Silodosin

Registered South African indications:

• Benign prostatic hyperplasia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Moderate to severe renal impairment
• Severe hepatic impairment
• Female patients
• Children
• Prostatic carcinoma
• May impair ability to drive and operate machinery

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

Benign prostatic hyperplasia

• Oral (cap): 8mg, dly

To be taken with meals

Do not cut/crush/chew/dissolve

Not indicated for use in children

Pregnancy

• Not indicated for use in women
• Animal studies did not reveal teratogenic effects

Breastfeeding

• Not indicated for use in women
• No data available on excretion into human milk

Renal Impairment

• CrCl >50ml/min: No dose adjustment recommended
• CrCl 30-50ml/min: Caution; dose adjustment recommended
  Starting dose: 4mg, dly, which may be increased to 8mg once daily after one week of treatment, depending on the individual patient’s response
• CrCl <30ml/min: Caution; not recommended

Hepatic Impairment

• Mild to moderate (Child-Pugh class A and B): No dose adjustment recommended
• Severe (Child-Pugh class C):  Caution; not recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Insomnia
• Syncope

Cardiovascular Disorders

• Orthostatic hypotension

Respiratory Disorders

• Nasal congestion
• Rhinorrhoea
• Sinusitis
• Pharyngeal oedema

Gastrointestinal Disorders

• Diarrhoea
• Abdominal pain
• Swollen tongue

Hepatobiliary Disorders

• Hepatic insufficiency
• Increased serum transaminases
• Jaundice

Genitourinary Disorders

• Retrograde ejaculation
• Increased prostate specific antigen
• Priapism

Musculoskeletal Disorders

• Weakness

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Purpura
• Rash
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Intraoperative floppy iris syndrome

• Alpha blockers
• Conivaptan
• CYP3A4 inducers
• CYP3A4 inhibitors
• Dabrafenib
• Enzalutamide
• Fusidic acid
• Idelalisib
• Mitotane
• P-glycoprotein/ABCB1 inhibitors
• Phosphodiesterase 5 inhibitors
• Pitosilant
• St John's wort
• Stiripentol

Blood pressure

Silodosin is highly selective for alpha-1 receptors found in the prostate. Blocking these receptors relaxes smooth muscle, which improves obstructive urinary symptoms.

Capsule 4mg

• Silodyx (Pharmaplan) originator

Capsule 8mg

• Silodyx (Pharmaplan) originator