Adult Dosing

Symptomatic benign prostatic hyperplasia

• 1 caps PO qd 30 mins after same meal each day

Note:

• Swallow the caps whole, do not chew/crush/open
• Irritation of the oropharyngeal mucosa may persist when contact with dutasteride/tamsulosin

Pediatric Dosing

• Contraindicated in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostate

• Hypersensitivity to any of the ingredients of the product
• Pregnancy
• Women of childbearing potential, including nursing women
• Pediatric patients

• N/A

Renal Dose Adjustment (Based on CrCl)

• Moderate to severe impairment (10-30 mL/min): No dose adjustments
• End stage renal impairment (<10 mL/min): Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Orthostatic hypotension and syncope can occur, advise patients having symptoms related to postural hypotension treated with dutasteride and tamsulosin to avoid situation where syncope could result in an injury
• Do not use in combination with strong inhibitors of CYP3A4. Avoid concomitant administration with other alpha-adrenergic antagonists as risk for symptomatic hypotension increases. Exercise caution when co-administered with cimetidine/moderate inhibitors of CYP3A4/strong or moderate inhibitors of CYP2D6/PDE-5 inhibitors/warfarin or in patients known to be poor metabolizers of CYP2D6
• Women who are pregnant or may become pregnant should not handle/ come in contact with the drug, it may fetal to exposed skin
• Therapy may increase the risk of development of high-grade prostate cancer
• Assess patients to rule out urological diseases including prostate cancer, prior to initiation of therapy and periodically thereafter. Carefully monitor patients with a large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy
• Dutasteride reduces the prostate-specific antigen (PSA) concentration by 40% in 3 months, followed by approximately 50 % in 24 months, for interpretation of serial PSAs, a new baseline PSA concentration should be established after 3-6 month of treatment; use this new value to assess potentially cancer-related changes in PSA
• Reduces total serum prostate-specific antigen (PSA) concentration by approximately 50%. Establish a new baseline PSA concentration after 3-6 months of treatment, and use this new value to assess potentially cancer-related changes in PSA. For interpreting an isolated PSA in men undergoing therapy for <6 months, double the PSA value for comparison with normal values in untreated men. Confirmed increase in PSA levels from nadir signals the presence of prostate cancer; carefully evaluate even if those values are still within the acceptable normal range for men not taking a 5a-reductase inhibitor
• Use with alpha-adrenergic antagonists (tamsulosin) may cause priapism which may result in permanent impotence
• Advise patients to avoid donation of blood until at least 6 months after their last dose
• Intraoperative Floppy Iris Syndrome has been reported during cataract surgery in patients treated with alpha-adrenergic antagonists, initiation of therapy in patients for whom cataract surgery is scheduled is not recommended
• Exercise caution in patients having history of serious or life-threatening sulfa allergy when administering the medication
• Decrease in sperm count has been reported
• Women who are pregnant or may become pregnant should not handle/ come in contact with the drug, may result in fetal exposure

Cautions: Use cautiously in

• Hepatic impairment
• Sulfonamide hypersensitivity
• Urological diseases
• Cataract surgery

Supplemental Patient Information

• Advise patients considering cataract surgery to inform their ophthalmologist that they take or have taken dutasteride/tamsulosin capsules

Pregnancy Category:X

Breastfeeding: According to manufacturer data, therapy is contraindicated for use in nursing women.

• CV: Cardiac failure, syncope, orthostatic hypotension
• CNS:Dizziness, headache
• EENT: Intraoperative Floppy Iris Syndrome (IFIS)
• GU: Impotence, decreased libido, breast disorders including breast tenderness and breast enlargement, ejaculation disorders, priapism, prostate-specific antigen (PSA)

Dutasteride

• Androgen hormone inhibitor; inhibits the enzyme 5-alpha-reductase, which is responsible for converting testosterone to dihydrotestosterone in prostate gland and other tissues responsible for prostatic hyperplasia
• Absolute bioavailability: 60%
• Metabolized by liver; CYP450: CYP3A4, CYP3A5 substrate (In vitro)
• 45% excreted in feces (5% unchanged), urine (<1%)
• Half-life: 5 wks

Tamsulosin

• Antiadrenergic, binds to alpha-1 adrenergic receptor resulting in relaxation of smooth muscle in bladder neck and prostate
• Bioavailability: >90%
• Metabolized by liver; CYP450: CYP3A4, CYP2D6 substrate (In vitro)
• 76 % excreted in urine (<10% unchanged) and feces (21%)
• Half-life: 14-15 hrs

US Trade Name(s)

• Jalyn

US Availability

dutasteride/tamsulosin (generic)

• CAPS: 0.5 mg/0.4 mg

Jalyn (dutasteride/tamsulosin)

• CAPS: 0.5 mg/0.4 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Combodart

UK Availability

Combodart (dutasteride/tamsulosin)

• CAPS: 0.5 mg/0.4 mg

Australian Trade Name(s)

• Duodart

Australian Availability

Duodart (dutasteride/tamsulosin)

• CAPS: 0.5 mg/0.4 mg

[Outline]

Urologic

Genitourinary Tract Agents;Miscellaneous

Pricing data from www.DrugStore.com in U.S.A.

• Jalyn 0.5-0.4 MG CAPS [Bottle] (GLAXO SMITH KLINE)
  30 mg = $129
  90 mg = $369.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Jalyn (dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG) Oral Capsule

Ingredient(s): Dutasteride mixture with tamsulosin

Imprint: GZ;7CZ

Color(s): Brown

Shape: Capsule

Size (mm): 23.00

Score: 1

Inactive Ingredient(s): butylated hydroxytoluene / caprylic/capric mono/diglycerides / ferric oxide yellow / gelatin / glycerin / titanium dioxide / methacrylic acid - methyl methacrylate copolymer (1:1) / cellulose, microcrystalline / talc / triethyl citrate / carrageenan / fd&c yellow no. 6 / hypromellose / ferric oxide red / potassium chloride / titanium dioxide

Drug Label Author:
GlaxoSmithKline LLC

DEA Schedule:
Non-Scheduled