Nolvadex-D Astrazeneca tablets for breast cancer treatment (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tamoxifen

Ingredient

Composition information	Content
Tamoxifen	20mg

Uses

Indications

Nolvadex-D indicated to use breast cancer treatment.

Pharmacological pharmacology

nolvadex-d (tamoxifen) belongs to the Triphenylene group, non-steroids have the effect of combined effects of pharmacological effects similar to the isomers and antagonists in different tissues, in breast cancer patients, in tamoxifen tumors, mainly as an anti-anti-Oestrogen resistant Consulus of the estrogen.

The clinical

is found that Tamoxifen reduces total cholesterol levels and LDL in the blood by 10-20% in women during post -menopause. Tamoxifen has no adverse effects on bone mineral density.

A non -control study was conducted on a heterogeneous group of 28 women from 2 to 10 years old with McCune Albright syndrome using 20mg of Tamoxifen once a day for 12 months. Among patients with vaginal bleeding in the pre -research period, 62% (13 out of 21 patients) did not suffer from vaginal bleeding for 6 months and 33% (7 out of 21 patients) without vaginal bleeding during the study period.

The average volume of uterus increased after 6 months of treatment and doubled at the end of the test lasting 1 year. Although these records are consistent with Tamoxifen's pharmacological properties, the causal relationship has not been set. There is no data on long -term safety for children. Specifically, the long -term impact of Tamoxifen for growth, puberty and general development has not been studied.

pharmacokinetics

After drinking, Nolvadex -D is absorbed quickly with maximum concentrations in serum achieved within 4 - 7 hours. The concentration in the state (about 300 ng/ml) is achieved after 4 weeks of treatment at a dose of 40mg daily.

Pigure is strongly connected to the serum albumin (> 99%). Metabolic by hydroxy, demethylation and combination, forming metabolites that have the same pharmacological effects with the original compound and contribute to the treatment effect. Elimination mainly in feces, the sale time is about 7 days for Tamoxifen and 14 days for the main metabolites during the circulation, N-Desmethylamoxifen.

In a clinical trial when 2-10 years old women have McCune Albright syndrome using 20mg of tamoxifen once a day for 12 months, recorded reduction of clearance depending on age and increasing the level of exposure -capacity under the concentration curve over time AUC (up to 50% in the youngest child) compared to adults.

Before taking Nolvadex-D Astrazeneca tablets for breast cancer treatment (3 blisters x 10 tablets)

How to use

nolvadex-D form of film tablets for orally.

Dosage

Adults (including the elderly): The dose is from 20 to 40 mg/day, drink only once or divided into twice. The recommended dose is 20mg/day. The dose of 40mg/day is only used when the patient does not respond to a dose of 20mg/day.

Use for children: It is not recommended to use Nolvadex-D for children because of the unused effect and safety.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Experiments on animals show that with very high doses (100-200 times compared to the daily dose), Nolvadex -D can cause estrogen effects.

There is a report in literature as Nolvadex-D when used in many times the standard dose that may be related to the extension of the qt segment on the electrocardiogram.

There is currently no specific antidote for overdose and treatment is symptomatic treatment.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Side effects of Nolvadex-D can be classified according to the pharmacological effects of the drug such as hot face, vaginal bleeding, vaginal discharge, vulva itching and skin reactions around the tumor or common adverse effects such as digestive disorders, headache, dizziness and less common fluid fluid and hair loss.

When these side effects are heavy, it can be treated by reducing the dose (to the extent that not less than 20mg/day) without affecting the control of the disease. If the side effects do not decrease when reducing the dose, may need to stop therapy.

Skin rashes (including rare cases such as diverse erythema, Stevens-Johnson syndrome, skin capillary inflammation, puffer pemphigut form) and hypersensitivity reactions, even anglasselines are often recorded.

few cases of patients with bone metastasis with hypercalci in the blood at the beginning of treatment.

