Levonorgestrel
Indications for use
- Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method
Age
- Levonelle One Step PIL states “If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.” Similarly, Emerres Una SmPC states that "levonorgestrel is not recommended for use by young women under 16 years of age without medical supervision." Ezinelle and Postinor SmPCs carry a similar message
Dose/Directions
- One tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse
Duration
- Single dose
Contra-indications/referral criteria
- Hypersensitivity
- OTC levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy)
- Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle (but note that repeated administration in the one cycle is not a contraindication)
Examples of drug interactions
- Barbiturates (including primidone), phenytoin, carbamazepine, St. John's Wort, rifampicin, ritonavir, rifabutin, griseofulvin, ciclosporin
- Levonelle One Step PIL states: if you have used any of the following medicines during the last 4 weeks i.e. barbiturates and other medicines used to treat epilepsy, rifampicin, rifabutin, ritonavir, efavirenz, griseofulvin and St John’s wort, Levonelle One Step may be less suitable for you. Your doctor may prescribe a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step
Side-effects
- Very common: bleeding not related to menses, headache, nausea, low abdominal pain, fatigue
- Common: breast tenderness, delay of menses, irregular bleeding and spotting, dizziness, diarrhoea, vomiting
Other pertinent information
- If vomiting occurs within three hours of taking the tablet another tablet should be taken immediately
- Will not offer protection for subsequent sexual intercourse
- If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, women should be referred to a doctor so that pregnancy may be excluded
- Use of emergency contraception does not replace the necessary precautions against sexually transmitted infections
- According to CoSRH (formerly FSRH), the effectiveness of levonorgestrel could be reduced if a woman has a BMI >26 kg/m2 or weight of >70 kg. In this situation, CoSRH recommend that either ulipristal acetate or a double dose (3 mg) of levonorgestrel is given. The woman should also be informed that the effectiveness of the Cu-IUD is not known to be affected by weight or BMI.
NB: In an OTC context, recommending a double dose of levonorgestrel in this situation would be acting outside of product licence and is not recommended. Therefore, if ulipristal acetate is not suitable or the woman wishes to consider a Cu-IUD, she will need to be referred to another EC-provider rather than being managed in an OTC setting
- Reclassified POM→P: 2001