- USES: Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). PHARMACOLOGY: Dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5-alpha-reductase. EPIDEMIOLOGY: Overdose is rare. TOXICITY: There are no reports of toxicity following acute overdose. In volunteer studies, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been administered with no significant effects reported. ADVERSE EFFECTS: COMMON: Impotence, decreased libido, and ejaculation disorders. LESS COMMON: Dizziness and breast disorders.
Range of Toxicity:
- TOXICITY: A maximum toxic dose has not been established for dutasteride. In volunteers, single doses of up to 40 mg (80 times the therapeutic dose) for 7 days have been given with no significant adverse events. THERAPEUTIC DOSE: The recommended dose is 0.5 mg (1 capsule) orally once daily, and may be prescribed alone or in combination with tamsulosin.
- Support: MANAGEMENT OF MILD TO MODERATE TOXICITY: Treatment is symptomatic and supportive. MANAGEMENT OF SEVERE TOXICITY: Dutasteride has a low toxicity profile. Treatment of overdose is symptomatic and supportive.
- Decontamination: PREHOSPITAL: Gastric decontamination is unlikely to be necessary unless a coingestant is involved. HOSPITAL: Gastric decontamination is unlikely to be necessary unless a coingestant is involved. If dutasteride exposure occurs in a woman who might be pregnant, activated charcoal should be administered as soon as possible to minimize potential exposure to the developing fetus.
- Antidote: None.
- Acute allergic reaction: Mild to moderate allergic reactions may be treated with antihistamines with or without inhaled beta agonists, corticosteroids or epinephrine. Treatment of severe anaphylaxis also includes oxygen supplementation, aggressive airway management, epinephrine, ECG monitoring, and IV fluids.
- Monitoring of patient: Obtain a pregnancy test in any woman of child bearing potential who is exposed to dutasteride. Monitoring after overdose is based on symptoms observed, no other specific laboratory evaluation is indicated.
- Enhanced elimination procedure: Due to large volume of distribution and high protein binding, dialysis is unlikely to be beneficial.
- Patient disposition: HOME CRITERIA: Asymptomatic children and adults with inadvertent overdose can be managed at home. OBSERVATION CRITERIA: All patients with deliberate overdose should be evaluated in a healthcare facility. ADMISSION CRITERIA: Patients demonstration toxicity should be hospitalized. CONSULT CRITERIA: If a pregnant woman is exposed to dutasteride, consultation with a toxicologist and neonatologist is recommended to assess the risk to the developing male fetus. Due to the long elimination half life of dutasteride (5 weeks), any woman exposed to it should avoid pregnancy because of the risk to the developing male fetus. Consultation with a toxicologist and neonatologist is advised to determine when attempting to become pregnant might be safe.