l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 22

▶ Myotonine (Glenwood GmbH)

Bethanechol chloride 10 mg Myotonine 10mg tablets | 100 tablet P £18.51

Bethanechol chloride 25 mg Myotonine 25mg tablets | 100 tablet P £27.26

5a-REDUCTASE INHIBITORS

Dutasteride 28-Jun-2018

l DRUG ACTION A specific inhibitor of the enzyme 5areductase, which metabolises testosterone into the more

potent androgen, dihydrotestosterone.

l INDICATIONS AND DOSE

Benign prostatic hyperplasia

▶ BY MOUTH

▶ Adult: 500 micrograms daily, review treatment at

3–6 months and then every 6–12 months (may require

several months treatment before benefit is obtained)

l INTERACTIONS → Appendix 1: dutasteride

l SIDE-EFFECTS

▶ Common or very common Breast disorder. sexual

dysfunction

▶ Uncommon Alopecia . hypertrichosis

▶ Frequency not known Angioedema . depressed mood . hypersensitivity . localised oedema . skin reactions . testicular disorders

l CONCEPTION AND CONTRACEPTION Dutasteride is excreted

in semen and use of a condom is recommended if sexual

partner is pregnant or likely to become pregnant.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment; avoid in severe impairment

(no information available).

l MONITORING REQUIREMENTS Manufacturer advises that

patients should be regularly evaluated for prostate cancer.

l EFFECT ON LABORATORY TESTS May decrease serum

concentration of prostate cancer markers such as prostatespecific antigen; reference values may need adjustment.

l HANDLING AND STORAGE Women of childbearing potential

should avoid handling leaking capsules of dutasteride.

l PATIENT AND CARER ADVICE Cases of male breast cancer

have been reported. Patients or their carers should be told

to promptly report to their doctor any changes in breast

tissue such as lumps, pain, or nipple discharge.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral solution

Capsule

CAUTIONARY AND ADVISORY LABELS 25

▶ Dutasteride (Non-proprietary)

Dutasteride 500 microgram Dutasteride 500microgram capsules | 30 capsule P £3.21–£19.99 DT = £3.21

▶ Avodart (GlaxoSmithKline UK Ltd)

Dutasteride 500 microgram Avodart 500microgram capsules | 30 capsule P £14.60 DT = £3.21

Combinations available: Tamsulosin with dutasteride, p. 785

Finasteride 02-Apr-2019

l DRUG ACTION A specific inhibitor of the enzyme 5areductase, which metabolises testosterone into the more

potent androgen, dihydrotestosterone.

l INDICATIONS AND DOSE

Benign prostatic hyperplasia

▶ BY MOUTH

▶ Adult: 5 mg daily, review treatment at 3–6 months and

then every 6–12 months (may require several months

treatment before benefit is obtained)

Androgenetic alopecia in men

▶ BY MOUTH

▶ Adult: 1 mg daily

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: RARE REPORTS OF DEPRESSION AND

SUICIDAL THOUGHTS (MAY 2017)

The MHRA has received reports of depression and, in

rare cases, suicidal thoughts in men taking finasteride

(Propecia ®) for male pattern hair loss; depression is also

associated with Proscar ® for benign prostatic

hyperplasia. Patients should be advised to stop

finasteride immediately and inform a healthcare

professional if they develop depression.

l CAUTIONS Obstructive uropathy

l SIDE-EFFECTS

▶ Common or very common Sexual dysfunction

▶ Uncommon Breast abnormalities . skin reactions

▶ Frequency not known Angioedema . depression . infertility

male . palpitations .testicular pain

l CONCEPTION AND CONTRACEPTION Finasteride is excreted

in semen and use of a condom is recommended if sexual

partner is pregnant or likely to become pregnant.

l EFFECT ON LABORATORY TESTS Decreases serum

concentration of prostate cancer markers such as prostatespecific antigen; reference values may need adjustment.

l HANDLING AND STORAGE Women of childbearing potential

should avoid handling crushed or broken tablets of

finasteride.

l PATIENT AND CARER ADVICE Cases of male breast cancer

have been reported. Patients or their carers should be told

to promptly report to their doctor any changes in breast

tissue such as lumps, pain, or nipple discharge.

l NATIONAL FUNDING/ACCESS DECISIONS

NHS restrictions Finasteride is not prescribable in NHS

primary care for the treatment of androgenetic alopecia in

men.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral suspension,

powder

Tablet

CAUTIONARY AND ADVISORY LABELS 25

▶ Finasteride (Non-proprietary)

