Dutasteride-Tamsulosin

Dutasteride-Tamsulosin is a combination medication used for the treatment of benign prostatic hyperplasia. 

• Dutasteride-Tamsulosin is available under various brand names: Jalyn

Common side effects of Dutasteride-Tamsulosin include:

• dizziness,
• lightheadedness,
• drowsiness,
• runny or stuffy nose,
• sexual problems (such as decreased sexual interest/ability, ejaculation problems, 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, eye pain or 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

Benign Prostatic Hyperplasia

Adult dosage

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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to 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 hypotension and/or syncope can occur
• Reduces total serum prostate-specific antigen (PSA) concentration by ~50%, evaluate any confirmed increases in PSA levels from nadir, even if those values are within normal range, for the presence of prostate cancer
• Caution patients about the possibility and seriousness of priapism
• Advise patients to not donate blood until 6 months after their last dose
• Intraoperative floppy iris syndrome has been observed during cataract surgery after alpha-adrenergic antagonist exposure
• 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
• Additive hypotensive effects
  • Coadministration with PDE-5 inhibitors (eg, sildenafil) or other alpha-antagonists (eg, doxazosin, terazosin may increase the risk of hypotension
• CYP3A4 and CYP2D6 inhibitors
  • Strong CYP3A4 inhibitors (eg, 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 of verapamil or diltiazem decreases 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 of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia
• Abnormalities in the genitalia of 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 and morphology were 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