Rx Item-Dutasteride-Tamsulosin0.5-0.4 MG 90 Cap by Zydus Pharma USA , Clinical Information:
Generic Code And Description: 66352 Dutasteride/Tamsulosin Hcl Oral Caps Er 24Hr 0.5-0.4 Mg
Strength: 0.5 Mg-0.4 Mg
Dose Form: Capsule Extended Release Multiphase 24Hr
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 92080000 5-Alpha-Reductase Inhibitors
12160412 Selective Alpha-1-Adrenergic Block.Agent
Active Ingredients: 6116 Tamsulosin Hcl 106463176
9824 Dutasteride 164656239
Inactive Ingredients: 2549 Gelatin 9000708
3203 Paraben 99967 Drug Class: Drug Class: 920800005- Alpha- Reductase Inhibitors
12160412 Selective Alpha-1- Adrenergic Gic Block. Agen, OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 90 , Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:90 , Item Strength Code:0.5-0.4 MG, Item Abbreviation: Dutast-Tamsul, Generic Form: CAP
These highlights do not include all the information needed to use DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES.
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Capsules, for oral use
Initial U.S. Approval: 2010
INDICATIONS AND USAGE
Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5 alpha-reductase inhibitor, and tamsulosin, an alpha adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. (1.1)
Limitations of Use: Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. (1.2)
DOSAGE AND ADMINISTRATION
Take one capsule daily approximately 30 minutes after the same meal each day. (2)
Swallow capsule whole. (2)
DOSAGE FORMS AND STRENGTHS
0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride. (3)
CONTRAINDICATIONS
Pregnancy. Dutasteride use is contraindicated in females who are pregnant. (45.6, 8.1)
Patients with previously demonstrated, clinically significant hypersensitivity (e.g. serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any component of dutasteride and tamsulosin hydrochloride capsules. (4)
WARNINGS AND PRECAUTIONS
Orthostatic hypotension and/or syncope can occur. Advise patients of symptoms related to postural hypotension and to avoid situations where injury could result if syncope occurs. (5.1)
Do not use dutasteride and tamsulosin hydrochloride capsules with other alpha adrenergic antagonists, as this may increase the risk of hypotension. (5.2)
Dutasteride and tamsulosin hydrochloride capsules reduce serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride and tamsulosin hydrochloride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. (5.3)
Do not use dutasteride and tamsulosin hydrochloride capsules with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole). Use caution in combination with moderate CYP3A4 inhibitors (e.g., erythromycin) or strong (e.g., paroxetine) or moderate CYP2D6 inhibitors, a combination of both CYP3A4 and CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. Concomitant use with known inhibitors can cause a marked increase in drug exposure. (5.2, 7.1, 12.3)
Exercise caution with concomitant use of phosphodiesterase-5 (PDE-5) inhibitors, as this may increase the risk of hypotension. (5.2)
Drugs that contain dutasteride, including dutasteride and tamsulosin hydrochloride capsules, may increase the risk of high-grade prostate cancer. (5.4, 6.1)
Prior to initiating treatment with dutasteride and tamsulosin hydrochloride capsules, consideration should be given to other urological conditions that may cause similar symptoms. (5.5)
Females who are pregnant or may be pregnant should not handle dutasteride and tamsulosin hydrochloride capsules due to potential risk to a male fetus. (5.6, 8.1)
Advise patients about the possibility and seriousness of priapism. (5.7)
Patients should not donate blood until 6 months after their last dose of dutasteride and tamsulosin hydrochloride capsules. (5.8)
Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery after alpha-adrenergic antagonist exposure. Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they take or have taken dutasteride and tamsulosin hydrochloride capsules. (5.9)
Exercise caution with concomitant use of warfarin. (5.2, 7.2, 12.3)
ADVERSE REACTIONS
The most common adverse reactions, reported in ≥1% of subjects treated with coadministered dutasteride and tamsulosin are ejaculation disorders, impotence, decreased libido, dizziness, and breast disorders. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2022
