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 intrauterine system for intrauterine use. It continuously releases levonorgestrel to suppress ovulation, thicken cervical mucus and induce endometrial atrophy, providing effective contraception and reducing 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, adhering to European Union medical device regulations and prescription‑only status to ensure quality and regulatory conformity across global markets.

Manufacturer / TM Owner

Bayer Hellas Sa

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Indications & Clinical Uses

Levonorgestrel in Mirena acts within the hormonal contraceptive and menstrual‑management pathways.

  • Contraception: provides highly effective, long‑term birth control for up to five years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and can improve anemia associated with excessive bleeding.
  • Endometrial hyperplasia (benign): induces regression of non‑cancerous endometrial overgrowth through local progestogenic effect.

How It Works

  • Mirena releases levonorgestrel directly into the uterine cavity at a rate of approximately 20 µg per day. The progestin binds to progesterone receptors in the endometrium, leading to glandular atrophy and reduced vascularization. It also thickens cervical mucus, creating a barrier to sperm, and suppresses the hypothalamic‑pituitary‑ovarian axis, inhibiting the mid‑cycle LH surge and thereby preventing ovulation.

Side Effects

Levonorgestrel delivered by Mirena may be associated with a range of adverse reactions.

Common Side Effects

  • Irregular vaginal bleeding or spotting.
  • Amenorrhea after several months of use.
  • Pelvic or uterine cramping after insertion.

Serious or Rare Side Effects

  • Uterine perforation during insertion.
  • Device expulsion or displacement.
  • Pelvic inflammatory disease or infection.

Precautions & Warnings

Mirena requires careful patient assessment and follow‑up.

  • Contraindicated in pregnancy: product must not be used in women who are pregnant.
  • Screen for uterine abnormalities: perform ultrasound or hysteroscopy before insertion.
  • Risk of infection: insert under aseptic conditions and monitor for signs of pelvic infection.
  • Smoking in women over 35: advise cessation as smoking increases thrombotic risk.
  • Follow‑up examinations: schedule regular checks to confirm correct device position.
  • Store at room temperature: keep in original packaging, protect from moisture and extreme heat.

Avoid Interactions

Levonorgestrel may interact with other medicines that affect hormone metabolism.

Major Interactions (Avoid)

  • Rifampin and other enzyme inducers: may reduce levonorgestrel efficacy.
  • Anticonvulsants (phenytoin, carbamazepine, phenobarbital): may lower hormone levels.
  • Antifungal ketoconazole: can increase levonorgestrel concentrations, raising risk of side effects.

Moderate Interactions (Monitor Closely)

  • St. John’s wort: may decrease hormonal effectiveness.
  • Certain antibiotics (e.g., tetracycline): generally minimal effect but monitor bleeding patterns.
  • Hormonal therapies (combined oral contraceptives): may alter bleeding profile.

Frequently Asked Questions

Mirena is an intrauterine system that delivers levonorgestrel directly to the uterus. It is approved for long‑acting contraception and for the treatment of heavy menstrual bleeding, helping to reduce menstrual blood loss and improve quality of life.

Levonorgestrel released from Mirena binds to progesterone receptors in the endometrium, causing glandular atrophy and reduced vascularity. It also thickens cervical mucus and suppresses the mid‑cycle luteinising hormone surge, which together prevent ovulation and create an environment hostile to sperm.

Mirena contains a total of 52 mg of levonorgestrel and releases the hormone at a low, continuous rate. The specific dosing regimen, including insertion timing and replacement interval, is determined by the prescribing clinician based on individual patient needs and regulatory guidelines.

Mirena is classified as pregnancy category X, meaning it must not be used by women who are pregnant or who may become pregnant. For breastfeeding women, the device can be used after delivery, but clinicians should assess risks and benefits, as levonorgestrel does pass into breast milk in low amounts.

To order Mirena, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies 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 contraceptives, Mirena offers a once‑in‑five‑year dosing interval, higher contraceptive efficacy and reduced systemic hormone exposure. Unlike injectable progestins, it does not require clinic visits for repeat injections, and it provides the added benefit of reducing heavy menstrual bleeding, which many other methods do not address.

Mirena should be stored at room temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme heat. Do not attempt to open or manipulate the system before insertion by a qualified healthcare professional.

Mirena is inserted by a trained clinician into the uterine cavity through the cervical canal using a specialized inserter. The procedure is performed in a clinical setting under sterile conditions. Once placed, the device remains in situ for up to five years, after which it should be removed or replaced.

Serious risks include uterine perforation during insertion, device expulsion or displacement, and pelvic inflammatory disease or infection. Although rare, these complications require prompt medical attention. Patients should be educated on symptoms such as severe abdominal pain, abnormal bleeding or signs of infection.

Mirena is contraindicated in women who are pregnant, have known or suspected uterine malignancy, active pelvic infection, unexplained vaginal bleeding, or a history of uterine perforation. It should also be avoided in women with severe liver disease or those who are allergic to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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