Flavoxate Hydrochloride

Registered South African indications:

• Antispasmodic action in urological disorders

Registered South African contraindications

• Hypersensitivity to flavoxate hydrochloride or to any of the excipients
• Pyloric or duodenal obstruction
• Obstructive intestinal lesions or ileus
• Achalasia
• Gastrointestinal haemorrhage
• Obstructive uropathies of the lower urinary tract
• Pregnancy
• Lactation
• Not recommended for use in children under 12 years of age
• Urinary retention
• Glaucoma
• Myasthenia gravis

Contraindications registered in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients
• Gastrointestinal obstructive conditions or ileus
• Gastro-intestinal haemorrhage
• Achalasia
• Urinary retention
• Glaucoma
• Myasthenia gravis

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Elderly
• Glaucoma
• Serious, uncontrolled, obstructive disorders of the lower urinary tract
• Urinary infection
• Galactose intolerance
• Lapp lactose deficiency 
• Glucose-galactose malabsorption

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

South African registered indications and dosages

Antispasmodic action in urological disorders

• Oral (fct): 200mg, 3 times a day (600 mg flavoxate hydrochloride) for as long as required

The safety and efficacy of flavoxate hydrochloride in children aged <12 years have not been established (See contraindications)

Pregnancy

South African recommendations

• Contraindicated
• There is no or limited amount of data from the use of flavoxate in pregnant women
• Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
• As a precautionary measure, it is preferable to avoid the use of flavoxate during pregnancy. Safety in pregnancy has therefore not been established

Recommendations in other jurisdictions

• Caution; no evidence of risk in studies
• There are no or limited amount of data from the use of flavoxate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of flavoxate during pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. Flavoxate should therefore not be used during breastfeeding

Recommendations in other jurisdictions

• Caution; not recommended
• It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. Flavoxate should not be used during breastfeeding

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• There is no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility

• Caution; no dose adjustment recommended  

• No dose adjustment recommended 

• Caution; no dose adjustment recommended 

Central Nervous System Disorders

• Drowsiness
• Dizziness
• Headache
• Mental confusion 
• Nervousness
• Vertigo
• Fatigue

Cardiovascular Disorders

• Palpitations
• Tachycardia

Gastrointestinal Disorders

• Diarrhoea
• Dry mouth
• Dyspepsia
• Dysphagia
• Nausea and vomiting

Genitourinary Disorders

• Dysuria

Endocrine and Metabolic Disorders

• Hyperpyrexia

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Urticaria
• Erythema
• Rash
• Pruritis

Immune, Blood and Lymphatic System Disorders

• Eosinophilia
• Leukopenia
• Hypersensitivity reactions

Sensory Disorders

• Blurred vision
• Disturbances in eye accommodation
• Increased ocular tension

• Glucagon
• Anticholinergics
• Potassium chloride
• Potassium citrate

None routine

Flavoxate hydrochloride is an antispasmodic selective to the urinary tract. The mechanism of action involves intracellular cyclic AMP accumulation and calcium blocking activity. It inhibits bladder contractions induced by various agonists or by electrical stimulation and inhibits the frequency of bladder voiding contractions and increases bladder volume capacity.

Tablet 200mg

• Urispas (Adcock) originator