Leaflet ROGLUTEN 250mg tablets

Indicated for: Cushing syndrome; breast cancer

Route of administration: oral

Substance: aminoglutethimide (antineoplastic agent)

ATC: L02BG01 (Antineoplastic and immunomodulating agents | Hormone antagonists and related agents | Aromatase inhibitors)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Aminoglutethimide is a medication primarily used in the treatment of certain types of cancer, such as breast cancer and adrenal cancer, as well as in Cushing's syndrome. It works by inhibiting the synthesis of steroid hormones, including cortisol, estrogens, and androgens, through the blockade of the aromatase enzyme and other enzymes involved in steroid production.

Aminoglutethimide is administered orally, usually in tablet form, with the dosage adjusted based on the patient's response and the severity of the condition. The treatment requires careful monitoring, as it can affect adrenal gland function and lead to adrenal insufficiency.

Common side effects include drowsiness, dizziness, nausea, skin rashes, and muscle weakness. In rare cases, severe adverse reactions such as hepatotoxicity or bone marrow suppression may occur.

Patients taking aminoglutethimide should undergo regular monitoring for liver and adrenal function. Additionally, the medication may interact with other hormonal treatments, necessitating dose adjustments. Aminoglutethimide is an important therapeutic option for managing hormone-dependent conditions, but its use must be carefully supervised by a specialist physician.

General data about ROGLUTEN 250mg

  • Substance: aminoglutethimide
  • Date of latest medicines list: 01-04-2014
  • Product code: W52201001
  • Concentration: 250mg
  • Pharmaceutical form: tablets
  • Quantity: 40
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.