Tamsulosin Hydrochloride 0.4 mg
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Tamsulosin Hydrochloride 0.4 mg
- 1. TAMSULOSIN BY: REZHWAN OMER JWAMER
- 2. CONTENTS ‣Introduction ‣Indication ‣MOA ‣Pharmacokinetics ‣Dosage Forms ‣Possible Side effects ‣Drug and food interactions ‣Contraindication ‣Adverse reaction ‣References
- 3. INTRODUCTION What is Tamsulosin? It is selective alpha 1 adrenergic receptor antagonist that relaxes the smooth muscle in prostate and bladder
- 4. INTRODUCTION Brand Name : Flomax® , Omnic® Active Ingredient: Tamsulosin Hydrochloride 0.4 mg Approved By FDA in 1997 , labelled by Boehringer Ingelheim Present in the form of Capsule.
- 6. INDICATION Tamsulosin for Voiding dysfunction in women ‣In may 2012 comprehensive search of the MEDLINE and EMBASE databases was performed. ‣The trials presented significant outcomes with tamsulosin in Female with LUTS especially in women with voiding dysfunction
- 7. INDICATION Tamsulosin for Voiding dysfunction in women
- 8. INDICATION Medical Expulsion Therapy Advantage Disadvantage Pass. of uret. stone Few study Time for stone passage Orth.Hypo.TN Analgesic requirement Cost effective
- 9. Distribution of alpha receptor in bladder and prostate
- 11. Pharmacokinetics ‣ Absorption:is Absorption of tamsulosin HCI from capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions. Effect of Food
- 12. Pharmacokinetics Distribution: Tamsulosin HCl is extensively bound to human plasma proteins (94% to 99%) & binding of tamsulosin HCl to human plasma proteins is not affected by amitriptyline, diclofenac, glyburide, simvastatin plus simvastatin-hydroxy acid metabolite, warfarin, diazepam, propranolol, trichlormethiazide, or chlormadinone. Likewise, tamsulosin HCl had no effect on the extent of binding of these drugs.
- 13. Pharmacokinetics Metabolism:Tamsulosin HCl is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged.
- 14. Pharmacokinetics Excretion:Tamsulosin HCl is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged.
- 15. Dosage Forms Tamsulosin HCl capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one- half 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 capsules can be increased to 0.8 mg once daily. If 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.
- 16. Dosage Forms
- 17. Dosage Forms Tamsulosin is extended release and should not be chewed or crushed it should be swallowed
- 18. Dosage Forms In case of Elderly patients with dysphagia Development Plan This new formulation called TAMSULOSIN DRS contains the same tamsulosin active pharmaceutical ingredient that is found in FLOMAX® (tamsulosin HCL) capsules and, as such, would be expected to have the same efficacy and safety as FLOMAX®. FDA has agreed that this formulation can be referenced under a 505(b)(2) NDA submission for TAMSULOSIN DRS. Veru has completed a preIND meeting with FDA, completed a bioequivalence study and plans to file the NDA in 2018.
- 19. Side Effects
- 20. Side Effects Common side effets that goes away by itself with drug adjustment
- 21. Side Effects Cardiac Side effects Common 1%-10% chest pain Uncommon 0.1%-1% Orthostatic hypotension Also there is arrhythmia , reflex tachycardia Also Syncope Pulmonary side effects include : Rhinitis
- 22. Side Effects Cardiac Side effects The α1 -selective agents are associated with an exaggerated orthostatic hypotensive response to the first dose in some patients. Therefore, the first dose is usually small and taken just before going to bed.
- 24. Side Effects Intraoperative floppy iris syndrome
- 25. Drug and food interactions ‣ Tamsulosin should not be given with other alpha 1 antagonists(prazosin, terazosin,doxazosin) ‣ There is also interaction with cimitidine, . The results indicate significant changes in tamsulosin HCl clearance ‣ Should not be prescribed in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole, erythromycin) ‣ Sulfa Allergy
- 26. Drug and food interactions ‣Chlorpromazine ‣Diclofenac ‣Fluoxetine ‣Ritonavir ‣Quinine ‣Pergolide ‣Paroxetine ‣Warfarin
- 27. Drug and food interactions
- 28. Contraindication • Sulfonamide hypersensitivity. Tamsulosin is a non- arylamine sulfonamide derivative. • Orthostatic hypotension, renal failure, renal impairment, syncope. • Hepatic disease. • Pregnancy. • Breast-feeding. • Children, infants. • Ocular surgery.
- 29. Adverse reaction Dizziness Lightheadedness Drowsiness, Runny/stuffy nose Or ejaculation problems may occur.
- 30. References
- 32. THANK YOU