Tamsulosin Hydrochloride 0.4 mg

It is all about Tamsulosin Hydrochloride 0.4 mg , including all Mechanism of action , its indication , pharmacokinetics , new research on it , dosage forms , contraindication , adverse reaction ,

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

10. Mechanism Of Action

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. PharmacokineticsDistribution: 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. PharmacokineticsMetabolism: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. PharmacokineticsExcretion: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
!is 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 #le 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.

23. Side Effects
Retrograde Ejaculation

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

31. Reference
‣http://www.pdr.net/drug-summary/Flomax-tamsulosin-hydrochloride-2893
‣http://njmonline.nl/getpdf.php?id=906
‣https://seekingalpha.com/article/4146583-verus-veru-ceo-dr-mitchell-
steiner-q1-2018-results-earnings-call-transcript
‣https://www.rxlist.com/flomax-drug.htm#side_effects_interactions
‣pubmed.com
‣https://prostate.net/articles/avoiding-prostate-drug-side-effects
‣https://www.accessdata.fda.gov/drugsatfda_docs/label/
2005/020579s016lbl.pdf

32. THANK YOU