The phenomenon of platelets, usually reduced to 80,000 to 90,000/mm3, sometimes lower, recorded in breast cancer patients treated with Tamoxifen.

Cases of visual disorders, including rare changes in the cornea and common reports on retinopathy have been recorded in patients treated with Nolvadex-D. Cataracts are often recorded related to the use of nolvadex-d.

Cases of visual neuritis and optic neuritis have been recorded in patients using tamoxifen, and a few cases of blindness occur.

Sensory disorders (including abnormalities and taste disorders) are commonly found in patients using Nolvadex-D.

Uterine fibroids, endometriosis and other endothelial changes including hyperplasia and polyps are also recorded.

Ovarian cysts rarely observe in patients using Nolvadex-D. Vaginal polyps rarely observe in patients using Nolvadex-D.

Observing leukocyte phenomenon after using Nolvadex-D, occasionally related to anemia and/or platelet reduction. Neutral leukemia is recorded in some rare cases; Sometimes it can become serious and rare cases of granulocytes.

Stroke due to ischemia and blood vessels due to thrombosis including deep veins, microscopic thrombosis and pulmonary disease often occur when treated with Nolvadex-D.

Nolvadex-D shares with cytotoxic substances can increase the risk of thrombosis.

cramped and muscle pain that has been reported is often occurring in patients using Nolvadex-D.

few cases of interstitial pneumonia have been recorded.

Nolvadex-D is associated with changing the concentration of liver enzymes and some worse liver abnormalities, which can lead to death in some cases, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis, liver cell damage (including liver necrosis).

The phenomenon of increased serum triglyceride concentration, in some cases, pancreatitis may occur due to Nolvadex-D.

Less endometrial cancer and rarely cases of uterine sacomy (mostly in the form of malignant mixed mullarians) are related to Nolvadex-D treatment.

Redic erythema dermatitis rarely observed in patients using Nolvadex-D.

Porphyrin metabolic disorders are rarely observed in patients using Nolvadex-D.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Nolvadex-D drugs contraindicated in the following cases:

Pregnant women: Nolvadex-D is not used during pregnancy. A few cases of natural miscarriage, fetal defects and fetuses have been recorded in pregnant women using Nolvadex-D, although the causal relationship has not been established. Premenopausal patients must be tested for kidneys to rule out the possibility of pregnancy before treatment.

Be cautious when using

While treating breast cancer with Nolvadex-D, some cases of premenopausal patients may lose menstruation.

Increasing the frequency of endometrial disorders including hyperplasia, polyps, endometrial cancer and uterine sacoma (most in the form of malignant mixed mullarian tumors) have been recorded related to Nolvadex-D treatment. The mechanism is not known but may be related to the similarity of Nolvadex-D. It is necessary to immediately monitor patients who have been taking Nolvadex-D with abnormal gynecological symptoms, especially vaginal bleeding, or menstrual disorders, vaginal disorders and symptoms such as pain or severe pelvis.

Some of the second primary primary tumors appear in the endometrium and the opposite breast that has been recorded in clinical trials in breast cancer patients after treatment with tamoxifen. The causal relationship has not been established and the clinical importance of these observations is still unclear.

In breast regeneration surgery with slow microscopic surgery, Nolvadex-D may increase the risk of complications on microchip.

venous venous embolism (VTE)

Increase 2-3 times the risk of VTE has been recorded in healthy women using Tamoxifen.

Doctors need to carefully consider the history of the patient and the patient's family that has been VTE. If there is a risk of thrombosis, patients need to be tested for blood thrombosis. Positive testing patients need to be instructed on the risk of thrombosis. The decision to use Tamoxifen for these patients should be based on the overall risk to patients.

In some selected patients, the use of Tamoxifen along with preventive anticoagulant may be helpful.

The risk of VTE increases when the patient is severe, when the patient's age increases and when there are other VTE risk factors. All patients should be carefully considered for risks and benefits before treatment with Tamoxifen. This risk also increases when there is a coordinated chemotherapy. The prolonged use of anticoagulants can be helpful for some patients with many VTE risk factors.

