Source: FDA, National Drug Code (US) Revision Year: 2017
LOESTRIN 21 and LOESTRIN Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Table I. Lowest Expected and Typical Failure Rates During the First Year of Continuous Use of a Method:
| % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use | ||
|---|---|---|
| Method | Lowest Expected* | Typical† |
| (No contraception) | (85) | (85) |
| Oral contraceptives combined progestin only | 0.1 0.5 | 3 N/A‡ N/A‡ |
| Diaphragm with spermicidal cream or jelly | 6 | 20 |
| Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) | 6 | 26 |
| Vaginal Sponge nulliparous parous | 9 20 | 20 40 |
| Implant | 0.05 | 0.05 |
| Injection: depot medroxyprogesterone acetate | 0.3 | 0.3 |
| IUD progesterone T copper T 380A LNg 20 | 1.5 0.6 0.1 | 2 0.8 0.1 |
| Condom without spermicides female male | 5 3 | 21 14 |
| Cervical Cap with spermicidal cream or jelly nulliparous parous | 9 26 | 20 40 |
| Periodic abstinence (all methods) | 1 to 9 | 25 |
| Withdrawal | 4 | 19 |
| Female sterilization | 0.5 | 0.5 |
| Male sterilization | 0.10 | 0.15 |
Adapted from RA Hatcher et al, Reference 7.
* The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
† This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
‡ N/A--Data not available.
The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets.
Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different days of the week stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days.
Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen.
The possibility of ovulation and conception prior to initiation of use should be considered.
To achieve maximum contraceptive effectiveness, LOESTRIN 21 must be taken exactly as directed and at intervals not exceeding 24 hours. LOESTRIN 21 provides the patient with a convenient tablet schedule of “3 weeks on 1 week off”. Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day-1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets.
Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.
Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after discontinuing medication. If spotting occurs while on the usual regimen of one tablet daily, the patient should continue medication without interruption.
If the patient forgets to take one or more tablets, the following is suggested:
One tablet is missed
Two consecutive tablets are missed (week 1 or week 2)
Two consecutive tablets are missed (week 3)
Sunday-Start Regimen:
Day-1 Start Regimen:
Three (or more) consecutive tablets are missed
Sunday-Start Regimen:
Day-1 Start Regimen:
The possibility of ovulation occurring increases with each successive day that scheduled tablets are missed. While there is little likelihood of ovulation occurring if only one tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive tablets are missed.
In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day 1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.
To achieve maximum contraceptive effectiveness, LOESTRIN Fe should be taken exactly as directed and at intervals not exceeding 24 hours.
LOESTRIN Fe provides a continuous administration regimen consisting of 21 light yellow or pink tablets of LOESTRIN and 7 brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no "off-tablet days."
Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule.
Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while the patient is taking light yellow or pink tablets, continue medication without interruption.
If the patient forgets to take one or more light yellow or pink tablets, the following is suggested:
One tablet is missed
Two consecutive tablets are missed (week 1 or week 2)
Two consecutive tablets are missed (week 3)
Sunday-Start Regimen:
Day-1 Start Regimen:
Three (or more) consecutive tablets are missed
Sunday-Start Regimen:
Day-1 Start Regimen:
The possibility of ovulation occurring increases with each successive day that scheduled light yellow or pink tablets are missed. While there is little likelihood of ovulation occurring if only one light yellow or pink tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive light yellow or pink tablets are missed.
If the patient forgets to take any of the seven brown tablets in week four, those brown tablets that were missed are discarded and one brown tablet is taken each day until the pack is empty. A back-up birth control method is not required during this time. A new pack of tablets should be started no later than the eighth day after the last light yellow or pink tablet was taken.
In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new tablet dispenser on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered.
After several months on treatment, bleeding may be reduced to a point of virtual absence. This reduced flow may occur as a result of medication, in which event it is not indicative of pregnancy.
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (79-84).
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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