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Anastrozol Cipla

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Anastrozol Cipla

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Anastrozol Cipla

Quick Facts

Property Description
Active ingredient Anastrozole (INN)
Form Tablet (Oral Dosage Form)
Pharmacological class Non-steroidal Aromatase Inhibitor (NSAI)
Common purpose To reduce circulating estrogen levels
Origin Synthetic (Non-steroidal compound)

Defining Anastrozol Cipla: Active Ingredient and Formulation

Anastrozol Cipla is a medication whose active component is Anastrozole, a synthetic compound that is clinically recognized as an Antineoplastic Agent. As a generic drug manufactured by Cipla, it provides the essential International Nonproprietary Name (INN) substance in a tablet form, intended for systemic absorption via oral administration. This single-ingredient product is distinguished by its origin as a synthetic non-steroidal molecule, a key characteristic supporting its unique mechanism of action. Anastrozole is consistently delivered as a solid oral dosage form, facilitating straightforward administration and promoting the consistent systemic effect required for its therapeutic role.

Pharmacological Classification and Endocrine Action

Anastrozole is classified as a Non-steroidal Selective Aromatase Inhibitor (NSAI). This pharmacological designation is critical because it identifies the drug as one that specifically targets the aromatase enzyme, contrasting it with hormone therapies that affect estrogen receptors or utilize steroidal structures.

This primary mechanism involves aromatase enzyme inhibition, which is the physiological action of blocking the final step in converting androgens into estrogen in peripheral tissues. By achieving significant estrogen suppression, Anastrozole establishes an altered hormonal environment within the body, positioning it as a foundational agent in endocrine therapy where reduced circulating estrogen is the required outcome.

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What side effects are possible with Anastrozol Cipla?

Possible Side Effects and Safety Information

The adverse reaction profile of Anastrozole is formally documented and categorized by occurrence frequency and the System Organ Class (SOC) affected, strictly reflecting observations from clinical trials and regulatory review. This information is derived from official government health authority sources, ensuring a neutral, descriptive safety profile.


Frequency-Based Adverse Reactions

The most frequently reported reactions are typically associated with the mechanism of reducing circulating estrogen.

Classification Examples of Officially Documented Adverse Reactions
Very Common (geq1/10) Hot flashes (Vasodilatation), Asthenia, Arthralgia/Joint stiffness, Nausea, Headache, Rash.
Common (geq1/100 to <1/10) Hypercholesterolaemia, Vomiting, Diarrhoea, Bone pain, Depression, Vaginal bleeding/dryness, Hypertension.

Serious adverse reactions, though rare, are documented and include severe hypersensitivity events like Angioedema and severe cutaneous reactions such as Stevens-Johnson Syndrome.


Safety Considerations and Restrictions

Official labeling addresses safety patterns related to exposure and special populations:

  • Long-Term Exposure: The medication is associated with a risk of reduction in bone mineral density, which may lead to an increased risk of fractures with prolonged use.
  • Cardiovascular Events: An increased incidence of Ischemic Cardiovascular Events has been noted in women with pre-existing ischemic heart disease.
  • Population Restriction: The drug is contraindicated in premenopausal women, and caution is advised for patients with severe hepatic impairment.
  • Concomitant Therapy: Co-administration with Tamoxifen or estrogen-containing therapies is restricted as it may diminish the expected safety profile and pharmacological action.
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Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the documented signs of Anastrozol Cipla overdose and the immediate actions mandated by regulatory authorities, based strictly on official prescribing information.

Experience with accidental overdosage of anastrozole is limited. Regulatory sources indicate that no life-threatening symptoms have been described following a single, high dose. Single doses up to 60 mg in healthy male volunteers and up to 10 mg daily in postmenopausal women were reported as generally well tolerated.

Documented Manifestations and Actions

Classification Official Regulatory Information
Documented Symptoms Nausea, vomiting, and diarrhoea are the documented clinical presentations.
Antidote Status There is no specific antidote documented for anastrozole overdosage.
Required Management Treatment must be symptomatic and consist of general supportive care. This includes frequent monitoring of vital signs and close observation of the patient.

When to Seek Urgent Medical Help

If an overdose is suspected, the patient should seek emergency medical attention or call a Poison Help line immediately. Urgent medical help is required if the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened, as stated in the official guidance. Regulatory documents also suggest considering the possibility that multiple agents may have been taken.

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Therapeutic Uses of Anastrozol Cipla

What Anastrozol Cipla Treats: Main Uses and Benefits

The core therapeutic value of Anastrozol Cipla is generally considered relevant for easing symptoms related to systemic imbalance in conditions where symptoms may intensify temporarily. This approach is applied across several key therapeutic domains. The medication is used to help with conditions presenting with systemic or localized discomfort in women who have completed menopause.


