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‑term hormonal contraception by preventing fertilisation and implantation in women of reproductive age, and is indicated for those seeking a reversible, highly effective contraceptive method.

GNH India supplies Levosert One as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and reliable logistics for timely delivery across global markets.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel delivered via Levosert One acts on the reproductive system to provide hormonal contraception.

  • Contraception: Provides long‑term prevention of pregnancy by thickening cervical mucus, inhibiting endometrial growth and suppressing ovulation.
  • Treatment of heavy menstrual bleeding: Reduces menstrual blood loss and improves bleeding patterns in women with dysfunctional uterine bleeding.
  • Management of dysmenorrhea: Alleviates painful menstrual cramps through local progestogenic effects on the endometrium.

How It Works

  • Levonorgestrel released from the intrauterine system binds to progesterone receptors in the cervical epithelium and endometrium. This action thickens cervical mucus, creates a hostile environment for sperm, suppresses endometrial proliferation, and may inhibit ovulation, collectively preventing fertilisation and implantation. The device provides a steady low‑dose release of about 20 µg per day over up to five years, maintaining local hormone concentrations sufficient for contraceptive effect while minimising systemic exposure.

Side Effects

Levosert One may be associated with a range of adverse reactions, which are generally classified by frequency and severity.

Common Side Effects

  • Irregular vaginal bleeding or spotting
  • Amenorrhea (absence of periods)
  • Pelvic cramping
  • Breast tenderness

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Device expulsion or displacement
  • Pelvic inflammatory disease or infection
  • Ectopic pregnancy if contraception fails

Precautions & Warnings

Prior to insertion of Levosert One, clinicians should observe several precautionary measures to ensure safety and effectiveness.

  • Confirm non‑pregnancy: Verify the patient is not pregnant before device placement.
  • Assess uterine anatomy: Evaluate for fibroids, septa, or other abnormalities that may impede insertion.
  • Screen for active infection: Defer insertion in the presence of pelvic inflammatory disease or genital infection.
  • Counsel on bleeding changes: Inform patients that irregular bleeding is common during the first months.
  • Review medication history: Identify drugs that may reduce contraceptive efficacy.
  • Store at room temperature: Keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from an intrauterine system can interact with other medicines, affecting its contraceptive reliability.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital): may markedly reduce levonorgestrel levels.
  • Rifampin or rifabutin: potent inducers that can compromise contraceptive effectiveness.
  • Protease inhibitor antiretrovirals (e.g., ritonavir): may alter hormone metabolism and reduce efficacy.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., ketoconazole, itraconazole): may increase levonorgestrel concentrations.
  • Herbal St John’s wort: may modestly decrease hormone levels.
  • Estrogen‑containing hormone therapy: may affect bleeding patterns and require monitoring.
  • Certain antibiotics (e.g., griseofulvin): may have a modest impact on hormone levels.

Frequently Asked Questions

Levosert One is a levonorgestrel‑containing intrauterine system indicated for the prevention of pregnancy. It provides a reversible, long‑acting hormonal contraceptive method for women of reproductive age who desire effective birth control without daily dosing.

Levonorgestrel released from the device binds to progesterone receptors in the cervix and endometrium, thickening cervical mucus, suppressing endometrial growth, and often inhibiting ovulation. These combined actions create an environment that prevents sperm penetration, fertilisation, and implantation.

Levosert One is supplied as a single intrauterine system containing 52 mg of levonorgestrel, designed to release a low, steady dose over up to five years. The prescriber determines suitability and timing of insertion; no patient‑controlled dosing is required.

Levosert One is contraindicated in pregnancy and should not be inserted in a pregnant woman. Women who become pregnant while the device is in place should have it removed promptly. Limited data suggest minimal levonorgestrel transfer into breast milk, but breastfeeding women should discuss risks with their healthcare provider.

To order, 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 (including any cold‑chain requirements) and necessary import documentation.

Levosert One and other levonorgestrel IUS products such as Mirena share the same active ingredient and mechanism, offering comparable contraceptive efficacy and duration. Differences may lie in approved labeling, specific release rates, or regulatory approvals in particular regions, but overall clinical performance is similar.

The device should be stored at room temperature, below 25 °C, in its original sealed packaging. Protect it from moisture, direct sunlight, and physical damage. No refrigeration is required for this intrauterine system.

Levosert One is inserted by a trained healthcare professional during a brief outpatient procedure. After a speculum exam, the device is placed through the cervical canal into the uterine cavity using a calibrated inserter. The procedure typically takes a few minutes and may be performed with or without local anaesthesia.

Serious risks include uterine perforation during insertion, device expulsion or displacement, pelvic inflammatory disease or infection, and the rare possibility of ectopic pregnancy if contraceptive failure occurs. Prompt medical evaluation is essential if severe abdominal pain, abnormal bleeding, or signs of infection develop.

Levosert One is contraindicated in women who are pregnant, have active pelvic infection, unexplained vaginal bleeding, known or suspected uterine anomalies that impede insertion, or a history of breast cancer. It should also be avoided in individuals with hypersensitivity to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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