Levonorgestrel oral 30mcg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing 30 micrograms of levonorgestrel.
Drugs List
Therapeutic Indications
Uses
Oral contraception - progestogen only
Dosage
Adults
Contraception
One tablet daily, starting on the first day of the menstrual cycle, at a time of day chosen by the patient. All subsequent tablets must then be taken at this time. The contraceptive effect is likely to be reduced if a tablet is delayed by more than three hours. Pack follows pack without interruption, and without regard to bleeding.
Additional Dosage Information
Changing from a combined oral contraceptive
Start the first tablet of levonorgestrel 30mcg the day after the last active tablet of the previous contraceptive pack. In the case of an every day (twenty eight day) preparation, start the day after the last active tablet has been taken, discarding the inactive tablets. Additional contraceptive precautions are not required. Withdrawal bleeding should not be expected until the end of the first pack of the new preparation.
Changing from a progestogen-only pill (POP), injection or implant
The switch from one POP to an other can be made at any time. Additional contraceptive precautions are not required.
Alternatively, the new preparation may be started before or when the next implant or injection is due.
Post-partum use
Oral contraception can be initiated up to twenty one days post-partum (no additional contraceptive is required). If started after twenty one days, an additional barrier method of contraception should be used for seven days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of levonorgestrel use or the woman has to wait for her first menstrual period.
After abortion or miscarriage
After a first trimester abortion or miscarriage, oral contraception may be started immediately in which case no additional contraceptive precautions are required. If started after this time, barrier methods of contraception are required for the first seven days of table taking.
Contraindications
Abnormal liver function test
Breast cancer
Diabetes mellitus with vascular involvement
Galactosaemia
Hepatic neoplasm
Hereditary fructose intolerance
History of breast cancer
History of hepatic neoplasm
History of hormone dependent neoplasm
History of severe hepatic disorder
History of thromboembolic disorder
Porphyria
Pregnancy
Severe hepatic impairment
Thromboembolic disorder
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of venous thromboembolism
Females over 35 years
History of ectopic pregnancy
Obesity
Prolonged immobilisation
Recent major surgery
Tobacco smoking
Breastfeeding
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cholestatic jaundice during pregnancy
History of pruritus during pregnancy
History of venous thromboembolism
Hypertension
Lactose intolerance
Migraine
Recurrent cholestatic jaundice
Assess family medical history prior to commencing treatment
Contains lactose
Preparation contains sucrose
Resume use only after 2wks full ambulation from surgery/immobilisation
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
Monitor blood pressure pre-treatment and periodically thereafter
If intra-abdominal haemorrhage consider liver tumour
If upper abdominal complaints/liver enlargement consider liver tumour
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients with existing or tendency towards diabetes mellitus
Avoid immobilisation-treatment may cause increased risk of thromboembolism
Increased risk of venous thromboembolism
May induce or enhance hepatic tumour development
May affect results of some laboratory tests
Discontinue 6 weeks before major surgery or prolonged immobilisation
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of jaundice, hepatitis or whole body itching
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if conditions likely to deteriorate in pregnancy worsen
Discontinue if differential diagnosis indicates liver tumour
Discontinue if sudden occurrence of visual/hearing/perceptual disorders
Discontinue-first occurrence/worsening migraine/severe or frequent headache
Advise patient concurrent St John's wort may reduce contraceptive effect
All contraceptive pills slightly increase the risk of breast cancer
Changes in menstrual bleeding patterns should be expected
Treatment does not protect against risk of sexually transmitted disease
Women with a history of chloasma should avoid exposure to sun/UV light
Patients should be individually assessed before oral contraceptives and at regular intervals thereafter. Assessment should include personal and family history which should then guide physical examination. Parameters to be measured should include blood pressure, weight and body mass index (BMI) and if judged appropriate by the clinician, breast, abdominal examination, pelvic examination and cervical cytology. Specific attention should be given to conditions associated with increased risk of adverse events including migraine and cardiovascular risk factors such as obesity, smoking, hypertension, thrombophilia, hyperlipidaemia and previous venous thromboembolism.
In the few epidemiological studies that have been carried out, there is little evidence to support an association between progestogen only pills and an increased risk of myocardial infarction or cerebral thromboembolism. In women with hypertension, progesterone-only pills may slightly increase the risk of stroke. There may be a small, but not statistically significant, increased risk of venous thromboembolism associated with the use of progesterone-only pills.
