AVODART SOFT CAPSULE 0.5 MG [SIN12434P]

Product Info

AVODART SOFT CAPSULE 0.5 MG

[SIN12434P]

Indication

Indications

AVODART is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in men with an enlarged prostate by alleviating symptoms, reducing prostate size, reducing the risk of acute urinary retention (AUR), and reducing the need for BPH-related surgery.

In addition, AVODART in combination with an alpha-1 adrenergic blocker is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. AVODART has primarily been studied in combination with the alpha-1 adrenergic blocker tamsulosin (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

Dosage and Administration

Pharmaceutical form: Soft capsules.

Populations

Adult males (including elderly)

AVODART can be administered alone or in combination with an alpha-1 adrenergic blocker tamsulosin.

The recommended dose of AVODART is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.

AVODART may be taken with or without food (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly.

Renal impairment

The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment (see Warnings and Precautions and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (See section Contraindications).

Contraindications

Contraindications

AVODART is contraindicated for use in women, children and adolescents (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

AVODART is contraindicated in patients with hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors (5-ARI), or any component of the formulation.

AVODART is contraindicated in patients with severe hepatic impairment.