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 20 µg/day release intrauterine system for intrauterine use. It provides long‑acting reversible contraception for 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

Levosert One, a levonorgestrel‑based intrauterine system, is indicated for hormonal contraception.

  • Contraception: provides up to five years of reliable pregnancy prevention.
  • Heavy menstrual bleeding: may reduce menstrual blood loss and the need for additional therapy.
  • Dysmenorrhea: can lessen menstrual pain associated with prostaglandin‑mediated cramps.

How It Works

  • Levosert One releases levonorgestrel locally within the uterine cavity at approximately 20 µg per day. The progestin binds to progesterone receptors in the endometrium, cervical mucus, and tubal epithelium, producing a thickened cervical mucus barrier, inhibiting sperm motility and viability, suppressing endometrial proliferation, and occasionally preventing ovulation, thereby creating a multifactorial contraceptive effect.

Side Effects

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

Common Side Effects

  • Irregular vaginal bleeding or spotting.
  • Amenorrhea (absence of periods).
  • Cramping or pelvic discomfort after insertion.
  • Insertion‑related pain.
  • Hormonal changes such as breast tenderness.
  • Headache or mild nausea.

Serious or Rare Side Effects

  • Uterine perforation during insertion.
  • Expulsion or displacement of the device.
  • Pelvic inflammatory disease or severe infection.
  • Ectopic pregnancy if contraception fails.
  • Device migration to adjacent organs.
  • Severe allergic reaction to device components.

Precautions & Warnings

Prior to insertion, clinicians should assess patient suitability and counsel on potential risks.

  • Pregnancy screening: confirm the patient is not pregnant before placement.
  • Uterine anomalies: avoid use in women with known congenital uterine malformations.
  • Active infection: contraindicated in the presence of pelvic inflammatory disease or genital infections.
  • Malignancy: not recommended for patients with estrogen‑dependent cancers.
  • Follow‑up: schedule a post‑insertion check to verify correct positioning.
  • Storage: Store at below 25 °C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Levonorgestrel released from an intrauterine system can be affected by certain concomitant medicines.

Major Interactions (Avoid)

  • Rifampicin, carbamazepine, phenytoin, or St. John’s wort: potent enzyme inducers that may lower levonorgestrel levels.
  • Antiretroviral efavirenz: may reduce contraceptive efficacy.
  • High‑dose enzyme‑inducing anticonvulsants: can compromise hormonal protection.

Moderate Interactions (Monitor Closely)

  • Ketoconazole or other azole antifungals: may increase levonorgestrel exposure.
  • Phenobarbital: moderate enzyme induction requiring monitoring.
  • Certain herbal supplements (e.g., ginseng): may alter hormone metabolism.

Frequently Asked Questions

Levosert One is an intrauterine system that delivers levonorgestrel locally to provide long‑acting reversible contraception. It is designed to prevent pregnancy for up to five years and may also help reduce heavy menstrual bleeding and menstrual pain.

Levonorgestrel released from the device acts on the cervical mucus, endometrium, and sperm. It thickens cervical mucus to block sperm entry, suppresses endometrial growth, reduces sperm motility, and may inhibit ovulation, creating multiple barriers to fertilisation.

The dose of levonorgestrel released by Levosert One is fixed at approximately 20 µg per day for the duration of use. The prescribing clinician determines suitability and duration based on the patient’s medical profile.

Levosert One is contraindicated in women who are pregnant. If pregnancy occurs, the device should be removed promptly. Limited data exist for breastfeeding; clinicians usually advise removal before initiating lactation, but individual assessment is required.

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 and any necessary import documentation.

Compared with oral progestins or combined pills, Levosert One offers continuous low‑dose levonorgestrel release without daily adherence, providing up to five years of protection. Unlike implants, it is placed in the uterus, which may result in fewer systemic side effects but requires a clinical insertion procedure.

Levosert One should be stored at temperatures below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. The device remains stable for its shelf‑life when these conditions are maintained.

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, and the device remains in place for up to five years unless removal is indicated.

Serious risks include uterine perforation during insertion, device expulsion or migration, pelvic inflammatory disease, 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.

Women with current pregnancy, active pelvic infection, untreated cervical or uterine cancer, unexplained vaginal bleeding, or known uterine anomalies should avoid Levosert One. Additionally, those with a history of severe allergic reaction to levonorgestrel or device components should not use it.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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