Finasteride 1 mg Finasteride 1mg tablets | 28 tablet P £8.36

Finasteride 5 mg Finasteride 5mg tablets | 28 tablet P £11.85

DT = £1.18

▶ Aindeem (Actavis UK Ltd)

Finasteride 1 mg Aindeem 1mg tablet | 28 tablet P £33.68 |

84 tablet P £88.40

▶ Propecia (Merck Sharp & Dohme Ltd)

Finasteride 1 mg Propecia 1mg tablets | 28 tablet P £33.68 | 84 tablet P £88.40

▶ Proscar (Merck Sharp & Dohme Ltd)

Finasteride 5 mg Proscar 5mg tablets | 28 tablet P £13.94 DT =

£1.18

BNF 78 Urinary retention 787

Genito-urinary system

7

1.3 Urolithiasis

Renal and ureteric stones 03-Apr-2019

Description of condition

Renal and ureteric stones are crystalline calculi that may

form anywhere in the upper urinary tract. They are often

asymptomatic but may cause pain when they move or

obstruct the flow of urine. Most stones are composed of

calcium salts (calcium oxalate, calcium phosphate or both).

The rest are composed of struvite, uric acid, cystine and

other substances. Patients are susceptible to stone formation

when there is a decrease in urine volume and/or an excess of

stone forming substances in the urine.

The following are risk factors that have been associated

with stone formation: dehydration, change in urine pH,

males aged between 40–60 years, positive family history,

obesity, urinary anatomical abnormalities, and excessive

dietary intake of oxalate, urate, sodium, and animal protein.

Certain diseases which alter urinary volume, pH, and

concentrations of certain ions (such as calcium, phosphate,

oxalate, sodium, and uric acid) may also increase the risk of

stone formation. Certain drugs such as calcium or vitamin D

supplements, protease inhibitors, or diuretics may also

increase the risk of stone formation.

Symptoms of acute renal or ureteric stones can include an

abrupt onset of severe unilateral abdominal pain radiating to

the groin (known as renal colic) that may be accompanied

with nausea, vomiting, haematuria, increased urinary

frequency, dysuria and fever (if concomitant urinary

infection is present).

Stones can pass spontaneously and will depend on a

number of factors, including the size of the stone (stones

greater than 6 mm have a very low chance of spontaneous

passage), the location (distal ureteral stones are more likely

to pass than proximal ureteral stones), and the degree of

obstruction.

Aims of treatment

g The aim of treatment is to improve the detection,

clearance and prevention of renal and ureteric stones

thereby reducing pain and improving quality of life. h

Non-drug treatment

g Consider watchful waiting for asymptomatic renal

stones if they are less than 5mm in diameter. If they are

larger; the risk and benefit of this option should be discussed

with the patient.

Options for surgical stone removal should be discussed by

the specialist hospital team depending on severity of

obstruction, patient factors, size and site of stone. Options

include shockwave lithotripsy, percutaneous

nephrolithotomy and ureteroscopy.

Consider stone analysis and measure serum calcium in

patients with recurring renal or ureteric stones.

Along with maintaining a healthy lifestyle, advise patients

to drink 2.5–3 litres of water a day with the addition of fresh

lemon juice and to avoid carbonated drinks. Maintain a

normal daily calcium intake of 700–1,200mg and salt intake

of no more than 6g a day. For patients with recurrent calcium

stones avoid excessive intake of oxalate-rich products, such

as rhubarb, spinach, cocoa, tea, nuts, soy products,

strawberries, and wheat bran. For patients with recurrent

uric acid stones, avoid excessive dietary intake of urate rich

products, such as liver, kidney, calf thymus, poultry skin, and

certain fish (herring with skin, sardines and anchovies). h

Pain Management

g Offer NSAIDs as first line treatment for the

management of pain associated with suspected renal colic or

renal and ureteric stones. If NSAIDs are contra-indicated or

not sufficiently controlling the pain, consider intravenous

paracetamol. Subsequently, opioids can be used if both

paracetamol and NSAIDs are contra-indicated or not

sufficiently controlling the pain. Do not offer antispasmodics

to patients with suspected renal colic. h

Medical Expulsive Therapy

g Consider alpha-adrenoceptor blockers for patients with

distal ureteric stones less than 10mm in diameter. Alphaadrenoceptor blockers may also be considered as adjunctive

therapy for patients having shockwave lithotripsy for

ureteric stones less than 10mm. h

Prevention of recurrence of stones

g Alongside lifestyle advice, consider potassium citrate

[unlicensed] in patients with recurrent stones composed of

at least 50% calcium oxalate. Thiazides [unlicensed] may be

given if patients also have hypercalciuria after restricting

their sodium intake to no more than 6g a day. h

1.4 Urological pain

Urological pain 03-Apr-2019

Treatment

Lidocaine hydrochloride gel is a useful topical application

in urethral pain or to relieve the discomfort of

catheterisation.

