Jalyn

DRUG DESCRIPTION

JALYN (dutasteride and tamsulosin hydrochloride) Capsules contain dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT) and tamsulosin (an antagonist of alpha1A-adrenoceptors in the prostate). Each JALYN Capsule contains the following:

  • One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide.
  • Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion, microcrystalline cellulose, talc, and triethyl citrate.

The above components are encapsulated in a hard-shell capsule made with the inactive ingredients of carrageenan, FD&C yellow 6, hypromellose, iron oxide red, potassium chloride, titanium dioxide, and imprinted with GS 7CZ in black ink.

Dutasteride

Dutasteride is a synthetic 4-azasteroid compound chemically designated as (5?,17?)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula:

Dutasteride Structural Formula Illustration

Dutasteride is a white to pale yellow powder with a melting point of 242 to 250C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.

Tamsulosin

Tamsulosin hydrochloride is a synthetic compound chemically designated as (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride.

The empirical formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.97. Its structural formula is:

Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 234C. It is sparingly soluble in water and slightly soluble in methanol, ethanol, acetone, and ethyl acetate.

What are the precautions when taking dutasteride and tamsulosin hydrochloride capsules (Jalyn)?

Before taking this product, tell your doctor or pharmacist if you are allergic to dutasteride or tamsulosin; or to finasteride; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness, lightheadedness, or fainting, get up slowly when rising from a sitting or lying position, especially when you first start taking this drug. If dizziness...

Read All Potential Precautions of Jalyn


Jalyn Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, runny/stuffy nose, sexual problems (such as decreased sexual interest/ability, ejaculation problems, decrease in the amount of semen/sperm), increased breast size, or breast tenderness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but serious side effect occurs: fainting.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to dutasteride or tamsulosin; or to finasteride; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness, lightheadedness, or fainting, get up slowly when rising from a sitting or lying position, especially when you first start taking this drug. If dizziness occurs, sit or lie down until you feel better. Also, when you first start taking this drug, avoid situations where you may be injured if you faint.

Before having surgery (including cataract eye surgery), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not donate blood while you are taking this medication and for at least 6 months after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.

This medication should not be used in women. This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. However, this medication should not be used in women.



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