a history of cataract, or a history of stroke or blood clot. Also tell your doctor if you if you are receiving chemotherapy or radiation treatment.

If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.

To be sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self exams on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

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