Therapeutic Applications

Anastrozol Cipla is used in contexts involving certain distressing symptoms associated with the potential for recurrent or episodic manifestations. It provides supportive relief when symptoms interfere with routine activities, contributing to improved comfort during symptomatic periods. The medication is considered relevant in settings involving the following clinical contexts: conditions presenting with acute episodes, conditions involving episodic or fluctuating manifestations, and conditions marked by increased physiological stress.

“It assists with maintaining functional stability and supports general well-being during phases where additional symptomatic support is needed.”


Quick Fact: Management of Systemic Strain

Property Description
Therapeutic Scope Applied across domains where additional symptomatic support is needed
Symptom Relevance Helps address symptom clusters that may become intense or disruptive
Context of Use Relevant in conditions characterized by periods of heightened symptoms

Regulatory References

  1. Anastrozole: MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Who Can and Cannot Use Anastrozol Cipla?

The population eligibility for Anastrozol Cipla (Anastrozole) is strictly defined by regulatory authorities based on the patient's hormonal status and pre-existing conditions.


Eligibility and Exclusion Status

Classification Population/Condition Regulatory Stance
Allowed Adult postmenopausal women Primary target group
Contraindicated Premenopausal women Absolute prohibition
Contraindicated Pregnancy or Lactation Absolute prohibition
Contraindicated Known hypersensitivity to anastrozole or excipients Absolute prohibition

Conditional Use and Restrictions

  • Pediatric Use: Use in children and adolescents is not recommended, as safety and efficacy have not been established by regulatory bodies.
  • Hepatic Impairment: Caution is advised for patients with moderate to severe liver (hepatic) impairment.
  • Renal Impairment: Caution is advised for patients with severe kidney (renal) impairment (creatinine clearance less than 20 mL/min).
  • Excipient Restrictions: Patients with hereditary problems of galactose intolerance or Lapp lactase deficiency are generally excluded due to the presence of lactose in the formulation.
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What should I know about interactions with other medicines?

Officially Documented Interaction Patterns

The interaction profile for Anastrozole is strictly defined by prohibitions and a documented low potential for metabolic conflicts. All information presented is based on official government drug labeling.

Contraindicated Combinations

Co-administration is strictly prohibited for the following substances, as mandated by regulatory documents:

Interacting Substance Official Interaction Outcome Mechanism Classification
Tamoxifen Reduces Anastrozole plasma concentration (AUC/Cmax) Reduced Exposure (Pharmacokinetic)
Estrogen-containing Therapies Directly counteracts the intended estrogen-lowering action Pharmacodynamic Conflict

Metabolic and Administration Constraints

Anastrozole exhibits a low overall potential for pharmacokinetic interactions with non-hormonal medicines, as confirmed by regulatory studies.

  • Metabolic Potential: Anastrozole does not significantly inhibit major cytochrome P450 (CYP) enzymes, including CYP1A2, CYP2C8/9, or CYP3A4. This fact limits the risk of altering the clearance of other co-administered medicinal products.
  • Non-Interacting Substances: Co-administration with Cimetidine, a recognized enzyme inhibitor, had no documented effect on Anastrozole plasma concentrations.
  • Food and Absorption: Official labeling confirms that concurrent intake of food does not affect the overall extent of Anastrozole absorption, meaning there is no documented drug-food interaction.
  • Timing Rules: Regulatory documents do not prescribe mandatory administration separation or timing rules for co-administered, non-contraindicated medications, nor do they specify interactions with alcohol or herbal products.

The entire interaction profile is primarily structured around avoiding direct conflicts with hormonal agents that either oppose the drug's effect or diminish its systemic presence, classifying these risks as strict contraindications.

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Mechanism of Action

Enzyme Inhibition and Estrogen Biosynthesis Blockade

This drug acts by engaging the Aromatase enzyme ( CYP19 A1) as a non-steroidal competitive inhibitor. . By binding reversibly to the enzyme's active site, it physically blocks the conversion of androgen hormones into estrogens (like estradiol), which is a key step in the steroidogenesis pathway. This action is primarily peripheral, occurring in tissues like fat and muscle where this conversion takes place.

Systemic Estrogen Deprivation and Signaling Modulation

The immediate consequence of enzyme blockade is a significant reduction in the levels of circulating estrogen throughout the body. This systemic reduction leads to the modulation of the Estrogen Signaling System by severely limiting the molecule required to activate Estrogen Receptors. The physiological consequence is a decrease in estrogen-dependent growth and proliferative signals in sensitive tissues.

