"March 2, 2010 --The first generic version of Flomax, a medication to treat the signs and symptoms of an enlarged prostate gland, has won the approval of the FDA.
The generic version of Flomax, known as tamsulosin, will be made by IMPAX"...
Flomax Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Flomax (tamsulosin hydrochloride) is a medication of the alpha-blocker class and is used to treat the symptoms of a prostate gland condition called BPH (benign prostatic hyperplasia). Flomax is available as a generic drug, and dosing should be taken by mouth, usually once daily. Take the first dose at bedtime to minimize the chances of getting dizzy or fainting. After the first dose, take your regularly scheduled dose 30 minutes after the same meal each day. Possible serious side effects include: an erection that is painful or lasts more than four hours, severe dizziness, or fainting. Less serious side effects include: mild dizziness or drowsiness, sleep problems (insomnia), abnormal ejaculation, decreased sex drive, runny or stuffy nose, or sore throat. This is not a complete list of side effects, and others may occur.
Drug interaction and warnings include that Flomax capsules should not be used in combination with other alpha andrenergic blocking agents. It should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole). Flomax should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin) and with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6. Flomax should also be used with caution in combination with cimetidine. Caution should be exercised with concomitant administration of warfarin and Flomax capsules. Flomax is not indicated for use in women. If a patient reports a serious, life-threatening sulfa allergy, caution is warranted when administering Flomax capsules.
Our Flomax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Flomax in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:
- feeling like you might pass out;
- chest pain;
- fever, chills, body aches, or flu symptoms; or
- penis erection that is painful or lasts 4 hours or longer.
Less serious side effects may include:
- mild dizziness;
- weakness, drowsiness;
- nausea, diarrhea;
- back pain;
- blurred vision;
- dental problems;
- sleep problems (insomnia);
- abnormal ejaculation, decreased sex drive; or
- runny nose, sore throat, cough.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Flomax (Tamsulosin Hydrochloride) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Flomax Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if this rare but serious side effect occurs: fainting.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Flomax (Tamsulosin Hydrochloride)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Flomax FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
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 FLOMAX capsules were used. These studies evaluated safety in 1783 patients treated with FLOMAX capsules and 798 patients administered placebo. Table 1 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 (US92-03A and US93-01) conducted in 1487 men.
Table 1 Treatment-Emergent1 Adverse Events Occurring
in ≥ 2% of FLOMAX Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled
|BODY SYSTEM/ ADVERSE EVENT||FLOMAX CAPSULES GROUPS||PLACEBO
|BODY AS WHOLE|
|Headache||97 (19.3%)||104 (21.1%)||99 (20.1%)|
|Infection2||45 (9.0%)||53 (10.8%)||37 (7.5%)|
|Asthenia||39 (7.8%)||42 (8.5%)||27 (5.5%)|
|Back pain||35 (7.0%)||41 (8.3%)||27 (5.5%)|
|Chest pain||20 (4.0%)||20 (4.1%)||18 (3.7%)|
|Dizziness||75 (14.9%)||84 (17.1%)||50 (10.1%)|
|Somnolence||15 (3.0%)||21 (4.3%)||8 (1.6%)|
|Insomnia||12 (2.4%)||7 (1.4%)||3 (0.6%)|
|Libido decreased||5 (1.0%)||10 (2.0%)||6 (1.2%)|
|Rhinitis3||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%)|
|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 (2.0%)||7 (1.4%)|
|Abnormal ejaculation||42 (8.4%)||89 (18.1%)||1 (0.2%)|
|Blurred vision||1 (0.2%)||10 (2.0%)||2 (0.4%)|
|1 A treatment-emergent adverse
event was defined as any event satisfying one of the following criteria:
The adverse event occurred for the first time after initial dosing with double-blind study medication.
The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment.
2 Coding preferred terms also include cold, common cold, head cold, flu, and flu-like symptoms.
3 Coding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever.
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 ≥ 10 mmHg 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 FLOMAX capsules 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 [see WARNINGS AND PRECAUTIONS].
Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease. As shown in Table 1, 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.
No laboratory test interactions with FLOMAX capsules are known. Treatment with FLOMAX capsules for up to 12 months had no significant effect on prostate-specific antigen (PSA).
The following adverse reactions have been identified during post-approval use of FLOMAX capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to FLOMAX capsules.
Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema, and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of dyspnea, palpitations, hypotension, atrial fibrillation, arrhythmia, tachycardia, skin desquamation including reports of Stevens-Johnson syndrome, constipation, and vomiting have been received during the postmarketing period.
During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha1 blocker therapy [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Flomax (Tamsulosin Hydrochloride) »
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