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Maxflo-U® Presentation Maxflo-U® Capsule: Each capsule contains Tamsulosin Hydrochloride INN 0.4 mg as modifiedrelease pellets. Description Maxflo-U® (Tamsulosin Hydrochloride) is a selective antagonist of alpha1A adrenoreceptor in the prostate. It is also called alpha1A-urospecific antagonist. This selectivity of Tamsulosin may result in a reduced incidence of cardiovascular side effects. Maxflo-U® (Tamsulosin Hydrochloride) binds selectively and competitively to postsynaptic Alpha1-adrenoreceptors, in particular to subtypes alpha1A and alpha1D. It brings about relaxation of Prostatic and urethral smooth muscle. Tamsulosin increases the maximum urinary flow rate. It relieves obstruction by relaxing smooth muscle in prostate and urethra. It also improves the irritative symptoms in which bladder instability plays an important role. These effects on storage and voiding symptoms are maintained during long-term therapy. The need for surgical treatment is significantly delayed. Alpha1-blockers can reduce blood pressure by lowering peripheral resistance. No reduction in blood pressure of any clinical significance was observed during studies with Maxflo-U® (Tamsulosin Hydrochloride).Tamsulosin Hydrochloride is not indicated for the treatment of hypertension. Indication and Use Maxflo-U® (Tamsulosin Hydrochloride) capsules are indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). Dosage and Administration Maxflo-U® (Tamsulosin Hydrochloride) 0.4 mg daily is recommended as the dose for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). It should be administered approximately half an hour following the same meal each day. For those patients who fail to respond to the 0.4-mg dose after two to four weeks of dosing, the dose of Maxflo-U® (Tamsulosin Hydrochloride) can be increased to 0.8 mg once daily. Contraindication Tamsulosin Hydrochloride is contraindicated in patients known to be hypersensitive to Tamsulosin Hydrochloride. It is also contraindicated to patients with a history of orthostatic hypotension and severe hepatic insufficiency. Use in Pregnancy and Lactation Tamsulosin Hydrochloride is not recommended for women. Pediatric Use Tamsulosin Hydrochloride is not indicated for use in the pediatrics. Effects on ability to Drive and use Machines No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness may occur. Side Effect The following adverse reactions have been reported during the use of Tamsulosin Hydrochloride Capsules: Dizziness, abnormal ejaculation and less frequently (1-2%) headache, asthenia, postural hypotension and palpitations. Precaution Carcinoma of the prostate: Carcinoma of the prostate and Benign Prostatic Hyperplasia (BPH) causes many of the same symptoms. These two diseases frequently co-exist. Patients should be evaluated prior to the start of Tamsulosin Hydrochloride therapy to rule out the presence of carcinoma of the prostate. The pharmacokinetic and pharmacodynamic interactions between Tamsulosin Hydrochloride and other alpha-adrenergic blocking agents have not been determined. However, interactions may be expected and Maxflo-U® should not be used in combination with other alpha-adrenergic blocking agents. Warning The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in Tamsulosin Hydrochloride. As with other alpha-1 adrenergic blocking agents, there is a potential risk of syncope. Drug Interaction Treatment with Cimetidine resulted in a significant decrease (26%) in the clearance of Tamsulosin Hydrochloride that resulted in a moderate increase in Tamsulosin Hydrochloride. Therefore, Maxflo-U® should be used with caution in combination with Cimetidine, particularly at doses higher than 0.4 mg. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril or nifedipine. In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin, warfarin changes the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin Hydrochloride change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin. Concurrent administration of other alpha1-adrenoreceptor antagonists could lead to hypotensive effects. Overdose As overdose of Tamsulosin Hydrochloride capsules lead to hypotension, support the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in supine position. If this measure is inadequate, then administration of intravenous fluid should be considered. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered. Storage Condition Store in a cool & dry place, protected from light & moister. Keep Maxflo-U® (Tamsulosin Hydrochloride) out of the reach of children. Commercial Pack Maxflo-U® capsule: Box containing 7x4 capsules in Alu-Alu blister pack.