Product image of Levosert One (Levonorgestrel) supplied by GNH India

Levosert One

Active Ingredient:
Levonorgestrel
Origin:
EU

Levosert One (Levonorgestrel)

Levonorgestrel, the active ingredient in Levosert One, is a progestin presented as a 52 mg intrauterine system for intrauterine use. It provides long‑acting reversible contraception and can be used to treat heavy menstrual bleeding in women of reproductive age.

GNH India supplies Levosert One as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel delivered via Levosert One is used within the hormonal contraceptive pathway to prevent pregnancy and manage menstrual disorders.

  • Contraception (long‑acting reversible contraceptive): provides up to three years of reliable pregnancy prevention.
  • Heavy menstrual bleeding: reduces menstrual blood loss and improves anemia associated with excessive bleeding.
  • Endometrial protection in estrogen therapy: helps prevent estrogen‑induced endometrial proliferation when combined with systemic estrogen.

How It Works

  • Levonorgestrel is released locally from the intrauterine system at approximately 20 µg per day. The hormone binds to progesterone receptors in the endometrium, suppressing its proliferation, thickening cervical mucus to impede sperm penetration, and altering tubal motility, thereby preventing fertilisation and implantation.

Side Effects

Levosert One may be associated with a range of adverse reactions.

Common Side Effects

  • Irregular bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic or abdominal cramping
  • Device expulsion or displacement
  • Vaginal discharge
  • Headache or mild nausea

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Pelvic inflammatory infection
  • Ectopic pregnancy if contraception fails
  • Severe allergic reaction (anaphylaxis)
  • Hormonal side effects such as severe depression or mood changes

Precautions & Warnings

Before insertion and during use, certain precautions should be observed.

  • Pregnancy testing: confirm a negative pregnancy test prior to insertion.
  • Uterine abnormalities: evaluate for fibroids, septa, or other malformations.
  • Active infection: screen for pelvic inflammatory disease and treat before placement.
  • Breastfeeding: discuss benefits and risks with the patient.
  • Follow‑up removal: schedule device removal or replacement at the end of the intended duration.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from an intrauterine system has limited systemic interactions, but certain drugs may affect its efficacy.

Major Interactions (Avoid)

  • Rifampicin and other strong CYP3A4 inducers: may markedly reduce contraceptive effectiveness.
  • Antiretroviral protease inhibitors (e.g., ritonavir): can alter hormone levels and compromise efficacy.
  • Ketoconazole and other potent antifungal agents: may decrease levonorgestrel activity.

Moderate Interactions (Monitor Closely)

  • Certain antibiotics (e.g., tetracycline): minimal effect but monitor for breakthrough bleeding.
  • St. John’s wort (hypericum perforatum): may modestly reduce hormone levels.
  • Combined estrogen‑containing therapies: may increase risk of thromboembolic events; monitor patient closely.

Frequently Asked Questions

Levosert One is an intrauterine system that releases levonorgestrel to provide long‑acting reversible contraception and to reduce heavy menstrual bleeding in women of reproductive age.

Levonorgestrel is released locally from the device, binding to progesterone receptors in the endometrium to suppress its growth, thickening cervical mucus, and impairing sperm function, which together prevent fertilisation and implantation.

The dose is set by the prescriber based on the approved 52 mg levonorgestrel intrauterine system, which releases approximately 20 µg of hormone per day for up to three years.

Levosert One is contraindicated in pregnancy (Category X) and should only be used in women who are not pregnant. Breastfeeding women should discuss potential risks and benefits with their healthcare provider.

Submit an enquiry on the product page at gnhindia.com, specifying 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 import documentation.

Levosert One delivers a comparable daily levonorgestrel release (≈20 µg) to other leading IUDs, offering up to three years of contraception and menstrual bleeding reduction, with a similar safety profile and insertion technique.

Store the intrauterine system at ambient temperature, below 25 °C, in its original sealed packaging. Protect it from moisture, direct sunlight and physical damage until the time of insertion.

Levosert One is inserted by a trained healthcare professional 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 infection, ectopic pregnancy if contraception fails, and rare severe allergic reactions. Patients should seek immediate medical attention if they experience severe abdominal pain, fever, or unusual bleeding.

Women who are currently pregnant, have known or suspected uterine anomalies, active pelvic infection, untreated cervical cancer, or a history of severe allergic reaction to levonorgestrel should not use Levosert One.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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