Dutasteride-Tamsulosin

Dutasteride-Tamsulosinis a combination medication used for the treatment ofbenign prostatic hyperplasia.

• Dutasteride-Tamsulosinis available under various brand names:Jalyn

Common side effects of Dutasteride-Tamsulosin include:

• dizziness,
• lightheadedness,
• drowsiness,
• runny orstuffy nose,
• sexual problems (such as decreased sexual interest/ability,ejaculationproblems, and decrease in the amount of semen/sperm),
• impotence(trouble getting or keeping an erection),
• increased breast size,
• breast tenderness,
• backache,
• diarrhea,
• feeling weak, and
• headache.

Serious side effects of Dutasteride-Tamsulosin include:

• fainting, or
• a painful or prolonged erection lasting 4 or more hours.

Rare side effects of Dutasteride-Tamsulosin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision、眼睛疼痛或swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 0.5 mg/0.4 mg

BenignProstaticHyperplasia

Adult dosage

• 1 capsule (dutasteride 0.5 mg/ tamsulosin 0.4 mg) orally every day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

如果你的医生使用这种药treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dutasteride-Tamsulosin has severe interactions with the following drug:
  • ombitasvir/paritaprevir/ritonavir& dasabuvir
• Dutasteride-Tamsulosin has serious interactions with at least 49 other drugs.
• Dutasteride-Tamsulosin has moderate interactions with at least 87 other drugs.
• Dutasteride-Tamsulosin has minor interactions with at least 12 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Clinically significant hypersensitivity (eg, serious skin reactions,angioedema,urticaria,pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, or tamsulosin
• Females who are pregnant

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dutasteride-Tamsulosin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dutasteride-Tamsulosin?”

Cautions

• Orthostatic hypotensionand/orsyncopecan occur
• Reduces total serumprostate-specificantigen(PSA) concentration by ~50%, evaluate any confirmed increases in PSA levels fromnadir, even if those values are withinnormal range, for the presence ofprostate cancer
• Caution patients about the possibility and seriousness ofpriapism
• Advise patients to not donate blood until 6 months after their last dose
• Intraoperativefloppy iris syndrome has been observed duringcataract surgeryafter alpha-adrenergicantagonistexposure
• 5-ARIs and prostate cancer risk
  • June 9, 2011: Recent data from 2 large, randomized, controlled trials, the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, observed an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs)
  • Revised prescribing information recommends that before initiating 5-ARIs, rule out other urological conditions, including prostate cancer that might mimic benign prostatic hyperplasia (BPH)
• Drug interaction overview
  • Tamsulosin: CYP3A4 and CYP2D6 substrate
  • Dutasteride: CYP3A4 and CYP3A5 substrate
• Additivehypotensiveeffects
  • Coadministration with PDE-5 inhibitors (eg,sildenafil) or other alpha-antagonists (eg,doxazosin,terazosinmay increase the risk ofhypotension
• CYP3A4 and CYP2D6 inhibitors
  • 强大的CYP3A4抑制剂(如ketoconazole): Avoid coadministration
  • Less potent CYP3A4 inhibitors (eg,terbinafine), strong or moderate (eg, terbinafine,paroxetine) CYP2D6 inhibitors, a combination of both CYP3A4 and CYP2D6 inhibitors, or poor metabolizers of CYP2D6: Use caution
  • Ketoconazole (a strong CYP3A4 inhibitor) and paroxetine (a strong CYP2D6 inhibitor) resulted in an increase in plasma levels of tamsulosin
  • Effects of CYP3A4 inhibitors on dutasteride have not been studied
• Calcium channel blockers
  • No dosage adjustment recommended
  • Coadministration ofverapamilordiltiazemdecreases clearance and increases the effects of dutasteride
• Warfarin
  • Use caution; monitor INR
  • Limited studies showed inconclusive results regarding the coadministration of tamsulosin with warfarin

Pregnancy & Lactation

• Not indicated for use in females; contraindicated for use in pregnancy because may cause harm to male fetus; dutasteride is a 5-alpha-reductase inhibitor that prevents the conversion oftestosteronetodihydrotestosterone(DHT), a hormone necessary for normal development ofmale genitalia
• Abnormalities in thegenitaliaof male fetuses are an expected physiological consequence of inhibition of this conversion; these results are similar to observations in male infants with genetic 5-alpha-reductase deficiency
• Reproductive potential
  • Effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up; at 52 weeks, mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group; sperm concentration andmorphologywere unaffected
  • After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline, while mean values for all semen parameters at all time points remained within normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at 24-week follow-up; the clinical significance of these effects on semen characteristics for an individual patient’s fertility is not known