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 for intrauterine use. It releases hormone locally to prevent pregnancy and is also indicated for the treatment 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, providing regulatory‑approved product documentation and logistics support for global distribution. The company adheres to stringent quality standards and works with procurement teams to ensure timely delivery.

Manufacturer / TM Owner

Bayer Ab

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Indications & Clinical Uses

Levonorgestrel delivered via Mirena acts on the reproductive hormonal axis to provide contraception and control uterine bleeding.

  • Contraception: Provides highly effective, long‑term birth control for up to five years.
  • Heavy menstrual bleeding: Reduces menstrual blood loss and improves anemia associated with menorrhagia.
  • Endometrial hyperplasia (non‑cancerous): Suppresses proliferation of the endometrial lining in selected cases.
  • Estrogen therapy adjunct: Provides endometrial protection for women using systemic estrogen.

How It Works

  • Mirena releases levonorgestrel directly into the uterine cavity at a low, steady rate. The hormone binds to progesterone receptors in the cervical mucus, endometrium and hypothalamic‑pituitary axis, causing thickening of cervical mucus, inhibition of endometrial proliferation, and, in many users, suppression of ovulation, thereby preventing implantation and reducing menstrual bleeding.

Side Effects

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

Common Side Effects

  • Irregular bleeding or spotting: Unpredictable menstrual patterns, especially during the first months.
  • Amenorrhea: Absence of menstrual bleeding.
  • Headache: Mild to moderate intensity.
  • Breast tenderness: Discomfort or swelling of breast tissue.
  • Acne or skin changes: New or worsening acne.
  • Ovarian cysts: Small, functional cysts that often resolve spontaneously.

Serious or Rare Side Effects

  • Pelvic inflammatory disease: Infection of the reproductive organs.
  • Uterine perforation: Rare injury to the uterine wall during insertion.
  • Expulsion of the device: Partial or complete loss of the IUS.
  • Ectopic pregnancy: Pregnancy occurring outside the uterus if contraception fails.
  • Severe allergic reaction: Rash, swelling, or anaphylaxis.
  • Hormone‑related thromboembolic events: Blood clots in veins or arteries.

Precautions & Warnings

Before using Mirena, several safety considerations should be reviewed.

  • Contraindications: Do not use in women with active pelvic infection, unexplained vaginal bleeding, or known or suspected pregnancy.
  • Screening: Perform a pregnancy test and assess uterine cavity size before insertion.
  • Follow‑up: Schedule a check‑up 4–6 weeks after placement to confirm correct positioning.
  • Hormone sensitivity: Avoid in patients with known hypersensitivity to levonorgestrel or any IUS components.
  • Breast cancer history: Use with caution in women with current or past estrogen‑dependent breast cancer.
  • Store at ambient temperature: Keep the device in its original packaging, protect from moisture and extreme heat, and store below 25 °C.

Avoid Interactions

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

Major Interactions (Avoid)

  • Antiepileptic enzymes: Strong CYP3A4 inducers such as carbamazepine, phenytoin, or rifampicin may reduce levonorgestrel efficacy.
  • Antiretrovirals: Certain protease inhibitors and efavirenz can lower hormone levels, increasing risk of unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Antifungals: Ketoconazole and other azole antifungals may increase levonorgestrel concentrations.
  • Antibiotics: While most do not affect IUS, prolonged use of rifampin‑based regimens warrants monitoring.
  • Herbal supplements: St. John’s wort may decrease hormone effectiveness.
  • Hormonal therapies: Concurrent use of other progestins or estrogen may alter bleeding patterns.

Frequently Asked Questions

Mirena is an intrauterine system that releases levonorgestrel to provide highly effective contraception for up to five years and to treat heavy menstrual bleeding by reducing menstrual blood loss.

Levonorgestrel binds to progesterone receptors in the cervical mucus, endometrium and hypothalamic‑pituitary axis, thickening mucus, suppressing endometrial growth, and often inhibiting ovulation, which together prevent pregnancy and lessen bleeding.

Mirena contains a total of 52 mg of levonorgestrel and releases a low, steady dose over time. The exact dosing schedule and duration are determined by the prescribing clinician.

Mirena must not be used in women who are pregnant. If pregnancy occurs, the device should be removed. Limited data exist for breastfeeding; clinicians usually assess risks and benefits before continuation.

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 and any necessary import documentation.

Compared with oral contraceptives, Mirena offers a once‑inserted, long‑acting method without daily adherence. It provides higher continuation rates and can also reduce heavy menstrual bleeding, whereas barrier methods have lower efficacy and hormonal implants may have different side‑effect profiles.

Store Mirena at ambient temperature, below 25 °C, in its original sealed packaging. Protect it from moisture, direct sunlight and extreme heat to maintain device integrity until insertion.

Mirena is inserted by a trained healthcare professional through the cervix into the uterine cavity using a specialized inserter. The procedure is performed in a clinical setting under aseptic conditions.

Serious risks include uterine perforation during insertion, pelvic inflammatory disease, expulsion of the device, ectopic pregnancy if contraception fails, and rare allergic reactions or thromboembolic events. Prompt medical attention is required if any of these occur.

Women with active pelvic infection, unexplained vaginal bleeding, known or suspected pregnancy, certain uterine abnormalities, or a history of breast cancer sensitive to hormones should avoid Mirena. Contraindications are confirmed by the prescribing clinician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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