Flomax is a branded product of Boehringer Ingelheim.

Flomax was discovered by Yamanouchi and has been licensed to Boehringer Ingelheim for marketing since the US launch in 1997.

Astellas co-promotes Flomax in the U.S with Boehringer Ingelheim. This partnership started in October 2004.

Note: World-drugs.net sells generic version of Flomax

2.FLOMAX FACTS

Boehringer Ingelheim was established in Ingelheim am Rhein ( Germany ) in 1885, where the corporate headquarters are still located today.

Boehringer Ingelheim headquartered in Ingelheim , Germany , currently has nearly 36,000 employees and 144 affiliated companies spread around the globe.

The business of Boehringer Ingelheim consists Prescription Medicines, Consumer Health Care and Animal Health. Activities grouped under Industrial Customer, include Fine Chemicals and Biopharmaceuticals.

The focus is on the production of innovative drugs and treatments that represent major therapeutic advances. 

3.ABOUT FLOMAX MEDICATION

Flomax tablets contain the active ingredient tamsulosin hydrochloride, which is a type of medicine called an alpha blocker. Flomax works by blocking alpha receptors that are found in the muscle in the prostate gland.

The prostate gland, which is found only in men, lies at the top of the tube connecting the bladder to the outside (urethra). The prostate gland often enlarges with advancing age (Benign prostatic hyperplasia), pressing on the urethra and obstructing the flow of urine from the bladder. This can cause various urinary symptoms, such as difficulty passing urine.

Flomax blocks alpha receptors in the muscle of the prostate gland, which causes the muscle in the prostate to relax. This allows urine to flow freely past the prostate and relieves the urinary symptoms. 

What is benign prostatic hyperplasia?
Benign prostatic hyperplasia (BPH) is a condition that affects the prostate gland in men.

The prostate is a gland found between the bladder (where urine is stored) and the urethra (the tube urine passes through). As men age, the prostate gland slowly grows bigger (or enlarges). As the prostate gets bigger, it may press on the urethra and cause the flow of urine to be slower and less forceful.

"Benign" means the enlargement isn't caused by cancer or infection. "Hyperplasia" means enlargement.

Most symptoms of BPH start gradually. One symptom is the need to get up more often at night to urinate. Another symptom is the need to empty the bladder often during the day. Other symptoms include difficulty in starting the urine flow and dribbling after urination ends. The size and strength of the urine stream may decrease.

These symptoms can be caused by other things besides BPH. They may be signs of more serious diseases, such as a bladder infection or bladder cancer. Tell your doctor if you have any of these symptoms, so he or she can decide which tests to use to find the possible cause.

How will my doctor know if I have BPH?
After your doctor takes a complete history of your symptoms, a rectal exam is the next step. This exam allows your doctor to actually feel the size of the prostate gland.

It might not be possible for your doctor to be sure that your prostate problem is benign just by taking a history and performing a physical exam. Your doctor might need to look at a sample of your urine for signs of infection. Your doctor may also do a blood test. An ultrasound exam or a biopsy of the prostate may help your doctor make the diagnosis.

How will my doctor treat my BPH?
Once your doctor is sure that your symptoms are caused by benign growth of the prostate gland, treatment can be recommended. However, your doctor may suggest that you wait to see if your symptoms get better because sometimes-mild symptoms get better on their own. If your symptoms get worse, your doctor may suggest another treatment option.

Surgery is considered the most effective treatment and is used in men with strong symptoms. This is also the best way to diagnose and cure early cancer of the prostate. Surgery is usually done through the urethra, leaving no scars. Surgery does have risks, such as bleeding, infection or impotence. These risks are generally small.

Are there any drugs I can take?
Drug treatments are available. Finasteride and dutasteride blocks a natural hormone that makes the prostate enlarge, but it does not help all patients. The side effects of finasteride are rare and mild, but they usually have to do with sexual function. They go away when the medicine is stopped. The prostate will enlarge again when the medicine is stopped, so another treatment may have to be tried.

