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7.0 Obstetrics, gynaecology & urinary-tract disorders

7.0 Obstetrics, gynaecology & urinary-tract disorders

7.1.1 Prostaglandins and oxytocics

Induction and augmentation of labour 
RED           Dinoprostone vaginal gel 1mg and 2mg 
RED           Oxytocin injection 5units/mL, 10units/mL


Dinoprostone 10mg vaginal delivery system (Propess®)

Propess® (dinoprostone) 10mg vaginal delivery system is licensed and now locally approved for the initiation of cervical ripening in patients, at term (from 38th week of gestation). It has a number of advantages over dinoprostone gel (Prostin®) and is expected to become the product of choice for this indication where appropriate. This is in line with recommendations from NICE in its Clinical Guideline advice on Induction of Labour which stated use of Propess® is expected to deliver downstream savings from its preferential use over Prostin® gel.

RED           Dinoprostone vaginal pessaries 10mg

Prevention and treatment of haemorrhage 
RED           Carboprost injection 250 microgram/mL 
RED           Ergometrine injection 500 microgram/mL 
RED           Oxytocin with ergometrine (Syntometrine®)

Prophylaxis of postpartum haemorrhage at caesarean section 
Specific Patient Group in enhanced treatment pathway, restricted use for elective caesarean section.(hospital use only) 
RED          Carbetocin100mcg/mL (Pabal®)

Induction of abortion – Consultant only 
RED           Misoprostol tablets 200micrograms [unlicensed]


7.1.1.1 Ductus arteriosus

Maintenance of patency 
RED           Alprostadil intravenous solution 500 microgram/mL 
RED           Dinoprostone 1mg/mL 0.75mL amp [unlicensed] 
 
Closure of ductus arteriosus 
RED           Indometacin injection 1mg


7.1.2 Mifepristone

RED           Mifepristone tablets 200mg

7.1.3 Myometrial relaxants

RED           Salbutamol solution for intravenous infusion 5mg/5mL 
 
GREEN      Nifedipine capsules 5mg, 10mg - Three times daily preparations 
                   (only for Raynaud’s, achalasia and pre-term labour [unlicensed])

7.2.1 Preparations for vaginal atrophy

Refer also to HRT section 6.4.1.1.

Topical Hormone Replacement Therapy 
Topical oestrogen may be used alone in the short term in the minimum effective amount.
Long term use may require oral progestogen for 10 - 14 days each month.
 
First Line 
GREEN      Ovestin® (estriol)  vaginal cream 0.1% 
                  
 
Second Line 
GREEN      Vagifem® (estradiol) vaginal tablets m/r 25 microgram        
 
For post menopausal urogential conditions, inserted every 3 months; maximum duration of use 2 years.
GREEN      Estring ®7.5micrograms/24 hours -   estradiol releasing vaginal ring 
 

7.2.2 Vaginal and vulval infections

Fungal infections 
Vaginal candidiasis should be treated primarily with pessaries or cream inserted high into the vagina.
Cream may also be needed for vulvitis and other sites of infection.
 

GREEN      Clotrimazole
                  cream 1% , vaginal cream 10%,   vaginal tablet 500mg  

Other infections 
GREEN      Clindamycin vaginal cream 2% 
GREEN      Metronidazole 0.75% vaginal gel 

                                       

7.3.1 Combined hormonal contraceptives

CSM advice - provided that women are fully informed of the small risks of venous thromboembolism    and do not have medical contraindications, it should be a matter of clinical judgement and personal    choice which type of oral contraceptive should be prescribed.

Group 1 - First line 
The cheapest and safest in terms of VTE risk
GREEN      Brevinor®/ Ovysmen®(ethinyloestradiol 35mcg/norethisterone 500mcg) 
GREEN      Microgynon 30®/Ovranette® (ethinyloestradiol 30mcg/ levonorgestrel 150mcg)  
 
Group 2 - Second line 
May be useful if acne or other androgenic side effects are problematical with the first line 
choice of pill.
GREEN      Cilest®(ethinyloestradiol 35mcg/ norgestimate 250mcg) 
GREEN      Femodene® (ethinyloestradiol 30 mcg/ gestodene 75mcg)   
GREEN      Marvelon®(ethinyloestradiol 30mcg/desogestrel 150mcg)      
 
Group 3 – Second line 
This pill with lower oestrogen content (20micrograms) may be useful if nausea, breast tenderness or general
 headache (not migraine) are problematical with the first line choice of pill.
 
