BEQ-1225-TAMS-2013

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Transcript of BEQ-1225-TAMS-2013

What is tamsulosin?Tamsulosin (Flomax) is an alpha-blocker that relaxes the muscles in the prostate and bladder neck, making it easier to urinate.Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).Tamsulosin is not approved for use in women or children.Important informationYou should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.If you stop taking this medicine for any reason, call your doctor before you start taking it again. You may need a dose adjustment.Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.There are many other drugs that can interact with this medicine. Tell your doctor about all medications you use.Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.Before taking this medicineYou should not use tamsulosin if you are allergic to it. Do not take tamsulosin together with similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).To make sure tamsulosin is safe for you, tell your doctor if you have: liver or kidney disease; a history of prostate cancer; low blood pressure; or an allergy to sulfa drugs.Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medicine. Do not stop using tamsulosin before surgery unless your surgeon tells you to.Although this medicine is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding.This medicine is not approved for use by anyone younger than 18 years old.\

Tamsulosin (rINN) (/tmsulsn/ or /tmslosn/) is used in the treatment of difficult urination, a common symptom of enlarged prostate. Tamsulosin, and other medications in the class called alpha blockers, work by relaxing bladder neck muscles and muscle fibers in the prostate itself and make it easier to urinate.[1]More specifically, tamsulosin is an 1aadrenergic receptor antagonist used in the symptomatic treatment of benign prostatic hyperplasia (BPH). Tamsulosin was developed by Yamanouchi Pharmaceuticals (now part of Astellas Pharma) and was first marketed in 1996 under the trade name Flomax, and also under the name Omnic.The U.S. patent for Flomax expired in October 2009.[2] The U.S. Food and Drug Administration (FDA) approved generic Flomax in March 2010.[3]

Mechanism[edit]Main article: Alpha blockerTamsulosin is a selective 1 receptor antagonist that has preferential selectivity for the 1A receptor in the prostate versus the 1B receptor in the blood vessels.[4]When alpha 1 receptors in the bladder neck and the prostate are blocked, this causes a relaxation in smooth muscle and therefore less resistance to urinary flow. Due to this the pain associated with BPH can be reduced.Selective action of tamsulosin in alpha 1A/D receptors is controversial and over three quarters of tamsulosin registered human studies are unpublished.[5]Clinical uses[edit]

Flomax 0.4 MG Oral CapsuleTamsulosin is primarily used for benign prostatic hyperplasia, but can also assist the passage of kidney stones by the same mechanism of smooth muscle relaxation via alpha antagonism.[6][7] Tamsulosin is also used as adjunct treatment of acute urinary retention. Multiple studies have shown patients will void more successfully after catheter removal if they are taking tamsulosin vs. placebo. Patients taking tamsulosin are also less likely to need re-catheterization.[8][9][10] An additional use for tamsulosin is its use in medical explusive therapy for some cases of nephrolithiasis.Adverse effects[edit] Immunologic: It contains a sulfa moiety, thus causing typical reactions to sulfa drugs.[citation needed] Ophthalmologic: Patients taking tamsulosin are prone to a complication known as floppy iris syndrome during cataract surgery. Adverse outcomes of the surgery are greatly reduced by the surgeon's prior knowledge of the patient's history with this drug, and thus having the option of alternative techniques.[11] Severe hypotension.[12][13]Tamsulosin has also affected sexual function in men. It can cause males to experience retrograde ejaculation.[14] In males, retrograde ejaculation occurs when the fluid to be ejaculated, which would normally exit the body via the urethra, is redirected to the urinary bladder. Normally, the bladder sphincter contracts and the ejaculate goes to the urethra, the area of least pressure. In retrograde ejaculation, this sphincter does not function properly. This side affect can be mitigated by exercising the sphincter muscle; this is done by practicing a pumping action during ejaculation and urination - some semen fluid can then be ejaculated.Clinical comparison[edit]Although prostate specific, it does not have the prostate apoptotic effects of other prostate drugs such as the 5 alpha-reductase inhibitors such as dutasteride and finasteride.[citation needed]Use in combination therapy[edit]The results of the CombAT (Combination of Avodart and Tamsulosin under the brand name Duodart) trial in 2008 demonstrated that treatment with the combination of dutasteride (Avodart) and tamsulosin provides greater symptom benefits compared to monotherapy with either agent alone for treatment of benign prostatic hyperplasia. [15] The CombAT trial became the medication Jalyn. It was approved by the FDA on June 14, 2010.[16] This combination can be useful as it can take up to six months for any symptomatic relief to be found by 5-alpha-reductase inhibitors such as dutasteride compared to alpha-1 receptor blockers which can provide relief in some cases within 48 hours.[17]Brand names[edit]Tamsulosin was first marketed in 1996 under the trade name Flomax. It is now marketed by various companies under licence, including Boehringer-Ingelheim and CSL. Tamsulosin hydrochloride extended-release capsules are marketed under the trade names Urisurge(India), Flomax, Flomaxtra, Contiflo XL,bestflo, Urimax and Pradif,[18] although generic, non-modified-release capsules are still approved and marketed in many countries (such as Canada). In Mexico, it is marketed as Secotex and as Harnal D in Japan and Indonesia.[19] In Egypt,[20] Italy and Iceland, it is marketed under the trade name Omnic by Astellas Pharma Europe. The largest manufacturer of tamsulosin, drug substance, is Synthon.

