Skyla

What is Skyla?

Skyla is an intrauterine device that contains levonorgestrel. This female hormone can cause changes to your cervical mucus or uterine lining. These changes make it more difficult for sperm to enter the uterus and for fertilised eggs to attach.

Skyla is an ultra-compact, flexible T-shaped plastic device. This device is placed inside the uterus, where it releases hormones to prevent pregnancy over a period of 3 years. Other types of intrauterine levonorgestrel systems are available that release different amounts and are used for different periods of time.

Skyla is suitable for anyone, whether or not you have children. Skyla should not be used while pregnant. Levonorgestrel, a progestin-like hormone, does not contain any oestrogen. Skyla iuds release levonorgestrel into the uterus. However, only small amounts reach the bloodstream. Skyla is not intended to be used for emergency contraception.

Warnings

Skyla IUD should not be used if there is abnormal vaginal blood flow, pelvic infection, or certain problems with the uterus, cervix, or breast. Do not use Skyla during pregnancy. If you suspect you may be pregnant, call your doctor.

Skyla is not a protection against HIV (AIDS) or other sexually transmitted diseases (stis). If you experience symptoms such as sudden numbness, weakness, a severe headache, or chest pain, call your doctor immediately.

Before you take this drug

Skyla may increase your chances of getting a serious infection in your pelvis, which could threaten your life and your ability to have future children. This is something you should discuss with your doctor.

Skyla should not be used during pregnancy. The hormone contained in the IUD can also have unwanted effects on a newborn female. If you fall pregnant, tell your doctor immediately. Watch for symptoms such as fevers, chills, and cramps.

Skyla should not be used if:

• Undiagnosed abnormal vaginal bleeding;
• Untreated or uncontrolled pelvic infections (vaginal, cervical, or uterine);
• Endometriosis, or a serious infection of the pelvis following a pregnancy (or an abortion) in the last 3 months.
• Pelvic Inflammatory Disease, unless you have had a normal pregnancy after the infection has been treated and cleared.
• Uterine fibroid tumours or conditions that alter the shape of the uterus
• Cancer of the cervix or breast;
• Liver disease or liver tumour (benign or cancerous);
• A condition that weakens the immune system, such as AIDS, leukaemia, or IV drug abuse
• If you already have an intrauterine device in place,
• If you have had an abortion, miscarriage, or loss of pregnancy in the last 6 weeks,
• If you have given birth in the last 6 weeks,

Tell your doctor about any of the following to ensure that Skyla will be safe for you:

• Blood pressure, cardiovascular conditions, heart attacks or strokes pose grave threats.
• Bleeding problems
• Migraine headaches
• A vaginal, pelvic, or sexually transmitted infection

Skyla can be used while breastfeeding. Levonorgestrel does not affect your milk production or quality, nor does it affect the health of your baby if you are breastfeeding. Nevertheless, isolated reports of reduced milk production have been made. While breastfeeding, you're at greater risk for uterine complications.

How to take Skyla?

Skyla iuds are inserted by doctors through the vagina into the uterus. You may experience minor vaginal bleeding or dizziness when inserting the IUD. If these symptoms persist for more than 30 minutes, tell your doctor.

Skyla shouldn't interfere with sexual activity, menstrual cups or tampons, or other vaginal medication. After a few days, your doctor should check to see if the IUD is still in position. You'll also need to have pap smears and pelvic exams every year.

Your periods may be irregular for a period of 3 to 6 weeks. You may have a lighter or heavier flow, and you may not get a period for several months. If you have not had a period in 6 weeks or you suspect you may be pregnant, tell your doctor. It may fall out on its own. You should still be able to feel the removal string at the opening of the cervix after each period.

If you can't feel the strings or you believe the IUD is slipping lower or out of your uterus and you are also experiencing pain or bleeding, call your doctor immediately. You can use a birth control method that does not contain hormones (condom, cervical cap, diaphragm or contraceptive foam) until your doctor can replace the IUD. Tell your carers that you are wearing a Skyla IUD if you will need an MRI.

