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MIRENA® Indications for Use

MIRENA® is a levonorgestrel-releasing intrauterine system (IUS) designed for long-term, reversible contraception. It is primarily used for birth control, the treatment of heavy menstrual bleeding, and as part of hormone replacement therapy (HRT) for post-menopausal women. The device is inserted into the uterus and provides effective contraception for up to five years.

Key Indications:

• Contraception: Effective for up to five years.
• Heavy Menstrual Bleeding: Reduces menstrual blood loss.
• Hormone Replacement Therapy (HRT): Protects the uterine lining when used alongside estrogen in post-menopausal women.

MIRENA® Dosage Information

MIRENA contains 52 mg of levonorgestrel and releases 20 mcg per day initially, gradually decreasing over time. It is designed to be placed in the uterus by a trained healthcare provider and remains effective for up to five years.

Key Dosage Information:

• Active Ingredient: Levonorgestrel, 52 mg.
• Release Rate: 20 mcg/24 hours initially, decreasing over time.
• Duration: Up to five years.
• Form: T-shaped intrauterine device.

Once inserted, MIRENA begins releasing levonorgestrel immediately, and its contraceptive effects start right away if inserted within the first seven days of menstruation.

MIRENA® Side Effects and Precautions

MIRENA, like other hormonal contraceptives, has side effects that range from mild to more severe. Patients should be monitored regularly, and proper care should be taken if any side effects are persistent or severe.

Common Side Effects:

• Spotting or irregular bleeding during the first few months.
• Headache, nausea, and breast tenderness.
• Acne or oily skin.
• Mood changes including irritability or depression.

Serious Side Effects:

• Pelvic Inflammatory Disease (PID): May occur, especially in the first 20 days post-insertion.
• Uterine Perforation: Although rare, MIRENA can perforate the uterine wall, which may require surgical removal.
• Ectopic Pregnancy: There is a risk of pregnancy outside the uterus if a woman becomes pregnant with MIRENA in place.

Precautions:

• Not recommended for women with a history of breast cancer, severe liver disease, or undiagnosed uterine bleeding.
• Should not be used in women with pelvic infections or active genital infections.

Patients should also be aware that MIRENA can cause changes in menstruation patterns, including lighter periods or the cessation of periods altogether.

MIRENA® Clinical Studies or Real-World Outcomes

Clinical trials have demonstrated that MIRENA is over 99% effective in preventing pregnancy, making it one of the most reliable forms of contraception. In trials focused on treating heavy menstrual bleeding, women experienced a reduction of blood loss by 79-96% within the first three months of use.

Efficacy:

• 99.9% effective as a contraceptive.
• Significant reduction in menstrual bleeding (79-96% decrease) after three months.

Patient Satisfaction:

• High levels of satisfaction among users for both contraceptive effects and reduction in menstrual bleeding.
• Side effects like irregular bleeding tend to decrease over time, with many women experiencing lighter periods or no periods at all after six months.

MIRENA® Drug Interactions

Although MIRENA has limited systemic effects, certain medications can influence its efficacy or increase the risk of complications.

Notable Drug Interactions:

• Liver enzyme-inducing medications (such as some anticonvulsants and antibiotics) can increase the metabolism of levonorgestrel, potentially reducing its contraceptive efficacy.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) may be taken for pain relief, but persistent or severe pain post-insertion should be evaluated by a healthcare professional.

MIRENA® Aftercare Instructions

After insertion, patients should monitor for any signs of complications and adhere to follow-up appointments with their healthcare provider.

Post-Insertion Care:

• A follow-up appointment is recommended 6 weeks after insertion to ensure the device is properly positioned.
• Women should check the device’s removal threads monthly to ensure that MIRENA remains in place. If the threads cannot be felt, contact a healthcare provider.

What to Expect:

• Cramping and spotting are common in the first few weeks after insertion but should subside over time.
• If severe abdominal pain, fever, or heavy bleeding occurs, patients should seek medical attention immediately as these may indicate infection or perforation.

Follow-Up Treatments

MIRENA can remain in place for up to five years. After this period, it should either be replaced with a new device or removed. If a woman wishes to become pregnant, fertility typically returns to normal soon after MIRENA is removed.

Recommendations:

• Replacement or removal at the five-year mark.
• Regular annual check-ups with a healthcare provider to monitor for side effects or complications.

For those using MIRENA for hormone replacement therapy, a healthcare provider will evaluate the need for continued use beyond four years as there is limited data on the effectiveness of MIRENA in HRT for periods longer than this.