Tamoxifen citrate

Use this medication only as directed by your doctor. Do not use more or less of it and do not use it more often than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. The recommended daily dose of tamoxifen citrate is 20 to 40 mg in a single or two divided doses. The lowest effective dose should be used. In early disease, the recommended duration of therapy is 5 years. The optimal duration of therapy remains to be determined.

Pediatric Use: The use of tamoxifen citrate is not recommended in children, as safety and efficacy have not been established.

Tamoxifen citrate is contraindicated in patients with hypersensitivity to the product or any of its components.

-Pregnancy

-In patients with a history of stroke, deep venous thrombosis or pulmonary embolism, and in patients who are at an increased risk of developing endometrial cancer.

Interactions:

Warfarin, aromatase inhibitors, such as (anastrozole, letrozole or exemestane), cytotoxic agents, rifampicin, SSRI antidepressants (e.g. paroxetine).

Pregnancy and Lactation:

Tamoxifen tablets must not be given during pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and fetal deaths after women have taken tamoxifen citrate.

 

It is not known if tamoxifen citrate is excreted in human milk and, therefore, the drug is not recommended during lactation. The decision either to discontinue nursing or discontinue should take into account the importance of the drug to the mother.

Warning and Precaution:

Before taking tamoxifen tablets, tell your doctor if any of the following apply to you:

-If you have ever had any unusual or allergic reaction to tamoxifen citrate or to any one of its ingredients

 -If you intend to become pregnant. It is best to use some kind of birth control while you are taking tamoxifen citrate and for about two months after you stop taking it. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by tamoxifen citrate. Tell your doctor right away if you think you have become pregnant while taking tamoxifen or within two months of having stopped it.

It is important that you tell your doctor immediately if you have any unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure) when you are taking tamoxifen citrate or anytime afterwards. This is because a number of changes to the lining of the womb (the endometrium) may occur, some of which may be serious and could include cancer.

-If you are breastfeeding or intend to breastfeed

-If you are taking or have recently taken any other prescription, including antidepressants such as paroxetine (to improve mood or symptoms of hot flushes), or over-the-counter medicine.

-If you have any other medical problems, especially cataracts (or other eye problems) or low blood cell counts.

-If you have a history of blood clots, including deep vein thrombosis (a blood clot in one of the deep veins of the body – usually within the leg) or are taking anticoagulants such as warfarin (to prevent blood clots).

– Tamoxifen citrate should not be taken with aromatase inhibitors, such as anastrozole, letrozole or exemestane.

– If you are going to have a breast reconstruction operation where your own tissue is moved to shape a new breast and this occurs weeks to years after the primary cancer operation, tamoxifen citrate may increase your risk of complications, including complete loss of the new tissue.

– If you have a history of pulmonary embolism (obstruction of a pulmonary artery by foreign matter such as fat, air, tumor tissue or a blood clot).

– If you have a history of stroke.

Adverse Reactions:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Incidence >10%

Nausea, Fatigue, Asthenia, Vaginal discharge, Fluid retention, Skin Rash, Anemia, Vaginal bleeding

 Incidence <10%

Cataracts, Hypersensitivity reactions, Elevated triglycerides, Leg cramp, Myalgia, Uterine fibroids, Headache, Light headedness, Paranesthesia, Alopecia, Vomiting, Diarrhea, Constipation, Fatty liver, Thromboembolic events.

Storage:

Store below 30 and protect from light and moisture.