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APO-TAMOX TAB is a brand name for Tamoxifen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-TAMOX (tamoxifen tablets) is indicated for: • the adjuvant treatment of early breast cancer in women with estrogen receptor positive tumours. • the treatment of women with hormone responsive locally advanced/ metastatic breast cancer. 1.1 Pediatrics Pediatrics (< 18 years of age): the use of APO-TAMOX is not…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The duration of treatment with APO-TAMOX (tamoxifen tablets) will depend on the patient’s response. The drug should be continued as long as there is a favourable response. With obvious disease progression, the drug should be discontinued.
However, because an occasional patient will have a local disease flare or an increase in bone pain shortly after starting tamoxifen citrate, it is sometimes difficult during the first few weeks of treatment to determine whether the patient’s disease is progressing or whether it will stabilize or respond to continued treatment (see 8 ADVERSE REACTIONS).
There are data to suggest that, if possible, treatment should not be discontinued before a minimum of three to four weeks. In clinical studies, the median duration of treatment before the onset of a definite objective response has been two months.
However, approximately one-quarter of patients who eventually responded were treated for four or more months before a definite objective response was recorded. 2 Recommended Dose and Dosage Adjustment The recommended daily dose of APO-TAMOX 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. Splitting the 20 mg tablet is not recommended.
Pediatric Use:
Health Canada has not authorized an indication for pediatric use. 4 Administration APO-TAMOX is for oral use only. 5 Missed Dose If a patient misses a dose, they should take the next usual dose as soon as they remember. Do not take two doses at the same time.
). There are data to suggest that, if possible, treatment should not be discontinued before a minimum of three to four weeks. In clinical studies, the median duration of treatment before the onset of a definite objective response has been two months.
However, approximately one-quarter of patients who eventually responded were treated for four or more months before a definite objective response was recorded. 2 Recommended Dose and Dosage Adjustment The recommended daily dose of APO-TAMOX 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. Splitting the 20 mg tablet is not recommended.
Pediatric Use:
Health Canada has not authorized an indication for pediatric use. 4 Administration APO-TAMOX is for oral use only. 5 Missed Dose If a patient misses a dose, they should take the next usual dose as soon as they remember. Do not take two doses at the same time.
5 OVERDOSAGE Acute overdosage in humans has not been reported. Possible overdosage effects might include hot flushes, nausea, vomiting, and vaginal bleeding. No specific treatment for overdosage is known and treatment must be symptomatic.
In the case of accidental ingestion by a child, gastric emptying is suggested. There have been reports in the literature that tamoxifen citrate given at several times the standard dose may be associated with prolongation of the QT interval of the ECG.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, and Composition Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Use Tablet / 10 mg and 20 mg Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
, Cardiovascular 08/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ..........................................................................................................................
4 2 CONTRAINDICATIONS ..................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................. 4 4 DOSAGE AND ADMINISTRATION .....................................................................................
1 Dosing Considerations ...................................................................................................... 2 Recommended Dose and Dosage Adjustment .................................................................
4 Administration .................................................................................................................. 5 Missed Dose ......................................................................................................................
6 5 OVERDOSAGE ................................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 6 7 WARNINGS AND PRECAUTIONS ......................................................................................
APO-TAMOX (tamoxifen tablets) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
APO-TAMOX 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 tablets, although no causal relationship has been established.
Women should be advised not to become pregnant while taking APO-TAMOX and for nine months following the cessation of therapy and should use a barrier or other non-hormonal contraceptive methods if sexually active. Pre-menopausal patients must be carefully examined before treatment to exclude the possibility of pregnancy.
Women should be informed of the potential risks to the fetus, should they become pregnant while taking APO-TAMOX or within nine months of cessation of therapy. When used in the prevention setting (an indication not approved in Canada), APO-TAMOX is contraindicated 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tamoxifen in Canada.
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APO-TAMOX (tamoxifen citrate) tablets 10 mg:
Each tablet contains 10 mg tamoxifen (as tamoxifen citrate). White to off-white, round, biconvex tablets, engraved “APO” on one side and “TAM” over “10” on the other side. Available in bottles of 100 and 500.
APO-TAMOX (tamoxifen citrate) tablets 20 mg:
Each tablet contains 20 mg tamoxifen (as tamoxifen citrate). White to off-white, octagonal, biconvex tablets, engraved “APO” on one side and “TAM” over score “20” on the other side. Available in bottles of 100 and 250 7 WARNINGS AND PRECAUTIONS Please see the 3 SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I: Health Professional Information.
