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Zymoplex (tamoxifen citrate) is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus. The estrogen and progesterone receptor values may help to predict whether adjuvant Zymoplex (tamoxifen citrate) therapy is likely to be beneficial. Tamoxifen is available in a tablet (10 mg or 20 mg) or an oral solution (10 mg/5 mL). If administered as an oral solution, it is important to use the supplied dosing cup for adequate administration.

In rare cases, Altamofen Tamoxifen Citrate can increase the risk of serious side effects such as blood clots or stroke. In Pakistan, the affordability of medicines, especially anticancer medicines, is widely affected by the proliferation of OBs [12]. Our findings showed that the LPGs (67.9%) are more affordable than the OBs (53.4%). Because of price constraints medicines are not 100% affordable for general public, so OBs were found to be more affordable (70.7%) for high income patients, less affordable (49.1%) for middle income patients, and least affordable (29.2%) for low income patients. This may cause a great risk of disease progression, higher rate of mortalities and morbidities.

Who should not take Zymoplex?

Of the patients randomized to Zymoplex (tamoxifen citrate) , the FIGO IA and IB cases were a MMMT and sarcoma, respectively; the FIGO II was a MMMT; and the FIGO III was a sarcoma; and the one patient randomized to placebo had a MMMT. A similar increased incidence in endometrial adenocarcinoma and uterine sarcoma was observed among women receiving Anastrozole Zymoplex (tamoxifen citrate) in five other NSABP clinical trials. In the NSABP B-14 study, women with axillary node-negative breast cancer were randomized to 5 years of tamoxifen 20 mg/day or placebo following primary surgery. The reported adverse effects are tabulated below showing adverse events more common on tamoxifen than on placebo.

• In patients that have been diagnosed with breast cancer, the benefits outweigh the risks, but it should still be used with caution in patients with a history of thromboembolic events.
• In the NSABP P-1 trial, women who required coumarin-type anticoagulants for any reason were ineligible for participation in the trial.
• In the Eastern Cooperative Oncology Group (ECOG) adjuvant breast cancer trial, tamoxifen or placebo was administered for 2 years to women following mastectomy.
• In an uncontrolled trial in 28 girls aged 2-10 years with McCune Albright Syndrome (MAS), who received 20 mg once a day for up to 12 months duration, mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study.
• In other adjuvant studies, Toronto and Tamoxifen Adjuvant Trial Organization (NATO), women received either tamoxifen or no therapy.

There are no data that address whether tamoxifen is excreted into human milk. If excreted, there are no data regarding the effects of tamoxifen in breast milk on the breastfed infant or breastfed animals. Tamoxifen produced impairment of fertility and conception in female rats at doses of 0.04 mg/kg/day (about 0.01-fold the daily maximum recommended human dose on a mg/m² basis) when dosed for two weeks prior to mating through day 7 of pregnancy. At this dose, fertility and reproductive indices were markedly reduced with total fetal mortality. Fetal mortality was also increased at doses of 0.16 mg/kg/day (about 0.03-fold the daily maximum recommended human dose on a mg/m² basis) when female rats were dosed from days 7-17 of pregnancy. Tamoxifen produced abortion, premature delivery and fetal death in rabbits administered doses equal to or greater than 0.125 mg/kg/day (about 0.05-fold the daily maximum recommended human dose on a mg/m² basis).

Zymoplex pharmaceutical active ingredients containing related brand and generic drugs:

Severe hot flashes occurred in 28% of women on placebo and 45% of women on Zymoplex (tamoxifen citrate). Vaginal discharge occurred in 35% and 55% of women on placebo and Zymoplex (tamoxifen citrate) respectively; and was severe in 4.5% and 12.3% respectively. There was no difference in the incidence of vaginal bleeding between treatment arms. Decreases in platelet counts, usually to 50, ,000/mm³, infrequently lower, have been occasionally reported in patients taking Zymoplex (tamoxifen citrate) for breast cancer. In patients with significant thrombocytopenia, rare hemorrhagic episodes have occurred, but it is uncertain if these episodes are due to Zymoplex (tamoxifen citrate) therapy.

In the NSABP P-1 trial, Zymoplex (tamoxifen citrate) treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (See Table 3 in CLINICAL PHARMACOLOGY). Tamoxifen is a selective estrogen receptor modulator (SERM) medication used to treat breast cancer in men and women and as a prophylactic agent against breast cancer in women. The drug was first synthesized in 1962 and initially intended to be a birth control drug, but while it failed for that indication, it has become a very successful anti-cancer medication.[1] Specifically, it is indicated for the treatment of breast cancer in a variety of settings.

Second, although this paper contains data on availability of anticancer drugs in Pakistan but it does not give insight in to what extent current guidelines of drug treatment of cancer are compromised by limited access to anticancer drugs. So, we cannot conclude what the effect of this is to outcome of anticancer treatment in Pakistan patients. Third, the authors measured households’ capacity to pay by collecting household income information, though it is often recommended that household ordinary expenditure excluding durable goods consumption will better reflect household’s capacity to pay. In the same study, prolongation of the QT interval on the electrocardiogram was noted when patients were given doses higher than 250 mg/m² loading dose, followed by maintenance doses of 80 mg/m² of Zymoplex (tamoxifen citrate) given twice a day. For a woman with a body surface area of 1.5 m² the minimal loading dose and maintenance doses given at which neurological symptoms and QT changes occurred were at least 6 fold higher in respect to the maximum recommended dose.

The aim of current study is to assess the availability of anticancer medicines in public and private sectors, and their affordability by high, middle, and low-income class patients. Availability and affordability of anticancer medicines is a matter of great concern especially for low and middle income countries e.g., Pakistan. Prime focus of this study was to evaluate the availability of anticancer medicines in public and private sectors, and their affordability among patients with different income levels.

But, it was also found that 10 medicines LPGs were not available in the market. These symptoms occurred within 3-5 days of beginning Zymoplex (tamoxifen citrate) and cleared within 2-5 days after stopping therapy. One patient experienced a seizure several days after Zymoplex (tamoxifen citrate) was discontinued and neurotoxic symptoms had resolved.

Patients with high income level could afford the expenditures on anticancer medicines; reverse was true for low income level patients. The most affordable LPGs (afforded by 100% patients) for low income class patients include Cytarabine, Flourouracil, Mercaptopurine, Methotrexate, Mitomycin and Tamoxifen, respectively. The mean availability of anticancer medicines in both public and private sectors was found to be 52.5% for OBs, while 28.1% for LPGs. Furthermore, study revealed a fairly high availability for OBs while generally low availability for LPGs. The availability of Fluorouracil (97%), Etoposide (95.5%), Methotrexate (95.5%) and Tamoxifen (95.5%) was maximal among the OBs; whereas, Gemicitabine (81.1%), Bleomycin (56.1%) and Doxorubicin (56.1%) had the highest availability amongst LPGs in all study settings (see Table 4).