Another kind of medicine, called alpha blockers, also can help the symptoms of BPH. Some of these drugs are terazosin, doxazosin, Flomax (Tamsulosin) and alfuzosin. Alpha blockers have been used for a long time to treat high blood pressure, but they can also help the symptoms of BPH, even in men with normal blood pressure. These medicines may not work in all men. The side effects of alpha blockers are mild and go away if you stop taking the medicine. The side effects include dizziness, fatigue and lightheadedness.  

4.FLOMAX EFFECTIVENESS
When is Flomax best taken?

The pharmacokinetics of Flomax have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg.

Absorption:
Absorption of tamsulosin HCI from Flomax capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions. Flomax exhibits linear kinetics following single and multiple dosing, with achievement of steady-state concentrations by the fifth day of once-a-day dosing.

Effect of Food:
The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when Flomax capsules are administered with food. Taking Flomax capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations (Cmax) compared to fed conditions.

Mean Plasma Flomax Concentrations Following Single-Dose Administration of Flomax capsules 0.4 mg Under Fasted and Fed Conditions (n=8)

Distribution:

The mean steady-state apparent volume of distribution of Flomax after intravenous administration to ten healthy male adults was 16L, which is suggestive of distribution into extracellular fluids in the body. Additionally, whole body autoradiographic studies in mice and rats and tissue distribution in rats and dogs indicate that Flomax is widely distributed to most tissues including kidney, prostate, liver, gall bladder, heart, aorta, and brown fat, and minimally distributed to the brain, spinal cord, and testes.

Flomax is extensively bound to human plasma proteins (94% to 99%), primarily alpha-1 acid glycoprotein (AAG), with linear binding over a wide concentration range (20 to 600 ng/mL). The results of two-way in vitro studies indicate that the binding of Flomax to human plasma proteins is not affected by amitriptyline, diclofenac, glyburide, simvastatin plus simvastatin-hydroxy acid metabolite, warfarin, diazepam, propranolol, trichlormethiazide, or chlormadinone. Likewise, Flomax had no effect on the extent of binding of these drugs. 

Metabolism:

There is no enantiomeric bioconversion from Flomax [R(-) isomer] to the S(+) isomer in humans. Flomax is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged. However, the pharmacokinetic profile of the metabolites in humans has not been established. Additionally, the cytochrome P450 enzymes that primarily catalyze the Phase I metabolism of Flomax have not been conclusively identified. Therefore, possible interactions with other cytochrome P450 metabolized compounds cannot be discerned with current information. The metabolites of Flomax undergo extensive conjugation to glucuronide or sulfate prior to renal excretion.

Incubations with human liver microsomes showed no evidence of clinically significant metabolic interactions between Flomax and amitriptyline, albuterol (beta agonist), glyburide (glibenclamide) and finasteride (5alpha-reductase inhibitor for treatment of BPH). However, results of the in vitro testing of the Flomax interaction with diclofenac and warfarin were equivocal.

Excretion:

On administration of the radiolabeled dose of Flomax to four healthy volunteers, 97% of the administered radioactivity was recovered, with urine (76%) representing the primary route of excretion compared to feces (21%) over 168 hours.

Following intravenous or oral administration of a dose of Flomax an immediate-release formulation, the elimination half-life of Flomax in plasma range from five to seven hours. Because of absorption rate-controlled pharmacokinetics with Flomax capsules, the apparent half-life of Flomax is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Flomax undergoes restrictive clearance in humans, with a relatively low systemic clearance (2.88 L/h).

5.FLOMAX EFFECTS ON SPECIAL POPULATION
How do different people react to Flomax?

Geriatrics (Age):

Cross-study comparison of Flomax capsules overall exposure (AUC) and half-life indicate that the pharmacokinetic disposition of tamsulosin HCI may be slightly prolonged in geriatric males compared to young, healthy male volunteers. Intrinsic clearance is independent of tamsulosin HCI binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects of age 55 to 75 years compared to subjects of age 20 to 32 years.

