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JALYN is a brand name for Dutasteride, supplied as a capsule (immediate and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS ............................................................................ 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
4 mg) is one capsule taken orally approximately 30 minutes after the same meal once daily (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption). Hepatic Impairment The effect of hepatic impairment on JALYN® pharmacokinetics has not been studied.
Caution should be used in the administration of JALYN® to patients with liver disease (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Renal Impairment The effect of renal impairment on JALYN® pharmacokinetics has not been studied.
No adjustment in dose is anticipated for patients with renal impairment (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Administration JALYN® should be taken approximately 30 minutes after the same meal each day (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption).
JALYN® modified release capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride soft gelatin capsule contained within the JALYN® hard-shell capsule may result in irritation of the oropharyngeal mucosa.
(see WARNINGS AND PRECAUTIONS, Exposure of Women - Risk to Male Fetus and SPECIAL HANDLING INSTRUCTIONS). Although an improvement in symptoms may be observed after 3 months in some patients, it can take up to 6 months before a response to the treatment can be achieved (see CLINICAL TRIALS).
Missed Dose If a dose is missed, it can be taken later in the same day. Extra capsules taken for missed doses are not necessary. Do not take two doses in the same day. Page 24 of
Adverse Drug Reaction Overview There have been no clinical trials conducted with JALYN® (dutasteride / tamsulosin); however, the clinical efficacy and safety of combination therapy has been evaluated in the co-administration study (CombAT) of dutasteride and tamsulosin.
In studies of dutasteride and tamsulosin combination therapy, most adverse reactions were mild or moderate and generally resolved while on treatment. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.
The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups. In BPH monotherapy clinical trials, providing 3,374 patient-years of exposure to dutasteride, there were 2 cases of breast cancer reported in dutasteride-treated patients, one after 10 weeks and one after 11 months of treatment and 1 case in a patient who received placebo.
In subsequent clinical trials in BPH and prostate cancer risk reduction providing 17,489 patient-years exposure to dutasteride and 5,027 patient-years exposure to dutasteride and tamsulosin combination, there were no additional cases in any of the treatment groups.
The relationship between long term use of dutasteride and male breast cancer is unknown. The relationship between long-term use of Dutasteride and Leydig cell tumours of the testis, Hepatocellular adenomas, and the Gleason score (grade of malignancy) of prostate cancer in patients taking long term Alpha reductase inhibitors is currently unknown.
Study withdrawal due to adverse reactions occurred in 4% of subjects receiving dutasteride, 6% of subjects receiving JALYN® and 4% of subjects receiving tamsulosin. The most common adverse event leading to withdrawal in all treatment groups was impotence.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dutasteride in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Information on the adverse event profiles of the individual components of JALYN® is also provided. Page 13 of 59 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 4 mg/day, n =1,610), dutasteride alone (n =1,623) or tamsulosin alone (n=1,611). Over the 4 years of treatment, 1,623 subjects received monotherapy with dutasteride; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy.
The population is aged 49 to 88 years (mean age 66 years) and 88% Caucasian. Table 1 summarizes adverse reactions reported in at least 1% of subjects in any treatment group over 4 years of treatment. 4 mg once daily. b These sexual adverse events are associated with dutasteride treatment (including monotherapy and combination with tamsulosin).
These adverse events may persist after treatment discontinuation. The role of dutasteride in the persistence is unknown. c Includes breast tenderness and breast enlargement. 6%). 07] compared with tamsulosin monotherapy, as shown in Table 2.
50 ] (Table 2). Table 2 Number (%) of Subjects with Cardiac Failure Adverse Events in Study ARI40005 and Study ARI40006, Year 4 Study Dut + Tam (n/N (%)) Dutasteride (n/N (%)) Tamsulosin (n/N (%)) Placebo (n/N (%)) Relative risk estimate1 [95% CI] Combination vs.
Dutasteride Combination vs. Tamsulosin Dutasteride vs. 7) --- 16 […]