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 presented as a 52 mg intrauterine system (IUS) for intrauterine use. It provides long‑acting hormonal contraception and is also indicated for the management of heavy menstrual bleeding in women of reproductive age.

GNH India supplies Mirena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring regulatory‑approved quality for global distribution. The product is manufactured for the European Union market and meets EU pharmacovigilance standards, and is distributed under strict quality‑assurance protocols.

Manufacturer / TM Owner

Bayer Ab

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Indications & Clinical Uses

  • Levonorgestrel in Mirena acts on the reproductive hormonal axis to provide contraception and control menstrual bleeding.
  • Contraception: offers a reversible, long‑acting method that prevents pregnancy for up to five years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves quality of life in women with symptomatic HMB.
  • Menstrual regulation: stabilises menstrual cycles and can lessen dysmenorrhoea associated with irregular bleeding.

How It Works

  • Levonorgestrel is released locally from the intrauterine system, where it thickens cervical mucus, suppresses endometrial proliferation, and, in many users, inhibits ovulation. These combined actions create a hostile environment for sperm and prevent implantation, while also reducing menstrual blood flow by stabilising the endometrial lining.

Side Effects

Levonorgestrel released from Mirena may cause a range of adverse reactions.

Common Side Effects

  • Irregular bleeding or spotting, especially in the first months.
  • Amenorrhea (absence of periods) after prolonged use.
  • Pelvic or abdominal cramping.
  • Breast tenderness or mild hormonal acne.
  • Mood changes or headache.

Serious or Rare Side Effects

  • Uterine perforation during insertion.
  • Expulsion of the device.
  • Pelvic inflammatory infection.
  • Ectopic pregnancy if conception occurs.
  • Ovarian cyst formation.
  • Device migration to adjacent organs.

Precautions & Warnings

  • Before Mirena insertion, clinicians should assess patient suitability and counsel on potential risks.
  • Screen for contraindications: ensure no active pelvic infection, unexplained vaginal bleeding, or known hypersensitivity to levonorgestrel.
  • Pregnancy testing: confirm the patient is not pregnant prior to placement.
  • Follow‑up schedule: arrange a pelvic examination 4–6 weeks after insertion to verify position.
  • Device removal planning: schedule removal or replacement after five years or earlier if clinical circumstances change.
  • Interaction with hormonal therapies: avoid concurrent use of systemic estrogen products unless medically indicated.
  • Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from Mirena can be affected by other medicines that alter hormone metabolism or uterine environment.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants such as carbamazepine or phenytoin, which may lower levonorgestrel efficacy.
  • Concurrent use of systemic estrogen‑containing contraceptives that could disrupt local hormone balance.

Moderate Interactions (Monitor Closely)

  • Rifampin and other strong enzyme inducers that may reduce device effectiveness.
  • Azole antifungals (e.g., ketoconazole) that could increase levonorgestrel levels.
  • Hormone replacement therapy that may modify bleeding patterns.
  • Uterine cavity‑distorting devices that could affect proper placement.

Frequently Asked Questions

Mirena is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception and for the management of heavy menstrual bleeding. It provides up to five years of pregnancy protection while also reducing menstrual blood loss in women who experience symptomatic heavy periods.

Levonorgestrel is released directly into the uterine cavity, where it thickens cervical mucus, suppresses the growth of the endometrium, and often inhibits ovulation. These actions together prevent sperm from reaching an egg and reduce the likelihood of implantation, while also decreasing menstrual flow.

Mirena is supplied as a single 52 mg intrauterine system that delivers a low, steady dose of levonorgestrel over five years. The exact release rate is set by the manufacturer, and the prescribing clinician determines suitability and timing of insertion and removal.

Mirena must not be used in women who are pregnant; insertion is contraindicated if pregnancy is confirmed. For breastfeeding mothers, the device can be inserted after delivery and is generally considered compatible with lactation, but clinicians should discuss individual risks and benefits with the patient.

To place an order, submit an enquiry on the Mirena 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 (including any cold‑chain requirements) and the necessary import documentation.

Mirena contains 52 mg of levonorgestrel and is approved for up to five years of use, offering a higher hormone dose than some smaller IUDs such as Kyleena. This higher dose can result in more pronounced reduction of menstrual bleeding, while still providing reliable contraception. Choice of device depends on individual bleeding patterns, uterine size and clinician preference.

Mirena should be stored at ambient temperature, preferably below 25 °C, in its original sealed packaging. It must be protected from moisture and direct sunlight. The device should be handled only by trained healthcare professionals during insertion and removal to maintain sterility and device integrity.

Mirena is inserted by a qualified clinician into the uterine cavity using a specially designed inserter. The procedure is performed in a clinical setting, typically after confirming the patient is not pregnant and after a brief pelvic examination. Once placed, the device remains in situ for up to five years unless removal or replacement is required earlier.

Serious risks include uterine perforation during insertion, expulsion of the device, pelvic inflammatory infection, ectopic pregnancy if conception occurs, and rare cases of device migration to adjacent organs. Patients should be instructed to seek immediate medical attention for severe abdominal pain, abnormal bleeding or signs of infection.

Mirena is contraindicated in women with active pelvic infection, unexplained vaginal bleeding, known or suspected pregnancy, uterine anomalies that prevent proper placement, or a history of hypersensitivity to levonorgestrel. It should also be avoided in patients with certain cancers or severe liver disease, and clinicians should assess each individual’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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