GREEN      Mercilon® (ethinyloestradiol 20mcg/desogestrel 150mcg)    
 
Group 4 - Second line 
Useful alternatives for breakthrough bleeding when other causes excluded.
GREEN      Loestrin 30® (ethinyloestradiol 30mcg/ norethisterone 1.5mg)     
GREEN      Norimin® tablets (ethinyloestradiol 35mcg/ norethisterone 1mg)      
 
Note: Everyday pills (eg MicrogynonED®) (21 active tablets followed by 7 inactive tablets)  may be useful for women
           who find it difficult to remember to restart after the pill free week.
 
Group 5 - Third line 
For women with acne, not settling with two previously tried second line pills.
GREEN       Yiznell® tablets (ethinylestradiol 30mcg/ drospirenone 3mg)     
GREEN       Lucette® tablets (ethinylestradiol 30mcg/ drospirenone 3mg)     
GREEN        Yacella® tablets (ethinylestradiol 30mcg/ drospirenone 3mg)
 
 

Interactions with liver enzyme inducing drugs

Faculty advice relating to a long term course of an enzyme inducing drug in women unable to use an alternative method of contraception is to use two low dose COCs providing a total daily dose of 50-60 micrograms of ethinyloestradiol (for example two Microgynon 30® daily - unlicensed). Women are advised to use additional contraception, such as condoms during use of a liver enzyme inducing drug and for 28 days after the liver enzyme-inducer is stopped.

Low Strength Transdermal 
Evra® is not recommended for routine use, but only for younger, or less compliant women, or those with GI disturbance whilst taking oral contraceptives.
GREEN      Evra® transdermal patch 
                  (ethinylestradiol 20micrograms/24hrs, norelgestromin 150micrograms/24hrs) 
 
Biphasic/triphasic pills have no advantage over monophasic pills and are not listed.

7.3.2 Progestogen-only contraceptives

These are useful for women in whom oestrogen is contraindicated or if breastfeeding.

7.3.2.1 Oral progestogen-only contraceptives 
GREEN      Micronor® / Noriday® (norethisterone 350mcg)    
GREEN      Norgeston® (levonorgestrel 30mcg)       
GREEN      Desogestrel 75 microgram         
 
Desogestrel should not routinely be used as an alternative to COCs but is reserved for  women who have problems
adhering to the 3 hour window for other oral progestogen only contraceptives.
(Desogestrel can be taken up to 12 hours overdue)  


7.3.2.2 Parenteral progestogen-only contraceptives

For IUS/IUD and Implanon fitting special training is required (primary care -see nGMS enhanced services contract for details and contact local CCG for further information as necessary). NICE guidance states that these methods together with Depo-Provera® are the most cost effective option and that their use should be encouraged.

The CSM have also advised that; 

  • In adolescents, medroxyprogesterone acetate (Depo-Provera®be used only when other methods of contraception are inappropriate 
  • In all women, benefits of using medroxyprogesterone acetate beyond 2 years should be evaluated against risks;
  • In women with risk factors for osteoporosis an alternative method of contraception instead of medroxyprogesterone acetate should be considered 
GREEN      Medroxyprogesterone depot injection 150mg/1ml (Depo-provera®) 
GREEN      Medroxyprogesterone suspension for injection 104mg/0.65ml (Sayana® Press)
 
 
The following are to be implanted by specially trained individuals only: 
GREEN      Etonogestrel 68mg implantable rod (Nexplanon®) 
 
7.3.2.3 Intra-uterine progesterone-only device 
To be implanted by specially trained individuals only 
GREEN      Levonorgestrel 20micrograms/24hrs intra-uterine system (Mirena®) 
GREEN      Levonorgestrel 13.5 mg intra-uterine system (Jaydess®▼)      