For information on the management of pain in renal and

ureteric stones, see Renal and ureteric stones above.

Alkalinisation of urine

Alkalinisation of urine can be undertaken with potassium

citrate. The alkalinising action may relieve the discomfort of

cystitis caused by lower urinary tract infections. Sodium

bicarbonate p. 1038 is used as a urinary alkalinising agent in

some metabolic and renal disorders.

ALKALISING DRUGS

Citric acid with potassium citrate

l INDICATIONS AND DOSE

Relief of discomfort in mild urinary-tract infections |

Alkalinisation of urine

▶ BY MOUTH USING ORAL SOLUTION

▶ Adult: 10 mL 3 times a day, diluted well with water

l CAUTIONS Cardiac disease . elderly

l INTERACTIONS → Appendix 1: potassium citrate

l SIDE-EFFECTS Hyperkalaemia . nausea . vomiting

l RENAL IMPAIRMENT Avoid in severe impairment.

Monitoring Close monitoring required in renal

impairment—high risk of hyperkalaemia.

l PRESCRIBING AND DISPENSING INFORMATION When

prepared extemporaneously, the BP states Potassium

Citrate Mixture BP consists of potassium citrate 30%, citric

acid monohydrate 5% in a suitable vehicle with a lemon

flavour. Extemporaneous preparations should be recently

prepared according to the following formula: potassium

citrate 3 g, citric acid monohydrate 500 mg, syrup 2.5 mL,

quillaia tincture 0.1 mL, lemon spirit 0.05 mL, doublestrength chloroform water 3 mL, water to 10 mL. Contains

about 28 mmol K+

/10 mL.

l EXCEPTIONS TO LEGAL CATEGORY Proprietary brands of

potassium citrate are on sale to the public for the relief of

discomfort in mild urinary-tract infections.

788 Bladder and urinary disorders BNF 78

Genito-urinary system

7

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Oral solution

CAUTIONARY AND ADVISORY LABELS 27

▶ Citric acid with potassium citrate (Non-proprietary)

Citric acid monohydrate 50 mg per 1 ml, Potassium citrate

300 mg per 1 ml Potassium citrate mixture | 200 ml G £1.38 DT

= £1.38 | 200 ml p £1.38 DT = £1.38

Sodium citrate

l INDICATIONS AND DOSE

Bladder washouts

▶ Adult: (consult product literature)

Relief of discomfort in mild urinary-tract infections

▶ BY MOUTH

▶ Adult: (consult product literature)

MICOLETTE ®

Constipation

▶ BY RECTUM

▶ Child 3–17 years: 5–10 mL for 1 dose

▶ Adult: 5–10 mL for 1 dose

MICRALAX ®

Constipation

▶ BY RECTUM

▶ Child 3–17 years: 5 mL for 1 dose

▶ Adult: 5 mL for 1 dose

RELAXIT ®

Constipation

▶ BY RECTUM

▶ Child 1 month–2 years: 5 mL for 1 dose, insert only half

the nozzle length

▶ Child 3–17 years: 5 mL for 1 dose

▶ Adult: 5 mL for 1 dose

l CONTRA-INDICATIONS

▶ With rectal use Acute gastro-intestinal conditions

l CAUTIONS

▶ With oral use Cardiac disease (in adults). elderly . hypertension (in adults). patients on a sodium-restricted

diet (in adults)

▶ With rectal use Debilitated patients (in adults). sodium and

water retention in susceptible individuals

l INTERACTIONS → Appendix 1: sodium citrate

l SIDE-EFFECTS Polyuria

l PREGNANCY

▶ With oral use in adults Use with caution.

l RENAL IMPAIRMENT

▶ With oral use In patients with fluid retention, avoid

antacids containing large amounts of sodium.

l PRESCRIBING AND DISPENSING INFORMATION Sodium

citrate 300 mmol/litre (88.2 mg/mL) oral solution is

licensed for use before general anaesthesia for caesarean

section (available from Viridian).

l EXCEPTIONS TO LEGAL CATEGORY Proprietary brands of

sodium citrate are on sale to the public for the relief of

discomfort in mild urinary-tract infections.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug. Forms available

from special-order manufacturers include: oral solution

Granules

▶ Sodium citrate (Non-proprietary)

