AVODART ® - Dutasteride

AVODART ® is a drug based on Dutasteride

THERAPEUTIC GROUP: Testosterone inhibitors 5 alpha reductase

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications AVODART ® - Dutasteride

AVODART ® is used in the symptomatological treatment of benign prostatic hyperplasia and in the reduction of the relative risk of acute urinary retention.

Mechanism of action AVODART ® - Dutasteride

AVODART ® is a drug based on Dutasteride, an active ingredient capable of inhibiting the two different isoforms of the testosterone 5 alpha reductase enzyme, an enzyme necessary to convert testosterone into its higher affinity for androgen receptors known as dihydrotestosterone.

The two enzymatic isoforms, expressed above all at the cutaneous level (hair follicles and sebaceous glands), prostatic and hepatic, responsible for the aforementioned conversion, are fundamental during the development phases in guaranteeing the correct androgenic action useful for determining the appearance and maintenance of the organs male genitals and secondary characters.

However, the high concentration of androgens, combined with progressive androgenic prostate stimulation, appears to be responsible for pathological conditions such as benign prostatic hyperplasia, for which treatment with inhibitors of the aforementioned enzyme could be particularly effective in regressing the symptoms and in the reduction of prostate volume.

Further studies are underway to evaluate the efficacy of this treatment also to combat hair loss, which in part seems associated with an intense androgenic action concentrated on the hair follicle.

Studies carried out and clinical efficacy

1. DUTASTERIDE IN PROSTATIC CARCINOMA: a possible way forward?

First ever study that tests the biological activity of dutasteride in prostate cancer. Regardless of the clinical efficacy of the treatment, this study may clarify some important points relating to androgenic hyperstimulation present in this condition.

2. THE CLINICAL EFFECTS OF DUTASTERIDE

The use of this innovative dual 5 alpha reductase inhibitor has been shown to be effective in reducing prostate volume during benign prostatic hyperplasia, the rate of acute urinary retention and the need for surgery.

3. THE DIFFERENT EFFECTIVENESS OF COMBINED DUTASTERIDE / TAMSULOSIN THERAPY

Combination therapy with tamsulosin appears to be more effective than dutasteride alone only in men with increased prostate volume between 30 and 58 ml. These advantages are lost in the most advanced benign prostatic hyperplasia.

Method of use and dosage

AVODART ®

Dutasteride 0.5 mg soft capsules:

the treatment of benign prostatic hyperplasia generally involves long-term therapy, since the therapeutic efficacy is observed only after about 6 months of treatment, characterized by the intake of one capsule a day of 0.5 mg dutasteride.

The capsule must be swallowed whole, as its contents may irritate the oro-pharyngeal mucosa.

All treatment must be supervised by your doctor.

Warnings AVODART ® - Dutasteride

The administration of AVODART ® must be preceded by a careful medical examination useful to exclude the possible presence of prostatic carcinomas, for which a different therapy would be indicated.

At the same time it is useful to remember that dutasteride significantly reduces PSA plasma concentrations, thus being able to distort the diagnostic index of this marker.

During the treatment routine medical checks are necessary, useful to evaluate the therapeutic efficacy and to exclude the possible appearance of neoplastic foci.

PREGNANCY AND BREASTFEEDING

AVODART ® is indicated for the exclusive treatment of male pathology, therefore it is contraindicated in women, particularly during pregnancy, and in children, given the possibility of altering the correct development of the external genital organs and secondary sexual characteristics.

Interactions

Hepatic metabolism, supported by the CYP3A4 isoform, to which dutasteride is subjected, exposes the patient to potential risks due to the simultaneous intake of inducers or inhibitors of the aforementioned enzyme.

More precisely, the concomitant intake of inhibitors could lead to an increase in dutasteride blood concentrations, with an accentuation of therapeutic effects and potential side effects, while the concomitant use of inducers could on the contrary reduce the efficacy of AVODART ® therapy

It is also important to remember that the ability of dutasteride to reduce PSA plasma concentrations could make the diagnosis of prostate cancer more difficult.

Contraindications AVODART ® - Dutasteride

Intake of AVODART ® is contraindicated in patients with severe liver disease or hypersensitivity to the active substance or to one of its excipients.

Undesirable effects - Side effects

Gentasteride monotherapy has been associated with the appearance of several side effects, mainly concentrated in the first year of therapy.

Impotence, decreased sexual libido, alteration in ejaculation, increase in volume with breast tenderness, skin rash, hives, angioedema and other hypersensitivity reactions are the most commonly observed side effects, whose incidence is significantly reduced during the second year of treatment.