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MYSTEP is a brand name for Levonorgestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MyStep (Levonorgestrel 1.5 mg Tablet) is an emergency contraceptive that can prevent pregnancy and is intended to be used within 72 hours (three days) following known or suspected contraceptive failure or unprotected intercourse such as: • when no contraceptive has been used • when a contraceptive method may have…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations MyStep can be administered at any time during the menstrual cycle. 2 Recommended Dose and Dosage Adjustment One tablet of MyStep should be taken orally as soon as possible but within 72 hours after unprotected intercourse.
5 mg levonorgestrel. The patient should be instructed to contact her health care professional if she vomits in the first two hours after taking the dose of medication. An additional dose may be administered, based on the judgment of the health care professional.
In clinical studies, of the 55 women who vomited as a result of taking levonorgestrel tablets, 40 took a replacement dose. Statistical analysis showed that the replacement dose did not increase efficacy significantly. 6 hours. If vomiting occurs, for other reasons (such as the flu), or if the pills are visible in the emesis, a replacement dose may be warranted.
, diaphragm or condom) until the next menstrual cycle. Most patients will have their next menstrual period at the expected time or within a week of the expected time. If a normal period is delayed beyond 1 week, the patient’s pregnancy status should be confirmed with a pregnancy test and follow-up with a health professional.
Health Canada has not authorized an indication for pediatric use. 4 Administration One tablet of MyStep should be taken orally. 5 Missed Dose The patient should be instructed to contact her health care professional if she vomits in the first two hours after taking the dose of medication.
An additional dose may be administered, based on the judgment of the health care professional.
1 Adverse Reaction Overview There are in general no serious adverse drug reactions to report following the use of levonorgestrel, either in clinical trials or post-market surveillance. Most commonly observed adverse drug reactions are presented in the following sections.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be MyStep (Levonorgestrel Tablets) Page 10 of 35 compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 75 mg at a 12-hour interval included: • Nausea: 23% • Abdominal pain: 18% • Fatigue: 17% • Headache: 17% • Vomiting: 6% Intermenstrual bleeding and altered menstrual cycles: Some women may experience spotting a few days after taking levonorgestrel.
The majority of women (58%) will have their next menstrual period at about the expected time or a few days early or late; if there is a delay in the onset of menses of more than one week, the possibility of pregnancy should be excluded.
Women who take levonorgestrel frequently are likely to experience disruptions of the menstrual cycle. Other: breast tenderness, dizziness and diarrhea have been reported in women using levonorgestrel and may be drug related. 01) less for women using levonorgestrel than for women receiving the Yuzpe regimen.
Adverse events reported in the other controlled clinical trial of the levonorgestrel regimen by Ho and Kwan were consistent with those in the Pivotal Study (#92908) (Table 2). 001 In the combined controlled clinical trials, the proportion of women receiving levonorgestrel who reported nausea was less than half of the proportion in the Yuzpe group (Table 3).
See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General • MyStep is not an abortifacient and should not be taken by pregnant women, as it will not be effective. • Patients should be advised that MyStep provides no protection against HIV infection (AIDS) and other sexually transmitted diseases, such as syphilis, gonorrhea, chlamydia, and herpes.
, thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, retinal thrombosis), hepatic neoplasia and gallbladder disease. These conditions have not been associated with the routine use of progestin-only oral contraceptives, but whether short-term (single dose) use of high-dose progestin-only contraceptives would accentuate the risk is unknown.
MyStep does not contain estrogen. Controlled clinical trials using levonorgestrel and post-market experience with levonorgestrel for post coital and emergency contraception have not so far identified any serious adverse events. MyStep is not recommended for routine use as a contraceptive.
5 mg tablet) is calculated for a single use. If MyStep is used on more than one occasion, the cumulative pregnancy rate will be higher.
Migraine and Headache:
During the use of MyStep, the onset or exacerbation of migraine or the development of a new pattern that is recurrent, persistent, or severe requires evaluation of the cause and may require re-evaluation of a future use of emergency contraceptive pills.
4 Drug-Drug Interactions). MyStep (Levonorgestrel Tablets) Page 8 of 35 Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY.
