NORLEVO ® - Levonorgestrel

NORLEVO ® 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 NORLEVO ® - The morning-after pill

NORLEVO ® is a post-coital emergency hormonal contraceptive, to be used within 72 two hours of unprotected sexual intercourse or following ineffective contraception.

Mechanism of action NORLEVO ® - Morning-after pill

NORLEVO ® is a post-coital contraceptive, used as an emergency contraceptive system, in case of unprotected sexual intercourse or ineffective contraceptive methods.

Although the precise mechanism of action is still not entirely clear, the intake of levonorgestrel at high doses seems to be:

Inhibit ovulation, thus being effective in the relationships that occurred in the pre-ovulatory period;
Induce histological changes of the endometrium, such as to prevent and make the embryo nesting more difficult.

In light of what has been said, it is easy to understand how this drug is practically ineffective following the embryo nesting, therefore having to provide for the timely recruitment following the unprotected relationship, to safeguard the contraceptive efficacy estimated at around 85%.

Studies carried out and clinical efficacy

1. POST-COITAL CONTRACEPTION

A study that demonstrates how the use of post-coital contraceptives represents the least invasive method, although potentially at risk given the efficacy of 85%, in avoiding unwanted pregnancies following unprotected sex.

2. EDUCATION IN CONTRACEPTION

Work that focuses its attention on the importance of broad-spectrum educational tools in the prevention of unwanted pregnancies. More precisely, the web currently appears to be the most effective tool in the mass dissemination of useful information to increase preventive effectiveness.

3. THE DIFFERENT EFFECTIVENESS OF POST-COITAL CONTRACEPTION

Study that evaluates the effectiveness of post-coital contraception when performed before or after the ovulatory period. These works may partly contribute to the definition of the mechanism of action of this drug.

Method of use and dosage

NORLEVO ® 1.5 mg tablet of levonorgestrel;

the NORLEVO ® tablet should preferably be taken within 12 hours of unprotected sexual intercourse to ensure maximum contraceptive efficacy.

Although this efficacy seems to gradually decrease over time, it is still present within 72 of the report.

If vomiting occurs, a new tablet should be taken immediately.

Warnings NORLEVO ® - The morning-after pill

Post-coital contraception must be considered as an emergency contraceptive method, to be used in case of ineffectiveness of the long-term contraceptive system.

The reduced effectiveness of the morning-after pill and the deleterious effects on the menstrual cycle guide the doctor and patients towards long-term contraception.

If NORLEVO ® is used, timely medical consultation is essential to assess the prescriptive appropriateness and the possible presence of conditions incompatible with this contraceptive method, while safeguarding its effectiveness.

NORLEVO ® 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

NORLEVO ® is contraindicated in pregnancy, given the potential side effects of high progestogen concentrations on the fetus.

Levonorgestrel's ability to permeate the breast filter and concentrate in breast milk also extends this contraindication to the subsequent breastfeeding period.

Interactions

Inducers of cytochromial enzymes, enzyme class involved in the hepatic metabolism of levonorgestrel, such as primidone, phenytoin, barbiturates, carbamazepine, (used to treat epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracyclines, griseofulvin (antibiotics used to treat infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), could reduce blood concentrations of the aforementioned hormone, lowering the contraceptive efficacy of NORLEVO ®

Disorders such as Crohn's disease could further reduce the contraceptive efficacy of levonorgestrel.

Contraindications NORLEVO ® - The morning-after pill

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

Undesirable effects - Side effects

The high dosage of the progestogen present in NORLEVO ® exposes the patient to numerous side effects, fortunately readily reversible, such as dizziness, headache, nausea, abdominal pains and alterations of the menstrual cycle.

In most cases, the aforementioned effects disappear spontaneously after about 48 hours .