General APO-TAMOX (tamoxifen tablets) should be used only for the conditions listed under the 1 APO-TAMOX (Tamoxifen Tablets) Page 7 of 35 INDICATIONS section. g. paroxetine, a known CYP2D6 inhibitor) (see 9 DRUG-INTERACTIONS). Carcinogenesis and Mutagenesis An increased incidence of uterine malignancies has been reported in association with tamoxifen citrate treatment.
The underlying mechanism is unknown, but may be related to the estrogen- like effect of tamoxifen tablets. Most uterine malignancies seen in association with tamoxifen citrate are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed Mullerian tumours, have also been reported.
Uterine sarcoma is generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users (≥ 2 years) of tamoxifen citrate than non-users.
An increased incidence of endometrial cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with tamoxifen citrate treatment. The incidence and pattern of this increase suggest that the underlying mechanism may be related to estrogenic properties of tamoxifen citrate.
Any patients receiving APO-TAMOX or having previously received APO-TAMOX who report abnormal gynaecological symptoms, especially vaginal bleeding, should be promptly investigated. Incidence rates for the following events were estimated from a long-term clinical study called the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention (NSABP P-1) Trial.
In this trial, high-risk patients were randomized to either tamoxifen citrate therapy or placebo, for the prevention of breast cancer. Uterine malignancies were separated into cases of endometrial adenocarcinomas and uterine sarcomas.
6 for deep vein thrombosis. Hepatocellular carcinomas have been reported in a 2 year oncogenicity study in rats receiving tamoxifen citrate (see 16 NON-CLINICAL TOXICOLOGY). In addition, gonadal tumours have been reported in mice receiving tamoxifen citrate in long-term studies (see 16 NON-CLINICAL TOXICOLOGY).
The clinical relevance of these cancer findings has not been established. A number of second primary tumours, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with tamoxifen citrate.
No causal link has been established and the clinical significance of these observations remains unclear. Cardiovascular An increased risk of stroke has been found to be associated with tamoxifen citrate therapy in high-risk patients being treated for the prevention of breast cancer.
The use of tamoxifen APO-TAMOX (Tamoxifen Tablets) Page 8 of 35 tablets for the prevention of breast cancer is not an approved […]
1 Special Populations ......................................................................................................... 1 Pregnant Women ..................................................................................................
2 Breast-feeding ....................................................................................................... 3 Pediatrics...............................................................................................................
10 8 ADVERSE REACTIONS .................................................................................................... 1 Adverse Reaction Overview ............................................................................................
2 Clinical Trial Adverse Reactions ...................................................................................... 3 Less Common Clinical Trial Adverse Reactions .............................................................. 5 Post-Market Adverse Reactions .....................................................................................
16 9 DRUG INTERACTIONS.................................................................................................... 2 Drug Interactions Overview ............................................................................................
4 Drug-Drug Interactions ................................................................................................... 16 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action ...................................................................................................... 2 Pharmacodynamics.........................................................................................................
3 Pharmacokinetics............................................................................................................ 18 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
18 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 18 PART II: SCIENTIFIC INFORMATION ......................................................................................
19 13 PHARMACEUTICAL INFORMATION ................................................................................ 19 14 CLINICAL TRIALS............................................................................................................
1 Clinical Trials by Indication ............................................................................................. 2 Comparative Bioavailability Studies ..............................................................................
19 15 MICROBIOLOGY ............................................................................................................ 20 16 NON-CLINICAL TOXICOLOGY .........................................................................................
20 17 SUPPORTING PRODUCT MONOGRAPH .......................................................................... 25 PATIENT MEDICATION INFORMATION ................................................................................. 26 APO-TAMOX (Tamoxifen Tablets) Page 4 of 35 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-TAMOX (tamoxifen tablets) is indicated for: • the adjuvant treatment of early breast cancer in women with estrogen receptor positive tumours.
• the treatment of women with hormone responsive locally advanced/ metastatic breast cancer. 1 Pediatrics Pediatrics (< 18 years of age): the use of APO-TAMOX is not recommended in children, as safety and efficacy have not been established.
2 CONTRAINDICATIONS APO-TAMOX (tamoxifen tablets) is contraindicated in patients who are […]