Tamoxifen Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

One hospital was excluded from the survey because it provides services solely to the pediatrics. Survey was carried out in 22 cancer-care hospitals and 44 private pharmacies in Punjab, a province of Pakistan. Data were collected from the pharmacies and cancer patients attending selected hospitals and evaluated PARABOL 76 VEDI-PHARMA according to the objectives of study. The type and frequency of adverse events in the NSABP B-24 trial were consistent with those observed in the other adjuvant trials conducted with Zymoplex (tamoxifen citrate). Leg cramps and myalgia have been reported commonly in patients receiving Zymoplex.

• Tamoxifen and N-desmethyl tamoxifen plasma concentrations have been shown to be reduced when coadministered with rifampin or aminoglutethimide.
• To date, in utero exposure to tamoxifen has not been shown to cause vaginal adenosis, or clear-cell adenocarcinoma of the vagina or cervix, in young women.
• Cases of optic neuropathy and optic neuritis have been reported in patients receiving Zymoplex and, in a small number of cases, blindness has occurred.

Women taking Zymoplex (tamoxifen citrate) as treatment for metastatic breast cancer should review this monitoring plan with their care provider and select the appropriate modalities and schedule of evaluation. There have been a few reports of endometriosis and uterine fibroids in women receiving Zymoplex (tamoxifen citrate). The underlying mechanism may be due to the partial estrogenic effect of Zymoplex (tamoxifen citrate). Ovarian cysts have also been observed in a small number of premenopausal patients with advanced breast cancer who have been treated with Zymoplex (tamoxifen citrate). Current data from clinical trials support five years of adjuvant Zymoplex (tamoxifen citrate) therapy for patients with breast cancer.

Side effects

The study revealed a fairly high availability for OBs and generally low availability for LPGs. The availability of these agents is greater in private sector as compared to public sector. The overall affordability of LPGs is more as compared to OBs irrespective of the income class; however, both of them are more affordable by high income class patients. Government and regulatory authorities must take adequate steps and formulate such policies to ensure the equitable availability and affordability of cancer medicines to fight against this deadly disease. In LMICs, the availability of medicines in the healthcare settings is considerably influenced by the cost [30]. This study revealed that the availability of these anticancer medicines was high in the private sector (71.9% for OBs and 20.0% for LPGs) as compared to the government healthcare settings (31.4% for OBs and 11.7% LPGs).

• There was no indication that doses greater than 20 mg per day were more effective.
• A total of 14 and 12 invasive breast cancers were seen among participants 65 and older in the placebo and tamoxifen groups, respectively.
• During blinded follow-up, there were 36 cases of FIGO Stage I endometrial adenocarcinoma (22 were FIGO Stage IA, 13 IB, and 1 IC) in women receiving tamoxifen and 15 cases in women receiving placebo [14 were FIGO Stage I (9 IA and 5 IB), and 1 case was FIGO Stage IV].

In rodent models of fetal reproductive tract development, tamoxifen (at doses 0.002 to 2.4-fold the daily maximum recommended human dose on a mg/m² basis) caused changes in both sexes that are similar to those caused by estradiol, ethynylestradiol and diethylstilbestrol. To date, in utero exposure to tamoxifen has not been shown to cause vaginal adenosis, or clear-cell adenocarcinoma of the vagina or cervix, in young women. However, only a small number of young women have been exposed to tamoxifen in utero, and a smaller number have been followed long enough (to age 15-20) to determine whether vaginal or cervical neoplasia could occur as a result of this exposure. Any patient receiving or who has previously received Zymoplex (tamoxifen citrate) who reports abnormal vaginal bleeding should be promptly evaluated. Menstruation is suppressed in a proportion of premenopausal women receiving Zymoplex for the treatment of breast cancer.

Pyrocare Pharmaceuticals Private Limited

In the Eastern Cooperative Oncology Group (ECOG) adjuvant breast cancer trial, Zymoplex (tamoxifen citrate) or placebo was administered for 2 years to women following mastectomy. When compared to placebo, Zymoplex (tamoxifen citrate) showed a significantly higher incidence of hot flashes (19% vs. 8% for placebo). The incidence of all other adverse reactions was similar in the 2 treatment groups with the exception of thrombocytopenia where the incidence for Zymoplex (tamoxifen citrate) was 10% vs. 3% for placebo, an observation of borderline statistical significance. Zymoplex tablets are effective in the 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. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.

• Cutaneous lupus erythematosus has been observed very-rarely in patients receiving Zymoplex.
• Continued clinical studies have resulted in further information which better indicates the incidence of adverse reactions with tamoxifen as compared to placebo.
• Patients receiving tamoxifen had a decrease in hypercholesterolemia [108 (3.5%)] compared to patients receiving anastrozole [278 (9%)].
• Leukopenia has been observed, sometimes in association with anemia and/or thrombocytopenia.

In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (see PRECAUTIONS, Information for Patients, Reduction in Breast Cancer Incidence in High Risk Women ). Any patient receiving or who has previously received tamoxifen who reports abnormal vaginal bleeding should be promptly evaluated. Zymoplex tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. If you are taking Zymoplex to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period.

Effects on the Liver: Liver Cancer

If you take thyroid medication, take it at least 4 hours before or after products that contain Zymoplex Capsule. If you are taking this product under your doctor’s direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. If you are treating the child yourself (without direction from a doctor), do not use more than 12 doses of Zymoplex Capsule per day.

Lab and/or medical tests (such as complete blood count, liver function, pelvic exams, mammogram, eye exams) should be done while you are taking this medication. Women using this medication should ask about reliable non-hormonal forms of birth control (such as condoms, diaphragms with spermicide) during treatment and for 2 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Also, in oligospermic males treated with tamoxifen, LH, FSH, testosterone and estrogen levels were elevated. Zymoplex (tamoxifen citrate) is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).

Patients receiving Zymoplex (tamoxifen citrate) had a decrease in hypercholesterolemia (108 [3.5%]) compared to patients receiving anastrozole (278 [9%]). An increased incidence of endometrial changes including hyperplasia and polyps have been reported in association with Zymoplex (tamoxifen citrate) treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the estrogenic properties of Zymoplex (tamoxifen citrate).