Flomax Capsule – Is It Safe? Uses, Side-Effects, Dosage

What is Flomax?

Flomax is a medicine administered in patients with a symptom of BPH. BPH is benign prostatic hyperplasia in which prostate in men gets enlarged which is not caused by cancer. It is generally seen in elderly men. It is a member of a drug family known as alpha 1A receptor antagonists which are also called alpha blockers. Main uses of alpha-blockers include lowering of high blood pressure and treatment of men with benign prostatic hyperplasia.

Flomax Capsule - Is It Safe? Uses, Side-Effects, Dosage

Flomax Capsule – Is It Safe? Uses, Side-Effects, Dosage


What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
How effective is this medicine?
What is the dosage?
What if I miss a dose?
What to do in case of overdosage?
What to do if there is an allergic reaction?
Can I drive after taking a dose?
Can it be taken with food?
Can it be taken with alcohol?
What are the side effects?
Does this medicine has any drug interactions?
Precautions
Can this medicine be given to children or infants?
Is this medicine available as (OTC) over the counter product?
Frequently asked questions
Reference

What is the Generic Name(s) of Flomax?

Flomax is a brand name for which generic name is Tamsulosin[1]. Tamsulosin is an alpha-adrenergic blocker. It is approved by US FDA. The main aim of this medicine is to improve urine[2] flow in men who have benign prostatic hyperplasia[3].

What is its composition?

Generic Name: Tamsulosin hydrochloride

Dosage form: Capsule

The practical formula of Tamsulosin hydrochloride is C20H28N2O5S. HCl. The molecular weight of tamsulosin hydrochloride is 444.98. The structural formula of tamsulosin hydrochloride is :

FLOMAX® (tamsulosin hydrochloride) Structural Formula Illustration

This is in white crystalline powder form which melts with decomposition at approx 230°C. It is sparsely soluble in water and methanol. Insignificantly soluble in glacial acetic acid and ethanol and insoluble in ether.

Each capsule comprises of tamsulosin hydrochloride, USP 0.4 mg and other inactive ingredients like microcrystalline cellulose; methacrylic acid copolymer dispersion; propylene glycol; triacetin; calcium stearate; gelatin; iron oxide; talc; FD&C blue No. 2; titanium dioxide;  and shellac.

How does it work?

As the prostate[4] gets enlarged in men, it starts putting pressure on the urethra[5], a tube that carries urine from the bladder to the outside of the body. It results in symptoms such as half emptying of the bladder, more urine frequency or feeling urgency or weak urine flow. When it is administered in a patient, it relaxes muscles in the prostate, bladder neck, and the arterioles. Arterioles are branches of small-sized blood vessels leading to capillaries. Thus resultant relaxation of muscles allows urine to flow freely and help to empty the bladder completely. As these are known as alpha blockers, adrenaline and non-adrenaline hormones behaviour are changed by these drugs resulting in relaxation of muscles in the urinary tract and giving relief while urinating.

Sometimes it is perceived that tamsulosin reduces the gland in size but this is not the case. Even though there is an improvement in symptoms of benign prostatic hyperplasia after taking tamsulosin, other steps should be taken so that gland returns to its original ie. healthy size.

What are its uses?

It is used for the treatment of enlarged prostate in men which causes difficulties while urinating like a weak stream, feeling half empty bladder and arising frequency and urgency to urinate. To pacify the symptoms in men arising due to benign prostatic hyperplasia, tamsulosin is administered. As the name of this medicine suggests aptly, it relaxes muscles in the prostate to increase the flow of urine which gives relief to the patient of BPH. It is also used for lowering down high blood pressure as well as the passage of large kidney stones in a patient with benign prostatic hyperplasia.

How effective is this medicine?

For initial diagnosis of BPH, the doctor will typically prescribe 0.4 mg of tamsulosin. It is to be taken once a day.  Normally when it is taken on an empty stomach, it takes 4-5 hours for the drug to take full effect. If taken after the meal, it takes longer about 6-7 hours. But a BPH patient can see the difference in health in a week after taking medicine.

Tamsulosin is also effective in the treatment of kidney stones[6]. Patient with large kidney stone goes through excruciating pain. This is an extremely painful condition when kidney stones are large. In that case, tamsulosin helps to pass large kidney stone effectively but it is not helpful in the case of smaller ones.


What is the dosage?

