ETHINYLESTRADIOL/LEVONORGESTREL oral

Last updated: October 2021

Prescription under medical supervision


Therapeutic action

– Combined hormonal contraceptive, oestrogen-progestogen

Indications

– Oral contraception
– Abnormal uterine bleeding (especially functional uterine bleeding unrelated to pregnancy) 

Forms and strengths

– 28-day pack: 21 active tablets of 0.03 mg (30 micrograms) ethinylestradiol + 0.15 mg (150 micrograms) levonorgestrel and 7 inactive tablets (ferrous salts)

Dosage and duration

– Oral contraception 
Adolescent and adult: one tablet daily, to be taken preferably at the same time each day, on a continuous basis, including during menstruation.
Explain to the woman which are the active and inactive tablets. Careful not to start with inactive tablets. 
Contraception may be started at any moment of the cycle if it is reasonably certain the woman is not pregnant, including when switching from another form of contraception. Contraception will be effective as of the 8th tablet. 
Use condoms for the first 7 days of the pack if the tablets are started:
• more than 5 days after the start of menstruation; 
• more than 28 days postpartum if not breastfeeding; 
• more than 7 days after an abortion.
– Continue treatment as long as this method of contraception is desired and well tolerated.
– If one or two active tablets are missed, take one tablet as soon as possible and then continue treatment as usual. 2 tablets can be taken at the same time: the missed tablet and the daily tablet.
– If 3 or more successive active tablets are missed, contraceptive effectiveness is compromised. Take one tablet as soon as possible, then continue treatment as usual and use condoms for the next 7 days. 
• if the tablets are missed during the 1st week of a pack (1st to 7th tablet) or if the woman has had intercourse in the 5 days before forgetting the tablets, use emergency contraception.
• if the tablets are missed during the 3rd week of the pack (15th to 21st tablet), finish all the active tablets and start a new pack the next day, without taking the inactive tablets. If it is not possible to start a new pack immediately, use condoms for the next 7 days.

– Persistent abnormal uterine bleeding despite tranexamic acid therapy or heavy bleeding when tranexamic acid is contra-indicated
Adolescent and adult: one tablet 3 times daily for 7 days

Long-term treatment of functional uterine bleeding
Adolescent and adult: one tablet daily (as for contraception). Continue treatment according to clinical response.

Contra-indications, adverse effects, precautions

– Do not administer to women with breast cancer, hypertension, uncontrolled or complicated diabetes, history of thromboembolic disorders, coronary insufficiency, valvular disease, stroke, severe or recent hepatic disease, migraine with neurological signs, renal impairment, hyperlipidaemia, to women smokers over age 35.
– May cause: reduced menstrual flow, nausea, weight gain, breast tenderness, mood changes, acne and headache. Other rare and severe adverse effects require discontinuation of treatment: hypertension, cardiovascular and thromboembolic disorders, jaundice, migraine, visual disturbances.
– Enzyme-inducing drugs (rifampicin, rifabutine, efavirenz, nevirapine, lopinavir, ritonavir, phenobarbital, phenytoin, carbamazepine, griseofulvin, etc.) reduce the effectiveness of the contraceptive.
– Clinical examinations must be carried out before (blood pressure, breasts) and during treatment (blood pressure).
PregnancyCONTRA-INDICATED
Breast-feeding: CONTRA-INDICATED before 6 weeks postpartum; not recommended between 6 weeks and 6 months (except if it is the only available or acceptable contraceptive method); no contra-indication after 6 months.

Remarks

– Oestrogen-progestogens are easier to take that progestogen-only tablets in that they do not requiring taking the tablet at an exact time of day. Taking ethinylestradiol/levonorgestrel at the same time every day helps avoid forgetting tablets.
– Also comes in packs with 21 active tablets of ethinylestradiol/levonorgestrel that require 7 days of interruption between two packs. 28-day packs help improve compliance.

Storage: below 25 °C -