Tamoxifen Citrate Tablets USP 10mg Technical Specification:

Product Name:Tamoxifen Citrate Tablets USP 10mg
Brand Name:Tamoxifen Citrate
Strength:10mg, 20mg, 40mg
Dosage Form:uncoated Tablet
Packing:100s, 200s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tamoxifen Citrate Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tamoxifen Citrate Tablets USP 10mg 
    Each uncoated tablet contains:
    Tamoxifen Citrate USP
    Equivalent to tamoxifen…………10mg
    Excipient………………………………..q.s.

THERAPEUTIC INDICATIONS:

Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Caution: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.

Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

PRESCRIPTION ONLY MEDICINE (POM)

ANTINEOPLASTIC AGENT (NON-STEROIDAL ANTIESTROGEN)

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Dispense in a well closed, light resistant container as defines in the USP, with a child resistant closure (as required)

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Taj Pharma stands as a beacon of trust and quality when it comes to Tamoxifen Citrate Tablets. Our unwavering dedication to pharmaceutical excellence is reflected in our cutting-edge manufacturing facilities and rigorous quality control processes. We prioritize the well-being of our customers by ensuring that every tablet meets the highest industry standards, earning the confidence of healthcare professionals and patients worldwide. At Taj Pharma, we understand that access to essential medications is paramount. We have established a robust distribution network to make Tamoxifen Citrate Tablets readily available, ensuring that patients have the opportunity to receive the treatment they require, regardless of their location. When you choose Taj Pharma for Tamoxifen Citrate Tablets, you’re choosing a partner committed to your health and peace of mind. Trust us for unmatched quality, reliability, and accessibility in the realm of healthcare.

What is Tamoxifen Citrate Tablets and its use?

Tamoxifen Citrate Tablets are a medication used primarily in the treatment and prevention of breast cancer. Tamoxifen is the active ingredient, and it is commonly available in tablet form. Here’s an overview of Tamoxifen Citrate Tablets and their uses:

Tamoxifen Citrate:

Tamoxifen is a medication classified as a selective estrogen receptor modulator (SERM). It works by binding to estrogen receptors in certain tissues, particularly in breast tissue. This binding action has different effects depending on the location of the receptors, which makes Tamoxifen a versatile medication in cancer treatment.

The primary uses of Tamoxifen Citrate Tablets include:

  • Breast Cancer Treatment: Tamoxifen is used in the treatment of breast cancer, particularly in women with hormone receptor-positive breast cancer. It interferes with the estrogen receptor, inhibiting estrogen’s ability to stimulate the growth of breast cancer cells. Tamoxifen is often prescribed as adjuvant therapy after surgery or other treatments to reduce the risk of cancer recurrence.
  • Breast Cancer Prevention: In some cases, Tamoxifen may be prescribed to women at high risk of developing breast cancer to reduce their risk of developing the disease.
  • Breast Cancer Risk Reduction: Tamoxifen may also be used in women with a history of breast cancer to reduce the risk of cancer developing in the opposite breast.

Treatment Duration:

The duration of Tamoxifen treatment can vary based on the individual’s medical condition and the recommendations of their healthcare provider. Treatment may continue for several years in some cases. Tamoxifen should only be used under the supervision and prescription of a qualified healthcare provider, and the specific treatment plan will depend on the individual patient’s medical history and needs.

How does Tamoxifen Citrate Tablets Work?

Tamoxifen Citrate Tablets work by interfering with the actions of estrogen, a hormone that can promote the growth and proliferation of certain types of breast cancer cells. Tamoxifen is classified as a selective estrogen receptor modulator (SERM), and its mechanism of action involves binding to estrogen receptors in various tissues, particularly in breast tissue. Here’s a detailed explanation of how Tamoxifen works:

  • Binding to Estrogen Receptors: Tamoxifen has a structure that is similar to estrogen, and it can bind to estrogen receptors on the surface of breast cancer cells. These receptors are proteins that can bind to estrogen and transmit signals to the cell’s nucleus, stimulating cell growth and division.
  • Blocking Estrogen’s Effects: When Tamoxifen binds to estrogen receptors on breast cancer cells, it acts as a competitive inhibitor. In other words, it competes with estrogen for binding to these receptors. By doing so, Tamoxifen effectively blocks estrogen from attaching to the receptors.
  • Inhibition of Cell Growth: By blocking the binding of estrogen to its receptors, Tamoxifen inhibits the signaling pathways that promote the growth and division of breast cancer cells. This helps to slow down the proliferation of cancer cells.
  • Apoptosis Promotion: Tamoxifen can also promote apoptosis, which is a process of programmed cell death. In some cases, Tamoxifen induces apoptosis in breast cancer cells, leading to their elimination from the body.
  • Estrogenic Effects in Other Tissues: While Tamoxifen acts as an anti-estrogen in breast tissue, it can have estrogenic effects in other tissues, such as bone and the cardiovascular system. In these tissues, Tamoxifen can help maintain bone density and reduce the risk of cardiovascular disease.

Tamoxifen’s ability to block estrogen receptors in breast tissue makes it an effective treatment for hormone receptor-positive breast cancer. It is often used as adjuvant therapy after surgery or as a preventive measure in women at high risk of developing breast cancer.

Benefits and Side effects of Tamoxifen Citrate Tablets?

