Anastrozole Tablets USP 1mg

Anastrozole Tablets USP 1mg Technical Specification:

Product Name:Anastrozole Tablets USP 
Brand Name:Anastrozole
Strength:1mg
Dosage Form:Film-coated Tablet
Packing:5s, 10s, 28s, 30s, 50s, 100s, 500s
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: Anastrozole is a type of hormone treatment. Anastrozole can be used to treat breast cancer that has come back (recurrence) in women.
Storage:Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Anastrozole Tablets USP 1mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Anastrozole Tablets USP 1 mg
    Each film-coated tablet contains:
    Anastrozole USP……………….1 mg
    Excipients…………………………q.s.
    Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Anastrozole is a type of hormone treatment. Anastrozole can be used to treat breast cancer that has come back (recurrence) in women.

CAUTION & WARNING:

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

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

Dispense in tight and light resistant container as defined in the USP.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals? 

The choice of Taj Pharmaceuticals as the manufacturer of Anastrozole Tablets USP 1mg, a crucial medication in breast cancer treatment, is influenced by several pivotal factors within the healthcare industry. One of the primary considerations is Taj Pharmaceuticals’ commitment to maintaining rigorous quality control standards and adherence to good manufacturing practices (GMP). This dedication ensures that Anastrozole Tablets USP 1mg, and other medications, meet the highest standards of quality, safety, and efficacy for patients. Another essential factor is the consistent availability of medications. The reliable supply of Anastrozole, a medication vital in breast cancer care, is paramount to healthcare facilities and patients. Selecting a reputable pharmaceutical manufacturer like Taj Pharmaceuticals helps ensure a stable and uninterrupted source of this critical medication. The reputation of a pharmaceutical company carries significant weight when making this choice. Manufacturers with a longstanding history of producing high-quality and dependable medications often become the preferred choice of healthcare professionals and institutions. A strong reputation for quality and safety is particularly crucial when selecting a manufacturer for medications as critical as Anastrozole.

Regulatory compliance is a fundamental requirement for pharmaceutical manufacturers. Companies like Taj Pharmaceuticals are expected to meet stringent regulatory standards set by health authorities in various countries. This involves obtaining the necessary approvals, licenses, and registrations to manufacture and distribute medications legally and safely. Research and development efforts also play a role in the decision-making process. Some pharmaceutical companies invest in research and development to enhance existing medications or develop new formulations. These endeavors can lead to advancements in medication effectiveness or safety, which can be advantageous for patients battling breast cancer. Proper packaging and accurate labeling are essential attributes of medications. Reputable pharmaceutical manufacturers prioritize clear, informative packaging, and labeling to ensure that healthcare providers and patients can use the medication safely and effectively.

Support services provided by pharmaceutical companies are another valuable asset. This support includes offering information on proper medication administration, dosing guidelines, and potential side effects. Such services are instrumental in ensuring the safe and effective use of medications. Consistency in dosage and formulation is paramount. Patients and healthcare providers rely on consistent dosages and formulations to ensure that patients receive the correct treatment, which reputable pharmaceutical manufacturers strive to maintain. Reliability in the supply chain is a crucial consideration for healthcare facilities. Knowing that a pharmaceutical company like Taj Pharmaceuticals can consistently deliver Anastrozole Tablets USP 1mg on time allows healthcare providers to plan and manage patient care effectively.

What are Anastrozole Tablets USP and its uses?

Anastrozole Tablets USP is a medication used in the treatment of breast cancer. It contains the active ingredient anastrozole, which belongs to a class of drugs known as aromatase inhibitors. Anastrozole is available in tablet form and is prescribed for specific purposes related to breast cancer treatment. Here’s an overview of Anastrozole Tablets USP and its uses:

  • Treatment of Early-Stage Breast Cancer (Adjuvant Therapy): Anastrozole is prescribed as adjuvant therapy for postmenopausal women who have undergone surgery or radiation therapy for early-stage breast cancer. This treatment aims to reduce the risk of cancer recurrence by suppressing the growth of any remaining cancer cells. Anastrozole is particularly effective in hormone receptor-positive breast cancer cases, where cancer cells are stimulated by the hormone estrogen.
  • Treatment of Advanced or Metastatic Breast Cancer: Anastrozole is also used in the management of advanced or metastatic breast cancer, where the cancer has spread to other parts of the body. In these cases, Anastrozole is administered to slow down the progression of the disease by reducing the production of estrogen. It can be employed as a first-line or subsequent therapy, especially when other hormonal treatments like tamoxifen are no longer effective.
  • Hormone Receptor-Positive Breast Cancer: Anastrozole is particularly beneficial in treating breast cancers that are hormone receptor-positive. These tumors have receptors for estrogen (ER-positive) and/or progesterone (PR-positive), making them dependent on these hormones for growth. Anastrozole works by lowering estrogen levels, thereby inhibiting the growth and proliferation of hormone receptor-positive cancer cells.

