Levonorgestrel intrauterine 52mg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Intrauterine system containing 52mg levonorgestrel.
Drugs List
Therapeutic Indications
Uses
Endometrial hyperplasia during oestrogen replacement therapy: prophylaxis
Intra-uterine contraception - progestogen only
Menorrhagia
Dosage
The initial release of levonorgestrel from the device is 20 micrograms/24 hours.
Adults
Contraception and treatment of idiopathic menorrhagia
The device will be effective for up to 5 years after which the device may be removed and if the women wishes to continue using the same method immediately replaced with a new system.
Levonorgestrel intrauterine 52mg system may be inserted into the uterine cavity at one of the following times:
Within 7 days of the onset of menstruation.
Immediately after first trimester termination.
Replaced by a new system at any time in the cycle.
Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than six weeks after delivery. If the patient is experiencing significant post-partum bleeding and or pain then infection or other causes should be excluded before insertion.
If pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is still experiencing regular menses. If the system is removed at some other time during the cycle or the women does not experience regular menses and the woman had has intercourse within a week, she is at risk of pregnancy. To ensure continuous contraception a new system should be immediately inserted or an alternative contraceptive method should have been initiated (e.g. condoms) starting at least 7 days before the removal.
Protection from endometrial hyperplasia during oestrogen replacement therapy
There is little clinical data beyond 4 years of use. Therefore, the intrauterine system should be removed after 4 years.
The system may be inserted into the uterine cavity at one of the following times:
Can be inserted at any time in women with amenorrhoea
During the last days of menstruation or withdrawal bleeding.
If patients wish to continue with a intrauterine system after removal, a new system may be inserted at any time.
Additional Dosage Information
For patients taking hormone replacement medication, levonorgestrel intrauterine system may be used in combination with oral or transdermal oestrogen only preparations.
Contraindications
Cervicitis
Postpartum endometritis
Uterine cancer
Within 3 months of infected abortion
Acute haematological malignancy
Acute hepatic disorder
Acute pelvic inflammatory disease
Breast cancer
Cervical cancer
Cervical dysplasia
Congenital abnormality of the uterus
Female genital infection
Hepatic neoplasm
Hormone dependent neoplasm
Leukaemias not in remission
Pregnancy
Recent trophoblastic disorder
Recurrent pelvic inflammatory disease
Severe hepatic disorder
Undiagnosed gynaecological haemorrhage
Uterine fibroids
Precautions and Warnings
Frequent headaches
History of ectopic pregnancy
Predisposition to arterial disease
Severe headache
Tobacco smoking
Advanced uterine atrophy
Congenital heart disease
Diabetes mellitus
Epileptic disorder
Haematological malignancy
History of symptomatic functional ovarian cysts
Hypertension
Jaundice
Leukaemias in remission
Migraine
Scarred uterus
Severe arterial disorder
Thromboembolic disorder
Valvular heart disease
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Exclude endometrial abnormalities before treatment
Exclude oestrogen dependent neoplasm before treatment
Not all available brands are licensed for all indications
Aseptic technique should be used throughout
Exclude perforation in cases of difficult insertion
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
Monitor blood pressure before starting treatment
Abnormal and/or irregular bleeding should be investigated
Examine patient six weeks after insertion
Exclude pregnancy if retrieval threads are not visible at cervix
If pregnancy occurs possibility of ectopic pregnancy should be considered
Menorrhagia - review treatment if no significant improvement after 3-6 mths
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with functional ovarian cysts/delayed follicular atresia
Advise patient to report any abdominal or pelvic pain
Advise patient to report any new or worsening depression/suicidal ideation
Consider ectopic pregnancy if abdominal and menstrual disturbances occur
Discontinue at first signs of jaundice
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if first appearance of migraine or severe or frequent headache
Discontinue if significant rise in blood pressure occurs
Remove if partial expulsion-cervical/uterine perforation-intractable pain
Remove if pelvic inflammatory disease resistant to treatment
Female: Additional contraception required 1 week before mid-cycle removal
Female: Not suitable for use as post-coital contraception
Advise patient to report signs of uterine perforation
The procedure may precipitate fainting as a vasovagal reaction, or a seizure in an epileptic patient. Abandon inserting or removal of the system in the event of early signs of a vasovagal attack. The patient should then be kept supine, the head lowered and the legs elevated to the vertical position if necessary in order to restore cerebral blood flow. Cardio-respiratory facilities should be immediately available. Persistent bradycardia may be controlled with intravenous atropine. Oxygen may be administered, if available.
Symptoms of the partial or complete expulsion of any intrauterine system may include bleeding or pain. However, a system can be expelled from the uterine cavity without the women being aware of this. Partial expulsion may decrease the effectiveness of the system. As the system decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion. A displaced system should be removed and a new system inserted. Advise patient on the symptoms of the partial or complete expulsion of any intrauterine system and the procedure for checking the threads of the system. If the retrieval threads are not visible at the cervix on follow up examination exclude pregnancy. The threads may have been drawn up into the uterus or cervical canal and may reappear during the next menstrual period. If they cannot be found, they may have broken off, or the system may have been expelled, or rarely the device may be extrauterine after having perforated the uterus. Ultrasound or X-ray may be required to locate the system.
