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Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 Chapter 7 Obstetrics, Gynaecology, and Urinary-Tract Disorders 7.1 Drugs used in obstetrics. 7.1.1 Prostaglandins and oxytocics 7.1.1.1 Drugs affecting the ductus arteriosus Ergometrine injection Red with oxytocin injection (“Syntometrine”) NB. This is by I.M injection. Intravenous injection no longer recommended. Oxytocin injection Red Dinoprostone – Red Vaginal Gel Pessaries Carboprost injection – Red Closure of the ductus arteriosus Ibuprofen injection – Red Maintenance of patency Alprostadil 500microgram/ml injection – Red 7.1.2 Mifepristone Mifepristone tablets – Red 7.1.3 Myometrial relaxants Atosiban – Red Injection Concentrate for I.V. Infusion Beta agonists Salbutamol injection – Red 7.2 Treatment of vaginal and vulval conditions 7.2.1 Preparations for vaginal and vulval changes Topical HRT for vaginal atrophy Oestrogens Gynest intravaginal cream 0.01% or pessaries 500micrograms Green Vagifem vaginal tablets MR 10micrograms Green Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 Additional prescribing advice: Topical oestrogens should be used in the smallest effective amount to minimise systemic effects. Safety of long-term or repeated use is uncertain; treatment should be reviewed at least annually Ovestin 0.1% is available for those with a peanut allergy Green 7.2.2 Vaginal and vulval infections See Intranet Antibiotic Guidelines – Genital Tract Additional prescribing advice: Clotrimazole is available over the counter. Candidal vulvitis is treated locally with clotrimazole cream but is invariably associated with vaginal candidiasis. Vaginal candidiasis is treated with clotrimazole pessaries or cream inserted high into the vagina. The partner may be the source of re-infection and, if symptomatic, should be treated with cream at the same time. N.B. Bacterial and viral infections normally require systemic treatment. 7.3 Contraceptives. 7.3.1 Combined hormonal contraceptives General notes MHRA advice, February 2014: Combined hormonal contraceptives and venous thromboembolism A review of the latest evidence on the risk of thromboembolism in association with combined hormonal contraceptives (CHCs) has concluded that: the risk of blood clots with all low-dose CHCs is small there is good evidence that the risk of venous thromboembolism (VTE) may vary between products, depending on the progestogen CHCs that contain levonorgestrel, norethisterone, or norgestimate have the lowest risk of VTE the benefits of any CHC far outweigh the risk of serious side effects prescribers and women should be aware of the major risk factors for thromboembolism, and of the key signs and symptoms • Different doses of oestrogen may be associated with different side effect profiles in individual women. • The androgenicity of different progestogens appears to be related to consistent differences in side-effects. Less androgenic progestogens (e.g. desogestrel) are of benefit to women with acne. • Most contraceptive failures are due to poor compliance which is strongly influenced by acceptability. It is important therefore to accept that women may prefer one brand to another despite similar or identical composition. • There is no good evidence that triphasic or biphasic COC's are associated with better cycle control; they are more complicated to use. • When the pill is used for management of gynaecological conditions, such as menorrhagia or dysmenorrhoea, the risk/benefit ratio changes and it may be prescribed for women who would have relative contraindications if they were using it solely for contraception. • Some drugs, including enzyme-inducers and antibiotics, may impair the efficacy of oral contraceptives; see BNF for details. Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 Group 1 - First line The cheapest and most straightforward options and lowest VTE risk for COCs listed. Ethinylestradiol 35mcg/norethisterone 500mcg (Brands: Brevinor®; Ovysmen®) - GREEN Ethinylestradiol 30mcg/ levonorgestrel 150mcg (Brands: Levest®; Microgynon 30®; Ovranette®; Rigevidon® ) - GREEN Group 2 - Second line May be useful if acne or other androgenic side effects are problematical, with the first line choice of pill. Cilest®(ethinylestradiol 35mcg/ norgestimate 250mcg) - GREEN Femodene®; Millinette 30/75® (ethinylestradiol 30 mcg/ gestodene 75mcg) - GREEN Gedarel 30/150®; Marvelon® (ethinylestradiol 30mcg/desogestrel 150mcg) - GREEN Group 3 – Second line This pill with lower oestrogen content (20 micrograms) may be useful if nausea, breast tenderness or general headaches (not migraine) are problematical with the first line choice of pill. Gedarel 20/150®; Mercilon® (ethinylestradiol 20mcg/desogestrel 150mcg) - GREEN Group 4 - Second line Useful alternatives for breakthrough bleeding when other causes excluded. Loestrin 30®(ethinylestradiol 30mcg/ norethisterone 1.5mg) - GREEN Norimin® tablets (ethinylestradiol 35mcg/ norethisterone 1mg) - GREEN 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 Group 2 second line pills. Yasmin® tablets (ethinylestradiol 30mcg/ drospirenone 3mg) - GREEN Transdermal (standard strength) Evra® is not recommended for first line use but may be more suitable for younger, or less compliant women, or those with GI disturbance whilst taking oral contraceptives. Evra® transdermal patch - GREEN (ethinylestradiol 33.9 micrograms/24hrs, norelgestromin 203 micrograms/24hrs) Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 7.3.2 Progestogen-only contraceptives 7.3.2.1 Oral progestogen-only contraceptives First choice: Micronor/Noriday - GREEN Second choice: Norgeston - GREEN Additional prescribing advice: These are useful for women in whom oestrogens are contra-indicated, or if breastfeeding. There is no evidence for any clinical advantage of any one brand of POP; Micronor® is currently less expensive than alternatives. Desogestrel (GREEN) 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 late before it is considered a ‘missed pill’) Desogesterol - Brands include: Cerazette®, Cerelle® but generic prescribing is recommended 7.3.2.2 Parenteral progestogen-only contraceptives For IUD/IUS and Contraceptive implant fitting special training is required (primary care - see nGMS enhanced services contract for details and contact Local Authority for further information as necessary). NICE guidance states that these methods together with Depo Provera® (LARC methods) are the most cost effective option and that their use should be encouraged. The MHRA has 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. First choice: Medroxyprogesterone acetate (Depo-provera) GREEN Implants: First choice: Etonogestrel (Nexplanon) GREEN Additional prescribing advice: Nexplanon® insertion and removal requires specialist training. Nexplanon® is a low dose long-acting progestogen. Contraceptive effect lasts for up to 3 years. The manufacturer advises that in heavier women, blood etonogestrel concentrations are lower and the implant may not provide effective contraception during the third year. Earlier replacement is advised. Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 7.3.2.3 Intra-uterine progesterone-only system (IUS) To be fitted by specially trained individuals only Note: For the majority of women with regular light periods an intra-uterine device (IUD) would be the first line choice due to the avoidance of potential troublesome intermenstrual bleeding with an IUS for the first 6 months, and it being the most cost effective option. IUS is beneficial for women requiring contraception who also have heavy menstrual bleeding. Follow NICE or Map of Medicine guidance on women who may or may not need gynaecological investigation before an IUS is fitted. First choice: Levonorgestrel 20micrograms/24hrs intra-uterine system (Mirena®) GREEN 7.3.3 Spermicidal contraceptives Gygel - Green Additional prescribing advice: Spermicides are not recommended for use as the sole method of contraception. They are suitable for use with barrier methods, such as diaphragms or caps; however, spermicidal contraceptives are not generally recommended for use with condoms as there is no evidence of any additional protection compared with non-spermicidal lubricants. All currently available spermicides contain nonoxinol '9' (N9) as the active compound. Spermicidal contraceptives are not suitable for use in those with or at high risk of sexually transmitted infections (including HIV) High frequency use of the spermicide nonoxinol 9 has been associated with genital lesions, which may increase the risk of acquiring these infections. 