It is recommended to have capsules 0.4 mg once in a day as the dose for the treatment of the signs and symptoms of BPH.
If the patient does not respond to the 0.4 mg dose after 2 to 4 weeks course, the dose of capsules can be increased to 0.8 mg once daily. FLOMAX capsules of strength 0.4 mg should not be consumed in combination with strong inhibitors.

What if I miss a dose?

If you miss your dose then take it when you remember. In case it is the time of next scheduled dose, skip the missed dose. The extra dose shouldn’t be taken to make up your missed dose. If the current dose of these capsules is discontinued or interrupted for any reason at either the 0.4 mg or 0.8 mg dose, then course again should be started again with the 0.4 mg once-daily dose like before. Talk to your doctor before you restart your medicine.

What to do in case of overdosage?

In case of overdosage immediately seek medical attention.

What to do if there is an allergic reaction?

Some of the allergic reaction can be rash[7], breathing trouble, swelling of throat and tongue, itching or hives[8]. It even can have serious skin reactions which may include fever, raised welts, facial swelling, burning in eyes, followed by a red or purple skin rash that spreads and causes blistering and peeling. If you observe any of these symptoms then you stop using tamsulosin and immediately get medical help.

Can I drive after taking a dose?

One of the side effects is feeling dizzy. It can cause low blood pressure too. It is recommended to be careful if you drive or avoid any activity which requires you to be alert.

Can it be taken with food?

This capsule can be taken with or without food. It can be consumed on a full or empty stomach. Swallow capsule whole.

Can it be taken with alcohol?

Alcohol directly does not affect the medicine. It is better to avoid drinking alcohol as tamsulosin may make you feel dizzy or sleepy and there are chances of these problems worsening if you drink alcohol.

What are the side effects?

There are different side effects for different people. Few people may experience it, some may not. Medicine can affect different people in a different way. Some side effects which are commonly seen are:

  • Dizziness[9] – If a person feels dizzy, he should lie down and should not get up until it passes.
  • Abnormal ejaculation[10] – It may cause retrograde ejaculation. This is not a harmful condition. In this case, semen may instead of leaving the body goes into the bladder through the penis[11]. A person may notice an absence of fluid or reduced volume of ejaculated fluid.

Uncommon side effects of tamsulosin may include:

  • Weakness
  • Palpitation[12] feeling awareness
  • A headache[13]
  • Blocked or a runny nose[14] as there is inflammation of the lining of the nose.
  • Diarrhoea[15], constipation, nausea or vomiting
  • Skin reaction such as itching or rash
  • Postural hypotension. Blood pressure may drop when a sitting or lying person tries to get up feeling dizzy or lightheaded. Try to get up slowly if a person experiences this.
  • Drowsiness/ Blurred vision/Impaired vision.
  • Dry mouth/ Nasal bleeding/ breath shortness.

Very rare Side effects may include:

  • Steven- Johnson Syndrome in which severe blistering skin reaction takes place affecting the tissues of mouth, eyes, throat, genitals. It begins with flu-like symptoms, followed by a rash which is red or purple that spreads.
  • Priapism in which there is the persistent erection of the penis which is painful.

Seek immediate medical help if the above conditions are seen in the patient.


Does this medicine has any drug interactions?

As per the study, a total of  512 drugs have interactions with Flomax.

  • out of which 38 are major drug interactions.
  • 470 have moderate interactions.
  • 4 minor.

Given below are few drugs which may interact with tamsulosin:

  • biraterone
  • alpha/beta agonists (e.g., epinephrine, norepinephrine)
  • alpha agonists (e.g., clonidine, methyldopa)
  • other alpha-blockers (e.g., alfuzosin, doxazosin, prazosin)
  • amiodarone
  • aprepitant
  • “azole” antifungals (e.g., fluconazole, itraconazole, ketoconazole)
  • barbiturates (e.g., phenobarbital, pentobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • boceprevir
  • bosentan
  • nefazodone
  • rifabutin
  • telaprevir
  • primidone
  • rifampin
  • quinidine
  • sertraline
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • cimetidine
  • conivaptan
  • cyclosporine
  • deferasirox
  • desipramine
  • dexamethasone
  • grapefruit juice
  • haloperidol
  • HIV non-nucleoside reverse transcriptase inhibitors  e.g., delavirdine, etravirine, nevirapine
  • HIV protease inhibitors like indinavir, lopinavir, nelfinavir etc.
  • macrolide antibiotics for e.g., clarithromycin, erythromycin etc.
  • medications for erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil)
  • metronidazole
  • mifepristone
  • mitotane
  • monoamine oxidase inhibitors for e.g., moclobemide, rasagiline, selegiline, tranylcypromine etc.
  • norfloxacin
  • oxcarbazepine
  • peginterferon Alfa-2b
  • phenytoin
  • silodosin
  • simeprevir
  • St. John’s Wort
  • tetracycline
  • tocilizumab

You need to speak to your doctor if you are taking any of the above medication.

