Jalyn (dutasteride/tamsulosin HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Dutasteride is a selective inhibitor of steroid 5alpha-reductase isoenzymes types 1 and 2, which are necessary for conversion of testosterone to 5alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulation of prostatic growth.
Tamsulosin hydrochloride is an alpha1-adrenergic blocking agent with selectivity for alpha1A-adrenergic receptors, which are mainly located in nonvascular smooth muscle (e.g., prostate).
Dutasteride is a synthetic 4-azasteroid compound. The drug is a specific, competitive inhibitor of both the type 1 and type 2 isoenzymes of steroid 5alpha-reductase. The type 2 isoenzyme is active principally in the reproductive system; the type 1 isoenzyme also is present in high concentrations in the liver and skin.
The conversion of testosterone to 5alpha-dihydrotestosterone (DHT) depends on the presence of these enzymes, and DHT appears to be the principal androgen responsible for initial development and subsequent enlargement of the prostate gland.
Inhibition of steroid 5alpha-reductase type 1 and 2 isoenzymes by dutasteride reduces serum and prostatic DHT concentrations substantially in a dose-dependent fashion within 1-2 weeks of initiation of therapy. Dutasteride therapy also results in increases in serum testosterone (generally remaining within the normal range) and prostatic testosterone concentrations. In controlled clinical studies of patients with BPH, decreases in prostate volume averaged about 27% after 24 months of dutasteride therapy.
Tamsulosin hydrochloride is a sulfamoylphenethylamine-derivative alpha1-adrenergic blocking agent. Commercially available tamsulosin hydrochloride is a racemic mixture of 2 isomers. The drug is pharmacologically related to doxazosin, prazosin, and terazosin; however, unlike these drugs, tamsulosin has higher affinity and selectivity for alpha1A-adrenergic receptors, which are mainly located in nonvascular smooth muscle (e.g., prostate), than for alpha1B-adrenergic receptors located in vascular smooth muscle (e.g., internal iliac artery).
Results of in vitro studies indicate that tamsulosin has 7-38 times greater affinity for alpha1A-adrenoceptors than for alpha1B-adrenoceptors; the drug has about 12 times greater affinity for alpha1-adrenergic receptors in the prostate than for those in the aorta. Such selectivity of tamsulosin for alpha1A-receptors may result in a reduced incidence of adverse cardiovascular effects (e.g., syncope, dizziness, hypotension). On a molar basis, the alpha1-adrenergic receptor affinity of tamsulosin is about 6 times that of prazosin when tested in human prostatic tissue.
Because of the prevalence of alpha-receptors on the prostate capsule, prostate adenoma, and bladder trigone and the relative absence of these receptors on the bladder body, alpha-adrenergic blocking agents decrease urinary outflow resistance in men.
SumMon(R) (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for detailed information on the usual cautions, precautions, and contraindications.
USES: This product is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Dutasteride works by reducing the size of the enlarged prostate. Tamsulosin is known as an alpha-blocker and works by relaxing muscles in the bladder and prostate.
This product helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer.
Talk to your doctor about the benefits and risks. This medication should not be used by women or children.
Generic name: dutasteride/tamsulosin HCl
Pronunciation: (doo-TAS-ter-ide/tam-SOO-loe-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Jalyn
Indications
The following indications are listed for Jalyn:
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptom
Also known as: Symptomatic Benign Prostatic Hyperplasia, Symptomatic Benign Prostatic Hypertrophy, Symptomatic Bph, Symptomatic Prostatic Hypertrophy.
Dosing
The manufacturer states that safety and efficacy of tamsulosin in children younger than 18 years of age have not been established, and clinical experience in these patients is not available.
Although protein binding of tamsulosin may be altered in patients with mild to moderate (i.e., creatinine clearance of 30-70 mL/minute per 1.73 m2) or severe (i.e., creatinine clearance of 10 to less than 30 mL/minute per 1.73 m2) renal impairment and in patients with moderate hepatic impairment resulting in changes of overall plasma concentrations of the drug, alterations in intrinsic clearance and concentrations of unbound tamsulosin do not appear to be substantial. Therefore, the manufacturer states that dosage adjustment in such patients is not necessary. However, tamsulosin has not been studied in patients with end-stage (i.e., creatinine clearance of less than 10 mL/minute per 1.73 m2) renal disease.
Dutasteride is administered orally without regard to meals. Dutasteride capsules should be swallowed whole and not chewed or opened, since contact with the capsule contents may result in irritation of the oropharyngeal mucosa.
Tamsulosin is administered orally. Because food may decrease peak plasma concentrations of tamsulosin and lengthen the time to achievement of peak plasma concentrations and decrease oral bioavailability of the drug, the manufacturer recommends that tamsulosin be taken 30 minutes after a meal; it is recommended that the drug be taken after the same meal each day. Patients should be advised that the capsules must be swallowed intact and not be opened, chewed, or crushed.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Pregnancy.
*Known hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, other 5alpha-reductase inhibitors, or any ingredient in the formulation.
Known hypersensitivity to tamsulosin or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in at least 1% of patients receiving dutasteride and more frequently than with placebo include impotence, decreased libido, ejaculation disorder, and breast disorders (including breast tenderness and enlargement). Ejaculation disorders have been reported more frequently with combined therapy with dutasteride and tamsulosin than with either drug alone.
Headache, infection, asthenia, back pain, chest pain, dizziness, somnolence, insomnia, decreased libido, rhinitis, pharyngitis, increased cough, sinusitis, diarrhea, nausea, tooth disorder, abnormal ejaculation, blurred vision.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy not established in children; the drug is not indicatedfor use in children.
Not indicated for use in children.
Dutasteride is not indicated for use in women and is contraindicated in women who are pregnant. If used during pregnancy or if pregnancy occurs, apprise the pregnant woman of potential fetal hazard to a male fetus.
Because 5alpha-reductase inhibitors inhibit the conversion of testosterone to DHT, dutasteride may cause abnormalities of the external genitalia of male fetuses exposed to the drug during pregnancy. In animal reproduction studies, dutasteride inhibited normal development of externalgenitalia in male offspring when given to rats or rabbits during organogenesis at doses lessthan the maximum recommended human dose (MRHD) of 0.5 mg daily, in the absenceof maternal toxicity.
Because of the possibility of absorption through the skin and subsequent risk to a male fetus, women who are pregnant or who potentially may be pregnant should not handle dutasteride capsules; if contact with a leaking dutasteride capsuleoccurs during pregnancy, the affected area should be washed immediately with soap and water.
Category B. Not indicated for use in women.
Not known whether dutasteride is distributed into milk in humans or if the drug has any effects on the breastfed infant or on milk production. Dutasteride is not indicated for use in women.
Not indicated for use in women.
No substantial differences in safety and efficacy relative to younger men in clinical studies or experience to date, but increased sensitivity cannot be ruled out.
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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