There is a small risk of developing breast cancer in women treated with progestogen-only contraceptives. The most important risk factor appears to be the age at which the contraceptive is stopped rather than the duration of use. The risk disappears gradually in the 10 years after stopping and there is no excess risk after 10 years. A possible small increase in the risk of breast cancer should be weighed against the benefits. Women should be advised of this increased risk before oral contraception is started.
If there is a history of ectopic pregnancy or one Fallopian tube is missing, the use of levonorgestrel should be decided only after carefully weighing the benefits against the risks.
Levonorgestrel has been associated with the occurrence of persistent ovarian follicles, most of which are asymptomatic. Some may, however, be accompanied by pelvic pain or dyspareunia. Usually, the enlarged follicles disappear spontaneously within two to three months of observation.
If no menstrual bleeding has occurred within 6 weeks after the last menstrual bleeding, pregnancy should be excluded before further tablets are taken. If pregnancy has been excluded and the amenorrhoea lasts longer than 3 months or recurs repeatedly, levonorgestrel should be withheld until normal menstrual bleeding has resumed.
Irregular bleeding is not a medical reason to stop the tablets, as long as organic causes for bleeding and pregnancy can be ruled out, provided it is ensured that the patient is fully compliant. It is not recommended to attempt to influence cycle disturbances with the concomitant administration of an oestrogen. This is because the oestrogen will reverse the changes made to the cervical mucus brought about by levonorgestrel, and thus reduce the contraceptive effect.
Pregnancy and Lactation
Pregnancy
Levonorgestrel is contraindicated during pregnancy.
Pregnancy must be excluded before starting treatment and the preparation should be withdrawn immediately if pregnancy occurs while taking oral contraception.
The low dose progesterone-only oral contraceptives are fairly well studied due to their frequent (accidental) use in pregnancies. They pose no substantial risk for genital or extra-genital malformations according to the current available knowledge (Schaefer, 2015).
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use levonorgestrel with caution during breastfeeding.
Progestogen-only pills are considered the second contraceptive of choice, after non-hormonal methods. Progestogen-only pills can be used during breastfeeding as there is little evidence to suggest that progestogen-only pills have a negative effect on breast milk, infant growth or infant development.
Schaefer (2015) suggests that gestagens, such as levonorgestrel, have minimal effect on the milk supply or the milk composition. LactMed indicates that progesterone-only pills may offer some protection against loss of bone mineral density during lactation, or at least they do not exacerbate it.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Counselling
Advise patients to take the tablets at the same time each day (preferably in the evening).
Missed pills (within 3 hours of correct administration time)
Take one tablet as soon as possible. Consequent tablets should be taken at the correct administration time.
Missed pills (more than 3 hours after correct administration time)
Take one tablet as soon as possible. Consequent tablets should be taken at the correct administration time. Additional methods of contraception should be used (barrier methods) for 7 days after the missed tablet was taken.
During gastrointestinal upsets
Vomiting or diarrhoea may reduce the effectiveness of the tablets by preventing them form being fully absorbed. If vomiting occurs within 2 hours of taking a tablet, another tablet should be taken as soon as possible. If this replacement pill is not taken within 3 hours of the normal time, additional barrier contraceptive methods should be used for 7 days. In patients experiencing persistent vomiting and/or severe diarrhoea, additional barrier contraceptive methods should be used during the illness and for 7 days after recovery.
Advise patients that taking St Johns Wort may reduce contraceptive efficacy.
Advise patient to seek advice at first signs of pregnancy.
When additional contraceptive precautions are required, advise patients either not to have sex or to use a cap plus spermicide, or for her partner to use a condom. Rhythm methods are not advisable as the pill disrupts the usual cyclical changes associated with the natural menstrual cycle.
Side Effects
Allergic reaction
Amenorrhoea
Changes in libido
Chloasma
Depressed mood
Dizziness
Headache
Hepatic tumours
Increased risk of breast cancer
Irregular menstruation
Ischaemic stroke
Life-threatening intra-abdominal haemorrhage
Menstrual disturbances
Migraine
Nausea
Pelvic pain
Stroke
Thromboembolic disorders
Transient ischaemic attack
Vomiting
Weight changes
Effects on Laboratory Tests
Oral contraceptives may influence the results of certain laboratory tests including:
Biochemical parameters of thyroid, hepatic, adrenal and renal function;
Plasma levels of carrier proteins and lipid/lipoprotein fractions;
Parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Changes generally remain within the normal laboratory range.
Laboratory technicians should be made aware of patients who are receiving oral contraception, so that any effects on the above tests can be taken into consideration.
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: May 2017
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Norgeston. Bayer plc. Revised August 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 September 2017
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. Last revised: 11 April 2017
Last accessed: 18 April 2017
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