LEVONELLE ® - Levonorgestrel

LEVONELLE ® is a levonorgestrel based drug

THERAPEUTIC GROUP: Systemic hormonal contraceptives - Progestins

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions LEVONELLE ® - The morning-after pill

LEVONELLE ® is an emergency hormonal contraceptive, to be used within 72 two hours of unprotected sexual intercourse or following ineffective contraception.

Mechanism of action LEVONELLE ® - Morning-after pill

LEVONELLE ® commonly known also as the "morning-after pill", is a drug based on levonorgestrel, a progestogen used for hormonal contraception.

Unlike the classic systemic hormonal contraceptives, which are taken according to well-defined dosage regimens, LEVONELLE ® is used within 72 hours of unprotected sexual intercourse in order to prevent pregnancy.

Its contraceptive efficacy, estimated by recent studies at around 85%, seems to be correlated to the inhibition of ovulation, effective for relationships realized in the pre-ovulatory period, and to sensitive histological variations induced on the endometrium, such as to prevent the nesting and growth of the embryo.

The high concentrations of levonorgestrel used in the contraception of the next day, are metabolized to the hepatic level and eliminated in equal parts through feces and urine after a half-life of about 26 hours.

Studies carried out and clinical efficacy

1. POST-COITAL CONTRACCEPTION AND ECTOPIC GRAVIDANCES

Case report which demonstrates how post-coital contraception based on progestogens such as levonorgestrel can increase the risk of ectopic pregnancies.

2. POST-COITAL CONTRACEPTION IN HOSPITAL PRACTICE

Study that evaluates the methods of prescribing post-coital contraception in various European countries. The need for proper training for hospital staff certainly represents the inevitable step for successful contraception that minimizes side effects while increasing contraceptive efficacy.

3. POST-INSTITUTIONAL CONTRACTION / PREGNANCY INTERRUPTION

Work with an ethical background, which assesses the impact of post-coital contraception with respect to abortion on the psycho-physical health of women.

Method of use and dosage

LEVONELLE ® 2 levonorgestrel 750 mcg tablets;

the contraceptive action of LEVONELLE ® is guaranteed by the simultaneous intake of both tablets preferably within 12 hours of sexual intercourse up to a maximum of 72 hours.

This method of contraception must clearly be quickly preceded by a medical consultation and the related prescription.

If vomiting occurs, it should be repeated immediately.

Warnings LEVONELLE ® - Morning-after pill

The morning-after pill must be considered exclusively as an emergency contraceptive method, not replacing absolutely the conventional long-term ones

The success of contraception, estimated at around 85%, tends to decrease with the increase in the time interval for recruitment from the unprotected relationship.

The reduced contraceptive effect and the variations in the menstrual cycle therefore suggest to use long-term, safer and better tolerated contraceptive methods.

LEVONELLE ® contains lactose, so its intake could be related to adverse reactions concentrated at the level of the gastro-intestinal tract, in women suffering from lactose intolerance, poor glucose-galactose absorption and lactase enzyme deficiency.

PREGNANCY AND BREASTFEEDING

The intake of LEVONELLE ® is contraindicated during pregnancy, given the possible adverse reactions of the fetus, but not yet documented in detail by significant clinical trials.

Levonorgestrel is secreted into breast milk, so its intake should also be contraindicated during breastfeeding.

Interactions

The concomitant intake of active ingredients such as primidone, phenytoin, barbiturates, carbamazepine, (used for the treatment of epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracyclines, griseofulvin ( antibiotics used for the treatment of infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), could lead to an induction of the cytochrome enzyme activity with an increase in the hepatic metabolism of levonorgestrel and a reduction in contraceptive power .

Disease-absorbing conditions such as Crohn's disease could further reduce the contraceptive efficacy of the drug.

Contraindications LEVONELLE ® - The morning-after pill

LEVONELLE ® is contraindicated in case of hypersensitivity to the active ingredient or one of its excipients.

Undesirable effects - Side effects

Despite the "acute" intake of levonorgestrel, the administration of LEVONELLE ® has been associated with some side effects, clinically insignificant and transient, such as nausea, vomiting, spotting hemorrhagic dizziness and fatigue.

Taking high doses of progestins could result in a change in the normal menstrual cycle.