Product image of Mirena (Levonorgestrel) supplied by GNH India

Mirena

Active Ingredient:
Levonorgestrel
Origin:
EU

Mirena (Levonorgestrel)

Levonorgestrel, the active ingredient in Mirena, is a progestogen (synthetic progestin) presented as a 52 mg intrauterine system for intrauterine use. It provides long‑acting reversible contraception and is also indicated for the management of heavy menstrual bleeding and endometriosis‑associated pain in women of reproductive age and is approved for use in the European Union.

GNH India supplies Mirena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance and reliable global logistics.

Manufacturer / TM Owner

Bayer Ltd

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Indications & Clinical Uses

  • Mirena, a levonorgestrel-releasing intrauterine system, is used in several gynecologic conditions.
  • Contraception (up to 5 years): provides highly effective, reversible birth control for women seeking long‑acting contraception.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding.
  • Endometriosis‑associated pain: alleviates chronic pelvic pain related to endometriosis.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the endometrium and cervical mucus. It binds to progesterone receptors, suppressing ovulation, thickening cervical mucus to impede sperm penetration, and inducing endometrial atrophy, which together prevent implantation of a fertilized egg. The device delivers approximately 20 µg of levonorgestrel per day, maintaining therapeutic levels directly within the uterine cavity while minimizing systemic exposure.

Side Effects

Levonorgestrel IUS may be associated with a range of adverse events, which are categorized by frequency and severity.

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Headache
  • Breast tenderness
  • Acne or oily skin
  • Mood changes

Serious or Rare Side Effects

  • Pelvic inflammatory disease
  • Uterine perforation during insertion
  • Expulsion of the device
  • Ectopic pregnancy if contraception fails
  • Ovarian cyst formation
  • Severe allergic reaction (anaphylaxis)

Precautions & Warnings

Before insertion and during use, several precautions should be observed to ensure safety and effectiveness.

  • Pregnancy testing: confirm non‑pregnant status prior to insertion.
  • Regular follow‑up: schedule post‑insertion visits to verify correct device position.
  • Contraindications: avoid in women with active pelvic infection, known uterine anomalies, or unexplained vaginal bleeding.
  • Medication interactions: consider reduced efficacy when used with enzyme‑inducing drugs such as certain anticonvulsants.
  • Smoking: advise cessation in women over 35 who smoke, due to increased cardiovascular risk.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from Mirena can interact with other medicines, affecting its contraceptive reliability.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may lower levonorgestrel effectiveness.
  • Rifampin and other strong enzyme‑inducing antibiotics: may reduce contraceptive reliability.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): possible modest reduction in hormone activity.
  • Protease inhibitor antiretrovirals: may alter levonorgestrel levels.
  • St. John’s wort (hypericum perforatum): may decrease contraceptive efficacy.

Frequently Asked Questions

Mirena is a levonorgestrel‑releasing intrauterine system indicated for up to five years of highly effective contraception, for reducing heavy menstrual bleeding, and for relieving pain associated with endometriosis in women of reproductive age.

Levonorgestrel released locally from the IUS binds to progesterone receptors in the uterus, suppressing ovulation, thickening cervical mucus to block sperm, and causing endometrial atrophy, which together prevent implantation of a fertilized egg.

The Mirena device contains 52 mg of levonorgestrel and releases approximately 20 µg per day. The exact dosing schedule and duration are determined by the prescribing clinician based on individual patient needs.

Mirena is classified as pregnancy category X and must not be used during pregnancy. It is not a method for terminating an existing pregnancy. For breastfeeding women, insertion after delivery is generally considered safe, but patients should discuss timing with their healthcare provider.

To order Mirena, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with oral progestin pills, Mirena offers continuous low‑dose hormone delivery directly to the uterus, resulting in higher efficacy, fewer systemic side effects, and no daily adherence. Compared with copper IUDs, Mirena reduces menstrual bleeding and may improve dysmenorrhea, but it does not protect against sexually transmitted infections.

Mirena should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Keep the device away from moisture, direct sunlight and extreme temperatures to maintain its integrity until insertion.

Mirena is inserted by a trained healthcare professional into the uterine cavity through the cervical canal. The procedure is performed in a clinical setting using a sterile inserter, and the device remains in place for up to five years unless removal or replacement is required.

Serious risks include pelvic inflammatory disease, uterine perforation during insertion, expulsion of the device, ectopic pregnancy if contraceptive failure occurs, ovarian cyst formation, and severe allergic reactions such as anaphylaxis. Patients should seek immediate medical attention if they experience severe abdominal pain, fever, or unusual bleeding.

Mirena is contraindicated in women who are pregnant, have active pelvic infections, known uterine anomalies, unexplained vaginal bleeding, or a history of breast cancer. It should also be avoided by individuals with severe liver disease or those who are hypersensitive to levonorgestrel.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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