Flomax

(FLOH-max) A drug used to treat urinary problems caused by an enlarged prostate. Flomax relaxes the muscles of the prostate and bladder, which helps the flow of urine. It is a type of alpha blocker. Also called tamsulosin and tamsulosin hydrochloride.

What are the uses of this medicine?

FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX capsules are not indicated for the treatment of hypertension.

How does this medicine work?

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.

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.

Who Should Not Use this medicine?

FLOMAX capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of FLOMAX capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms.

Is this medicine FDA approved?

The results of the CombAT (combination of dutasteride (Avodart) and tamsulosin, under the brand name Duodart) trial in 2008 demonstrated that treatment with the combination of dutasteride and tamsulosin provides greater symptom benefits compared to monotherapy with either agent alone for treatment of benign prostatic hyperplasia. It was approved by the FDA on 14 June 2010.

How should this medicine be used?

• 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 are the dosage forms and brand names of this medicine?

Capsule: 0.4 mg, olive green and orange hard gelatin, imprinted on one side with FLOMAX 0.4 mg and on the other side with BI 58

What side effects can this medication cause?

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

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.

What special precautions should I follow?

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.

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.

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

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy and children?

FLOMAX is not for women.

FLOMAX is not for children.

What should I know about storage and disposal of this medication?

Store FLOMAX capsules at Room Temperature [77°F (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.

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• Dailymed label info on Flomax
• FDA Flomax

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