Drug Action
Misoprostol is a synthetic prostaglandin analogue that acts as a potent uterine stimulant.
Source page 894
Loading InternPractice…
Individual generic drug information
Extracted information for Misoprostol only.
Misoprostol is a synthetic prostaglandin analogue that acts as a potent uterine stimulant.
Source page 894
Termination of pregnancy following mifepristone (gestation up to 49 days) ▶BY MOUTH ▶Adult: 400 micrograms for 1 dose, dose to be given 24–48 hours after mifepristone Termination of pregnancy following mifepristone (gestation 50 to 63 days) ▶INITIALLY BY VAGINA, OR BY BUCCAL ADMINISTRATION, OR BY SUBLINGUAL ADMINISTRATION ▶Adult: 800 micrograms for 1 dose, dose to be given 24–48 hours after mifepristone, if abortion has not occurred 4 hours after first misoprostol dose a further dose may be given, (by mouth or by vagina) 400 micrograms for 1 dose Termination of pregnancy following mifepristone (gestation of 9 to 13 weeks) ▶INITIALLY BY VAGINA ▶Adult: 800 micrograms for 1 dose, dose to be given 36–48 hours after mifepristone, followed by (by vagina or by mouth) 400 micrograms every 3 hours if required for a maximum of 4 doses Termination of pregnancy following mifepristone (gestation of 13 to 24 weeks) ▶INITIALLY BY VAGINA ▶Adult: 800 micrograms for 1 dose, dose to be given 36–48 hours after mifepristone, followed by (by vagina or by mouth) 400 micrograms every 3 hours if required for a maximum of 4 doses, if abortion has not occurred 3 hours after the last dose of misoprostol, a further dose of mifepristone may be given, and misoprostol may be recommenced 12 hours later MYSODELLE ® VAGINAL DELIVERY SYSTEM Induction of labour (specialist supervision in hospital) ▶BY VAGINA ▶Adult: 200 micrograms for 1 dose, to be inserted (in vaginal delivery system) high into posterior fornix; if oxytocin required, remove at least 30 minutes before oxytocin administration, for information on when to remove the delivery system—consult product literature l UNLICENSED USE Misoprostol doses for termination of pregnancy may differ from those in product literature.
Source pages 894, 895
MYSODELLE ® VAGINAL DELIVERY SYSTEM Before 36 weeks’ gestation. chorioamnionitis (unless adequate prior treatment initiated). fetal malpresentation. placenta praevia. suspicion or evidence of fetal compromise. unexplained vaginal bleeding after 24 weeks gestation. uterine abnormality. uterine scar
Source page 895
▶When used for termination of pregnancy Cardiovascular disease. risk factors for cardiovascular disease MYSODELLE ® VAGINAL DELIVERY SYSTEM Modified Bishop score greater than 4
Source page 895
MYSODELLE ® VAGINAL DELIVERY SYSTEM All Wales Medicines Strategy Group (AWMSG) decisions AWMSG No. 3627 The All Wales Medicines Strategy Group has advised (March 2018) that misoprostol (Mysodelle ®) is recommended as an option for use within NHS Wales for the induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.
Source page 895
Extracted information for Misoprostol only.
MHRA/CHM ADVICE: MISOPROSTOL VAGINAL DELIVERY SYSTEM (MYSODELLE ®): REPORTS OF EXCESSIVE UTERINE CONTRACTIONS (TACHYSYSTOLE) UNRESPONSIVE TO TOCOLYTIC TREATMENT (FEBRUARY 2018) Mysodelle ® can cause excessive uterine tachysystole that may not respond to tocolytic treatment. Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby. Be prepared to administer tocolytic therapy—if needed, it can be administered immediately after removal of Mysodelle ®.
Source page 895
▶Common or very common Nausea. neonatal respiratory depression. rash. transient tachypnoea of the newborn. vomiting ▶Uncommon Genital pruritus. hypoxic-ischaemic encephalopathy. uterine rupture
Source page 895
Manufacturer advises avoid—present in milk, and may cause diarrhoea in nursing infants. g Tertiary sources state present in milk but amount probably too small to be harmful; to further reduce risk following termination of pregnancy, consider interrupting breastfeeding for 5 hours after a dose. k l HANDLING AND STORAGE MYSODELLE ® VAGINAL DELIVERY SYSTEM Manufacturer advises store in a freezer (-10 to -25°C); no thawing required prior to use.
Source page 895
Extracted information for Misoprostol only.