Benefits:

  • Breast Cancer Treatment: Tamoxifen Citrate Tablets are highly effective in treating hormone receptor-positive breast cancer, which is one of the most common types of breast cancer. It helps to slow down the growth and spread of cancer cells in the breast.
  • Reduction in Recurrence Risk: Tamoxifen is often used as adjuvant therapy after surgery or other treatments for breast cancer. It significantly reduces the risk of cancer recurrence in the treated breast and decreases the likelihood of developing a new breast cancer.
  • Breast Cancer Prevention: In women at high risk of developing breast cancer, Tamoxifen may be prescribed as a preventive measure. It can reduce the risk of developing breast cancer, particularly hormone receptor-positive breast cancer.
  • Bone Health: Tamoxifen’s estrogenic effects in bone tissue can help maintain bone density. This is especially important in postmenopausal women who may be at risk of osteoporosis.
  • Cardiovascular Health: Tamoxifen’s estrogenic effects in the cardiovascular system may contribute to reducing the risk of cardiovascular disease in some women.

Common Side Effects:

  • Hot Flashes: Many women taking Tamoxifen experience hot flashes, which can be bothersome but are usually manageable.
  • Vaginal Dryness or Discharge: Some women may experience vaginal dryness or an increase in vaginal discharge.
  • Mood Changes: Mood swings, depression, and anxiety are possible side effects, although they are relatively rare.
  • Irregular Menstrual Periods: In premenopausal women, Tamoxifen may cause irregular menstrual periods or amenorrhea (absence of menstruation).
  • Weight Changes: Some individuals may experience weight gain while taking Tamoxifen.
  • Increased Risk of Uterine Cancer: Tamoxifen is associated with a slightly increased risk of uterine cancer (endometrial cancer). Regular gynecological check-ups are important to monitor for any signs of uterine changes.
  • Blood Clots: Tamoxifen may increase the risk of blood clots, which can be serious. Symptoms of blood clots include leg swelling and pain, shortness of breath, and chest pain.
  • Cataracts: There is a potential association between Tamoxifen use and an increased risk of developing cataracts.

It’s essential to note that not all individuals will experience these side effects, and their severity can vary. Additionally, the benefits of Tamoxifen in reducing the risk of breast cancer recurrence or preventing breast cancer often outweigh the potential side effects. Patients prescribed Tamoxifen should have regular follow-up appointments with their healthcare provider to monitor their response to treatment and manage any side effects. Any concerning or persistent side effects should be promptly reported to a healthcare provider.

Frequently asked questions (FAQs) about Tamoxifen Citrate Tablets:

  1. What is Tamoxifen Citrate, and how does it work?

Tamoxifen Citrate is a medication used primarily for breast cancer treatment and prevention. It works by blocking estrogen receptors in breast tissue, slowing down the growth of cancer cells.

  1. What types of breast cancer are treated with Tamoxifen?

Tamoxifen is most commonly used to treat hormone receptorpositive breast cancer, where the cancer cells have receptors for estrogen or progesterone.

  1. Is Tamoxifen used as a preventive measure for breast cancer?

Yes, Tamoxifen may be prescribed to women at high risk of developing breast cancer as a preventive measure to reduce their risk.

  1. How is Tamoxifen Citrate taken?

Tamoxifen is typically taken orally in tablet form, usually once daily. The dosage and duration of treatment are determined by a healthcare provider.

  1. What are the common side effects of Tamoxifen Citrate Tablets?

Common side effects may include hot flashes, vaginal dryness or discharge, mood changes, and irregular menstrual periods (in premenopausal women).

  1. Are there serious side effects associated with Tamoxifen?

Yes, Tamoxifen can be associated with serious side effects, including an increased risk of uterine cancer, blood clots, and cataracts. Regular medical monitoring is important to detect and manage these risks.

  1. How long do I need to take Tamoxifen for breast cancer treatment?

The duration of Tamoxifen treatment varies depending on the individual’s specific cancer and treatment plan. It can range from several years to a decade or more.

  1. Can I become pregnant while taking Tamoxifen?

Tamoxifen can have harmful effects on a developing fetus, so it is generally not recommended during pregnancy. Effective contraception is advised for women of childbearing age during Tamoxifen treatment.

  1. Are there any dietary restrictions while taking Tamoxifen?

While there are no specific dietary restrictions, maintaining a healthy lifestyle with a balanced diet and regular exercise is recommended for overall wellbeing.

  1. Can I continue taking other medications or supplements while on Tamoxifen?

It’s important to inform your healthcare provider about all medications, including overthecounter drugs and supplements, to check for potential interactions with Tamoxifen.

  1. What should I do if I experience side effects while on Tamoxifen?

Any concerning or persistent side effects should be promptly reported to your healthcare provider. They can provide guidance on managing side effects or adjusting the treatment plan if necessary.

As Tamoxifen Citrate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Tamoxifen Citrate Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Tamoxifen Citrate Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Tamoxifen Citrate Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Tamoxifen Citrate Tablets USP 10mg
b) Tamoxifen Citrate Tablets USP 20mg
c) Tamoxifen Citrate Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Tamoxifen Citrate Tablets USP 10mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………10mg
Excipient………………………………..q.s.

b) Tamoxifen Citrate Tablets USP 20mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………20mg
Excipient………………………………..q.s.

c) Tamoxifen Citrate Tablets USP 40mg
Each uncoated tablet contains:
Tamoxifen Citrate USP
Equivalent to tamoxifen…………40mg
Excipient………………………………..q.s.

THERAPEUTIC INDICATIONS:

Tamoxifen Citrate is used to treat certain types of breast cancer in women and men, to prevent invasive breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast), and to prevent breast cancer in women who are at a high risk of developing the disease.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Caution: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
PRESCRIPTION ONLY MEDICINE (POM)
ANTINEOPLASTIC AGENT (NON-STEROIDAL ANTIESTROGEN)
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
Dispense in a well closed, light resistant container as defines in the USP, with a child resistant closure (as required)
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.