Tamsulosin

Registered South African indications:

• Benign prostatic hyperplasia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe hepatic impairment
• History of orthostatic hypotension
• Coadministration with potent CYP3A4 inhibitors (e.g. ketoconazole)

Cautions

• Severe renal impairment
• Cataract and glaucoma surgery
• Patients with poor metaboliser CYP2D6 phenotype
• May impair ability to drive and operate machinery

Form avail. in SA and covered in this monograph: cap

Benign prostatic hyperplasia

• Oral (SR cap): 0.4mg after first meal of the day

Swallow whole, do not chew

Not established for use in children

Pregnancy

• Not indicated for use in women

Breastfeeding

• Not indicated for use in women

Fertility

• Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation, and ejaculation failure have been reported in the post-marketing safety studies

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Contraindicated

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Syncope
• Asthenia
• Drowsiness

Cardiovascular Disorders

• Palpitations
• Orthostatic hypotension
• Atrial fibrillation
• Dysrhythmia
• Tachycardia

Respiratory Disorders

• Rhinitis
• Epistaxis
• Dyspnoea

Gastrointestinal Disorders

• Constipation
• Diarrhoea
• Nausea and vomiting
• Dry mouth

Genitourinary Disorders

• Ejaculation disorders including retrograde ejaculation and ejaculation failure
• Priapism

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Angioedema
• Stevens-Johnson syndrome
• Erythema multiforme
• Dermatitis exfoliative
• Oedema

Sensory Disorders

• Blurred vision
• Visual impairment

• CYP3A4 inhibitors
• Ketoconazole
• Erythromycin
• Alpha-1 adrenoceptor antagonist
• Diclofenac
• Warfarin
• Anaesthetic agents

• Prostate specific antigen (PSA)
• Digital rectal examination
• Blood pressure  

Directions of use:

• The tablet should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active ingredient

Intraoperative Floppy Iris Syndrome

The “Intraoperative Floppy Iris Syndrome” (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients previously treated with tamsulosin 0,4 mg SR. IFIS may increase the risk of eye complications during and after the operation. Discontinuing tamsulosin 0,4 mg SR 1 to 2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not yet been established. IFIS has also been reported in patients who had discontinued tamsulosin 0,4 mg SR for a longer period prior to eye surgery.

The initiation of therapy with tamsulosin 0,4 mg SR in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin 0,4 mg SR in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

Tamsulosin is a selective and competitive antagonist at the postsynaptic alpha -1 adrenoceptors in particular subtype alpha-1A and alpha-1D.Antagonism of these receptors causes relaxation of smooth muscle in the prostate, increasing maximum urinary flow rate by reducing muscle tension in the prostate and urethra.

Capsule 0.4mg

• Beniprosin SR (Ranbaxy) 
• Flomax SR (Astellas) originator
• Omsal (Litha Pharma)
• Prostaflo SR (Brimpharm)
• Tamsul SR (Pharmacare)
• Uromax (Cipla Medpro)