Sodium citrate 4 gram Sodium citrate 4g oral granules sachets | 6 sachet G £2.38

▶ Brands may include CanesOasis, Cymalon (sodium citrate), Cystocalm

Oral solution

▶ Sodium citrate (Non-proprietary)

Sodium citrate 88.23 mg per 1 ml Sodium citrate 0.3M oral solution

| 30 ml P £4.50 DT = £4.50

Powder

▶ Sodium citrate (Non-proprietary)

Sodium citrate 4 gram Sodium citrate 4g oral powder sachets | 6 sachet G £1.65 DT = £1.65

Irrigation solution

▶ Sodium citrate (Non-proprietary)

Sodium citrate 3% irrigation solution 1litre bags | 1 bag s

Enema

▶ Micolette Micro-enema (Pinewood Healthcare)

Sodium citrate 90 mg per 1 ml Micolette Micro-enema 5ml |

12 enema p £4.50

▶ Micralax Micro-enema (RPH Pharmaceuticals AB)

Sodium citrate 90 mg per 1 ml Micralax Micro-enema 5ml | 12 enema p £4.87

HEPARINOIDS

Pentosan polysulfate sodium 04-Sep-2018

l INDICATIONS AND DOSE

Bladder pain syndrome

▶ BY MOUTH

▶ Adult: 100 mg 3 times a day, review treatment after

6 months and discontinue if no response

l CONTRA-INDICATIONS Active bleeding

l CAUTIONS Patients at increased risk of bleeding

l SIDE-EFFECTS

▶ Common or very common Alopecia . asthenia . back pain . diarrhoea . dizziness . gastrointestinal discomfort. haemorrhage . headache . increased risk of infection . nausea . pelvic pain . peripheral oedema

▶ Uncommon Amblyopia . anaemia . appetite decreased . arthralgia . constipation . depression . dyspnoea . emotional lability . excessive tearing . flatulence . hyperhidrosis . hyperkinesia . insomnia . leucopenia . melanocytic naevus size increased . myalgia . oral

ulceration . paraesthesia . photosensitivity reaction . skin

reactions .thrombocytopenia .tinnitus . vomiting . weight

changes

▶ Frequency not known Coagulation disorder. hepatic

function abnormal

l PREGNANCY Manufacturer advises avoid—no information

available.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

l HEPATIC IMPAIRMENT Manufacturer advises caution—

evidence of hepatic involvement in elimination.

l RENAL IMPAIRMENT Manufacturer advises caution—

evidence of renal involvement in elimination.

l MONITORING REQUIREMENTS Manufacturer advises

careful monitoring in patients with history of heparin or

pentosan polysulfate sodium induced thrombocytopenia.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS 23

▶ Elmiron (Sovereign Medical Ltd, Consilient Health Ltd)

Pentosan polysulfate sodium 100 mg Elmiron 100mg capsules | 90 capsule P £450.00–£699.40

TERPENES

Anethol with borneol, camphene,

cineole, fenchone and pinene

l INDICATIONS AND DOSE

Urolithiasis for the expulsion of calculi

▶ BY MOUTH

▶ Adult: 1–2 capsules 3–4 times a day, to be taken before

food

BNF 78 Urological pain 789

Genito-urinary system

7

l LESS SUITABLE FOR PRESCRIBING Preparation is less

suitable for prescribing.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS 25

▶ Rowatinex (Meadow Laboratories Ltd)

Cineole 3 mg, Anethol 4 mg, Fenchone 4 mg, Borneol 10 mg,

Camphene 15 mg, Pinene 31 mg Rowatinex capsules | 50 capsule P £7.35

2 Bladder instillations and

urological surgery

Bladder instillations and urological

surgery

Bladder infection

Various solutions are available as irrigations or washouts.

Aqueous chlorhexidine p. 1211 can be used in the

management of common infections of the bladder but it is

ineffective against most Pseudomonas spp. Solutions

containing chlorhexidine 1 in 5000 (0.02%) are used but they

may irritate the mucosa and cause burning and haematuria

(in which case they should be discontinued); sterile sodium

chloride solution 0.9% p. 1040 (physiological saline) is

usually adequate and is preferred as a mechanical irrigant.

Continuous bladder irrigation with amphotericin

50 micrograms/mL p. 593 may be of value in mycotic

infections in adults.