You can remove your IUD at any time if you stop using birth control. Skyla has to be removed three years after it was implanted. If you want to continue using the birth control method, your doctor can install a new device. Only your doctor can remove the IUD. Remove the IUD only with your doctor's help. You may have to begin using a new method of birth control a week prior to the removal of your IUD.

Details on dosage

Adult dose for contraception:

The insertion of an intrauterine device (IUD) should be done by a healthcare professional who is familiar with the product. It is important to consult the product labelling.
Insert 1 Skyla IUD (13.5mg) into the uterus.
When to insert the insertion:
If you are not using intrauterine or hormonal contraception, insert the device at any time when the woman is not expecting.
Switching from a hormonal contraceptive (oral, transdermal, or vaginal): Insertion can occur at any time. If inserted during the hormone phase, continue to use the product for seven days following insertion, or until the current treatment cycle is over.
Switching from injectable progestin contraceptives: Insertion can occur at any time. If inserted after 3 months, an alternative method of contraception must be used for the first 7 days.
Switching from a contraceptive IUD or implant: The insertion should be done on the same date as the IUD or implant is removed.
Inserting after miscarriage or abortion:
First trimester: IUD can be inserted immediately after an abortion or miscarriage in the first trimester.
Second trimester: Insertion should be deferred for a minimum of four weeks, or until the uterus has fully involuted. If involution occurs late, the IUD insertion should also be postponed until it is completed. Consider the possibility that conception and ovulation could occur before insertion. Advise the patient to use an additional contraceptive method for seven days following insertion.
After childbirth, the IUD should not be inserted for at least 4 weeks or until the uterus has fully involuted. If involution occurs late, the IUD should only be inserted when involution is complete. Consider the possibility that ovulation may occur before insertion, and inform the patient of the need for a contraceptive method for the first 7 days following insertion.
Skyla iuds should be replaced every 3 years. You can continue using the IUD by inserting a new one.
Comment: The Skyla IUD can be removed at any point, but it must be done by the time limit. If you wish to continue using the IUD after the time period has expired, then replace the IUD with a brand new one.
Uses: Prevent pregnancy for up to three years.

What happens if I miss the dose?

Levonorgestrel is not missed when the IUD releases it continuously.

What happens if I overdose?

It is unlikely that an overdose will occur from levonorgestrel being released into the intrauterine system.

What should be avoided?

Avoid having more than one sexual partner. Iuds can increase the risk of developing serious pelvic infections, which are often caused by sexually transmitted diseases. Skyla does not protect against sexually transmissible diseases, including HIV or AIDS. A condom can help you protect yourself against these diseases. If your partner has HIV or any other sexually transmitted diseases, or if there is a change in your sexual relationship, you should call your doctor.

Side effects of Skyla

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, or tongue, or swelling in your throat, get emergency medical attention. If you experience severe pain on your side or lower stomach, seek emergency medical attention. This could be an indication of a tube pregnancy.

Iuds can become embedded in the wall of the uterus or perforate the uterus. In this case, the IUD may not prevent pregnancy, or it could move outside the uterus and cause scarring, infection, or damage to the other organs. The device may have to be surgically removed by your doctor.

If you experience:

• Severe cramps or pelvic pain; pain during sexual intercourse;
• Extreme dizziness, or a feeling of being light-headed;
• Severe headache
• Heavy or continuous vaginal bleeding; sores on the vaginal area; or unusual vaginal discharge (watery, foul-smelling, or other symptoms)
• Pale skin, weakness, easy bleeding or bruising, fever, chills, or other signs of an infection
• Jaundice
• A sudden feeling of numbness (especially on one side), problems with vision, or sensitivity to lights

Skyla may cause side effects such as:

• Changes in menstrual patterns, pain or discomfort, or bleeding pattern;
• Vaginal swelling or itching
• The IUD may cause temporary discomfort, bruising, or dizziness.
• Ovarian cysts
• Stomach pain, nausea, vomiting, and bloating;
• Headache, migraine, depression, mood changes;
• Breast tenderness or pain;
• Weight gain, acne, oily or dry skin, hair changes, and loss of interest in sexual activity;
• You may experience puffiness on your hands, feet, ankles, or face.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Levonorgestrel may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the other medications you take.