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Exeget 25 Tablet

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Brand Name: Exeget 25 Tablet
International Trade Name: Aromasin
Active Substance: Exemestane
Strength: 25mg
Category: Anti-Cancer
Manufacturer: GLS Pharma Ltd
Pack: 10 Tablets in a Strip
Product Form: Tablet
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Description of Exeget 25 (Exemestane 25mg) tablet 

Aromatase inhibitor (Exemestane) is a steroidal hormone available as 25mg of the active pharmaceutical ingredient per tablet as Exeget 25. The use of this formulation is mostly used in the treatment of hormone-receptor-positive breast carcinoma in postmenopausal women. It has a therapeutic effect through its irreversible binding to aromatase thus successfully suppressing the conversion of androgens to oestrogen.

Indications of Exeget 25 (Exemestane 25mg) tablet 

Exemestane is indicated for the effectiveness of adjuvant therapy of hormone receptor advanced breast cancer among postmenopausal women in the early stage of the disease. Long term adjuvant treatment after tamoxifen therapy, and Metastatic or advanced breast cancer with hormone receptor-positive.

Mechanism of action of Exeget 25 (Exemestane 25mg) tablet 

The pharmacodynamic mechanism of Exemestane is irreversible inactivation of the aromatase enzyme of cytochrome P450 and prevent peripheral transformation between androstenedione and testosterone into estradiol. Then, this irreversible inhibition results in a marked drop in systemic oestrogen levels, which subsequently dampen ominous signalling pathways that promote the expansion of oestrogen-dependent neoplasia.

How to consume of Exeget 25 (Exemestane 25mg) tablet 

The optimal dosage schedule should be a single tablet per day at a fixed time. The tablet can be consumed either with or without food. The entire tablet should be taken whole with water and not crushed and chewed as this can change kinetics of absorption. The therapy can take many years depending on the stage of the disease and response to clinical therapy.

Side Effects of Exeget 25 (Exemestane 25mg) tablet 

  1. Common side effects
  • Hot flashes
  • Fatigue or weakness
  • Headache
  • Pain in the bones
  • Appetite gets lower
  1. Serious side effects
  • Loss of bone mineral loss resulting in osteoporosis
  • Increased rate of fractures
  • Allergic issues (rashes itchy, or swelling)
  1. Rare side effects
  • Severe allergic reactions
  • Heart attacks or other complications like angine
  • Drastic changes of mood and effect

Safety Advice for Exeget 25 (Exemestane 25mg) tablet 

Patients taking Exemestane ought to have routine medical cheque-ups, such as bone mineral density assessment and lipid profile cheques. Chronic use of the drug can lead to bone demineralisation and fracture because of the decrease in circulating oestrogen.

Breastfeeding: The drug is not to be used in lactation, it is likely to have negative impact on the baby.

Pregnancy: Exemestane is not to be used in pregnancy because of the possible harm of the fetus.

Alcohol: Intake of alcohol should be restricted since it can increase the side effect on the liver.

Liver: It is recommended that care be used in patients with hepatic impairment; periodical observation of liver functions is necessary.

Lungs: Pulmonary toxicity is not a common condition, but the patients are advised to report the new onset or worsening of cough, dyspnea, and chest pain to their doctor.

Kidney: Care should be taken in case of severe kidney failure.

Driving: Dizziness or fatigue may result with the use of the drug; patients should avoid driving or using heavy machinery in case of these effects.

Interaction of Exeget 25 (Exemestane 25mg) tablet 

  • Drug-Drug Interaction :

Rifampicin × Exemestane

Rifampicin is a strong inducer of the hepatic enzyme and can reduce plasma levels of Exemestane, which can negatively impact the anticancer effects of such a drug. It is recommended that clinical monitoring is done.

Phenytoin × Exemestane

Exemestane may have its hepatic metabolism increased through co-administration with phenytoin thus decreasing its plasma concentration. Caution and therapeutic drug monitoring is thus suggested.

Carbamazepine × Exemestane

Carbamazepine is likely to enhance the hepatic enzyme activity thus lowering the concentration and efficacy of Exemestane.

Warfarin × Exemestane

Though a considerable interaction is not usual; it is recommended that monitoring be applied when the two drugs are used simultaneously because of anticoagulant response changes.

Ketoconazole × Exemestane

Ketoconazole which is an inhibitor of CYP enzyme can increase the plasma levels of Exemestane. Special attention to side effects should be followed.

  • DrugFood Interaction:

It has not been reported that Exemestane and food had any significant interaction in pharmacokinetics. Tablet can be given with or without concomitant food as per the choice of the patient or as per clinically convenient.

