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Steronate Dosage |
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Effectiveness of
Oral Contraceptive: When used perfectly, without missing any pills, the chance of becoming pregnant is 0.5% (5 pregnancies per 1000 women per year of use). Typical failure rates are actually 5% in the 1st year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.
Dosage: To achieve the maximum contraceptive effectiveness Steronate tablets must be taken at exactly the same time each day. One tablet is taken without interruption for 28 days. After 28 tablets have been taken, a tablet from a new package is then taken the next day.
For the initial cycle of therapy, treatment should commence from day 1 up to and including day 5 of the menstrual cycle: One tablet daily with water at the same time of the day for 28 days. If this procedure is correctly followed, Steronate provides protection against pregnancy starting from the 1st day of intake.
Missed Dose(s): If 1 tablet has been missed or there is a delay of >3 hrs in taking the tablet, the missed tablet should be taken as soon as it is remembered. The next tablet should be taken at the usual time, even if that means taking 2 tablets in 1 day. Whenever a progestin-only oral contraceptive tablet is taken ≥3 hrs late, a reliable supplementary non-hormonal contraceptive method should be used for the next 48 hrs.
Switching from Another
Oral Contraceptive: For a switch-over from a combination oral contraceptive (COC), treatment with Steronate should begin on the 1st day following the last active tablet from the previous combination oral contraceptive cycle. For a switch-over from another brand of POPs, Steronate can be started at any time, but no later than 24 hrs after the last active tablet.
Use After Childbirth: Women who elect not to breastfeed may start progestin-only oral contraceptive therapy immediately after childbirth. Women who are breastfeeding should start Steronate 6 weeks after delivery. However, in non-fully breastfeeding women (women who are supplementing with some formula or food) fertility may return as soon as 4 weeks postpartum, therefore, the possibility of pregnancy must be considered when Steronate is started after 4 weeks postpartum.
Use After Abortion or Miscarriage: After an abortion or miscarriage progestin-only oral contraceptives can be started as soon as the next day. Since fertility can return as early as 10 days post-abortion or miscarriage, the possibility of pregnancy must be considered when starting Steronate later than 10 days following an abortion or miscarriage.
Breakthrough Bleeding or Spotting: In the event of breakthrough bleeding or spotting, treatment should be continued. Breakthrough bleeding is common among women using progestin-only oral contraceptives. If breakthrough bleeding persists or is accompanied by abdominal pain, additional medical evaluation should be considered.
In Case of Vomiting and Diarrhea: If vomiting occurs within 2 hrs of pill intake or if severe diarrhea lasting for >24 hrs occurs, the effectiveness of the contraception may be diminished. Patients should continue taking the pills on schedule if possible. An additional non-hormonal method of contraception during the time of illness and for an additional 48 hrs following the illness should be used.
Special Populations: Children (≤16 years): Safety and efficacy of Steronate tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <16 years and for users ≥16 years. Use of Steronate before menarche is not indicated.
Elderly: Use of Steronate is not indicated in post-menopausal women.
Administration: For oral administration.
If a woman on Steronate takes a drug or herbal product that induces an enzyme(s) that metabolizes Steronate, particularly CYP3A4, the patient should be counseled to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of Steronate and may decrease the effectiveness of Steronate or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: Some anti-epileptics (eg, carbamazepine, phenytoin), (fos)aprepitant, barbiturates, bosentan, griseofulvin, some (combinations of) HIV protease inhibitors (eg, nelfinavir, some ritonavir-boosted protease inhibitors), some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), rifampin and rifabutin, St. John's Wort.
In vitro studies suggest that activated charcoal binds to Steronate, however the therapeutic effect of Steronate is not affected when activated charcoal is administered 3 hrs after the previous dose or 12 hrs before the next dose.
Physicians are advised to consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations and the possible need to adjust dosages.
Laboratory Tests: Certain endocrine and liver function tests and blood components may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin concentrations may be decreased; thyroxine concentrations may be decreased, due to a decrease in thyroxine binding globulin. Incompatibilities:
Users | % | ||
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Twice in a day | 11 | 68.8% | |
Once in a day | 3 | 18.8% | |
3 times in a day | 2 | 12.5% |
Users | % | ||
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1-5mg | 15 | 93.8% | |
11-50mg | 1 | 6.2% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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