Pregnancy

Flomax is used only in men. However, animal studies have not demonstrated any risk to the fetus. There are no adequate studies in pregnant women. 

Nursing Mothers
Flomax is used only in men. It is not known if Flomax is secreted into breast milk.

6.FLOMAX EFFECTS ON MEDICAL CONDITIONS
How does Flomax affect your existing condition/ailment?

Renal Dysfunction:

The pharmacokinetics of Flomax has been compared in 6 subjects with mild-moderate or moderate-severe renal impairment and 6 normal subjects. While a change in the overall plasma concentration of Flomax was observed as the result of altered binding to AAG, the unbound (active) concentration of tamsulosin HCI, as well as the intrinsic clearance, remained relatively constant. Therefore, patients with renal impairment do not require an adjustment in Flomax capsules dosing. However, patients with endstage renal disease have not been studied.

Hepatic Dysfunction:

The pharmacokinetics of Flomax have been compared in 8 subjects with moderate hepatic dysfunction and 8 normal subjects. While a change in the overall plasma concentration of Flomax was observed as the result of altered binding to AAG, the unbound (active) concentration of Flomax does not change significantly with only a modest (32%) change in intrinsic clearance of unbound Flomax. Therefore, patients with moderate hepatic dysfunction do not require an adjustment in Flomax capsules dosage. 

7.OTHER/ALTERNATE USES OF FLOMAX
(What else does Flomax treat?)

Flomax can be used in other circumstances for treatment, if prescribed by your doctor. 

8.ADVERSE/SIDE EFFECTS of FLOMAX
What are the side effects of Flomax?)

The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg Flomaxcapsules were used. These studies evaluated safety in 1783 patients treated with Flomax capsules and 798 patients administered placebo. The table below summarizes the treatment-emergent adverse events that occurred in = 2% of patients receiving either Flomax capsules 0.4 mg, or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials conducted in 1487 men.

Signs and Symptoms of Orthostasis

In the two U.S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and by no patients in the placebo group. Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group and 0.6% of patients (3 of 493) in the placebo group. Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group, and 10% of patients (50 of 493) in the placebo group. Vertigo was reported by 0.6% of patients (3 of 502) in the 0.4 mg group, 1% of patients (5 of 492) in the 0.8 mg group and by 0.6% of patients (3 of 493) in the placebo group.

Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met one or more of the following criteria: (1) a decrease in systolic blood pressure of = 20 mmHg upon standing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure = 10mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test; (3) an increase in pulse rate of = 20 bpm upon standing with a standing pulse rate = 100 bpm during the orthostatic test; and (4) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test.

Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of 498) who received Flomaxcapsules 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. At 8 hours post-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received Flomax capsules 0.4 mg once daily and 4% (9 of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the first week of Study 1).

In Studies 1 and 2, at least one positive orthostatic test result was observed during the course of these studies for 81 of the 502 patients (16%) in the Flomax capsules 0.4 mg once daily group, 92 of the 491 patients (19%) in the Flomax capsules 0.8-mg once daily group and 54 of the 493 patients (11%) in the placebo group.

Because orthostasis was detected more frequently in Flomax capsule-treated patients than in placebo recipients, there is a potential risk of syncope. 

Abnormal Ejaculation: Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation and ejaculation decrease. As shown in the table above, abnormal ejaculation was associated with Flomax capsules administration and was dose-related in the U.S. studies. Withdrawal from these clinical studies of Flomax capsules because of abnormal ejaculation was also dose-dependent with 8 of 492 patients (1.6%) in the 0.8 mg group, and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation.

Post-Marketing Experience : Allergic-type reactions such as skin rash, pruritus, angioedema of tongue, lips and face and urticaria have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of palpitations, constipation and vomiting have been received during the post-marketing period.

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