Uterine perforation may occur with insertion of an intrauterine device or system. The most important risk factors associated uterine perforation are insertion during breastfeeding and insertion in the 36 weeks after giving birth. The risk of perforation may be increased with a fixed retroverted uterus. Consider partial perforation if severe pain occurs after insertion, even if the threads are visible.
In case of a difficult insertion and/or pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound.
Levonorgestrel intrauterine system should not be used in patients with active or previous severe arterial disease, such as stroke or myocardial infarction in conjunction with an oestrogen for hormone replacement therapy use.
Pregnancy and Lactation
Pregnancy
Levonorgestrel intrauterine system is contraindicated during pregnancy.
Use of levonorgestrel during pregnancy is contraindicated by the manufacturer.
In the event of pregnancy occurring whilst the system is in place, the system must be removed and a termination of the pregnancy considered. Removal of the system or probing of the uterus may result in spontaneous abortion. If removal of the system or termination is not possible, the patient should be informed of the possible risk of spontaneous abortion or premature labour observed during the use of copper and plastic intrauterine devices. If the pregnancy continues, women should be monitored closely and the presence of an ectopic pregnancy should be excluded. Instruct the patient to report all symptoms to suggest complications of the pregnancy, like cramping abdominal pain with fever.
Because of the intrauterine administration and the local exposure to the hormone, teratogenicity (especially virilisation) cannot be completely excluded. It can be expected that the systemic hormone exposure of the foetus through the maternal circulation is lower than with any other hormonal contraceptive method. Clinical experience of the outcomes of pregnancies with the system in situ is limited. However, the woman should be informed that, to date, there is no evidence of birth defects where the pregnancy continues to term with the system in place.
Lactation
Levonorgestrel intrauterine system is considered safe for use in breastfeeding.
The manufacturer states levonorgestrel may be used safely when breastfeeding.
Levonorgestrel is excreted in very small quantities in breast milk, the amount released from the intrauterine system is unlikely to produce any risk to the child. When using a progestogen-only method of contraception starting 6 weeks after childbirth, there appears to be no deleterious effects on the growth or development of breastfed infants. Lactmed (2021) suggests that the risk of progesterone-only contraception are generally acceptable for breastfeeding mothers and that progesterone-only medication may provide protection against bone mineral density loss whilst breastfeeding.
Uterine bleeding has been reported (rarely) in women using levonorgestrel intrauterine system during lactation.
Counselling
Advise patient to report any abdominal or pelvic pain.
Advise patient to report signs of uterine perforation. Symptoms include:
severe pelvic pain after insertion (worse than period cramps);
pain or heavy bleeding after insertion which continues for more a few weeks;
sudden changes in period;
pain during sex;
not being able to feel the threads.
Advise patient to report any new or worsening depression/suicidal ideation.
Side Effects
"Spotting" bleeding
Abdominal distension
Abdominal pain
Acne
Alopecia
Amenorrhoea
Angioedema
Back pain
Breast pain
Breast tenderness
Cervicitis
Chloasma
Delayed follicular atresia
Depressed mood
Depression
Dizziness
Dysmenorrhoea
Dyspareunia
Eczema
Endometritis
Epileptic seizure on insertion
Headache
Hirsutism
Hypersensitivity reactions
Hypertension
Increased risk of ectopic pregnancy
Increased skin pigmentation
Irregular uterine bleeding
Local pain
Menstrual bleeding increased
Menstrual disturbances
Migraine
Mood changes
Nausea
Nervousness
Oedema
Oligomenorrhoea
Ovarian cysts
Pelvic inflammatory disease
Pelvic pain
Presyncope
Prolonged bleeding
Pruritus
Rash
Reduced libido
Sepsis
Syncope
Urticaria
Uterine perforation
Uterine spasm
Vaginal discharge
Vasovagal attack on insertion
Vomiting
Vulvovaginal infections
Weight gain
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: April 2019
Reference Sources
Summary of Product Characteristics: Benilexa One Handed 20 micrograms/24 hours IDS. Gedeon Richter (UK) Ltd. Revised May 2021.
Summary of Product Characteristics: Levosert 20 micrograms/24 hours IDS. Gedeon Richter (UK) Ltd. Revised March 2019.
Summary of Product Characteristics: Mirena. Bayer Plc. Revised February 2019.
MHRA Drug Safety Update June 2015
Available at: https://www.mhra.gov.uk
Last accessed: 27 March 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 December 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Levonorgestrel Implant. Last revised: 16 August 2021
Last accessed: 03 December 2021
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