Systematic (IUPAC) name

(R)-5-(2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl)-2-methoxybenzene-1-sulfonamide

Clinical data

Trade namesFlomax

AHFS/Drugs.commonograph

MedlinePlusa698012

Licence dataUSFDA:link

Pregnancycategory AU:B2 US:B

Legal status AU:Prescription Only (S4) UK:POM US:-only

Routesoral

Pharmacokinetic data

Bioavailability100% (oral)

Metabolismhepatic

Half-life913 hours

Excretion76% renal

Identifiers

CAS number106133-20-4Y

ATC codeG04CA02

PubChemCID 129211

IUPHAR ligand488

DrugBankDB00706

ChemSpider114457Y

UNIIG3P28OML5IY

KEGGD08560Y

ChEBICHEBI:9398Y

ChEMBLCHEMBL836Y

Chemical data

FormulaC20H28N2O5S

Molecular mass408.51

SMILES[show] CCOc1ccccc1OCCN[C@@H](C)Cc1ccc(OC)c(c1)S(=O)(=O)N

InChI[show] InChI=1S/C20H28N2O5S/c1-4-26-17-7-5-6-8-18(17)27-12-11-22-15(2)13-16-9-10-19(25-3)20(14-16)28(21,23)24/h5-10,14-15,22H,4,11-13H2,1-3H3,(H2,21,23,24)/t15-/m1/s1YKey:DRHKJLXJIQTDTD-OAHLLOKOSA-NY

Y(what is this?)(verify)

Tamsulosin (rINN) (/tmsulsn/ or /tmslosn/) is used in the treatment Why is this medication prescribed?Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.How should this medicine be used?Tamsulosin comes as a capsule to take by mouth. It is usually taken once a day. Take tamsulosin 30 minutes after the same meal each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tamsulosin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.Swallow tamsulosin capsules whole; do not split, chew, crush, or open them. Your doctor will probably start you on a low dose of tamsulosin and may increase your dose after 2 to 4 weeks.Tamsulosin may help control your condition, but it will not cure it. Continue to take tamsulosin even if you feel well. Do not stop taking tamsulosin without talking to your doctor.Other uses for this medicineReturn to top This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.What special precautions should I follow?Return to top Before taking tamsulosin, tell your doctor and pharmacist if you are allergic to tamsulosin, sulfa medications, or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: other alpha blocker medications such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin (Hytrin); anticoagulants ('blood thinners') such as warfarin (Coumadin); cimetidine (Tagamet); and medications for erectile dysfunction (ED) such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. tell your doctor if you have or have ever had prostate cancer or liver or kidney disease. you should know that tamsulosin is only for use in men. Women should not take tamsulosin, especially if they are pregnant or could become pregnant or are breast-feeding. If a pregnant woman takes tamsulosin, she should call her doctor. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tamsulosin. If you need to have eye surgery at any time during or after your treatment, be sure to tell your doctor that you are taking or have taken tamsulosin. you should know that this medication may make you drowsy or dizzy. Do not drive a car, operate machinery, or perform dangerous tasks until you know how this medication affects you. you should know that tamsulosin may cause dizziness, lightheadedness, a spinning sensation, and fainting, especially when you get up too quickly from a lying position. This is more common when you first start taking tamsulosin or after your dose is increased. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Call your doctor if these symptoms are severe or do not go away.What should I do if I forget a dose?Return to top Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you interrupt your treatment for several days or longer, call your doctor before restarting the medication, especially if you take more than one capsule of tamsulosin a day.What side effects can this medication cause?Return to top Tamsulosin may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section are severe or do not go away: sleepiness difficulty falling asleep or staying asleep weakness back pain diarrhea runny or stuffy nose pain or pressure in the face sore throat, cough, fever, chills, or other signs of infection blurred vision difficulty ejaculating l 37 Discuss Tweet Take one tablet or capsule each day. Your first dose of tamsulosin may make you feel faint. If this happens, lie down and do not get up again until the dizziness has passed. Do not drive or use tools or machines if you feel tired or dizzy.

