Tamsulosin

2: Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)].

5.2 Drug Interactions
Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Tamsulosin hydrochloride capsules should be used with caution in combination with cimetidine, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Tamsulosin hydrochloride capsules should not be used in combination with other alpha adrenergic blocking agents [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Caution is advised when alpha adrenergic blocking agents including tamsulosin hydrochloride are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride capsules [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)].

8.6 Renal Impairment
Patients with renal impairment do not require an adjustment in tamsulosin hydrochloride capsules dosing. However, patients with end-stage renal disease (CLcr<10 mL/min/1.73 m2) have not been studied [see Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment
Patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules dosage. Tamsulosin hydrochloride has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

8.5 Geriatric Use
Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)].

Patient Information: If you miss a dose of tamsulosin hydrochloride capsule, 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 tamsulosin hydrochloride capsules for several days, talk with your doctor before starting again.

Section 2: If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

Highlights: The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1)

6.1: Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either tamsulosin hydrochloride 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 (US92-03A and US93-01) conducted in 1487 men.

Table 1 Treatment-Emergent Adverse Events Occurring in ≥2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies (tamsulosin 0.4 mg n=502 / 0.8 mg n=492 / placebo n=493)
BODY AS WHOLE: Headache 97 (19.3%) / 104 (21.1%) / 99 (20.1%); Infection 45 (9%) / 53 (10.8%) / 37 (7.5%); Asthenia 39 (7.8%) / 42 (8.5%) / 27 (5.5%); Back pain 35 (7%) / 41 (8.3%) / 27 (5.5%); Chest pain 20 (4%) / 20 (4.1%) / 18 (3.7%)
NERVOUS SYSTEM: Dizziness 75 (14.9%) / 84 (17.1%) / 50 (10.1%); Somnolence 15 (3%) / 21 (4.3%) / 8 (1.6%); Insomnia 12 (2.4%) / 7 (1.4%) / 3 (0.6%); Libido decreased 5 (1%) / 10 (2%) / 6 (1.2%)
RESPIRATORY SYSTEM: Rhinitis 66 (13.1%) / 88 (17.9%) / 41 (8.3%); Pharyngitis 29 (5.8%) / 25 (5.1%) / 23 (4.7%); Cough increased 17 (3.4%) / 22 (4.5%) / 12 (2.4%); Sinusitis 11 (2.2%) / 18 (3.7%) / 8 (1.6%)
DIGESTIVE SYSTEM: Diarrhea 31 (6.2%) / 21 (4.3%) / 22 (4.5%); Nausea 13 (2.6%) / 19 (3.9%) / 16 (3.2%); Tooth disorder 6 (1.2%) / 10 (2%) / 7 (1.4%)
UROGENITAL SYSTEM: Abnormal ejaculation 42 (8.4%) / 89 (18.1%) / 1 (0.2%)
SPECIAL SENSES: Blurred vision 1 (0.2%) / 10 (2%) / 2 (0.4%)

How should I take tamsulosin hydrochloride capsules?
Take tamsulosin hydrochloride capsules exactly as prescribed by your doctor.
Do not crush, chew, or open tamsulosin hydrochloride capsules.
Take tamsulosin hydrochloride capsules one time each day, about 30 minutes after the same meal each day. For example, you may take tamsulosin hydrochloride capsules 30 minutes after dinner each day.
If you miss a dose of tamsulosin hydrochloride capsule, 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 tamsulosin hydrochloride capsules for several days, talk with your doctor before starting again.
If you take more tamsulosin hydrochloride capsules than prescribed, call your doctor right away.

What should I avoid while taking tamsulosin hydrochloride capsules?
Avoid driving, operating machinery, or other dangerous activities, until you know how tamsulosin hydrochloride capsules affect you. Tamsulosin hydrochloride capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses.

What should I tell my doctor before using tamsulosin hydrochloride capsules?
Before taking tamsulosin hydrochloride 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 tamsulosin hydrochloride capsules work. Especially tell your doctor if you take a medicine for high blood pressure. You should not take tamsulosin hydrochloride capsules if you are already taking certain blood pressure medicines.

What are the possible side effects of tamsulosin hydrochloride capsules?
Possible side effects of tamsulosin hydrochloride capsules may include:
Decreased blood pressure when changing positions. Tamsulosin hydrochloride 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 tamsulosin hydrochloride 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 tamsulosin hydrochloride capsules. 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. Tamsulosin hydrochloride 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 tamsulosin hydrochloride capsules. If you need to have cataract or glaucoma surgery, be sure to tell your surgeon if you take or have taken tamsulosin hydrochloride capsules.
Common side effects of tamsulosin hydrochloride capsules may include: runny nose; dizziness; decreased semen

Tamsulosin comes as a capsule to take by mouth. Take once a day 30 minutes after a meal. Take around the same time every day.
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.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tamsulosin, call your doctor.
you should know that this medication may decrease fertility (ability to produce or have children) in women and men. This does not mean you can't get pregnant while taking tamsulosin and you should still use effective contraception.
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.