Flomax

What is Flomax?

Flomax is a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition your doctor may refer to as an enlarged prostate. Flomax is not for women. Flomax is not for children.

Description

Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.

Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether.

The empirical formula of tamsulosin hydrochloride is C20H28N2O5S ∙ HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is:

Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.

 Mechanism of Action

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.

The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in the human prostate. At least three discrete alpha1 adrenoceptor subtypes have been identified: alpha1A, alpha1B, and alpha1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1 receptors in the human prostate are of the alpha1A subtype.

FLOMAX capsules are not intended for use as an antihypertensive drug.

Who should not take Flomax?

Do not take Flomax capsules if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Flomax capsules.

What should I tell my healthcare provider before taking Flomax?

Before taking Flomax capsules, tell your doctor about all your medical conditions, including:

• any kidney or liver problems.
• any history of low blood pressure.
• any allergies to sulfa or any other medicines.
• if you are planning to have cataract or glaucoma surgery.

Tell your doctor about all the medicines you take, including:

• any prescription medicines, including blood pressure medicines.
• any non-prescription medicines, including vitamins and herbal supplements.

Some of your other medicines may affect the way Flomax capsules work. Especially tell your doctor if you take a medicine for high blood pressure. You should not take Flomax if you are already taking certain blood pressure medicines.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Flomax?

• Take Flomax exactly as prescribed by your doctor.
• Do not crush, chew, or open Flomax capsules.
• Take Flomax one time each day, about 30 minutes after the same meal each day. For example, you may take Flomax 30 minutes after dinner each day.
• If you miss a dose of Flomax, take it as soon as you remember. If you miss your dose for the whole day, continue with your next dose on your regular schedule. Do not take two doses at the same time.
• If you stop or forget to take Flomax for several days, talk with your doctor before starting again.
• If you take more Flomax capsules than prescribed, call your doctor right away.

What should I avoid while taking Flomax?

• Avoid driving, operating machinery, or other dangerous activities, until you know how Flomax affects you.
• Flomax capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses.
• See “What are the possible side effects of flomax capsules?”

What are the possible side effects of Flomax?

Possible side effects of Flomax may include:

• Decreased blood pressure when changing positions. Flomax capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. Symptoms may include:
  • fainting
  • dizziness
  • lightheadedness

Change positions slowly from lying down to sitting up or from a sitting to a standing position until you learn how you react to Flomax capsules. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms are severe or do not improve, call your doctor.

• Allergic reactions. Make your doctor aware of any allergic reactions you may experience while taking Flomax. Allergic reactions may include:
  • rash
  • itching
  • hives
• Rare and more serious allergic reactions may also occur. Get medical help right away if you have any of the following reactions:
  • swelling of face, tongue, or throat
  • difficulty breathing
  • blistering of the skin
• Priapism – a painful erection that will not go away. Flomax capsules can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.
• Eye problems during cataract or glaucoma surgery. During cataract or glaucoma surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Flomax capsules. If you need to have cataract or glaucoma surgery, be sure to tell your surgeon if you take or have taken Flomax capsules.

Common side effects of Flomax capsules may include:

• runny nose
• dizziness
• decreased semen

These are not all the possible side effects with Flomax capsules. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

General information about the safe and effective use of Flomax

This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. Do not give Flomax to other people, even if they have the same symptoms that you have. It may harm them.

While taking Flomax, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.

BPH can occur with other more serious conditions, including prostate cancer. Therefore, ask your doctor about screening for prostate cancer prior to treatment with Flomax capsules and at regular intervals afterwards.

This patient information guide summarizes the most important information about Flomax. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Flomax that is written for health professionals. For current prescribing information, access www.4Flomax.com or call sanofi-aventis U.S. LLC at 1-800-633-1610.

How should I store Flomax?

Store Flomax capsules at Room Temperature 68°F to 77°F (20°C to 25°C). Short-term exposure to higher or lower temperatures (from 59°F [15°C] to 86°F [30°C]) is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules.

Keep Flomax capsules and all medicines out of the reach of children.

What are the ingredients in Flomax?

Active Ingredient: tamsulosin hydrochloride

Inactive Ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.

Label

PRINCIPAL DISPLAY PANEL – 0.4 MG CAPSULE BOTTLE LABEL

• NDC 0024-5837-01
• Flomax ®
  (tamsulosin
  hydrochloride)
• 0.4 mg
  100 capsules
• Rx only
• Dosage: Read accompanying
  prescribing information.
• SANOFI