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 (synthetic progestogen) presented as a 52 mg total intrauterine system that releases approximately 20 µg levonorgestrel per day for intrauterine use. It provides 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, with regulatory‑approved quality, traceability and reliable logistics for global markets, and timely delivery.

Manufacturer / TM Owner

Bayer D.O.O

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Indications & Clinical Uses

Mirena (levonorgestrel) is a hormonal intrauterine device used in reproductive health.

  • Contraception: provides highly effective, reversible birth control for up to five years.
  • Heavy menstrual bleeding: reduces menstrual blood loss and may improve anemia associated with excessive bleeding.
  • Dysmenorrhea: can alleviate painful periods that accompany heavy bleeding.
  • Endometrial hyperplasia (benign): may be employed off‑label to manage non‑cancerous endometrial overgrowth.

How It Works

  • Levonorgestrel released from the intrauterine system acts locally on the endometrium and cervical mucus. It suppresses ovulation by inhibiting the luteinizing hormone surge, induces a thickened cervical mucus barrier that impedes sperm penetration, and creates a thin, atrophic endometrial lining that is unsuitable for implantation. These combined actions maintain a contraceptive environment within the uterus for the duration of device use.

Side Effects

Levonorgestrel IUS may be associated with a range of adverse reactions, which are categorized by frequency and severity, and should be monitored during use.

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or uterine cramping
  • Breast tenderness
  • Ovarian cyst formation
  • Headache

Serious or Rare Side Effects

  • Uterine perforation
  • Device expulsion
  • Pelvic infection (including tubo‑ovarian abscess)
  • Ectopic pregnancy
  • Severe mood changes or depression
  • Allergic reaction (rash, swelling, anaphylaxis)

Patients should report any unexpected symptoms promptly to their healthcare provider. Most side effects are mild and resolve over time, but serious events require immediate medical attention.

Precautions & Warnings

Before insertion and during use of Mirena, healthcare professionals should observe several precautionary measures to ensure safety and effectiveness.

  • Confirm uterine position: perform a pelvic exam and ultrasound to verify correct placement.
  • Exclude pregnancy: ensure the patient is not pregnant before insertion.
  • Avoid in active infection: do not insert in the presence of pelvic inflammatory disease or genital infection.
  • Counsel on bleeding pattern: inform patients that irregular bleeding or spotting is common initially.
  • Review hormone‑sensitive conditions: assess history of breast cancer, liver disease, or thromboembolic disorders.
  • Store at room temperature: keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from Mirena can interact with other medicines that affect hormone metabolism or uterine environment.

Major Interactions (Avoid)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): may reduce levonorgestrel efficacy.
  • Antifungal azoles (e.g., ketoconazole, itraconazole): can increase systemic hormone levels, raising side‑effect risk.
  • Protease inhibitors (e.g., ritonavir): may alter hormone concentrations and affect contraceptive reliability.

Moderate Interactions (Monitor Closely)

  • St. John’s wort: may modestly decrease levonorgestrel exposure.
  • Certain antibiotics (e.g., rifampin is major, others generally low risk): monitor for breakthrough bleeding.

Frequently Asked Questions

Mirena is a hormonal intrauterine system that provides highly effective contraception for up to five years and is also approved for the management of heavy menstrual bleeding, helping to reduce blood loss and improve quality of life for many women.

Levonorgestrel released from the device acts locally in the uterus to suppress ovulation, thicken cervical mucus, and create a thin, atrophic endometrial lining, all of which together prevent sperm from reaching an egg and make implantation unlikely.

The dosing regimen for Mirena is set by the prescribing clinician. The device contains a total of 52 mg of levonorgestrel and releases approximately 20 µg per day for up to five years, after which replacement is recommended.

Mirena must not be used in women who are pregnant. For breastfeeding mothers, the device is generally considered compatible, but clinicians evaluate each case individually to balance contraceptive benefits with any potential infant exposure.

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 IUD, which provides non‑hormonal contraception. Mirena releases levonorgestrel, offering additional benefits such as reduced menstrual bleeding and lighter periods, whereas the copper IUD may increase bleeding but has no hormonal side effects.

Mirena should be stored at room temperature, below 25 °C, in its original sealed packaging. Keep the device away from moisture and direct sunlight until it is inserted by a qualified healthcare professional.

Mirena is inserted by a trained clinician into the uterine cavity through the cervix using a specialized inserter. The procedure is performed in a medical setting under aseptic conditions and typically takes only a few minutes.

Serious risks include uterine perforation during insertion, device expulsion, pelvic infection, and the rare possibility of ectopic pregnancy if contraception fails. Prompt medical evaluation is essential if severe abdominal pain, fever, or abnormal bleeding occurs.

Mirena is contraindicated in women who are currently pregnant, have active pelvic infection, unexplained vaginal bleeding, known or suspected uterine malignancy, or a history of severe hormone‑sensitive cancers. A thorough medical assessment is required before placement.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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