About tamsulosinType of medicine Alpha-blocker

Used for Enlargement of the prostate gland in men

Also called Cositam, Contiflo, Diffundox, Faramsil, Flomax Relief, Flomaxtra, Galebon, Losinate, Maxtron, Pamsvax, Petyme, Pinexel, Prosurin, Stronazon, Tabphyn,TamurexAlso Combodart (this contains tamsulosin in combination with dutasteride)

Available as Prolonged-release tablets and capsules

The prostate gland commonly becomes larger in older men. Prostate gland enlargement is also called benign prostatic hyperplasia (BPH). It can cause problems with passing urine, such as having to wait before your urine starts to flow, taking longer at the toilet, dribbling, and a feeling that your bladder is not quite empty.

Tamsulosin works by relaxing the muscles around your bladder and prostate so that you can pass urine more easily. It is available on prescription, or you can buy it at pharmacies without a prescription.

Sometimes, more than one type of medicine is needed to control the symptoms of prostate enlargement. Tamsulosin is available in combination with another medicine for prostate enlargement, called dutasteride.

Before taking tamsulosinSome medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking tamsulosin it is important that your doctor or pharmacist knows: If you have liver or kidney problems. If you ever feel dizzy or faint when you stand up, or if you have ever fainted after passing urine. If you are are due to have cataract eye surgery. If you have ever had an allergic reaction to this or to any other medicine. If you are taking any other medicines, including those available to buy without a prescription, herbal and complementary medicines.How to take tamsulosin Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The leaflet will give you more information about the specific brand of tamsulosin you have been given, and a full list of possible side-effects from taking it. Take tamsulosin exactly as your doctor or pharmacist has told you. Take one tablet or capsule each day. Try to take your doses at the same time of day, as this will help you to remember to take them. Swallow each dose with a drink of water - do not crush, break, or chew the tablets or the capsules. Your first dose of tamsulosin may make you feel dizzy of faint. If you are affected in this way (or if you start sweating), lie down and do not get up again until these symptoms have gone. You can take tamsulosin tablets before or after your meals. If you forget to take a dose, do not worry, just take the next dose when it is due and carry on as before. Do not take two doses together to make up for a forgotten dose.Getting the most from your treatment Tamsulosin can cause dizziness, particularly when you first start taking it. Make sure your reactions are normal before you drive or do things which would be dangerous if you were not fully alert. You are advised not to drink alcohol while you are on tamsulosin. Alcohol will increase the side-effects of tamsulosin, such as feeling faint and dizzy. Keep your regular appointments with your doctor so your progress can be monitored. If you are a smoker, stopping smoking may significantly improve your symptoms. This is because nicotine irritates the bladder. Ask your doctor for advice on quitting. If you are having an operation or any medical treatment, tell the person carrying out the treatment that you are taking tamsulosin. This is because some men who have had cataract surgery while they are on tamsulosin have developed an eye problem known as 'floppy iris syndrome', so your doctor may advise you to stop taking tamsulosin for a short while. Also, if you have an anaesthetic while you are on tamsulosin, your blood pressure may drop suddenly.Can tamsulosin cause problems?Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.Common tamsulosin side-effects - these affect less than 1 in 10 people who take this medicine What can I do if I experience this?

Feeling tired, dizzy, faint, or weak, blurred vision If any of these happen, do not drive or use tools or machines. Do not drink alcohol

Feeling light-headed when getting up from a lying or sitting position Getting up more slowly may help. If you begin to feel dizzy, lie down so that you do not faint, then sit for a few moments to prevent the dizziness returning

Constipation or diarrhoea, feeling sick Eat a well-balanced diet and avoid spicy foods. Drink plenty of water

Headache Ask your pharmacist to recommend a suitable painkiller

Palpitations, dry mouth, rash, ejaculation problems If any of these become troublesome, speak with your doctor

If you experience any other symptoms which you think may be due to this medicine, discuss them with your doctor or pharmacist. How to store tamsulosin Keep all medicines out of the reach and sight of children. Store in a cool, dry place, away from direct heat and light.Important information about all medicines If you buy any medicines check with a pharmacist that they are safe to take with your other medicines. Never take more than the prescribed dose. If you suspect that someone has taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty. This medicine is for you. Never give it to other people even if their condition appears to be the same as yours. Never keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you. If you have any questions about this medicine ask your pharmacist