7.3.4 Contraceptive devices Intra-uterine devices First choices: T-Safe® 380A Quickload or Multiload® Cu375 (or Mirena®) - Green Additional prescribing advice: IUD insertions and removals should be performed by someone who has been properly trained, regularly updated and performs regular insertions. They should provide full patient counselling backed where available by a patient information leaflet. Copper IUDs provide long-acting highly effective contraception for at least 5 years and do not rely on compliance for their efficacy. The most effective intra-uterine devices have at least 380mm of copper and have banded copper on the arms. Devices which contain less than 300mm of copper should no longer be used as they are less effective. GyneFix® is a frameless flexible device which may be associated with a reduction in dysmenorrhoea. Smaller than the framed devices, it is particularly useful for nulliparous women. Since the device is anchored to the myometrium it may be useful for women who have a history of expulsion of a framed device. Diaphragms First choice: Ortho All- flex® - Green Second choice: Reflexions® - Green Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 Condoms Additional prescribing advice: Condoms are available free of charge from Family Planning Services, Brook, C-card outlets and certain GPs. Condoms are the only method, which protect against sexually transmitted diseases including HIV; condom users should be informed about emergency contraception. 7.3.5 Emergency hormonal contraception First line - offer emergency IUD as the most effective method of emergency contraception. Second line – if woman declines IUD, then levonorgestrel for presentation 0-72 hours after unprotected sexual intercourse (UPSI), or ulipristal for presentation 72-120 hours after UPSI. If an emergency IUD cannot be fitted immediately, emergency hormonal contraception should still be offered as appropriate in case the woman does not return for IUD, or an IUD cannot be fitted. First choice: Levonelle® (levonorgestrel 1500microgram) GREEN EllaOne® (ulipristal acetate 30mg) (72 – 120 hours after UPSI) GREEN – primary care Secondary care - Only approved for the safe centre, RPH 7.4 Drugs for genito-urinary disorders 7.4.1 Drugs for urinary retention ALPHA-BLOCKERS Indications: benign prostatic hyperplasia First choice Tamsulosin MR - Green Second choice Alfuzosin - Green Additional prescribing advice: Watchful waiting may be preferable to treatment in men with mild to moderate symptoms. Alpha-blockers are the treatment of choice and likely to provide symptom relief in men with prostates of any size. Effects should be noticed in several days, with full response after 46 weeks. The benefit may be seen for up to 3 years in those who continue to take the drug. There is lack of data beyond 3 years. All alpha-blockers are equally effective but there are differences in tolerability. Caution in patients already receiving antihypertensives, these patients may need lower starting doses. Alpha blockers should be avoided in patients with a history of postural hypotension and micturition syncope Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 5alpha-reductase inhibitors Alternative treatment to alpha-blockers; particularly in men with a significantly enlarged prostate. Finasteride Amber 0 Additional prescribing advice: Review treatment at 3-6 months and then every 6-12 months. Several months’ treatment may be required before benefit is obtained and any benefit could be lost after 3-6 months if treatment is discontinued. Finasteride decreases plasma levels of PSA by approximately 50%. After 6 months of treatment, the PSA value should be doubled for comparison with normal ranges in untreated men. Women of childbearing potential should avoid handling crushed or broken tablets. Finasteride is excreted in the semen and use of a condom is recommended if sexual partner is pregnant or likely to become pregnant. 