It’s important to note that Anastrozole is specifically indicated for use in postmenopausal women. This is because its mechanism of action involves blocking the conversion of androgens into estrogen, which is more relevant in postmenopausal individuals. Premenopausal women with hormone receptor-positive breast cancer may require different treatment approaches to suppress ovarian estrogen production. The decision to prescribe Anastrozole Tablets USP and the specific treatment plan are made by oncologists or healthcare providers based on the patient’s individual medical history, type, and stage of breast cancer, hormone receptor status, and overall health. Patients taking Anastrozole should follow their healthcare provider’s instructions carefully and should be monitored regularly for any side effects or changes in their condition during the course of treatment.

How Does Anastrozole Tablets USP Work?

Anastrozole Tablets USP works by inhibiting the activity of an enzyme called aromatase. This enzyme plays a crucial role in the production of estrogen in the body. Anastrozole is specifically designed to reduce the levels of estrogen, a female sex hormone, in postmenopausal women. Here’s how Anastrozole works:

  • Aromatase Inhibition: Aromatase is an enzyme found in various tissues, including fat cells, muscles, and the adrenal glands. Aromatase’s primary function is to convert androgens (male hormones), such as testosterone, into estrogens (female hormones), including estradiol. This conversion occurs through a series of chemical reactions.
  • Reduction in Estrogen Production: Anastrozole, as an aromatase inhibitor, binds to the active site of the aromatase enzyme and prevents it from converting androgens into estrogen. By blocking aromatase, Anastrozole effectively reduces the production of estrogen in the body.
  • Lowered Estrogen Levels: With decreased aromatase activity, the levels of estrogen in the bloodstream decrease. This reduction in estrogen is particularly significant in postmenopausal women, as their ovaries are no longer the primary source of estrogen production, and peripheral tissues become more important sources.
  • Impact on Hormone Receptor-Positive Breast Cancer: Many breast cancers are classified as hormone receptor-positive, meaning they have receptors for estrogen (ER-positive) and/or progesterone (PR-positive). These receptors play a role in stimulating the growth of cancer cells when they bind to their corresponding hormones. By reducing estrogen levels, Anastrozole effectively deprives hormone receptor-positive breast cancer cells of the hormone they need to grow and divide.
  • Inhibition of Cancer Cell Growth: The reduction in estrogen levels creates an unfavorable hormonal environment for hormone receptor-positive breast cancer cells. With less estrogen stimulation, the cancer cells’ growth is slowed down or inhibited, leading to tumor shrinkage and decreased cancer progression.

It’s important to note that Anastrozole is effective primarily in postmenopausal women because it targets peripheral estrogen production, which becomes more significant after menopause when ovarian estrogen production declines. In premenopausal women, whose ovaries still produce substantial estrogen, other treatment approaches are typically required to suppress ovarian estrogen production or block estrogen receptors directly. Anastrozole’s mechanism of action makes it a valuable medication in the treatment of hormone receptor-positive breast cancer, both in the adjuvant setting (after surgery or radiation therapy to prevent recurrence) and in advanced or metastatic breast cancer cases. However, it is essential for healthcare providers to carefully assess each patient’s suitability for Anastrozole therapy and monitor their progress during treatment.

Anastrozole Tablets USP offer benefits in the treatment of hormone receptor-positive breast cancer, primarily in postmenopausal women. However, like all medications, it can also be associated with side effects. Here are the benefits and potential side effects of Anastrozole Tablets USP:

Benefits of Anastrozole Tablets USP:

  • Effective Treatment: Anastrozole is an effective treatment for hormone receptor-positive breast cancer in postmenopausal women. By reducing estrogen levels in the body, it inhibits the growth and proliferation of cancer cells that rely on estrogen for their growth.
  • Reduced Risk of Recurrence: In the adjuvant setting, Anastrozole is prescribed after surgery or radiation therapy to reduce the risk of breast cancer recurrence. It helps prevent the growth of any remaining cancer cells and decreases the likelihood of the disease coming back.
  • Slowed Tumor Growth: Anastrozole is used to treat advanced or metastatic breast cancer, where it can slow down the progression of the disease and provide relief from symptoms. It may also help shrink tumors.
  • Well-Tolerated: Anastrozole is generally well-tolerated by many patients, and it does not cause some of the more severe side effects associated with other breast cancer treatments, such as chemotherapy.

