Mirena Intrauterine Device 20mcg/24hours IUCD

Mirena Intrauterine Device 20mcg/24hours IUCD

Description:

Mirena Intrauterine Device 20mcg/24hours IUCD is a long-acting reversible contraceptive (LARC) and a hormone-releasing intrauterine delivery system designed for reliable, long-term pregnancy prevention. Classified as a medical device with a medicinal component, it continuously releases the progestin levonorgestrel directly into the uterine cavity, providing up to 5 years of highly effective contraception. Mirena is inserted by a trained healthcare professional into the uterus, where it acts locally to prevent fertilization and implantation, offering a convenient, low-maintenance birth control option for women seeking long-term protection without daily pills or frequent dosing.

Indications:

• Long-term prevention of pregnancy (contraception) for up to 5 years in women of reproductive age.
• Suitable for women seeking a highly effective, reversible, and low-maintenance contraceptive method.
• May be considered in women who prefer a hormone-based intrauterine contraceptive rather than oral or injectable methods.
• Helps reduce the risk of user-related failure associated with daily or on-demand contraceptive methods.

Active Ingredients / Key Components:

• Active pharmaceutical ingredient: Levonorgestrel – releases 20 microgram (20 mcg) per 24 hours (local intrauterine release). Exact total levonorgestrel content in the device is not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).
• Type: Synthetic progestin (progestagen) – levonorgestrel.
• Delivery system: Intrauterine delivery system (IUD/IUCD) with a T-shaped plastic frame and a hormone-containing reservoir (detailed material composition not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).
• Mechanism of action (levonorgestrel): Binds to nuclear progesterone receptors in the female genital tract, breast, central nervous system, and pituitary; modulates gene transcription via progesterone response elements; reduces luteinizing hormone (lh) pulse frequency, attenuates lh surge, and can suppress ovulation; thickens cervical mucus, inhibits sperm penetration, induces endometrial changes (sloughing and thinning), and interferes with fertilization and implantation.

Dosage & Administration / How to Use:

• Dosage: One Mirena intrauterine device delivering 20 mcg levonorgestrel per 24 hours, intended for continuous use for up to 5 years.
• Route: Intrauterine – the device is placed inside the uterine cavity.
• Insertion: Must be inserted by a trained and qualified healthcare professional (gynecologist or appropriately trained clinician) under aseptic conditions, typically during or shortly after menstruation, or according to the physician’s judgment and official prescribing information.
• Positioning: The device is inserted through the cervix into the uterine cavity using a dedicated inserter supplied with the product. Correct fundal placement must be confirmed by the clinician.
• Duration of use: Provides contraceptive protection for up to 5 years. After 5 years, the device must be removed and may be replaced with a new Mirena if continued contraception is desired.
• Patient self-check: The woman should be instructed on how to feel for the threads in the vagina regularly (e.g., after each menstrual period) to confirm the device remains in place. If threads are not felt or feel longer/shorter than usual, or if she feels the plastic part, she must contact her doctor.
• Removal: Must be performed by a healthcare professional by gently pulling on the threads. Removal is usually scheduled at the end of the 5-year period or earlier if pregnancy is desired, side effects occur, or medical indications arise.
• Missed dose concept: Not applicable, as this is a continuous intrauterine delivery system and not a daily oral dose.
• Special populations: Use only in women of reproductive age as assessed appropriate by a healthcare professional. Not for use before menarche or after menopause.

Clinical Benefits:

• Provides highly effective, long-term contraception for up to 5 years with a very low failure rate when correctly inserted.
• Offers a convenient, low-maintenance birth control option that does not require daily pills, injections, or user-dependent timing.
• Acts primarily locally in the uterus, resulting in lower systemic hormone exposure compared to many oral hormonal contraceptives.
• Thickens cervical mucus, making it difficult for sperm to pass through the cervix and reach the egg, thereby reducing the likelihood of fertilization.
• Induces endometrial changes (thinning and sloughing) that reduce the probability of implantation if fertilization occurs.
• May reduce menstrual blood loss and menstrual cramps in many users, leading to lighter and shorter periods over time (clinical effect varies between individuals).
• Rapid return of fertility after removal in most women, allowing planning of future pregnancy.

Warnings & Contraindications:

• Mirena must only be inserted and removed by a trained healthcare professional with experience in intrauterine device placement.
• Contraindicated in known or suspected pregnancy.
• Contraindicated in women with acute pelvic inflammatory disease (pid), current sexually transmitted infection, or a history of recurrent pid unless risk factors have been resolved and a physician considers it safe.
• Contraindicated in uterine anomalies (e.g., fibroids distorting the uterine cavity, congenital uterine malformations) that interfere with correct placement.
• Contraindicated in unexplained abnormal uterine bleeding until a diagnosis is established.
• Contraindicated in known or suspected hormone-dependent malignancies (such as breast cancer or certain genital tract cancers) unless the treating specialist deems use acceptable.
• Use with caution in women with risk factors for pelvic infection, ectopic pregnancy, or those with severe liver disease or liver tumors; consult a specialist before use.
• There is a risk of uterine perforation during insertion, particularly in breastfeeding women or those with a recently postpartum uterus; insertion must follow official guidelines.
• Mirena does not protect against hiv (aids) or other sexually transmitted infections (stis); barrier protection (e.g., condoms) is required for sti prevention.
• If pregnancy occurs with Mirena in place, there is an increased risk of ectopic pregnancy; immediate medical evaluation is required.
• Consult your doctor before use if you have a history of ectopic pregnancy, severe migraines, clotting disorders, stroke, or cardiovascular disease.
• Not intended to diagnose, treat, cure, or prevent any disease other than its approved contraceptive indication.
• Keep out of reach of children. The device and packaging are for professional handling only and must not be opened or inserted by the patient.

Side Effects:

• Common side effects: Irregular bleeding or spotting, especially in the first months after insertion; changes in menstrual pattern (lighter, shorter, or sometimes absent periods); abdominal or pelvic pain; breast tenderness; headache; mood changes; acne or oily skin in some users.
• Less common but important: Ovarian cysts (usually transient), back pain, nausea, changes in libido, weight changes (variable and not always directly attributable).
• Serious side effects (seek immediate medical attention): Signs of pelvic infection (fever, severe lower abdominal pain, unusual or foul-smelling vaginal discharge), severe or persistent pelvic pain, suspected pregnancy, signs of ectopic pregnancy (sharp one-sided abdominal pain, shoulder tip pain, dizziness or fainting), signs of uterine perforation (severe pain, heavy bleeding, inability to feel threads), or severe allergic reaction (rash, swelling, difficulty breathing).
• If you experience any unexpected or severe symptoms, contact your doctor or seek emergency medical care promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight and excessive heat, in accordance with the manufacturer’s recommendations. Keep the sterile package intact until use. Do not use if the inner sterile pack is damaged or opened. Keep out of reach of children. The device is for single use only and must not be resterilized or reused.

Specifications:

• Product form: Intrauterine device (iu d/iu cd) – hormone-releasing T-shaped system.
• Hormone release rate: Levonorgestrel 20 mcg per 24 hours (local intrauterine release).
• Intended duration of use: Up to 5 years of continuous contraception.
• Application: For intrauterine insertion by a healthcare professional only.
• Regulatory status: Prescription-only contraceptive medical device with hormonal component (regulatory classification may vary by country).

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.