Ella is an emergency contraception. The main component – levonorgestrel – aims at preventing unwanted pregnancy in case of unprotected sexual intercourse.
Indications for use
Mechanism of action
Ulipristal acetate (Ella) is a synthetic selective modulator of progesterone receptors. The mechanism of action of is the ovulation inhibition and its delay. Ulipristal acetate allows delaying the rupture of the follicle in women in the case of taking the drug immediately before presumed ovulation. Ulipristal acetate has high affine properties for progesterone and glucocorticosteroid receptors, low affine properties for androgen receptors and has no affinity for estrogen or mineralocorticoid receptors.
Mode of application and dosage
1 tablet should be taken as soon as possible after unprotected sexual intercourse, but no later than 120 hours. Food intake has no influence on the drug effect.
If within 3 hours after taking the drug, vomiting occurs, you should take a second pill.
This preparation can be taken any day of the menstrual cycle. Before taking the drug, pregnancy should be excluded.
Renal and hepatic insufficiency: special recommendations regarding Ella dose in patients with renal and hepatic insufficiency do not exist. Unfortunately, in-depth studies have been carried out.
Severe hepatic insufficiency: to apply this drug for severe hepatic insufficiency is not recommended. The detailed studies have been made.
Ella is not dangerous under any known circumstances. It doesn’t bring a threat to women with any health problems. In particular, the following circumstances are NOT contraindications to the application of emergency contraception:
- young age;
- personal or family history of venous thromboembolism;
- history of or present breast cancer;
- previous ectopic pregnancy;
- a migraine;
- cardiovascular disease;
- liver disease;
Ella is not prescribed for women with a pregnancy that has already occurred, as in such cases these pills are not effective. However, if a pregnancy test is not performed or if it is clear whether there is pregnancy or not, then this emergency contraception drug can be used because there is no evidence indicating harm to the developing fetus.
Ella is extremely safe. There was not a single case of a causal relationship between the use and serious complications or fatalities. Below there is a description of the side effects, which are not common but may be of concern to some women.
Irregular vaginal bleeding
In most women, the next menstrual cycle occurs within 7 days before or after the usual period. Reportedly, when using Ella, menstruation occurs on average one day ahead of the expected time. About 24% of women who took part in clinical trials were reported a delay at the beginning of the cycle for more than 7 days. Some women experience irregular bleeding or bleeding after taking an emergency contraceptive drug. The percentage of women experiencing these side effects varies from trial to trial. Irregular bleedings are not dangerous and stop without any treatment.
Nausea and vomiting
Nausea, occasionally accompanied by vomiting, occurs in less than 20% of women who adhere to the above method of using levonorgestrel, and almost 12% of women using ulipristal acetate.
Since these symptoms are rare, it is usually not possible to take an anti-emetic drug before using these hormonal agents. In the case of vomiting for 2 or 3 hours after taking a dose, some experts recommend the repeated intake of the same dose.
Other symptoms that can occur in women taking Ella include a headache, abdominal pain, mammary sensitivity, dizziness and fatigue. These side effects usually last no more than a few days; as a rule, they pass within 24 hours.
- CYP3A4 inducers (for example, rifampicin, phenytoin, phenobarbital, carbamazepine, St. John’s wort / Hypericum perforatum, can reduce the contraception concentration.
- CYP3A4 inhibitor of ritonavir can also induce CYP3A4 provided it is used for a long time. In this case, ritonavir can reduce the ulipristal concentration
- CYP3A4 inducers can have an influence on ulipristal concentration in the blood plasma.
- Potent inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone) can improve the contraceptive effect.
- Simultaneous intake of drugs that provoke the pH of gastric juice (for example, proton pump inhibitors, antacids and H2 receptor antagonists) decreases the concentration of ulipristal in the blood plasma.
Ella and pregnancy
Studies of women who became pregnant despite taking ulipristal, or who used it accidentally after pregnancy, show that this hormonal drug does not bring harm either the pregnant woman or the fetus. In particular, it does not increase the probability of miscarriage, low birth weight, fetus congenital malformations, or complications of pregnancy.