Potential Side Effects of Anastrozole Tablets USP:

  • Musculoskeletal Symptoms: Some patients may experience musculoskeletal symptoms, including joint pain, stiffness, and muscle aches. These side effects are relatively common with Anastrozole.
  • Osteoporosis and Bone Fractures: Anastrozole can lead to a decrease in bone density, increasing the risk of osteoporosis and fractures. Regular bone density monitoring and appropriate measures to maintain bone health may be necessary.
  • Hot Flashes: Postmenopausal women may experience hot flashes, similar to menopausal symptoms, as a side effect of Anastrozole.
  • Vaginal Dryness and Discomfort: Some women may experience vaginal dryness and discomfort.
  • Fatigue: Fatigue and weakness are potential side effects of Anastrozole, although they are generally less severe than those associated with chemotherapy.
  • Nausea and Upset Stomach: Some individuals may experience nausea, upset stomach, or diarrhea.
  • Mood Changes: Mood changes, including depression and anxiety, have been reported in some patients.
  • Cardiovascular Effects: Rarely, Anastrozole may have an impact on cardiovascular health, including increased cholesterol levels.
  • Skin Changes: Skin rashes or other skin changes may occur in some individuals.
  • Liver Enzyme Abnormalities: Elevated liver enzyme levels have been reported in rare cases.

It’s important to note that not all patients will experience these side effects, and the severity of side effects can vary from person to person. Healthcare providers carefully weigh the potential benefits of Anastrozole in treating breast cancer against the risks and side effects when making treatment decisions.

Patients taking Anastrozole should maintain open communication with their healthcare team, report any side effects promptly, and follow the recommended monitoring and management strategies. Additionally, the decision to use Anastrozole should be made in consultation with an oncologist or healthcare provider experienced in breast cancer treatment.

Frequently Asked Questions About Anastrozole Tablets USP:

Here are some frequently asked questions about Anastrozole Tablets USP:

  1. What is Anastrozole Tablets USP used for?

Anastrozole Tablets USP is primarily used in the treatment of hormone receptor-positive breast cancer in postmenopausal women. They may be used as adjuvant therapy to reduce the risk of recurrence or as a treatment for advanced or metastatic breast cancer.

  1. How does Anastrozole work in breast cancer treatment?

Anastrozole is an aromatase inhibitor that lowers estrogen levels in the body. It inhibits the enzyme aromatase, which is responsible for converting androgens into estrogen. By reducing estrogen, slows down or inhibits the growth of hormone receptor-positive breast cancer cells.

  1. Is Anastrozole suitable for all breast cancer patients?

Anastrozole is specifically indicated for postmenopausal women with hormone receptor-positive breast cancer. It may not be effective in premenopausal women, and different treatment approaches are often required for this group.

  1. What are the potential side effects of Anastrozole Tablets USP?

Common side effects may include joint pain, muscle aches, hot flashes, bone density loss (osteoporosis), mood changes, fatigue, and gastrointestinal symptoms. Regular bone density monitoring and management are essential.

  1. How is Anastrozole administered?

Anastrozole is taken orally in the form of tablets. It is typically prescribed as a once-daily medication.

  1. Is it safe to use Anastrozole during pregnancy or breastfeeding?

Anastrozole is contraindicated during pregnancy and is not recommended during breastfeeding. It can harm a developing fetus and may affect breast milk production.

  1. What should I do if I miss a dose of Anastrozole?

If you miss a dose, take it as soon as you remember unless it is close to the time for your next dose. Do not take a double dose to make up for a missed one. Consult your healthcare provider for guidance.

  1. Is it safe to consume alcohol while taking Anastrozole?

Alcohol consumption should be discussed with your healthcare provider. Some studies suggest that alcohol may increase the risk of certain side effects associated with Anastrozole, such as bone density loss.

  1. How long will I need to take Anastrozole?

The duration of Anastrozole treatment varies depending on the specific breast cancer diagnosis and treatment plan. It may be prescribed for several years in the adjuvant setting or as long as it continues to be effective in the treatment of advanced or metastatic breast cancer.

  1. Can Anastrozole be used in combination with other breast cancer treatments?

Yes, Anastrozole can be used in combination with other breast cancer therapies, such as surgery, radiation, or targeted therapies, depending on the individual patient’s treatment plan and cancer stage.

As Anastrozole Tablets USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Anastrozole Tablets USP 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

Anastrozole Tablets USP 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 Anastrozole Tablets USP, 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:

Anastrozole Tablets USP 1mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Anastrozole Tablets USP 1 mg
Each film-coated tablet contains:
Anastrozole USP……………….1 mg
Excipients…………………………q.s.
Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Anastrozole is a type of hormone treatment. Anastrozole can be used to treat breast cancer that has come back (recurrence) in women.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Dispense in tight and light resistant container as defined in the USP.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

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