Indirect Endocrine Feedback Modulation

By reducing systemic estrogen, the drug indirectly influences the body’s hormonal control center, the Hypothalamic-Pituitary-Gonadal ( HPG) Axis. The loss of estrogen's natural negative feedback signal can lead to a compensatory increase in pituitary gonadotropins (LH and FSH), which demonstrates the drug's influence on the endocrine system's regulatory feedback mechanisms.

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Dosage and Administration Information

Anastrozole is a medication for postmenopausal women and must be administered strictly in accordance with established guidelines.

Administration Scope

Instruction Detail
Route of administration Oral (by mouth)
Dosing schedule One 1 mg tablet taken once daily.
Timing in relation to meals May be taken with or without food.
Preparation requirements None; the tablet should be swallowed whole with water.
Age-group administration rules Adults (including the elderly): The standard 1 mg daily dose is recommended, with no routine dosage adjustment necessary.
Missed-dose rules If a dose is missed, patients should skip the missed dose and take the next dose at the regular scheduled time. Do not take a double dose.
Special procedural conditions No dosage adjustment is necessary for patients with mild or moderate renal impairment. Caution is advised in patients with moderate-to-severe hepatic or severe renal impairment.

Resulting Procedural Structure

The administration protocol is designed for simplicity and consistency. The required procedural sequence is:

  • Take one 1 mg tablet of anastrozole daily.
  • Swallow the tablet whole.
  • Repeat the dose once every 24 hours (once daily) for the full treatment duration, which is typically five years for adjuvant treatment.

Connection to the Official Use Protocol

A standardized, once-daily oral administration regimen using a fixed 1 mg dose supports achieving the necessary steady plasma concentrations within approximately seven days. This uncomplicated protocol is maintained for the majority of patients, including the elderly and those with mild-to-moderate organ impairment, thus defining a clear, long-term pattern of use.

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Recent Clinical Evidence

Recent Clinical Evidence Overview

Anastrozol, a non-steroidal aromatase inhibitor, has been extensively studied in clinical trials, primarily for the management of hormone receptor-positive breast cancer in postmenopausal women. The evidence base supporting its use is largely defined by large-scale, long-term Phase III trials, such as the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial.


Adjuvant Therapy and Long-Term Outcomes

Research has explored the role of anastrozole in the adjuvant (post-surgery) setting, often comparing its effects to those of tamoxifen. Key findings from long-term follow-up analyses suggest a consistent trend:

  • Disease-Free Survival: Studies, including 5- to 10-year follow-ups, consistently showed that the use of anastrozole was associated with an increase in disease-free survival (DFS) rates compared to tamoxifen in hormone receptor-positive early breast cancer.
  • Recurrence: Analysis of clinical data indicates an association between anastrozole use and a lower incidence of disease recurrence and the development of new primary tumors in the opposite breast (contralateral breast cancer) when compared to tamoxifen.

Risk Reduction and Prevention Studies

Beyond treating established disease, clinical research has also investigated the use of anastrozole for breast cancer risk reduction in postmenopausal women who are at high risk for the disease. The International Breast Cancer Intervention Study II (IBIS-II) Prevention trial, a major randomized study, examined this application. Follow-up data showed that participants taking anastrozole for five years were found to have a reduced incidence of breast cancer compared to those receiving a placebo, with the effect persisting even several years after treatment discontinuation.

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Frequently Asked Questions (FAQ)

Common questions about Anastrozol Cipla (FAQ)

Q: Is Anastrozol Cipla the same medicine as Arimidex?

Arimidex is the original brand name developed for the active ingredient anastrozole. Anastrozol Cipla is a generic formulation that contains the exact same active substance. Official documents indicate that both products deliver the same key ingredient.

Q: What is the difference between Anastrozol Cipla and generic anastrozole?

Anastrozol Cipla is a specific brand name for a generic version of the medicine, which contains the active ingredient anastrozole. Regulatory documents indicate that the focus is on the safety and efficacy of the active ingredient itself, and do not specifically detail differences between various generic manufacturers like Cipla.

Q: Is Anastrozol Cipla considered a form of chemotherapy?

Anastrozol Cipla is officially classified as a non-steroidal aromatase inhibitor, which places it in a category of treatments called endocrine (hormone) therapy. This means it works by targeting the body's hormones, specifically by reducing estrogen production. It is not classified as traditional cytotoxic chemotherapy, which works by directly killing cells.

Q: Why is Anastrozol Cipla sometimes used for early-stage and sometimes for advanced conditions?

