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 an intrauterine system for intrauterine use. The device continuously releases levonorgestrel directly into the uterine cavity, delivering effective, long‑acting reversible contraception and preventing pregnancy in women of reproductive age.

GNH India supplies Levosert One as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance for global distribution. The company adheres to stringent Good Distribution Practice standards and provides comprehensive documentation to meet the requirements of health authorities across the European Union and other markets.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel, a progestin hormone, is used as a long‑acting reversible contraceptive delivered via an intrauterine system.

  • Contraception: provides continuous, hormone‑based birth control for up to five years, reducing the need for daily pills.
  • Pregnancy prevention: maintains effective prevention of pregnancy throughout the device’s lifespan when correctly placed.
  • Management of heavy menstrual bleeding: can reduce menstrual blood loss and improve cycle regularity in women with dysfunctional uterine bleeding.

How It Works

  • Levosert One releases levonorgestrel locally within the uterine cavity, where the hormone binds to progesterone receptors in cervical mucus, endometrium and tubal epithelium. This action thickens cervical mucus, impairs sperm motility and viability, suppresses endometrial proliferation, and may inhibit ovulation, collectively preventing fertilization and implantation. The continuous low‑dose release ensures sustained pharmacologic effect over several years.

Side Effects

Levosert One may be associated with a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Irregular vaginal bleeding or spotting
  • Prolonged periods or amenorrhea
  • Breast tenderness
  • Abdominal discomfort

Serious or Rare Side Effects

  • Uterine perforation during insertion
  • Pelvic inflammatory infection
  • Ectopic pregnancy

Precautions & Warnings

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

  • Confirm non‑pregnant status: verify absence of pregnancy before device placement.
  • Screen for active pelvic infection: defer insertion until infection resolved.
  • Evaluate uterine anatomy: ensure cavity size and shape are suitable for IUS placement.
  • Counsel on bleeding changes: inform patient about possible irregular bleeding patterns.
  • Store at room temperature: keep the device in its original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert One’s hormonal release can be affected by certain concomitant medicines, requiring attention to potential interactions.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may markedly reduce levonorgestrel efficacy.
  • Rifampin or other strong CYP3A4 inducers: can lower hormone levels and increase risk of contraceptive failure.

Moderate Interactions (Monitor Closely)

  • Certain antibiotics (e.g., tetracycline, metronidazole): may slightly diminish contraceptive effect.
  • Antiretroviral agents (e.g., efavirenz): may reduce levonorgestrel concentrations.
  • Herbal supplements such as St. John’s wort: potential to increase hormone metabolism.

Frequently Asked Questions

Levosert One is a levonorgestrel‑releasing intrauterine system indicated for long‑acting reversible contraception. It provides continuous hormone‑based birth control for women of reproductive age, preventing pregnancy for up to several years after a single insertion by a qualified clinician.

Levonorgestrel released from the intrauterine system acts locally on the cervix, endometrium and tubal epithelium. It thickens cervical mucus, reduces sperm motility, suppresses endometrial growth, and may inhibit ovulation, thereby preventing fertilisation and implantation of a fertilised egg.

The dose is predetermined by the device’s design; each Levosert One unit contains a specific amount of levonorgestrel that is released at a low, steady rate for up to five years. The prescribing clinician selects the appropriate device based on the patient’s clinical needs.

Levosert One is not intended for use during an existing pregnancy and must be inserted only after confirming the patient is not pregnant. Women who become pregnant after insertion should consult their healthcare provider. Breastfeeding is generally considered compatible, but the prescriber should evaluate individual risk‑benefit factors.

To order Levosert One, 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 any necessary import documentation.

Levosert One, like other levonorgestrel IUS devices, offers hormone‑based contraception with reduced menstrual bleeding, whereas copper IUDs provide non‑hormonal contraception but may increase bleeding. Compared with similar levonorgestrel systems, Levosert One delivers comparable efficacy and duration, with a comparable safety profile.

Levosert One should be stored at room temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures until it is ready for insertion by a qualified healthcare professional.

Levosert One is inserted into the uterine cavity by a trained clinician during an outpatient procedure. The device is placed through the cervical canal using a specialised inserter, after confirming the patient is not pregnant and that the uterine cavity is suitable for placement.

Serious but uncommon risks include uterine perforation during insertion, pelvic inflammatory infection, and ectopic pregnancy if contraceptive failure occurs. Patients should be advised to seek immediate medical attention for severe abdominal pain, fever, abnormal bleeding or signs of infection.

Levosert One is contraindicated in women with a current pregnancy, active pelvic infection, known or suspected uterine anomalies that could impede placement, a history of breast cancer, or unexplained vaginal bleeding. It should also be avoided in patients with severe liver disease or those taking medications that markedly reduce levonorgestrel effectiveness.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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