Levonorgestrel oral 1500mcg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing 1500 micrograms levonorgestrel.
Drugs List
Therapeutic Indications
Uses
Emergency contraception - post-coital (within 72 hours of intercourse)
Dosage
Levonorgestrel may be taken at any time during the menstrual cycle, except when menstrual bleeding is overdue.
Adults
A single dose of 1500 micrograms to be taken preferably within 12 hours and no later than 72 hours after unprotected sexual intercourse.
If vomiting occurs with three hours of taking the tablet, another tablet should be taken immediately.
Unlicensed dose
In patients weighing over 70kg or have a BMI greater than 26kg/metre squared consider higher dose of levonorgestrel 3000 micrograms.
Additional Dosage Information
Concomitant use of hepatic enzyme inducers (particularly CYP3A4 enzyme inducers) results in the increased metabolism of levonorgestrel. This may reduce emergency contraceptive efficacy. The elevated levels of CYP3A4 enzymes can persist for 4 weeks after the discontinuation of the enzyme inducing medicine.
Females seeking emergency contraception, who have used CYP3A4 enzyme inducers in the last 4 weeks, should use a non-hormonal emergency contraceptive (for example a copper intrauterine device). However, if this is not an option, double the usual dose of levonorgestrel to 3000 micrograms.
Contraindications
History of ectopic pregnancy
Galactosaemia
History of salpingitis
Porphyria
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Children under 16 years
Breastfeeding
Gastrointestinal hypermotility
Glucose-galactose malabsorption syndrome
Lactose intolerance
Malabsorption syndrome
Patients weighing over 70kg or with BMI over 26kg/m2: Consider higher dose
Contains lactose
Repeated use within one menstrual cycle is not advisable
Treatment is ineffective more than 72 hours after unprotected intercourse
Exclude pregnancy prior to initiation of treatment
If pregnancy occurs possibility of ectopic pregnancy should be considered
Advise patient to consult doctor if lower abdominal pain occurs
Advise patient to consult doctor if menstruation overdue >5 days/ abnormal
Vomiting or severe diarrhoea may impair efficacy
Advise patient not to take St John's wort concurrently
Female: Barrier contraception recommended for the rest of the monthly cycle
Advise patient early or late onset of next menstrual period is possible
Take another dose if vomiting occurs within 3 hours
Treatment does not protect against risk of sexually transmitted disease
Pregnancy and Lactation
Pregnancy
Levonorgestrel is contraindicated in pregnancy.
The manufacturer advises that levonorgestrel should not be given to pregnant women. Levonorgestrel will not interrupt a pregnancy. Limited epidemiological data indicates that there are no adverse effects on the foetus from Levonorgestrel use during pregnancy. However there is limited clinical data on doses greater than 1500 micrograms.
Lactation
Use levonorgestrel with caution in breastfeeding.
The manufacturers advises potential exposure of the infant can be reduced by taking the tablets immediately after breastfeeding, and not breastfeeding for 8 hours after the tablets are taken. Levonorgestrel is secreted in breast milk, it has been indicated that this does not affect the composition of milk, the growth and development of the infant or the milk supply.
Counselling
If vomiting occurs within 3 hours of taking the tablets, a further 1500 micrograms should be taken immediately. The patient should be advised to contact her doctor, family planning clinic or pharmacist for advice and more tablets.
Patients should be advised that after taking levonorgestrel, barrier methods of contraception should be adopted until the next menstrual period begins.
Patients should be advised that their next period may be early or late.
If menstrual bleeding is overdue by more than 5 days, or abnormal bleeding occurs (e.g. abnormally light, heavy or brief) at the normal time of menstruation, or pregnancy is suspected for any other reason, a doctor should be consulted so that pregnancy may be ruled out.
Patients should be advised to consult their doctor if lower abdominal pain occurs, as this could indicate an ectopic pregnancy.
Women who repeatedly request emergency contraception should be advised to consider a conventional regular method of contraception.
Patients purchasing levonorgestrel should be advised to seek medical advice if taking any other drugs, including herbal remedies such as St John's Wort.
Side Effects
Breast tenderness
Diarrhoea
Dizziness
Dysmenorrhoea
Facial oedema
Fatigue
Headache
Irregular uterine bleeding
Lower abdominal pain
Menstrual disturbances
Nausea
Pelvic pain
Pruritus
Rash
Urticaria
Vaginal bleeding
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2015
Reference Sources
Summary of Product Characteristics: Emergency contraceptive consilient 1500 microgram tablet. Consilient Health Ltd. Revised April 2017.
Summary of Product Characteristics: Emerres 1.5 mg tablet. Morningside Healthcare Ltd. Revised March 2018.
Summary of Product Characteristics: Emerres Una 1.5 mg tablet. Morningside Healthcare Ltd. Revised December 2017.
Summary of Product Characteristics: Ezinelle 1.5 mg tablet. Mylan Ltd. Revised October April 2017.
Summary of Product Characteristics: Levonelle tablets 1500mcg. Bayer plc. Revised March 2018.
Summary of Product Characteristics: Levonelle One Step. Bayer plc. Revised June 2020.
Summary of Product Characteristics: Melkine 1.5mg tablets. Crescent Pharma Ltd. Revised December 2016.
Summary of Product Characteristics: Postinor 1500 microgram tablet. Gedeon Richter (UK) Ltd. Revised May 2021.
Summary of Product Characteristics: Upostelle 1500 microgram tablet. Consilient Health Ltd. Revised January 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 August 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Levonogrestrel Last revised: 18 July 2022
Last accessed: 05 August 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.