Cardiovascular Hypertension:
Patients with essential hypertension whose blood pressure is well controlled may be given combined oral contraceptives containing estrogen and progestin, but only under close supervision. Progestin-only oral contraceptives are not contraindicated for such patients.
• Levonorgestrel is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see section 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.
• Women with known or suspected pregnancy. The method is not to be used by a woman who is pregnant due to a previous act of intercourse, especially if there is recent abnormal bleeding, a pregnancy test should be performed before taking MyStep.
• Patients with undiagnosed abnormal vaginal bleeding, a pregnancy test should be performed before taking MyStep. Progestin-only oral contraceptives are used as a routine method of birth control over longer periods of time and are contraindicated in some conditions (acute liver disease or history of or actual benign or malignant liver tumours, known or suspected carcinoma of the breast, and undiagnosed abnormal vaginal bleeding).
It is not known whether these same conditions apply to the MyStep regimen consisting of the emergency use of one progestin pill, but these risks should be considered if MyStep needs to be administered several times.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The proportion that reported vomiting in the levonorgestrel group was only one-fourth that in the Yuzpe group. 001 The OTC Label Comprehension Study was conducted to evaluate whether levonorgestrel can be used safely and effectively without oversight by a licensed medical practitioner.
A total of 540 women used the study product. No serious adverse events were reported. The findings of the study, compared to those of the Pivotal study, indicate that the pattern of adverse events does not change when the product is provided in a non-prescription setting (Table 4).
75 mg at a 12-hour interval (study 97902). A total of 2,756 women used the study product. There was no statistically significant difference in the incidence of the adverse events between the two levonorgestrel groups (Table 5). 5) * The denominator for “Delay of menses more than 7 days” is 1359 and 1353, compared […]
Endocrine and Metabolism Diabetes:
The effects of levonorgestrel on carbohydrate metabolism are unknown. Some users of progestin-only oral contraceptives experience slight deterioration in glucose tolerance, with increases in plasma insulin; however, women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements.
Nevertheless, diabetic women should be monitored while taking MyStep.
Body weight:
Limited and inconclusive data suggest that there may be reduced efficacy of levonorgestrel with increasing body weight or body mass index (BMI). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the women’s body weight or BMI.
75 mg, levonorgestrel does not appear to be significantly metabolized by the liver. The risks of levonorgestrel to women with a history of liver disease are unknown. Women with a history of liver disease should be given MyStep under medical supervision especially if the method needs to be administered more than once.
Reproductive Health:
Female Potential Effects on Menses: Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking MyStep.
At the time of expected menses, approximately 77% of women using levonorgestrel had vaginal bleeding similar to their normal menses, 11-12% bled more than usual, and 11% bled less than usual. 5% had a delay of more than 7 days beyond the anticipated onset of menses.
If there is a delay in the onset of menses beyond 1 week, the possibility of pregnancy should be considered. 7 per 1000 reported pregnancies). Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only oral contraceptives are ectopic.
However, there appears to be no increase in the rate of ectopic pregnancy after use of levonorgestrel for emergency contraception. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraceptive method.
However, physicians should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking MyStep.
MyStep (Levonorgestrel Tablets) Page 9 of 35 Suspected Pregnancy:
A pregnancy test is warranted if pregnancy is suspected. Women should be counselled to abstain from sexual intercourse or use an alternative contraceptive method until the onset of their next normal menstrual period. If a normal menstrual period is delayed beyond 1 week, the patient’s pregnancy status should be confirmed with a pregnancy test and follow-up with a health professional.
Counselling on routine contraception for future use should be provided as appropriate. 1 Pregnant Women MyStep is not an abortifacient and should not be taken by pregnant women, as it will not be effective. Studies involving women who have taken combined oral contraceptives containing levonorgestrel inadvertently during early pregnancy do not suggest that these drugs have an adverse effect on the fetus and there is no evidence that levonorgestrel taken as an emergency contraceptive would have an adverse effect on an established pregnancy.
However, there are insufficient data to rule out the possibility of adverse effects on the fetus if […]