Each capsule contains 0.5 mg dutasteride.
For a full list of excipients, see section 6.1
Therapeutic indicationsTreatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
For information on effects of treatment and patient populations studied in clinical trials please see section 5.1.
Posology and method of administration
Avodart can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8 and 5.1).
Adults (including elderly):
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. The capsules may be taken with or without food. 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 section 5.2).
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 section 4.4 and section 5.2). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (see section 4.3).
Contraindications
Avodart is contraindicated in:
- women and children and adolescents (see section 4.6).
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors soya, peanut or any of the other excipients.
- patients with severe hepatic impairment.
Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
For information on effects of treatment and patient populations studied in clinical trials please see section 5.1.
Posology and method of administration
Avodart can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8 and 5.1).
Adults (including elderly):
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. The capsules may be taken with or without food. 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 section 5.2).
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 section 4.4 and section 5.2). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (see section 4.3).
Contraindications
Avodart is contraindicated in:
- women and children and adolescents (see section 4.6).
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors soya, peanut or any of the other excipients.
- patients with severe hepatic impairment.
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