7.4.2 Drugs for urinary frequency, enuresis and incontinence Urinary incontinence First choices: Oxybutynin immediate release - Green Side effects may be reduced by starting at a lower dose Oxybutynin Patch – restricted for use in patients who benefit from oral oxybutynin but cannot tolerate its side effects. Tolterodine - Green Second choice: Trospium MR - Green Additional prescribing advice: Combine drug therapy with conservative methods for managing urge incontinence such as pelvic floor exercises and bladder training; stress incontinence is generally managed by non-drug methods. Anti-muscarinic drug therapy should be reviewed after 3-6 months. Duloxetine may be offered to women as second line treatment in preference to surgery or if surgery is not suitable. Green NICE TA290 – Mirabegron can be prescribed if the anti-muscarinics do not work, if they are not suitable, or their side effects are unacceptable. (Green with restrictions) Nocturnal enuresis in children Desmopressin tablets - amber 0 Additional prescribing advice: Common in young children but treatment is not appropriate in those under 5 years. It is usually not needed in under 7 years and in cases where the child or parents are not anxious about the bedwetting. Do not give intranasally for nocturnal enuresis due to an increased incidence of side effects. Treatment is usually on a short-term basis – treatment should not be continued for longer than 3 months without interrupting treatment for 1 week for a full patient re-assessment. Used also in Multiple sclerosis patients for nocturnal frequency. Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 7.4.3 Drugs used in urological pain Alkalinisation of urine Indications: relief of discomfort in mild urinary tract infections; alkalinisation of urine Potassium citrate Mixture - Green Additional prescribing advice: Many patients obtain good relief from the symptoms of cystitis with over-the-counter medicines. Sodium bicarbonate is used as a urinary alkalinisation agent in some metabolic and renal disorders. May cause hyperkalaemia with prolonged high dosage. Use with great caution in renal impairment, cardiac disease and in patients on potassium-sparing diuretics or ACE inhibitors. Potassium citrate tablets (unlicensed) – named patient basis only - red Acidification of urine Ascorbic acid tablets - Green Acidification has been undertaken with ascorbic acid but is not always reliable. 7.4.4 Bladder instillations and urological surgery Bladder instillations Maintenance of indwelling urinary catheters First choice: Sodium chloride 0.9% 50ml urotrainer or 100ml bladder irrigation Second choice: “Solution G” (citric acid 3.23%, magnesium oxide 0.38%, sodium bicarbonate 0.7%, disodium edetate 0.01%) Consultant /Hospital Only Cystistat or Gepan (hyaluronic acid used in interstitial cystitis) – Unlicensed use BCG bladder instillation – ImmuCyst/OncoTice Urological surgery Glycine 1.5% for irrigation Sodium chloride 0.9% in 3L irrigation Lancashire Teaching Hospitals NHS Foundation Trust and Greater Preston CCG and Chorley & South Ribble CCG Joint Formulary 2014 7.4.5 Drugs for erectile dysfunction Sildenafil - Green Tadalafil - Green Alprostadil (prostaglandin E1) Alprostadil injection Additional prescribing advice: Drug treatments for erectile dysfunction may only be prescribed on the NHS under certain circumstances. See latest issue of BNF. GPs can issue private prescriptions for these drugs and devices for patients on their list but cannot charge patients for issuing a private prescription. Treatment should be available from specialist services in cases where erectile dysfunction is causing severe distress. Examination of the patient is important to check for anatomical abnormalities and Peyronie's disease, which may need referral to Urology. Diabetes needs to be excluded and cardiovascular risk factors addressed because they are commonly present. Tadalafil may be suitable alternative for patients who develop visual disturbances with sildenafil or for whom a longer duration of action is required. Sildenafil and tadalafil are contra-indicated in men receiving nitrates in any form and nicorandil. Consider discontinuing nitrates if no longer needed. Cardiovascular disease and multiple antihypertensive drug regimens are not contraindications to sildenafil or tadalafil therapy provided the man is capable of ordinary daily tasks (and therefore sexual activity) without cardiac symptoms. Intracavernosal self-injection with alprostadil is a suitable second choice to sildenafil if treatment with sildenafil fails or is contraindicated. All patients commencing intracavernosal injection therapy require supervised instruction on its use and advice on action required should a prolonged erection (>6 hours) occur