Surgical surgery and immovable condition: Should only stop therapeutic with Tamoxifen when the risk of thrombosis due to Tamoxifen surpasses the risks due to stopping treatment. All patients should take appropriate measures to prevent thrombosis, and should be instructed on how to use with pressure during hospitalization, early practice, if possible, and treat with anticoagulants.

If the patient shows VTE, should stop immediately Tamoxifen and take appropriate anticoagulant measures. The decision to reuse Tamoxifen should be evaluated based on the overall risk of the patient, in some selective patients, the use of Tamoxifen along with preventive anticoagulant drugs may be helpful.

All patients should contact the doctor immediately if the patient has any VTE symptoms.

In a non -control study over 28 women from 2 - 10 years old suffered from McCune Albright (MAS) using 20mg of Tamoxifen once a day for 12 months, the average volume of uterus increased after 6 months of treatment and doubled at the end of the test lasting 1 year. Although these records are consistent with the pharmacological properties of Tamoxifen, the causal relationship is established.

Using drugs for women during pregnancy and lactation

Pregnant women

Nolvadex-D is not used during pregnancy. A few cases such as natural miscarriage, fetal defects and fetuses have been recorded in pregnant women using Nolvadex-D, although the causal relationship has not been established.

Toxic studies on the reproductive system in mice, rabbits and monkeys show that Nolvadex-D has no teratogenicity potential. For the development of the fetal reproductive system in rodents, Tamoxifen is related to similar changes with changes caused by oestradiol, ethynyl-octradiol, clomiphen and diethylstilboestrol (DES).

Despite the unknown clinical links of these changes, some changes, especially the abnormal development of the vaginal epithelium similar to the changes in young women using DES in the uterus and patients with 1/1000 risk of light cell cancer in the vagina or cervical. Only a small number of patients who are pregnant women use Tamoxifen, in young female patients using this tamoxifen, do not record any abnormal development of gland epithelium in the vagina or light cell cancer in the vagina or cervix.

Women's patients should not be pregnant while being treated with Nolvadex-D and should use hormonal contraception or partition form. Premenopausal patients need to be carefully examined to eliminate the possibility of pregnancy before treatment. The patient should be informed about the potential risk to the fetus if pregnant during nolvadex-d or within 2 months after the treatment.

breastfeeding women

Although Nolvadex-D is not clearly defined whether or not they are excreted through breast milk or not, people still recommend not using Nolvadex-D during breastfeeding. The decision to stop breastfeeding or stop taking the drug should depend on the importance of the drug to the mother.

The effect of drugs on driving and operating machinery

There is no evidence that Nolvadex-D has impaired these activities.

Drug interaction

Nolvadex-D sharing with coagulant antagiggers can significantly increase anticoagulant effects. When starting to use such a combination of drugs should monitor patients carefully.

Nolvadex-D shares with cytotoxic substances, to treat breast cancer, can increase the risk of blood tolerance. Due to this increased risk of VTE, the prevention of thrombosis should be considered in patients in the period of chemotherapy.

Using Tamoxifen in combination with aromatase inhibitors such as complementary treatment does not show improvement in effectiveness compared to monomers of Tamoxifen.

Do Nolvadex-D is metabolized through the cytochrome P450 3A4 enamel system, so when used with drugs such as rifampicin, it is known to cause this enzyme, it should be cautious because the tamoxifen level may be reduced. Clinically related relationships of this concentration decrease is still unclear.

Interactive pharmacokinetics with CYP2D6 enzyme inhibitors shows a decrease in plasma concentrations of the activity of Tamoxifen, 4-Hydroxy-N-Desmethylamoxifen (endoxifen) that have been reported in medicine. The effectiveness of Tamoxifen has been recorded when used simultaneously with some antidepressants inhibitors inhibiting Serotonin selective reabsorption (such as paroxetin).

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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