Dissolution of blood clots

Clot retention is usually treated by irrigation with sterile

sodium chloride solution 0.9% but sterile sodium citrate

solution for bladder irrigation 3% p. 789 may also be helpful.

Bladder cancer

Bladder instillations of doxorubicin hydrochloride p. 901 and

mitomycin p. 919 are used for recurrent superficial bladder

tumours. Such instillations reduce systemic side-effects;

adverse effects on the bladder (e.g. micturition disorders and

reduction in bladder capacity) may occur.

Instillation of epirubicin hydrochloride p. 902 is used for

treatment and prophylaxis of certain forms of superficial

bladder cancer; instillation of doxorubicin hydrochloride is

also used for some papillary tumours.

Instillation of BCG (Bacillus Calmette-Guérin p. 958), a

live attenuated strain derived from Mycobacterium bovis is

licensed for the treatment of primary or recurrent bladder

carcinoma in-situ and for the prevention of recurrence

following transurethral resection.

Urological surgery

Glycine below irrigation solution 1.5% is the irrigant of

choice for transurethral resection of the prostate gland and

bladder tumours; sterile sodium chloride solution 0.9%

(physiological saline) is used for percutaneous renal surgery.

Maintenance of indwelling urinary catheters

The deposition which occurs in catheterised patients is

usually chiefly composed of phosphate and to minimise this

the catheter (if latex) should be changed at least as often as

every 6 weeks. If the catheter is to be left for longer periods a

silicone catheter should be used together with the

appropriate use of catheter maintenance solutions. Repeated

blockage usually indicates that the catheter needs to be

changed.

ANTISEPTICS AND DISINFECTANTS

Chlorhexidine with lidocaine

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, chlorhexidine p. 1211, lidocaine

hydrochloride p. 103.

l INDICATIONS AND DOSE

Urethral sounding and catheterisation

▶ BY URETHRAL APPLICATION

▶ Adult: 6–11 mL

Cystoscopy

▶ BY URETHRAL APPLICATION

▶ Adult: 11 mL, then 6–11 mL if required

l INTERACTIONS → Appendix 1: antiarrhythmics

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Gel

EXCIPIENTS: May contain Hydroxybenzoates (parabens)

▶ Instillagel (CliniMed Ltd)

Chlorhexidine gluconate 500 microgram per 1 ml, Lidocaine

hydrochloride 20 mg per 1 ml Instillagel gel | 60 ml p £14.05 DT

= £14.05 | 110 ml p £15.76 DT = £15.76

IRRIGATING SOLUTIONS

Glycine

l INDICATIONS AND DOSE

Bladder irrigation during urological surgery | Irrigation for

transurethral resection of the prostate gland and

bladder tumours

▶ Adult: (consult product literature)

l CAUTIONS

CAUTIONS, FURTHER INFORMATION

▶ Urological surgery There is a high risk of fluid absorption

from the irrigant used in endoscopic surgery within the

urinary tract.

l SIDE-EFFECTS Cardiovascular disorder. electrolyte

depletion . fluid overload . pulmonary disorder. seizure . vision blurred

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Irrigation solution

▶ Glycine (Non-proprietary)

Glycine 1.5% irrigation solution 3litre Easyflow bags | 1 bag s

Glycine 1.5% irrigation solution 1litre Flowfusor bottles | 1 bottle s

Glycine 1.5% irrigation solution 1litre Easyflow bags | 1 bag s

Glycine 1.5% irrigation solution 2litre Flowfusor bottles | 1 bottle s

Catheter maintenance solutions

l CATHETER MAINTENANCE SOLUTIONS

OptiFlo G citric acid 3.23% catheter maintenance solution

(Bard Ltd)

50 ml . NHS indicative price = £3.66 . Drug Tariff (Part IXa)100 ml . NHS

indicative price = £3.66 . Drug Tariff (Part IXa)

OptiFlo R citric acid 6% catheter maintenance solution (Bard

Ltd)

50 ml . NHS indicative price = £3.66 . Drug Tariff (Part IXa)100 ml . NHS

indicative price = £3.66 . Drug Tariff (Part IXa)

Uro-Tainer PHMB polihexanide 0.02% catheter maintenance

solution (B.Braun Medical Ltd)

100 ml . NHS indicative price = £3.46 . Drug Tariff (Part IXa)

Uro-Tainer Twin Solutio R citric acid 6% catheter maintenance

solution (B.Braun Medical Ltd)

60 ml . NHS indicative price = £4.89 . Drug Tariff (Part IXa)

790 Bladder instillations and urological surgery BNF 78

Genito-urinary system

7

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