(contraceptive for up to 3 years, second line to Mirena®, only for women who want periods or if  there are problems insterting Mirena®)   

7.3.5 Emergency contraception

GREEN      Levonelle® (levonorgestrel 1500microgram) 
 
EllaOne®  Ulipristal acetate (EllaOne®) is to be used only for patients who present  
between 72 and 120 hours after UPSI. Patients presenting before 72 hours should 
continue to receive Levonelle® 
GREEN      EllaOne®(ulipristal acetate 30mg) 

7.4.1 Drugs for urinary retention

Alpha-blockers relax smooth muscle in benign prostatic hyperplasia producing an increase in urinary flow rate and an improvement in obstructive symptoms.  Watchful waiting may be preferable to treatment in men with mild to moderate symptoms. Alpha-blockers are the treatment of choice for benign prostatic obstruction, and are likely to provide symptom relief in men with prostates of any size. The effect should be noticed within several days, with full response after 4-6 weeks.  They appear to be equally effective but there are differences in tolerability. All alpha-blockers reduce blood pressure, and first doses may cause drowsiness and dizziness. Modified release preparations may reduce these effects. Patients also receiving antihypertensives may need lower doses and supervision. 

Tamsulosin capsules m/r should be used first line, but some patients may experience a higher incidence of adverse sexual dysfunction, so alfuzosin m/r is often preferable for those in whom this is an issue.

First Line
GREEN      Tamsulosin  capsules m/r 400microgram  

Second Line
GREEN      Alfuzosin  tablets m/r 5mg, 10mg
                                     tablets 2.5mg
GREEN      Doxazosin tablets 1mg, 2mg, 4mg 
                  (Note M/R preps of Doxazosin should NOT be prescribed.)  
GREEN      Terazosin tablets 2mg, 5mg   
AMBER     Tamsulosin 400mcg/dutasteride 500mcg   
 
Parasympathomimetics
AMBER      Bethanechol tablets 10mg, 25mg (rarely used)    
RED            Distigmine tablets 5mg (for post-operative use in gynaecology patients only)
 

7.4.2 Drugs for urinary frequency, enuresis and incontinence

Urinary incontinence
Bladder training lasting for a minimum of 6 weeks should be offered as first-line treatment to women with urge or mixed
Urinary incontinence.  A trial of supervised pelvic floor muscle training of at least 3 months’ duration should be offered as first-line treatment to women with stress or mixed Urinary incontinence. 
Tolterodine or Oxybutynin should be offered to women with OAB or mixed UI as first-line drug treatment if bladder 
training has been ineffective. When offering antimuscarinic drugs to treat OAB always take account of:
 
       >     coexisting conditions (for example, poor bladder emptying, constipation, glaucoma) 
       >     use of other existing medication affecting the total antimuscarinic load
       >     risk of adverse effects
 
Discuss with patient:
       >     the likelihood of success and associated common adverse effects, and
       >     the frequency and route of administration, and
       >     that some adverse events such as dry mouth and constipation may indicate that treatment is starting to have                   an effect, and that they may not see the full benefits until they have been taking the treatment for 4 weeks

Oxybutynin immediate release is recommended by NICE but some patients may not tolerate its adverse effects if used 
on a regular basis. However, some patients prefer to use an immediate release product to enable them to take prior to 
certain situations, allowing them to use it 'as required'. This can also be helpful in allowing patients to balance the 
benefits with the side effects, enabling them to retain control of the timing of their treatment.
 
If after a 4 week trial first choice treatment is ineffective or not tolerated then solifenacin, darifenacin or trospium. 
should be considered as second line alternatives. Women should be counselled about the adverse effects of 
antimuscarinic drugs. The need for continuing antimuscarinic drug therapy should be reviewed after 6 months.
 
In accordance with NICE TA290 Mirabegron is recommended as an option ONLY for patients in whom antimuscarinic  
drugs are ineffective, contra-indicated, or not tolerated.
 
