Mirena Bayer Intrauterine Delivery System

Active Ingredient:
Levonorgestrel 52 mg

Pharmacological Class:
Levonorgestrel-releasing intrauterine system (IUS) / Hormonal contraceptive

Dosage Form:
Intrauterine device (IUD) – releases levonorgestrel directly into the uterine cavity at an initial rate of approximately 20 micrograms per day.

Indications:

• Long-term reversible contraception (up to 5 years)

• Treatment of heavy menstrual bleeding (idiopathic menorrhagia)

• Endometrial protection during estrogen replacement therapy

Mechanism of Action:
Mirena continuously releases levonorgestrel, a synthetic progestin, which acts mainly locally within the uterus. It thickens cervical mucus to prevent sperm penetration, inhibits sperm motility and function, reduces endometrial growth to prevent implantation, and may partially suppress ovulation in some women.

Dosage and Administration:

• Inserted into the uterine cavity by a trained healthcare professional under aseptic conditions.

• Should be inserted within 7 days of the onset of menstruation, or immediately after a first-trimester abortion.

• Provides contraceptive protection for up to 5 years.

• Replace after 5 years if continued contraception is desired.

Side Effects:

• Irregular or prolonged bleeding during the first months of use

• Amenorrhea with long-term use

• Headache, breast tenderness, mood changes

• Pelvic pain, ovarian cysts

• Rare: uterine perforation, device expulsion, pelvic infection

Precautions:

• Contraindicated in pregnancy, uterine anomalies, pelvic inflammatory disease, unexplained vaginal bleeding, and hormone-dependent tumors.

• Should be removed if infection, uterine perforation, or persistent bleeding occurs.

• Clinical follow-up recommended after the first menstruation post-insertion and periodically thereafter to confirm correct placement.

Storage:

• Store below 30°C

• Keep in the original sterile packaging until insertion

• For single use only and must be inserted by qualified medical personnel