There can be variation in the licensing of different medicines containing the same drug. Vaginal delivery system ▶Mysodelle (Ferring Pharmaceuticals Ltd) Misoprostol 7 microgram per 1 hour Mysodelle 200micrograms vaginal delivery system | 5 unit P £465.00 Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Misoprostol (Non-proprietary) Misoprostol 200 microgram Misoprostol 200microgram vaginal tablets | 4 tablet P s (Hospital only) ▶Topogyne (Nordic Pharma Ltd) Misoprostol 400 microgram Topogyne 400microgram tablets | 16 tablet P £128.00 (Hospital only) Vaginal and vulval Genito-urinary system conditions Vaginal and vulval conditions Management Symptoms are often restricted to the vulva, but infections almost invariably involve the vagina which should also be treated. Applications to the vulva alone are likely to give only symptomatic relief without cure. Aqueous medicated douches may disturb normal vaginal acidity and bacterial flora. Topical anaesthetic agents give only symptomatic relief and may cause sensitivity reactions. They are indicated only in cases of pruritus where specific local causes have been excluded. Systemic drugs are required in the treatment of infections such as gonorrhoea and syphilis. Vaginal and vulval changes Topical HRT for vaginal atrophy A cream containing an oestrogen may be applied on a short- term basis to improve the vaginal epithelium in menopausal atrophic vaginitis. It is important to bear in mind that topical oestrogens should be used in the smallest effective amount to minimise systemic effects. Modified-release vaginal tablets and an impregnated vaginal ring are now also available. The risk of endometrial hyperplasia and carcinoma is increased when systemic oestrogens are administered alone for prolonged periods. The endometrial safety of long-term or repeated use of topical vaginal oestrogens is uncertain; treatment should be reviewed at least annually, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma. Topical oestrogens are also used in postmenopausal women before vaginal surgery for prolapse when there is epithelial atrophy. Non-hormonal preparations for vaginal atrophy Several non-hormonal vaginal moisturisers are available and some are prescribable on the NHS (consult Drug Tariff). Vaginal and vulval infections Effective specific treatments are available for the common vaginal infections. Fungal infections Candidal vulvitis can be treated locally with cream, but is almost invariably associated with vaginal infection which should also be treated. Vaginal candidiasis is treated primarily with antifungal pessaries or cream inserted high into the vagina (including during menstruation). Single-dose preparations offer an advantage when compliance is a problem. Local irritation may occur on application of vaginal antifungal products. Imidazole drugs (clotrimazole p. 875, econazole nitrate p. 875, fenticonazole nitrate p. 876, and miconazole p. 876) are effective against candida in short courses of 1 to 14 days according to the preparation used; treatment can be repeated if initial course fails to control symptoms or if symptoms recur. Vaginal applications may be supplemented with antifungal cream for vulvitis and to treat other superficial sites of infection. Oral treatment of vaginal infection with fluconazole p. 630 or itraconazole p. 632 is also effective. Vulvovaginal candidiasis in pregnancy Vulvovaginal candidiasis is common during pregnancy and can be treated with vaginal application of an imidazole (such as clotrimazole), and a topical imidazole cream for vulvitis. Pregnant women need a longer duration of treatment, usually about 7 days, to clear the infection. Oral antifungal Genito-urinary system treatment should be avoided during pregnancy. Recurrent vulvovaginal candidiasis Recurrence of vulvovaginal candidiasis is particularly likely if there are predisposing factors, such as antibacterial therapy, pregnancy, diabetes mellitus, or possibly oral contraceptive use. Reservoirs of infection may also lead to recontamination and should be treated; these include other skin sites such as the digits, nail beds, and umbilicus as well as the gastro-intestinal tract and the bladder. The partner may also be the source of reinfection and, if symptomatic, should be treated with a topical imidazole cream at the same time. Treatment against candida may need to be extended for 6 months in recurrent vulvovaginal candidiasis. Other infections Trichomonal infections commonly involve the lower urinary tract as well as the genital system and need systemic treatment with metronidazole p. 572 or tinidazole p. 574. Bacterial infections with Gram-negative organisms are particularly common in association with gynaecological operations and trauma. Metronidazole is effective against certain Gram-negative organisms, especially Bacteroides spp. and can be used prophylactically in gynaecological surgery. Clindamycin cream below and metronidazole gel are indicated for bacterial vaginosis. Vaginal preparations intended to restore normal acidity may prevent recurrence of vaginal infections and permit the re-establishment of the normal vaginal flora. The antiviral drugs aciclovir p. 670, famciclovir p. 672, and valaciclovir p. 673 can be used in the treatment of genital infection due to herpes simplex virus, the HSV type 2 being a major cause of genital ulceration; they have a beneficial effect on virus shedding and healing, generally giving relief from pain and other symptoms. 6.1 Vaginal and vulval infections 6.1a Vaginal and vulval bacterial infections ANTIBACTERIALS › LINCOSAMIDES
Source pages 895, 896
Extracted information for Misoprostol only.
Driving and skilled tasks Manufacturer advises patients should be cautioned on the effects on driving and performance of skilled tasks—increased risk of dizziness.
Source page 895
Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
400 micrograms for 1 dose, dose to be given
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 894
First line only; read the complete Indications and dose section above.
800 micrograms for 1 dose, dose to be given
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 894
First line only; read the complete Indications and dose section above.
800 micrograms for 1 dose, dose to be given
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 894
First line only; read the complete Indications and dose section above.
800 micrograms for 1 dose, dose to be given
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 894
First line only; read the complete Indications and dose section above.
200 micrograms for 1 dose, to be inserted (in
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 894