Formulary
Levonorgestrel: Indications, Dosing, Side Effects and Interactions
Levonorgestrel clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 9 min read
Levonorgestrel: Indications, Dosing, Side Effects and Interactions
Levonorgestrel clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Emergency contraception for levonorgestrel**
- **Females of childbearing potential** (By mouth): 1.5 mg for 1 dose, taken as soon as possible after coitus, preferably within 12 hours and no later than after 72 hours (may also be used between 72-96 hours after coitus but efficacy decreases with time), alternatively 3 mg for 1 dose, taken as soon as possible after coitus, preferably within 12 hours and no later than after 72 hours (may also be used between 72-96 hours after coitus but efficacy decreases with time). Higher dose should be considered for patients with body-weight over 70 kg or BMI over 26 kg/m2.
**Contraception for levonorgestrel**
- **Females of childbearing potential** (By mouth): 30 micrograms daily starting on day 1 of the cycle then continuously, dose is to be taken at the same time each day, if administration delayed for 3 hours or more it should be regarded as a "missed pill".
**Contraception, Menorrhagia for Benilexa One Handed 20micrograms/24hours intrauterine delivery system**
- **Females of childbearing potential** (By intra-uterine administration): Insert within 5 days of onset of menstruation, post-abortion or miscarriage, or at any time if replacement within licensed duration of use or if reasonably certain female is not pregnant and there is no risk of conception; postpartum insertions should be performed 48 hours after delivery, or delayed until 4 weeks and, either inserted within 5 days of onset of menstruation, or at any time if criteria for lactational amenorrhoea method are met. If the above criteria are not met, additional contraceptive precautions, e.g. barrier methods, should be used for at least 7 days before replacement or following insertion. Effective for 8 years when used for contraception if age <45, or until age 55 if age 45 at time of insertion; effective for 3 years when used for menorrhagia.
**Prevention of endometrial hyperplasia during oestrogen replacement therapy for Benilexa One Handed 20micrograms/24hours intrauterine delivery system**
- **Females of childbearing potential** (By intra-uterine administration): Insert during last days of menstruation or withdrawal bleeding or at any time if amenorrhoeic; effective for 5 years.
**Contraception for Jaydess 13.5mg intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert within 5 days of onset of menstruation, post-abortion or miscarriage, or at any time if replacement within licensed duration of use or if reasonably certain female is not pregnant and there is no risk of conception; postpartum insertions should be performed 48 hours after delivery, or delayed until 4 weeks and, either inserted within 5 days of onset of menstruation, or at any time if criteria for lactational amenorrhoea method are met. If the above criteria are not met, additional contraceptive precautions, e.g. barrier methods, should be used for at least 7 days before replacement or following insertion. Effective for 3 years.
**Contraception for Kyleena 19.5mg intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert within 5 days of onset of menstruation, post-abortion or miscarriage, or at any time if replacement within licensed duration of use or if reasonably certain female is not pregnant and there is no risk of conception; postpartum insertions should be performed 48 hours after delivery, or delayed until 4 weeks and, either inserted within 5 days of onset of menstruation, or at any time if criteria for lactational amenorrhoea method are met. If the above criteria are not met, additional contraceptive precautions, e.g. barrier methods, should be used for at least 7 days before replacement or following insertion. Effective for 5 years.
**Contraception, Menorrhagia for Levosert 20micrograms/24hours intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert within 5 days of onset of menstruation, post-abortion or miscarriage, or at any time if replacement within licensed duration of use or if reasonably certain female is not pregnant and there is no risk of conception; postpartum insertions should be performed 48 hours after delivery, or delayed until 4 weeks and, either inserted within 5 days of onset of menstruation, or at any time if criteria for lactational amenorrhoea method are met. If the above criteria are not met, additional contraceptive precautions, e.g. barrier methods, should be used for at least 7 days before replacement or following insertion. Effective for 8 years when used for contraception if age <45, or until age 55 if age 45 at time of insertion; effective for 3 years when used for menorrhagia.
**Prevention of endometrial hyperplasia during oestrogen replacement therapy for Levosert 20micrograms/24hours intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert during last days of menstruation or withdrawal bleeding or at any time if amenorrhoeic; effective for 5 years.
**Contraception, Menorrhagia for Mirena20micrograms/24hours intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert within 5 days of onset of menstruation, post-abortion or miscarriage, or at any time if replacement within licensed duration of use or if reasonably certain female is not pregnant and there is no risk of conception; postpartum insertions should be performed 48 hours after delivery, or delayed until 4 weeks and, either inserted within 5 days of onset of menstruation, or at any time if criteria for lactational amenorrhoea method are met. If the above criteria are not met, additional contraceptive precautions, e.g. barrier methods, should be used for at least 7 days before replacement or following insertion. Effective for 8 years when used for contraception if age <45, or until age 55 if age 45 at time of insertion; effective for 5 years when used for menorrhagia.
