Prescribing Information of Avodart

Published Saturday October 24 2009

Avodart can give relief in severe symptoms of benign prostatic hyperplasia (BPH) decreasing the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. A prescription is required to buy Avodart

Dosage and Administration

Adults (including elderly): One capsule (0.5mg) taken orally once a day. Capsules should be swallowed whole and 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.

Contraindications

Generic Avodart must not be used in women, children and adolescents. Patients with severe hepatic impairment are also denied to use it.

Drug Interaction

Some medicines or medical conditions may interact with this medicine. INFORM YOUR doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. If you are taking cimetidine, ciprofloxacin, diltiazem, ketoconazole, ritonavir, troleandomycin, or verapamil, be cautious of your doses.

Special Warnings and Precautions

  • Before taking avodart, the patient with BPH should test for prostate cancer, with DRE.
  • Women, children and adolescents must keep themselves away from contact with breaking or crushing capsules. If contact is happened with leaking capsules, wash the contact area immediately with soap and water. 
  • Make use of dutasteride with care in patients with mild to moderate hepatic impairment.

Pregnancy and Lactation

Avodart is contraindicated in women. Small amounts of dutasteride have been found in semen of patients treated with dutasteride 0.5mg. As with all 5 alpha reductase inhibitors, a condom is suggested for use in patients when their partner is or may possibly become pregnant to evade exposure to semen.

Side effects

Clinical trials have showed some of the severe side effects taking the drug. The following are some of those side effects: Impotence altered (decreased) libido, ejaculation disorders, gynaecomastia (including breast enlargement and/or breast tenderness). If they continue for long, inform your doctor. There are hardly allergic reaction to this medicine, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction may be swelling of the mouth, face, lips, or tongue; or unusual hoarseness rash; hives; itching; difficulty breathing; tightness in the chest. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Effect on 5α-Dihydrotestosterone and Testosterone

 

It works in the reduction of DHT which is very essential for fetus development. It was noticed subsequent to 1 and 2 weeks of daily dosing with dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively. A treatment with dutasteride 0.5 mg/day for 4 years in patients with benign prostatic hyperplasia (BPH) reduced the median in serum DHT by 94% at 1 year, 93% at 2 years, and 95% at both 3 and 4 years. The median increase in serum testosterone was 19% at both 1 and 2 years, 26% at 3 years, and 22% at 4 years.