If treatment remains ineffective or is not tolerated patients should be referred to secondary care for further
investigations. Propiverine and Fesoterodine are available as treatment options as Amber traffic light drugs

First Line Choices
GREEN      Tolterodine capsules (IR) 2mg (twice daily) 
GREEN      Tolterodine capsules (m/r) 4mg (once daily)    
GREEN      Oxybutynin tablets (I/R) 5mg (2-3 times daily)  
GREEN      Oxybutynin tablets m/r 5mg, 10mg (once daily)      
 
Second Line Choices       
GREEN      Solifenacin tablets 5mg, 10mg  
GREEN     Darifenacin tablets m/r 7.5mg, 15mg 
GREEN     Trospium capsules m/r 60mg     
 
Other options available to secondary care  
AMBER    Propiverine Hydrochloride tablets 15mg  
AMBER    Propiverine Hydrochloride m/r capsules 30mg  
AMBER    Fesoterodine tablets  4mg, 8mg    


Mirabegron is recommended by NICE TA290 as an option for treating the symptoms of overactive bladder only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects. The dose needs to be reduced in renal/hepatic impairment. Patient’s should be reviewed 4 weeks after initiating.

Following a review by the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency (MHRA), there are now new recommendations for the use of Betmiga▼ (mirabegron).     

The new recommendations follow a review by the European Medicines Agency of cumulative data associated with mirabegron and increased blood pressure. Serious cases of hypertension and increased blood pressure have been reported in patients on mirabegron treatment.

In addition, there have been some reports of hypertensive crisis and cerebrovascular and cardiac events associated with hypertension with a clear temporal relationship with the use of mirabegron.

Its use in patients with severe uncontrolled high blood pressure is now contraindicated. Blood pressure should be measured at the start of treatment and monitored regularly, especially in patients with hypertension.

GREEN      Mirabegron tablets 25mg, 50mg

Oxybutyin patches are not routinely recommended and should be reserved only for individuals who are unable to tolerate oral medication.

A guideline for the management of the condition can be found here      

7.4.3 Drugs used in urological pain

Alkalinisation of urine 
GREEN      Potassium citrate (30%) mixture BP
RED           Potassium citrate matrix tablets (Urocit-K®) 5mEq, 10mEq (unlicensed)
                   For use in specific group of patients only
GREEN      Sodium bicarbonate capsules 500mg
GREEN      Sodium bicarbonate tablets 600mg
 
Acidification of urine
GREEN      Ascorbic acid (Vitamin C) tablets 500mg

7.4.4 Bladder instillations and urological surgery

Irrigation for infected bladder or dissolution of blood clots
GREEN      Sodium chloride solution 0.9%
 
Interstitial cystitis
Dimethyl sulphoxide may be used for symptomatic relief in patients with interstitial cystitis. Treatment may be repeated
every two weeks but long term use requires ophthalmic, renal and hepatic assessment every 6 months.
 
RED           Dimethyl sulphoxide (DMSO) bladder instillation 50% (50mL) – (unlicensed) 
 
Pentosan polysulfate sodium may be used for bladder pain or discomfort associated with interstitial cystitis.
RED           Pentosan polysulfate sodium (Elmiron®) 100mg tablets -(Unlicensed) 
 
Sodium hyaluronate may be used as a bladder coating therapy to treat the symptoms of interstitial cycstitis. 
RED           Sodium hyaluronate (Cystistat®) intravesical instillation (40 mg in 50 mL) -(Unlicensed)
 
Urological surgery
RED           Purisole® irrigation solution
 
Catheter Patency Solutions
GREEN      Sodium chloride 0.9% (OptiFlo S® solution 50ml)
GREEN      Solution G (OptiFlo G® solution 50mL)
GREEN      Solution R (OptiFlo R® solution 50mL)
 
Bladder Cancer Installations see section 8.2.4 (BCG) and 8.1.2 (Mitomycin) 


7.4.5 Drugs for erectile dysfunction

An amendment to the SLS regulations, effective from the 1 August 2014 means that prescribers will no longer be required to annotate prescriptions for the generic erectile dysfunction tablet sildenafil with the letters "SLS".