**Prevention of endometrial hyperplasia during oestrogen replacement therapy for Mirena20micrograms/24hours intrauterine device**
- **Females of childbearing potential** (By intra-uterine administration): Insert during last days of menstruation or withdrawal bleeding or at any time if amenorrhoeic; effective for 5 years.
Cautions
General cautions: Cardiac disease-seek specialist advice for intra-uterine insertion; diabetes; history of breast cancer-seek specialist advice before use; history of stroke (including transient ischaemic attack); history of venous thromboembolism; ischaemic heart disease; migraine; multiple risk factors for cardiovascular disease; positive antiphospholipid antibodies; rheumatoid arthritis; systemic lupus erythematosus Specific cautions: With intra-uterine use Anatomical abnormalities-seek specialist advice before use; cervical intraepithelial neoplasia; epilepsy (risk of seizure at time of insertion); immunosuppression (risk of infection)-seek specialist advice before use; postpartum-seek specialist advice before use; risk of sexually transmitted infections; young age With oral use Malabsorption states When used for Contraception With oral use Undiagnosed vaginal bleeding Cautions, further information With intra-uterine use: If removal is after day 7 of the menstrual cycle, intercourse should be avoided or another method of contraception used for at least 7 days before removal of intra-uterine device. M Sexually transmitted infections and pelvic inflammatory disease With intra-uterine use: The main excess risk of pelvic infection occurs in the first 3 weeks after insertion and is believed to be related to existing carriage of a sexually transmitted infection. The CoSRH advises pre-insertion screening (for chlamydia and, depending on sexual history and local prevalence of disease, Neisseria gonorrhoeae ) be performed in women at risk of sexually transmitted infections. Cautions For Mirena20micrograms/24hours intrauterine device Advanced uterine atrophy
Contraindications
General contra-indications: Current breast cancer (use with caution for emergency contraception) Specific contra-indications: With intra-uterine use Active trophoblastic disease (until return to normal of urine- and plasma-gonadotrophin concentration); acute malignancies affecting the blood (use with caution in remission); not suitable for emergency contraception; pelvic inflammatory disease; post-abortion sepsis; postpartum sepsis; recent sexually transmitted infection (if not fully investigated and treated); unexplained uterine bleeding; uterine or cervical malignancy With oral use Acute porphyrias
Side effects
General side-effects: Common or very common Dizziness; gastrointestinal discomfort; haemorrhage; headaches; menstrual cycle irregularities; nausea; skin reactions Specific side-effects: Common or very common With intra-uterine use Back pain; breast abnormalities; depression; device expulsion; hirsutism; increased risk of infection; libido decreased; nervousness; ovarian cyst; pelvic disorders; vulvovaginal disorders; weight increased With oral use Breast tenderness; diarrhoea; fatigue; vomiting Uncommon With intra-uterine use Alopecia; endometritis; oedema; uterine rupture Rare or very rare With oral use Face oedema; pelvic pain Frequency not known With intra-uterine use Breast cancer With oral use Arterial thromboembolism; cerebrovascular insufficiency; depressed mood; diabetes mellitus; neoplasms; sexual dysfunction; weight changes Side-effects, further information Breast cancer risk with contraceptive use The benefits of using progestogen-only contraceptives (POCs), such as levonorgestrel, should be weighed against the possible risks for each individual woman. There is a possible small increase in the risk of breast cancer in women using, or who have recently used, progestogen-only contraception. Causal association is not clearly established, and absolute risk remains very small, and is like that of current or recent use of combined hormonal contraception. The most important risk factor for breast cancer appears to be the age the contraceptive is stopped rather than the duration of use; the risk gradually disappears during the 10 years after stopping. With intra-uterine use Patients should be informed about the device that has been inserted and when it should be removed or replaced (including referring them to a patient information leaflet and other sources of information). Patients may experience irregular, prolonged or infrequent menstrual bleeding in the 3-6 months following insertion; bleeding pattern improves with time but persists in some patients. Progestogenic side-effects resolve with time (after the first few months).
Interactions
**Other interactions (2):**
- The metabolism of progestogens may be increased by concomitant use of substances known to induce drug-metabolizing enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g.,...
- On the other hand, substances known to inhibit drug-metabolizing enzymes (e.g.
Pregnancy
With oral use: Not known to be harmful. With intra-uterine use: If an intra-uterine device fails and the woman wishes to continue to full-term, the device should be removed in the first trimester if possible. Avoid-if pregnancy occurs remove intra-uterine device.
Breast feeding
Progestogen-only contraceptives do not affect lactation.
Hepatic impairment
With intra-uterine use or oral use for Contraception: Manufacturer advises avoid in liver tumour. With oral use for Contraception or Emergency contraception: Manufacturer advises avoid in severe impairment. With intra-uterine use: Manufacturer advises avoid in acute hepatic disease or in severe impairment (no information available)-consult product literature.
Medicinal forms
Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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