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 progestin presented as a 52 mg levonorgestrel (approximately 20 µg/day release) intrauterine system for intrauterine use. It provides birth control and reduces heavy menstrual bleeding in women of reproductive age, and is approved in the European Union.

GNH India supplies Mirena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing a reliable, quality‑assured source for this EU‑approved intrauterine system.

Manufacturer / TM Owner

Bayer Hispania Sl

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Indications & Clinical Uses

Mirena, a levonorgestrel intrauterine system, acts within the reproductive hormonal pathway to provide contraceptive and menstrual management benefits.

  • Long‑term contraception: provides up to five years of highly effective birth control.
  • Management of heavy menstrual bleeding: reduces menstrual blood loss and improves quality of life.
  • Endometrial protection in hormone therapy: helps prevent endometrial hyperplasia when combined with estrogen therapy.

How It Works

  • Levonorgestrel released from the intrauterine system diffuses locally into the uterine cavity, where it binds to progesterone receptors in the endometrium and cervical mucus glands. This action thickens cervical mucus, inhibits endometrial proliferation, and suppresses the mid‑cycle luteinizing hormone surge, thereby preventing ovulation and creating an environment unsuitable for sperm penetration and implantation.

Side Effects

Adverse reactions to Mirena may vary in frequency and severity.

Common Side Effects

  • Irregular bleeding or spotting: unpredictable bleeding patterns, especially in the first months.
  • Amenorrhea: absence of menstrual periods after prolonged use.
  • Headache: mild to moderate headache episodes.
  • Breast tenderness: discomfort or swelling of the breasts.

Serious or Rare Side Effects

  • Uterine perforation: rare injury to the uterine wall during insertion.
  • Pelvic inflammatory disease: infection that can spread to reproductive organs.
  • Ectopic pregnancy: pregnancy occurring outside the uterus if contraception fails.
  • Hormone‑dependent tumor growth: potential stimulation of existing breast or ovarian tumors.

Precautions & Warnings

Precautions should be observed to ensure safe use of Mirena.

  • Patient selection: confirm no active pelvic infection or uterine anomalies before insertion.
  • Pregnancy status: contraindicated in known or suspected pregnancy (Category X).
  • Breastfeeding: assess risk‑benefit; may be used but discuss with a clinician.
  • Smoking: advise cessation, especially in women over 35, due to increased cardiovascular risk.
  • Follow‑up: schedule pelvic exam 4–6 weeks after insertion to verify placement.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Drug interactions may affect the efficacy or safety of Mirena.

Major Interactions (Avoid)

  • Antiepileptic enzyme inducers (e.g., carbamazepine, phenytoin): may reduce levonorgestrel efficacy.
  • Rifampin and other strong CYP3A4 inducers: can lower hormone levels, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole): may increase levonorgestrel exposure, monitor for side effects.
  • Antiretroviral protease inhibitors (e.g., ritonavir): may alter hormone metabolism, assess efficacy.
  • Herbal supplements containing St. John’s wort: possible reduction in effectiveness, advise caution.

Frequently Asked Questions

Mirena is a levonorgestrel-releasing intrauterine system indicated for long‑term contraception and for the management of heavy menstrual bleeding. It provides up to five years of highly effective birth control while also reducing menstrual blood loss, improving quality of life for many women.

Levonorgestrel released from the intrauterine system acts locally on the uterine lining and cervical mucus. It thickens cervical mucus, suppresses endometrial growth, and can inhibit the mid‑cycle luteinizing hormone surge, thereby preventing ovulation and creating an environment that is hostile to sperm and implantation.

Mirena contains 52 mg of levonorgestrel that releases approximately 20 µg per day. The dosing regimen is set by the prescribing clinician at the time of insertion and is not adjusted by the patient.

Mirena is contraindicated in known or suspected pregnancy (Category X) and should be removed if pregnancy occurs. For breastfeeding women, the device may be used after discussion with a healthcare professional, weighing potential benefits against any theoretical risks to the infant.

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.

The primary alternative is the copper intrauterine device (e.g., Paragard), which provides non‑hormonal contraception. Mirena offers hormonal benefits such as reduced menstrual bleeding and lighter periods, whereas copper IUDs do not affect bleeding patterns but may cause heavier periods. Choice depends on individual preferences and clinical considerations.

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

Mirena is inserted into the uterine cavity by a trained healthcare professional using a sterile insertion device. The procedure is performed in a clinical setting, typically after a pelvic examination, and may involve a brief analgesic or local anesthetic for patient comfort.

Serious risks include uterine perforation during insertion, pelvic inflammatory disease, ectopic pregnancy if contraception fails, and the potential for hormone‑dependent tumor growth. Patients should be monitored for signs of infection, severe abdominal pain, or abnormal bleeding and seek medical attention promptly if they occur.

Mirena should not be used by women with a known or suspected pregnancy, active pelvic infection, unexplained vaginal bleeding, uterine anomalies that preclude proper placement, or a history of breast cancer. Contraindications also include severe liver disease and certain hormonal disorders; a clinician must evaluate suitability before insertion.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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