According to official product information, this medication is indicated for two main purposes in postmenopausal women. These include its use in the adjuvant setting, meaning treating early breast cancer, and for managing advanced or metastatic breast cancer.

Q: Does Anastrozol Cipla cause the body to stop producing estrogen completely?

Regulatory documents state that the medication works by causing a significant reduction in the body's estrogen levels. Studies have indicated that the drug achieves at least an 85% decrease in the circulating estrogen called estradiol. However, official information does not claim 100% complete suppression of estrogen.

Q: Are there official statements regarding Anastrozol Cipla and weight gain?

According to official adverse reaction data, weight gain is listed as a Common metabolic side effect in clinical trials. Conversely, weight loss has also been noted as a Common side effect in official documents.

Q: Is hair loss or thinning a commonly described side effect of Anastrozol Cipla?

Hair thinning, also referred to as alopecia, is listed in regulatory sources as a Common adverse reaction. This means it has been observed in between 1 in 100 and 1 in 10 patients in studies.

Q: Is there information on how Anastrozol Cipla may affect vision or eye health?

Official product information lists the formation of cataracts as a Common ocular adverse reaction. This means the side effect was observed in between 1% and 10% of patients during clinical trials.

Q: How is the descriptive information on driving or operating machinery while using Anastrozol Cipla?

The official product label includes a warning regarding the potential effects of the medicine on a person's ability to drive. Since the drug may cause general weakness (asthenia) or drowsiness (somnolence), the label describes the need for caution when driving or operating heavy machinery.

Q: How long does Anastrozol Cipla typically stay in the body after the last dose?

Pharmacokinetic data in official sources indicate that the mean terminal half-life of the active ingredient is about 50 hours. This means it takes approximately 10 to 11 days for the drug to be nearly eliminated from the body after the last dose is taken.

Q: Are there official descriptions of interactions with common pain relievers?

Official regulatory documents indicate that the drug does not significantly interfere with major enzyme systems responsible for clearing many other medications. Therefore, no mandatory timing rules or interactions are specified for common, non-hormonal medications like routine pain relievers.

Q: Has research explored the use of Anastrozol Cipla in patients with a history of blood clots?

Official safety reports indicate an association with an increased risk of venous thromboembolism (blood clots) in clinical trial reports. Monitoring for thromboembolic events is a recommended safety assessment.

Q: What are the official documented effects of discontinuing Anastrozol Cipla abruptly?

Official information indicates that a gradual tapering is not specified in the protocol for stopping treatment. However, discontinuing use before the full recommended duration is associated with an increased risk of cancer recurrence.

Q: What is the descriptive information on using Anastrozol Cipla for men?

The official regulatory indication is strictly for adult postmenopausal women. The use of this drug in adult men is considered off-label, meaning it is not approved by major health authorities for this purpose.

Q: Is Anastrozol Cipla officially recommended for conditions other than breast cancer?

The official approved indications for Anastrozol Cipla are limited to various stages of hormone receptor-positive breast cancer in postmenopausal women. The regulatory documents do not list approved indications for other medical conditions.

Q: What are the official recommendations for monitoring while using Anastrozol Cipla?

Official documents describe two main types of monitoring that may be performed while using this medication. Monitoring for bone mineral density and the patient's lipid profile are described in the regulatory texts.

Q: Are there common scenarios where a patient's blood work might be affected by the medicine?

Studies and official documents indicate that the medicine can affect certain blood markers. Common scenarios where blood work is affected include an increase in cholesterol, known as hypercholesterolaemia. Increases in certain liver enzymes, such as alkaline phosphatase and aminotransferases, have also been observed.

Q: Where can patients find reliable research evidence about Anastrozol Cipla?

Patients can find reliable summaries of the research evidence and official drug information on governmental health authority websites. These sources include the FDA, the EMA, and the NIH's MedlinePlus.

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How should Anastrozol Cipla be stored and disposed of?

Official Storage and Disposal Profile

Anastrozol (Anastrozol Cipla) is classified as an antineoplastic/hazardous drug by regulatory authorities, requiring specific handling and disposal to prevent exposure.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Security Keep out of reach and sight of children and pets.
Packaging Store in the original, tightly closed container.

Handling and Disposal

The product label dictates that tablets must not be crushed, broken, or chewed; pregnant or nursing women must avoid handling the medication. Disposal of unused medicine should strictly utilize drug take-back programs or special mail-back envelopes. If these options are unavailable, the drug should be mixed with an unappealing substance, placed in a sealed bag, and discarded in the household trash. It must not be flushed down the toilet or discharged into water systems.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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