  • DrugDisease Interaction:

Osteoporosis:

Long-term exemestane leads to hypogonadism, hence reducing the oestrogen level and possibly increasing the loss of bone mineral density which could increase the fracture rate of osteoporosis. Consistent bone density evaluation, in addition to calcium and vitamin D supplementation, should be recommended in patients with already diagnosed osteoporosis or with reduced bone mass..

Cardiovascular Disease:

Exemestane could raise the level of cholesterol in the blood, thus increasing the risk of cardiovascular disease.

Hepatic Impairment:

The Exemestane metabolism in the liver dysfunctioned patients can be altered. During therapy, liver functioning tests are to be observed.

Renal Impairment:

Exemestane may increase serum cholesterol, which may lead to cardiovascular risk..

Contraindication of Exeget 25 (Exemestane 25mg) tablet 

Exeget 25 (Emestatin 25 mg) should not be used in those who have already stopped their menstrual cycle or are in menopause; those who are hypersensitive to the active ingredient or any of the excipient components are also not to use it. Moreover, unless ovarian suppression therapy is done, the drug should not be used in premenopausal patients because the pharmacologic activity of exemestane depends on an environment of a postmenopausal oestrogen milieu.

Dosage of Exeget 25 (Exemestane 25mg) tablet 

The typical therapeutic protocol includes 1mg/day of medication taken at a point in time that is regular daily. The total period of treatment is also personalised and determines the treating oncologist and may take several years depending on clinical goals and treatment effectiveness.

Storage of Exeget 25 (Exemestane 25mg) tablet 

The formulation must be kept at ambient temperature, dry and free of overheating and this must be locked away where it cannot be accessed by children.

Missed Dose of Exeget 25 (Exemestane 25mg) tablet 

Where a dose is missed, one should take it as soon as they remember but there should be no huge time interval between successive scheduled doses.

Other General Information of Exeget 25 (Exemestane 25mg) tablet 

The long-term treatment may cause dermatologic dryness and long-term joint stiffness; hence, hydration and light physiotherapy should be promoted to reduce the pain. Patients need to practise skeletal health by consuming a calcium-based diet, ensuring that they engage in sufficient vitamin D intake and in instances when it is medically possible, they ought to engage in weight-threatening exercise. Oncologic follow-ups must be performed periodically to measure the effectiveness of the therapeutic interventions, as well as to identify the adverse events early in life. They are advised to visit the doctor as soon as possible in the event of unusual drug symptoms, including bone pain, chest pain, or deep-seated fatigue.

FAQs of Exeget 25 (Exemestane 25mg) tablet 

  1. Why is it that Exemestane is only used in postmenopausal women?

Exemestane works by blocking aromatase which is an enzyme that produces oestrogen after menopause. In premenopausal women, ovarian activity is still capable of generating the large amount of oestrogen; hence the effects of a drug are constrained unless the ovarian suppression is performed simultaneously.

  1. Is Exemestane associated with bone weakness?

Yes. Oestrogen is necessary in preserving bone density and its depletion may gradually weaken bone. Bone density cheques are commonly prescribed by the clinicians as long-term treatment.

  1. Is Exemestane a weight gaining drug?

Direct adverse effects are not common, but weight gain may be caused by hormonal changes, a lack of exercise owing to fatigue in some patients.

  1. What is the average length of time Exemestane should be used?

The drug is used normally in a period of five years and above depending on the staging of the tumour, the risk of its recurrence and the judgement of the physician who is treating the patient.

  1. Is it possible that Exemestane influences cholesterol level?

Indeed. Others might develop hypercholesterolemia, and this will be a reason to repeat lipid profile monitoring.

  1. Do you experience joint pain in the course of treatment?

Such symptoms as arthralgia and stiffness in the joints are common as a result of oestrogen deprivation. These complaints can be treated by gentle physical activities and supportive therapies.

Fact Box of Exeget 25 (Exemestane 25mg) tablet:

Field Details
Generic/Molecule Name Exemestane
Therapeutic Class Anti-neoplastic agent
Pharmacological Class Aromatase Inhibitor
Dosage form Tablet
Habit forming No
Indication Hormone Receptor-positive Breast cancer

 

References
  1. FDA Prescribing Information – Aromasin (Exemestane)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020541s026lbl.pdf

  1. European Medicines Agency (EMA) – Aromasin Summary of Product Characteristics

https://www.ema.europa.eu/en/documents/product-information/aromasin-epar-product-information_en.pdf

  1. DrugBank – Exemestane Profile

https://go.drugbank.com/drugs/DB01396

  1. National Cancer Institute (NCI) – Exemestane

https://www.cancer.gov/about-cancer/treatment/drugs/exemestane

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