Precautions

When the doctor prescribes Flomax before you start medicine please speak with your doctor about your other medicine dose, allergies, medical conditions or any other significant health facts. Following factors may affect the use of this medicine:

  • People going through cataract or glaucoma surgery may have to stop medicine before going for surgery.
  • Sulfonamide antibiotic allergic people may experience an allergic reaction to tamsulosin. If any allergic reaction is found, contact your doctor.
  • Tamsulosin may cause low BP, dizziness, drowsiness. Therefore avoid hazardous tasks like operating machinery, driving etc.
  • Priapism is the risk caused by tamsulosin. This may lead to penis damage or impotence if quick steps are not taken.
  • Before tamsulosin is started, any probability of prostate cancer should be ruled out as two diseases frequently co-exist.
  • Tamsulosin is not recommended to ladies who are pregnant or breastfeeding.

Can this medicine be given to children or infants?

No, this medicine is not recommended for children or infants.


Is this medicine available as (OTC) over the counter product?

yes, now it is available  (OTC) over the counter for treatment of benign prostatic hyperplasia (BPH).  (Flomax Relief MR – Boehringer Ingelheim). It is advised that you visit your doctor for the effective treatment result.

Frequently asked questions

  • What is the dosage of Tamsulosin and how often should I take it?

Tamsulosin dosage is 400 micrograms to be consumed once a day. Usually, you take it at the same time each day. It comes as modified release tablet or capsule to gradually pass through stomach and intestines, so that steady amount gets absorbed in the bloodstream during the day.

  • Who should not take this medicine?

A person should not take this medication if

  1. He is allergic to tamsulosin or any of its ingredient.
  2. Is taking any medication that liver is removing from the body such as clarithromycin, ketoconazole, nefazodone, protease inhibitors etc.
  • How long should I take this medicine?

It is advised to continue taking this medicine every day on long term basis until your symptoms are under control. Please remember that this medicine is not a cure for enlarged prostate. Don’t stop this medication until your doctor tells you so. If you stop midway, your urinary symptoms may come back.

  • What is the most important information to know about tamsulosin?

Before start taking this medicine, let your doctor know about your allergies, medical conditions if any and other medication which you are going through. Please read and follow all the instructions and directions on medicine label and package.

  • What should I tell my doctor before taking tamsulosin?

When you visit your doctor, tell him about low blood pressure, liver or kidney disease, allergy to the sulfa drug, history of prostate cancer if any.

  • Does flomax cause any weight change?

In any of the side effects, weight gain is not documented. In conducted clinical trials for in-depth research on the drug, in listed side effects, weight gain was not included. Other drugs in combination may cause weight gain. If you notice any weight gain after taking this medicine, you should discuss with the doctor. He will have a look at what is causing weight gain. He may advise you on certain lifestyle changes like regular exercise or a balanced diet to help weight gain issue.

  • Where can I get more information about tamsulosin (Flomax)?

Your doctor is the best source for any information regarding the medicine. Even pharmacist can provide you with optimal information.

The medicine also comes along with the leaflet which can be referred to in case of any minor doubts.

  • Can I take herbal medicines or other medicines with Flomax?

Before you start tamsulosin (Flomax), you need to tell your doctor or pharmacist about any herbal medicine or other medicines. It is always better if they check about the safe combination. In case you are taking any medicines that are reducing your blood pressure like alprostadil, anaesthetics, baclofen, diuretics such as furosemide, levodopa, other alpha-blockers such as prazosin, high blood pressure treating medicines etc. you might feel more dizzy or faint. Let your doctor know that you are feeling very dizzy. There are certain other over the counter medicines which may not suit your prostate problem rather than because you are taking tamsulosin to treat it. Therefore it is always best to check with your pharmacist/ doctor to check about any medicines which you are not taking with the prescription.

Reference

Wikipedia page on Prostate

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