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 20 µg/day release intrauterine system for intrauterine use. It provides long‑acting contraception and is also indicated for the treatment of heavy menstrual bleeding and endometriosis‑associated pain in women of reproductive age.

GNH India supplies Mirena as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with full regulatory approvals and rigorous quality assurance processes. Our distribution network ensures timely delivery and compliance with local import requirements across multiple regions.

Manufacturer / TM Owner

Bayer Ag

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Indications & Clinical Uses

Mirena, a levonorgestrel-releasing intrauterine system, is used in several gynecologic indications.

  • Contraception: provides up to five years of highly effective pregnancy prevention by inhibiting ovulation and altering cervical mucus.
  • Heavy menstrual bleeding: reduces menstrual blood loss by up to 80 % and improves anemia associated with excessive bleeding.
  • Endometriosis-associated pain: alleviates chronic pelvic pain and dysmenorrhea related to endometriosis through local hormonal effects.
  • Menstrual cycle regulation: can lead to lighter, more predictable periods in women without heavy bleeding.

How It Works

  • Mirena continuously releases levonorgestrel directly into the uterine cavity at approximately 20 µg per day. The progestin binds to progesterone receptors in the endometrium, suppressing ovulation, thickening cervical mucus to impede sperm passage, and inducing endometrial atrophy, which together prevent implantation of a fertilized egg. These local actions occur with minimal systemic exposure, allowing effective contraception while reducing systemic hormonal side effects.

Side Effects

Levonorgestrel released from Mirena may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Irregular bleeding or spotting: unpredictable bleeding patterns during the first months.
  • Amenorrhea: absence of menstrual periods after prolonged use.
  • Headache: mild to moderate intensity.
  • Breast tenderness: discomfort or soreness in the breasts.
  • Acne: worsening of skin lesions.
  • Mood changes: irritability or depression.

Serious or Rare Side Effects

  • Uterine perforation: rare injury to the uterine wall during insertion.
  • Pelvic infection: severe infection requiring medical treatment.
  • Ectopic pregnancy: pregnancy occurring outside the uterus if contraception fails.

Precautions & Warnings

Before Mirena insertion, clinicians should evaluate patients for specific contraindications and follow recommended safety measures.

  • Assess for active pelvic infection: postpone insertion until infection is resolved.
  • Screen for unexplained vaginal bleeding: investigate underlying causes before use.
  • Evaluate pregnancy status: Mirena must not be placed in a pregnant woman.
  • Review liver disease or hormone‑sensitive cancers: avoid use in patients with severe hepatic impairment or known breast cancer.
  • Check for uterine anomalies: abnormal cavity shape may increase risk of expulsion or perforation.
  • Store at room temperature below 25°C: keep in 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)

  • Enzyme inducers (e.g., rifampin, carbamazepine): may lower levonorgestrel levels and reduce efficacy.
  • Antifungal azoles (e.g., ketoconazole): can increase levonorgestrel concentrations, potentially raising side‑effect risk.
  • Certain antiretrovirals (e.g., efavirenz): may decrease contraceptive effectiveness.

Moderate Interactions (Monitor Closely)

  • Concurrent hormonal contraceptives: may alter bleeding patterns but generally safe.
  • Antibiotics such as tetracycline: unlikely to affect efficacy but monitor for changes in menstrual bleeding.

Frequently Asked Questions

Mirena is a levonorgestrel‑releasing intrauterine system indicated for long‑term contraception, for the treatment of heavy menstrual bleeding, and for relief of pain associated with endometriosis. It provides up to five years of pregnancy protection while also helping to reduce menstrual blood loss and pelvic discomfort.

Levonorgestrel released from Mirena binds to progesterone receptors in the endometrium, suppresses ovulation, thickens cervical mucus to block sperm entry, and causes endometrial atrophy. These combined actions create an environment that prevents fertilization and implantation, delivering effective contraception with minimal systemic hormone exposure.

Mirena is supplied as a single intrauterine system that continuously releases approximately 20 µg of levonorgestrel per day for up to five years. The exact dosing regimen is determined by the prescribing clinician based on the patient’s medical history and therapeutic goals.

Mirena is contraindicated in pregnancy (Category X) and must not be inserted in a pregnant woman. For breastfeeding women, the device may be inserted postpartum; levonorgestrel exposure through breast milk is low, but clinicians should discuss individual risks and benefits with the patient.

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.

Compared with oral hormonal contraceptives, Mirena offers a once‑in‑place, five‑year solution with lower systemic hormone levels, which can reduce side‑effects such as nausea. Relative to other intrauterine systems like Kyleena, Mirena delivers a higher daily levonorgestrel dose, providing stronger bleeding control but a similar safety profile.

Mirena should be stored at room temperature below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. The device must be handled by trained healthcare professionals using sterile technique during insertion and removal.

Mirena is inserted by a qualified clinician into the uterine cavity using a specialized inserter. The procedure is performed in a clinical setting, typically after a pelvic examination, and may involve a brief local anesthetic. Once placed, the system remains effective for up to five years without daily user action.

Serious risks include uterine perforation during insertion, pelvic infection that can develop after placement, and the rare possibility of an ectopic pregnancy if contraception fails. Patients should be instructed to seek immediate medical attention for severe abdominal pain, fever, or abnormal bleeding.

Mirena is not recommended for women who are currently pregnant, have active pelvic infections, unexplained vaginal bleeding, known hypersensitivity to levonorgestrel, severe liver disease, or hormone‑sensitive cancers such as breast cancer. Women with certain uterine abnormalities should also be evaluated carefully before insertion.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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