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Brand Name :
Afdura
Synonyms :
alfuzosin/dutasteride, Alfuzosina/Dutasterida
Class :
Urinary bladder relaxant, Alpha-blockers/5-alpha reductase inhibitor
Dosage Forms & Strengths
Tablet
10 mg/0.5 mg
Benign Prostatic Hyperplasia (BPH)
The usual dose is one tablet of (10 mg/0.5mg) this medication daily via oral administration for a duration of 4 to 6 weeks
Dose Adjustments
Limited data is available for renal or hepatic impairment
Benign Prostatic Hyperplasia (BPH)
The usual dose is one tablet of (10 mg/0.5mg) this medication daily via oral administration for a duration of 4 to 6 weeks
Dose Adjustments
Limited data is available for renal or hepatic impairment
Safety and efficacy are not seen in pediatrics
Refer to the adult dosing
when alfuzosin/dutasteride is used in combination with ritonavir, there is an increased risk of side effects
when alfuzosin/dutasteride is used in combination with clarithromycin, there is an increased risk of side effects
Actions and Spectrum:
Actions:
The combination of alfuzosin/dutasteride is used to relieve the symptoms that emerge from BPH, where urinary problems, especially at night, occur.
Spectrum:
The spectrum of the combination of alfuzosin/dutasteride is used in BPH to relieve the symptoms of urination problems and bladder problems.
Frequency defined
Ejaculation disorder
Fatigue
Impotence
Angioedema
Swollen lips
Chest pain
Erectile dysfunction
Orthostatic hypertension
Urticaria
Dizziness
Infection
Stomach pain
Rash
Decreased libido
Sinus inflammation
Dyspepsia
Pharyngitis
Headache
Decreased semen volume
Black Box Warning:
Donation of blood is stopped for 6 months while on this combinational drug. Avoid driving as this combination can cause dizziness and blurring of the vision.
Contraindication/Caution:
Contraindications
Cautions
Pregnancy consideration:
No data is available regarding the administration of the drug during pregnancy.
Breastfeeding warnings:
No data is available regarding the excretion of drug in breast milk.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
A combination of alfuzosin/dutasteride shows the action of alphablocker/5-alpha reductase inhibitor by relaxing both bladder muscles and prostate gland at the exit, allowing free flow of urine, thereby relieving symptoms that emerge from BPH.
Pharmacodynamics:
alfuzosin relaxes the prostate gland, and dutasteride reduces inflammation of prostate gland muscles by decreasing the dihydrotestosterone hormone, which relieves symptoms of BPH, reduces the need for prostate surgery, and decreases the risk of urinary retention.
Pharmacokinetics:
Absorption
The bioavailability is 49% for alfuzosin and 60% for dutasteride.
The time to achieve peak effect is 8 hours for alfuzosin and 2-3 hours for dutasteride.
Distribution
Protein-bound is 82-90% for alfuzosin and 96% for dutasteride 300-500 L/kg.
The volume of distribution is 3.2 L/kg for alfuzosin and 96% for dutasteride.
Metabolism
A combination of these drugs is metabolized in the liver.
Elimination and Excretion
The half-life is 10 hours for alfuzosin and five weeks for dutasteride.
Alfuzosin is excreted 69% in feces and 24% in urine, and dutasteride is eliminated as its metabolites in urine and feces.
Administration:
Swallow the tablet with a drink of water, and it can be taken with food or after having it. It should be taken at the same time every day. Keep it out of reach of children and store it In a cool, dry place. Don’t double dose if you skipped it.
Patient information leaflet
Generic Name: alfuzosin/dutasteride
Pronounced: al-FYOO-zoh-sin/doo-TAS-tuh-ryd
Why do we use alfuzosin/dutasteride?
A combination of alfuzosin/dutasteride shows the action of alphablocker/5-alpha reductase inhibitor by relaxing both bladder muscles and prostate gland at the exit, allowing free flow of urine, thereby relieving symptoms that emerge from BPH.