Following consultation the Department of Health (DH) selected to remove sildenafil from the list of medicines that may only be prescribed where they meet the selected list scheme requirements.

Whilst generically written prescriptions for sildenafil no longer require the prescriber to annotate the prescription with the letters “SLS”  the branded version of the drug -  Viagra s should be annotated “SLS” in order to be valid for NHS prescribing. Viagra is black lighted in East Lancashire.

The regulation amendment applies only to generic sildenafil.  Other oral PDE5 for erectile dysfunction remain subject to the “SLS” requirements.

Prescribers should make clear to any patients prescribed sildenafil outside the selected list scheme that they will not be eligible for other treatment options for erectile dysfunction on NHS prescription, unless they met the appropriate “SLS” criteria.  If treatment with sildenafil proves unsuccessful and patients do not meet SLS criteria then any alternative treatment for erectile dysfunction should be offered on a private prescription.

Prescribing of other PDE5  preparations should be in line with the Health Service Circular Guidelines (HSC 1999/115). NHS prescriptions (endorsed "SLS") can be issued for alprostadil, tadalafil, vardenafil and certain vacuum tumescence devices to men suffering from erectile dysfunction who have these medical conditions: diabetes, prostate cancer or prostatectomy, spinal cord injury, radical pelvic surgery or severe pelvic injury, parkinson's disease, renal failure requiring dialysis or following transplant, multiple sclerosis, spina bifida, poliomyelitis, single gene neurological disease, plus men who were receiving treatment for erectile dysfunction who was a member of the EU before 14th september 1998. GPs can issue private prescriptions for the above drugs and devices for patients on their list who do not meet these criteria, but cannot charge patients for issuing a private prescription.

In cases where erectile dysfunction is causing severe distress ALL prescribing should only be carried out from specialist services.

Sildenafil
When used for any unlicensed indication e.g. Raynaud's all prescribing must be retained by the specialists. GP's are 
unable to prescribe due to the restrictions for all PDE-5 inhibitors. The PPD will not re-imburse prescriptions for any 
unlicensed use. 
 
First Line 
GREEN     Generic Sildenafil tablets 25mg, 50mg, 100mg 
Trial lowest effective dose. Consider moving to second line choice only when maximum strength dose has been tried on eight occasions.
 
Second line
GREEN      Tadalafil tablets 10mg, 20mg*     
 
GREEN - More than one treatment a week may be considered in younger patients such as those suffering from  
severe distress. Prescribing and supply for this group of patients should either be retained by the psychosexual 
service or a maximum of 3 month’s supply can be issued by a GP at the request of the psychosexual service whilst 
under specialist care. Treatment beyond 3 months is not recommended. 
 
AMBER     Alprostadil (Caverject® or Viridal Duo®) Injection: 10microgram, 20microgram  
AMBER     Papaverine injection (unlicensed) 

Vardenafil remains available on formulary for any patients started on this drug prior to July 2012

AMBER     Alprostadil (Vitraos®) Cream
                   treatment option in line with Erectile Dysfunction Guidelines if resistant to PDE5 inhibitors
GREEN      Alprostadil (Vitraos®) Cream           
                   treatment option in line with Erectile Dysfunction Guidelines if PDE5 inhibitors not tolerated or contra-indicated
AMBER     Alprostadil (Muse®) urethral sticks    
                  treatment option in line with Erectile Dysfunction Guidelines -  SPECIALIST INITIATION
 
Please refer to the Erectile Dysfunction Guideline click here                  
       
 
Aviptadil (VIP) 25micrograms / Phentolamine Mesilate 2mg (Invicorp) (solution for injection) 
Specilaist initiation only, Reserved for patients not responding or intolerant to Alprostadil, as an option before referral for surgical procedure.
AMBER          Aviptidil with Phentolamine Mesilate  25mcg/2mg/0.35ml (Invicorp®) 
                            solution for injection