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PROSTAM-0.4

Generic Name:                                Tamsulosin HCl

Therapeutic Category:                 Benign Prostatic Hyperplasia Agents/Urinary Tract Antispasmodic

Pharmacological Class:               Alpha-Adrenergic Blocker

Composition:                                  Each capsule contains Tamsulosin HCl USP 0.4 mg

(As controlled release tablets)

Pregnancy Category:                    X

Presentation:                                  Available in the pack size as 10 tablets X 10 blisters

What is Prostam 0.4 and what is it used for?

Prostam 0.4 contains Tamsulosin Hydrochloride 0.4 mg (400 mcg) in capsule form. It is used to treat the lower urinary tract symptoms (LUTS) of a common condition called benign prostatic hyperplasia (BPH). This is when the prostate gland gets bigger. When your prostate gland gets bigger, it can:

·         Make it difficult for you to start urinating (peeing)

·         Mean you take longer or have to urinate more often

·         Lead to the feeling that you still need to urinate again, even though you have just done so

·         Cause you to get up several times in the night to urinate

It is used in

·         Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

·         Adjunct treatment of Acute Urinary Retention (AUR) and Bladder Outlet Obstruction (BOO)

·         Expulsion of ureteral stones up to 5mm.

How does it work?

Prostam 0.4 works by:

·         Relaxing the muscles in the prostate gland

·         Relaxing the muscles in the urethra (the tube from the bladder to the outside of the body). This lets urine pass more freely through the urethra, making it easier to urinate.

How to take Prostam 0.4?

Take one capsule each day. Take it at the same time each day, after a meal. It must be administered on an empty stomach approximately one-half hour after the same meal each day. Make a note of the date you start taking Prostam 0.4.

After 2 weeks

If you are using Prostam 0.4 for the first time and you have not got any better after 2 weeks, or if you get worse, you must stop taking this medicine and ask your pharmacist or doctor for further advice.

Within 6 weeks

You should see your doctor within 6 weeks of starting treatment to confirm that your symptoms are due to BPH.

Every 12 months

You should see your doctor every 12 months to check your prostate. See the doctor sooner if your symptoms change or get worse.

What if you miss a dose?

Take your capsule later the same day after food. If you have missed a dose, just take your daily capsule on the next day at the usual time. Do not take two capsules to make up for a forgotten capsule.

What to do in case of overdose?

If you take more of this medicine than you should, talk to a doctor or pharmacist straight away

What do you need to know before you take Prostam 0.4?

Prostam 0.4 should be used only by men who are 45 to 75 years of age.

Do not take Prostam 0.4:

·         If you have ever had an allergic reaction to a medicine.

·         If you are suffering from Intraoperative Floppy Iris Syndrome– Patients considering cataract surgery should be advised to tell their ophthalmologist

·         If you have severe Hypotension/ Postural Hypotension

·         You have pain when you urinate, or your urine was cloudy or bloody, at sometime in the last three months

·         You have a fever due to an infection of your kidneys or bladder (urinary tract infection)

·         You think you have diabetes and it is not properly controlled

·         You have had prostate surgery

 

Prostam 0.4 and other medications

Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines

·         to lower your blood pressure such as verapamil and diltiazem

·         Medicines to treat HIV such as ritonavir or indinavir

·         Medicines to treat a fungal infection such as ketoconazole or itraconazole

·         Other alpha-blockers such as doxazosin, indoramin, prazosin, or alfuzosin

·         Erythromycin, an antibiotic used to treat infections

Tell your doctor or dentist that you are on Prostam 0.4 before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.

Pregnancy and breast-feeding

Pregnancy

Prostam 0.4 is generally considered safe to take during pregnancy. Regardless, you should tell your doctor if you’re pregnant or plan to become pregnant before taking this medication.

Breast-feeding

There are no data of on presence of Prostam 0.4 in human milk, effects on breastfed infant, or on milk production. Therefore, breastfeeding is not recommended.

Driving and using machines

If you feel weak or dizzy or have blurred vision while taking this medicine, do not drive or use machines.

Prostam 0.4 and special population

Patients with impaired kidney function

No dose modification of Prostam 0.4 is required in symptomatic BPH patients with renal impairment.

What are the possible side effects?

Common side effects are orthostatic/postural hypotension, ejaculation disorders, dizziness, rhinitis, priapism and allergic reactions.

Mechanism of action:

Prostam 0.4 (Tamsulosin HCl) which is alpha-1 adrenoreceptor blockers, selectively blocks alpha 1A -adrenergic receptors causing relaxation of prostate smooth muscle resulting in an increase in urinary flow rate and a reduction in symptoms of benign prostatic hyperplasia.

Pharmacokinetic properties:

Absorption: Oral tamsulosin is 90% absorbed in fasted patients. The maximum plasma concentration is 3.1-5.3ng/mL for a 0.4mg oral dose and 2.5-3.6ng/mL for a 0.8mg oral dose. Taking tamsulosin with food increases the time to maximum concentration from 4-5 hours to 6-7 hours but increases bioavailability by 30% and maximum plasma concentration by 40-70%.

Protein Binding: Tamsulosin is 94%-99% protein bound, mostly to alpha-1-acid glycoprotein.

Metabolism:  Tamsulosin is mostly metabolized in the liver by cytochrome P450 (CYP) 3A4 and 2D6, with some metabolism by other CYPs. CYP3A4 can deacetylate tamsulosin to the M-1 metabolite or perform oxidative deamination to the AM-1 metabolite. CYP2D6 can hydroxylate tamsulosin to the M-3 metabolite or demethylate tamsulosin to the M-4 metabolite. Finally, an unknown enzyme can hydroxylate tamsulosin at a different position to form the M-2 metabolite. The M-1, M-2, M-3, and M-4 metabolites can be glucuronidated or the M-1 and M-3 metabolites can undergo sulfate conjugation to form other metabolites before excretion.

Excretion: 97% of an orally administered does is recovered in studies, which 76% in the urine and 21% in the feces after 168 hours. 8.7% of the dose is excreted as unmetabolized tamsulosin.

Elimination Half-life: The half-life in fasted patients is 14.9±3.9 hours. The elimination half-life is 5-7 hours and the apparent half-life is 9 to 13 hours in healthy subjects.

Clearance: 2.88L/h