Skyla
Loading...Skyla Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Skyla® is indicated to prevent pregnancy for up to 3 years.
The system should be replaced after 3 years if continued use is desired.
History
There is currently no drug history available for this drug.
Other Information
Skyla (LNG-releasing intrauterine system) contains 13.5 mg of LNG, a progestin, and is intended to provide an initial release rate of approximately14 mcg/day of LNG after 24 days.
Levonorgestrel USP, (-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one, the active ingredient in Skyla, has a molecular weight of 312.4, a molecular formula of C21H28O2, and the following structural formula:
Skyla consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. The reservoir consists of a whitish or pale yellow cylinder, made of a mixture of LNG and silicone (polydimethylsiloxane), containing a total of 13.5 mg LNG. The reservoir is covered by a semi-opaque silicone membrane, composed of polydimethylsiloxane and colloidal silica. A ring composed of 99.95% pure silver is located at the top of the vertical stem close to the horizontal arms and is visible by ultrasound. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body. The polyethylene of the removal thread contains iron oxide as a colorant (see Figure 10).
The components of Skyla, including its packaging, are not manufactured using natural rubber latex.
Figure 10: Skyla
Skyla is packaged sterile within an inserter. The inserter (Figure 11), which is used for insertion of Skyla into the uterine cavity, consists of a symmetric two-sided body and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The outer diameter of the insertion tube is 3.8 mm. The vertical stem of Skyla is loaded in the insertion tube at the tip of the inserter. The arms are pre-aligned in the horizontal position. The removal threads are contained within the insertion tube and handle. Once Skyla has been placed, the inserter is discarded.
Figure 11: Diagram of Inserter
Sources
Skyla Manufacturers
-
Bayer Healthcare Pharmaceuticals Inc.
![Skyla (Levonorgestrel) Intrauterine Device [Bayer Healthcare Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Skyla | Lupin Pharmaceuticals, Inc.
To achieve maximum contraceptive effectiveness, Enskyce must be taken exactly as directed and at intervals not exceeding 24 hours. Enskyce is available in the wallet which is preset for a Sunday Start. Day 1 Start is also provided.
Day 1 StartThe dosage of Enskyce for the initial cycle of therapy is one light orange "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day.
The use of Enskyce for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also (PRECAUTIONS , Nursing Mothers) If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) light orange "active" tablet in Weeks 1, 2, or 3, the light orange "active" tablet should be taken as soon as she remembers. If the patient misses two (2) light orange "active" tablets in Week 1 or Week 2, the patient should take two (2) light orange "active" tablets the day she remembers and two (2) light orange "active" tablets the next day; and then continue taking one (1) light orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) light orange "active" tablets in the third week or misses three (3) or more light orange "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
Sunday StartWhen taking Enskyce, the first light orange "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first light orange "active" tablet is taken on that day. If switching directly from another oral contraceptive, the first light orange "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.
The use of Enskyce for contraception may be initiated 4 weeks postpartum. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also (PRECAUTIONS, Nursing Mothers).
If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) light orange active tablet in Weeks 1, 2, or 3, the light orange "active" tablet should be taken as soon as she remembers. If the patient misses two (2) light orange "active" tablets in Week 1 or Week 2, the patient should take two (2) light orange "active" tablets the day she remembers and two (2) light orange "active" tablets the next day; and then continue taking one (1) light orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) light orange "active" tablets in the third week or misses three (3) or more light orange "active" tablets in a row, the patient should continue taking one light orange "active" tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENSBreakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period:
If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.
Login To Your Free Account