Drugs List

Therapeutic Indications

Uses

For the symptomatic relief of dysuria, urgency, nocturia, vesical supra-pubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethro-cystitis and urethrotrigonitis.

For the relief of vesico-urethral spasms due to catheterisation, cytoscopy or indwelling catheters; prior to cytoscopy or catheterisation: sequelae of surgical intervention of the lower urinary tract.

Contraindications

Intestinal obstruction or ileus
Obstructive uropathies of the lower urinary tract
Gastrointestinal haemorrhage
Achalasia
Pyloric obstruction or duodenal obstruction
Myasthenia gravis
Severe ulcerative colitis
Toxic megacolon
Intestinal atony
Urinary retention
Angle closure glaucoma
Children under 12 years
Galactosaemia

Precautions and Warnings

Where evidence of urinary infection is present, appropriate anti-infective therapy should be instituted concomitantly.

Antimuscarinics should be used with caution in the elderly (especially if frail) and in those with autonomic neuropathy. It should also be used with caution in patients with hiatus hernia with reflux oesophagitis, in hepatic and renal impairment and in patients with suspected glaucoma (especially closed angle cases).

Antimuscarinics may worsen hyperthyroidism, coronary artery disease, congestive heart failure, hypertension, prostatic hypertrophy, arrhythmias and tachycardia.

In the event of drowsiness, blurred vision or vertigo, the patient should not drive or operate machinery.

Antimuscarinics such as flavoxate can reduce sweating and may lead to heat sensations and fainting in hot environments or in patients with fever.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

This product contains lactose and should be used with caution in patients with Lactose intolerance and Glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

There is no evidence of the drug's safety in human pregnancy, nor any evidence from animal work that it is free from hazard.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution should be exercised when flavoxate is administered during breast feeding.

It is not known whether flavoxate is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Eosinophilia
Leucopenia
Angioedema
Drowsiness
Dizziness
Headache
Mental confusion
Nervousness
Vertigo
Blurred vision
Disturbances in eye accommodation
Increased ocular tension
Dry eyes
Palpitations
Tachycardia
Arrhythmias
Diarrhoea
Dry mouth
Dyspepsia
Dysphagia
Nausea
Vomiting
Constipation
Dry skin
Rash
Photosensitivity
Urticaria
Dysuria
Fatigue
Hyperpyrexia
Difficulty in micturition
Urinary retention
Restlessness
Disorientation
Hallucination
Convulsion
Reduction in sweating which may lead to heat sensations and fainting in hot environments or in patients with fever.
Hypersensitivity reactions
Erythema
Pruritus

Drugs List

Therapeutic Indications

Uses

For the symptomatic relief of dysuria, urgency, nocturia, vesical supra-pubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethro-cystitis and urethrotrigonitis.

For the relief of vesico-urethral spasms due to catheterisation, cytoscopy or indwelling catheters; prior to cytoscopy or catheterisation: sequelae of surgical intervention of the lower urinary tract.

Dosage

Adults

Elderly

Children

Contraindications

Intestinal obstruction or ileus
Obstructive uropathies of the lower urinary tract
Gastrointestinal haemorrhage
Achalasia
Pyloric obstruction or duodenal obstruction
Myasthenia gravis
Severe ulcerative colitis
Toxic megacolon
Intestinal atony
Urinary retention
Angle closure glaucoma
Children under 12 years
Galactosaemia

Precautions and Warnings

Where evidence of urinary infection is present, appropriate anti-infective therapy should be instituted concomitantly.

Antimuscarinics should be used with caution in the elderly (especially if frail) and in those with autonomic neuropathy. It should also be used with caution in patients with hiatus hernia with reflux oesophagitis, in hepatic and renal impairment and in patients with suspected glaucoma (especially closed angle cases).

Antimuscarinics may worsen hyperthyroidism, coronary artery disease, congestive heart failure, hypertension, prostatic hypertrophy, arrhythmias and tachycardia.

In the event of drowsiness, blurred vision or vertigo, the patient should not drive or operate machinery.

Antimuscarinics such as flavoxate can reduce sweating and may lead to heat sensations and fainting in hot environments or in patients with fever.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

This product contains lactose and should be used with caution in patients with Lactose intolerance and Glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

There is no evidence of the drug's safety in human pregnancy, nor any evidence from animal work that it is free from hazard.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Caution should be exercised when flavoxate is administered during breast feeding.

It is not known whether flavoxate is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Eosinophilia
Leucopenia
Angioedema
Drowsiness
Dizziness
Headache
Mental confusion
Nervousness
Vertigo
Blurred vision
Disturbances in eye accommodation
Increased ocular tension
Dry eyes
Palpitations
Tachycardia
Arrhythmias
Diarrhoea
Dry mouth
Dyspepsia
Dysphagia
Nausea
Vomiting
Constipation
Dry skin
Rash
Photosensitivity
Urticaria
Dysuria
Fatigue
Hyperpyrexia
Difficulty in micturition
Urinary retention
Restlessness
Disorientation
Hallucination
Convulsion
Reduction in sweating which may lead to heat sensations and fainting in hot environments or in patients with fever.
Hypersensitivity reactions
Erythema
Pruritus

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Do not store above 30 degrees C.
Keep in the outer carton.

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Urispas 200mg Film-coated Tablets. Recordati Pharmaceuticals Ltd. Revised June 2010.