0000112172 00000 n No adverse developmental effects were observed in animal studies in which Tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data].In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.Administration of Tamsulosin hydrochloride to pregnant female rats during the period of organogenesis at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus.
Flomax (tamsulosin) Capsule. 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.

xref Because orthostasis was detected more frequently in Tamsulosin hydrochloride capsule-treated patients than in placebo recipients, there is a potential risk of syncope [ see Warnings and Precautions (5.1) ].Tamsulosin hydrochloride capsules are not indicated for use in women. 0000008096 00000 n 0000002502 00000 n 0000147829 00000 n These studies evaluated safety in 1783 patients treated with Tamsulosin hydrochloride capsules, USP and 798 patients administered placebo. 0000007156 00000 n 0000001056 00000 n There are no data on the presence of Tamsulosin hydrochloride in human milk, the effects of Tamsulosin hydrochloride on the breastfed infant, or the effects of Tamsulosin hydrochloride on milk production.

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. Data sources include IBM Watson Micromedex (updated 2 Sep 2020), Cerner Multum™ (updated 1 … 0000021106 00000 n Female fertility in rats was significantly reduced, considered to be due to impairment of fertilization [see Nonclinical Toxicology (13.1)]The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
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If therapy is interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should resume at the 0.4 mg/day dosage. Clomipramine Hydrochloride Capsules USP are available as capsules of 25, 50, and 75 mg for oral administration.Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro 5H-dibenz[b,f ] azepine monohydrochloride, and its structural formula is:C19H23ClN2 ● …

0000007808 00000 n 1 Adverse Events Occurring in ≥ 2% of Tamsulosin hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical StudiesFigure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-Dose Administration of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted and Fed Conditions (n = 8)Figure 2A Mean Change from Baseline in Total AUA Symptom Score (0-35) Study 1Figure 2B Mean Change from Baseline in Total AUA Symptom Score (0-35) Study 2Figure 3A Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 1Figure 3B Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C–30°C (59°F–86°F)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:Tell your doctor about all the medicines you take, including:How should I take Tamsulosin hydrochloride capsules?What are the possible side effects of Tamsulosin hydrochloride capsules?Get medical help right away if you have any of the following reactions:What should I avoid while taking Tamsulosin hydrochloride capsules?What are the possible side effects of Tamsulosin hydrochloride capsules?Keep Tamsulosin hydrochloride capsules and all medicines out of the reach of children.What are the ingredients in Tamsulosin hydrochloride capsules?We comply with the HONcode standard for trustworthy health information - 0000003019 00000 n 0000007963 00000 n LIMITATION OF USE: Tamsulosin is not indicated for the treatment of hypertension. 0000001996 00000 n We’d prefer to avoid using an indwelling urine catheter because the risk for UTIs. 0000144974 00000 n 0000002723 00000 n 0000085145 00000 n 0000010933 00000 n In patients who fail to respond to this dose after 2 to 4 weeks of therapy, the dose can be increased to 0.8 mg PO once daily. 0000003679 00000 n < 0000013639 00000 n