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 prevents 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.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Levonorgestrel, a progestin hormonal contraceptive, is used to prevent pregnancy.

  • Contraception: provides up to three years of reliable pregnancy prevention when placed correctly in the uterus.

How It Works

  • Levosert One releases levonorgestrel locally from the intrauterine system at approximately 20 µg per day. The hormone thickens cervical mucus, reduces sperm motility and viability, and suppresses endometrial proliferation, creating an environment that prevents fertilisation and implantation.

Side Effects

Levosert One may cause a range of adverse reactions, most of which are mild and related to the device or hormone release.

Common Side Effects

  • Irregular vaginal bleeding or spotting: changes in bleeding pattern are frequent during the first months.
  • Amenorrhea: absence of periods may occur after continued use.
  • Pelvic or abdominal pain: discomfort around the insertion site is common.
  • Device expulsion: the IUS may be partially or fully expelled.
  • Insertion site irritation: local soreness or swelling after placement.
  • Hormonal effects: acne, breast tenderness, or mood changes.

Serious or Rare Side Effects

  • Uterine perforation: a rare event during insertion that can cause abdominal injury.
  • Pelvic infection: severe infection requiring medical treatment.
  • Ectopic pregnancy: occurs if pregnancy happens despite the device.
  • Severe allergic reaction: anaphylaxis or hypersensitivity to levonorgestrel or device materials.
  • Device migration: movement of the IUS from its intended position.
  • Heavy bleeding: unexpected profuse bleeding that may need intervention.

Precautions & Warnings

Before using Levosert One, clinicians should assess patient history and ensure appropriate conditions are met.

  • Pregnancy contraindication: do not insert in a known or suspected pregnancy.
  • Uterine abnormalities: avoid placement in women with fibroids, congenital anomalies, or significant scarring.
  • Active pelvic infection: postpone insertion until infection resolves.
  • Unexplained vaginal bleeding: investigate before device placement.
  • Follow‑up checks: schedule routine examinations to confirm correct IUS position.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levosert One may interact with medications that affect levonorgestrel metabolism or hormone balance.

Major Interactions (Avoid)

  • Rifampin, carbamazepine, phenytoin, or St. John's wort: strong enzyme inducers that can markedly reduce levonorgestrel levels.
  • Antifungal agents such as ketoconazole: may increase systemic exposure.

Moderate Interactions (Monitor Closely)

  • Antiretroviral drugs (e.g., efavirenz): may modestly lower hormone concentrations.
  • Certain antibiotics (e.g., griseofulvin): limited effect but monitoring is advised.
  • Hormonal therapies (e.g., estrogen‑containing products): may alter bleeding patterns and require clinical observation.

Frequently Asked Questions

Levosert One is an intrauterine system that releases levonorgestrel to provide long‑acting hormonal contraception. It is designed to prevent pregnancy for up to three years when correctly placed in the uterus of women of reproductive age.

Levonorgestrel released from the device thickens cervical mucus, impairs sperm motility and function, and suppresses the growth of the endometrium. These actions together create conditions that prevent fertilisation and implantation of a fertilised egg.

The dose of levonorgestrel released by Levosert One is fixed by the device design, delivering about 20 µg per day for up to three years. The prescribing clinician determines suitability and placement; no patient‑adjustable dosing is involved.

Levosert One is contraindicated in pregnancy (Category X) and must not be inserted in a pregnant woman. Women who become pregnant while using the device should seek medical advice. Limited data exist on breastfeeding; clinicians usually advise caution and evaluate risks versus benefits.

To order Levosert One, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details and import documentation.

Compared with oral progestin pills, Levosert One offers continuous, low‑maintenance contraception without daily dosing. Unlike copper IUDs, it uses a hormonal mechanism, often resulting in reduced menstrual bleeding. Its efficacy and duration (up to three years) are comparable to other long‑acting reversible contraceptives.

Levosert One should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures to maintain the integrity of the intrauterine system until insertion.

Levosert One is inserted by a qualified healthcare professional into the uterine cavity through the cervical canal. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place for up to three years, after which removal or replacement is required.

Serious risks include uterine perforation during insertion, pelvic infection, ectopic pregnancy if conception occurs, and device expulsion or migration. Patients should be advised to seek immediate medical attention for severe abdominal pain, heavy bleeding, or signs of infection.

Levosert One is not suitable for women who are pregnant, have active pelvic infections, unexplained vaginal bleeding, uterine anomalies (e.g., large fibroids, congenital malformations), or known hypersensitivity to levonorgestrel or any component of the device.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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